xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06022809</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001336</org_study_id>
      <secondary_id>125110</secondary_id>
      <nct_id>NCT06022809</nct_id>
    </id_info>
    <brief_title>Comparative Effectiveness of Individual Versus Group-Level Interventions to Reduce Human Immunodeficiency Virus (HIV)/ Sexually Transmitted Infections (STI) Incidence</brief_title>
    <official_title>Comparative Effectiveness of Individual Versus Group-level Interventions to Reduce HIV Risk Among African Immigrant Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>RAND</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Fenway Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Patient-Centered Outcomes Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Boston University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Muslim Women's Institute for Research and Development</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Whittier Street Health Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Harvard Street Neighborhood Health Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Harvard Medical School (HMS and HSDM)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The HIV diagnosis rate among African-born Black women is the highest of all Black individuals&#xD;
        living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis&#xD;
        (PrEP) are two effective means of decreasing HIV risk among women, but they remain suboptimal&#xD;
        among Black women.&#xD;
  &#xD;
        The specific aims of this study are:&#xD;
  &#xD;
          1. To culturally adapt two widely utilized, evidence-based HIV prevention interventions&#xD;
             originally designed for US born Black women (Sister-to-Sister (S2S) and Sisters&#xD;
             Informing Sisters about Topics on AIDS (SISTA)) for use by African-born women&#xD;
  &#xD;
          2. To conduct a randomized controlled comparative effectiveness trial (RCT) to determine&#xD;
             the effectiveness of adapted versions of S2S versus SISTA on increasing condom use and&#xD;
             PrEP uptake among African-born women.&#xD;
  &#xD;
        The adapted versions of these interventions will be given new names that resonate with the&#xD;
        African culture. The adapted version of S2S intervention will be called &quot;Dada Kwa Dada (DKD)&quot;&#xD;
        intervention while the adapted version of SISTA intervention will be called &quot;DADA&quot;&#xD;
        intervention. &quot;DADA&quot; means &quot;Sister&quot; in Swahili and other languages in Eastern and Western&#xD;
        Africa.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background and Significance&#xD;
  &#xD;
        African immigrants comprise a growing share of the US Black population, particularly in the&#xD;
        Northeast. The population of African-born individuals in the US has doubled every decade&#xD;
        since 1970; in 2015, there were 2.1 million African-born individuals in the US, more than 50%&#xD;
        are female. Most are from Eastern (Ethiopia, Kenya and Somalia) and Western sub-Saharan&#xD;
        Africa (Nigeria, Ghana and Liberia). Approximately one-third of the Black population within&#xD;
        US cities are non-US born. One-third of new HIV diagnoses among African-born individuals&#xD;
        occur in the Northeast, as opposed to the South where the majority of newly diagnosed US born&#xD;
        Black individuals reside.&#xD;
  &#xD;
        Among Black individuals in the US, African-born women have the highest rate of new HIV&#xD;
        diagnoses due to heterosexual transmission. In 2014, the HIV diagnosis rate among&#xD;
        African-born Black women was 400% higher than US born Black women. The rate of new HIV&#xD;
        diagnoses among all Black women has decreased significantly, however the disparity between&#xD;
        African-born and US born Black women increased. More than half of African-born Black&#xD;
        individuals newly diagnosed with HIV are women (60.7%) compared to US born (27.0% women).&#xD;
  &#xD;
        A significant proportion of HIV transmission cases among African-born women occurs&#xD;
        post-immigration, here in the US. In a qualitative analysis conducted by our team in MA and&#xD;
        NYC, 62% of HIV-infected African-born women believed that they contracted HIV in the US.&#xD;
        Utilizing data on length of time in US, HIV testing, and life history, Wiewel et al concluded&#xD;
        that 34% of HIV-infected African-born individuals were most likely infected in the US.&#xD;
  &#xD;
        HIV risk among African-born Black women is due to complex cultural, psychosocial, and&#xD;
        structural issues. PrEP is an effective HIV prevention strategy in women, and education about&#xD;
        PrEP will be added to both interventions. Though African-born Black women are at-risk, there&#xD;
        are no evidence-based interventions to address PrEP use, and little is known about its use&#xD;
        among African-born women.&#xD;
  &#xD;
        The key evidence gap is the lack of culturally adapted evidence-based interventions to&#xD;
        address the HIV/STI prevention needs of at-risk African-born Black women. Current&#xD;
        evidence-based interventions do not address cultural norms regarding sexual partnerships,&#xD;
        HIV-related stigma, immigration challenges, PrEP education or culturally determined sexual&#xD;
        practices such as &quot;dry sex&quot; which increases HIV risk. Formative data collected through&#xD;
        Tulumbe! have revealed that culturally adapted interventions are needed to reduce HIV risk&#xD;
        and will fill this critical gap.&#xD;
  &#xD;
        Significance&#xD;
  &#xD;
        This study is designed to address a critical gap and to inform an important decisional&#xD;
        dilemma by adapting two HIV/STI prevention interventions and compare their effectiveness&#xD;
        among African-born Black women.&#xD;
  &#xD;
        S2S (a brief, health profession-led, individual-level intervention proven to increase condom&#xD;
        use and decrease STIs) is the only Centers for Disease Control and Prevention (CDC) High&#xD;
        Impact HIV Prevention Intervention (HIP) culturally tailored for heterosexually active US&#xD;
        born Black women.&#xD;
  &#xD;
        SISTA (a peer-led, group-level intervention also proven to increase condom use and decrease&#xD;
        STIs) is also culturally tailored for heterosexually active US born Black women and utilizes&#xD;
        the Theory of Gender and Power to overcome gender inequality, which may address many of the&#xD;
        drivers of HIV risk among African-born Black women.&#xD;
  &#xD;
        Specific Aims and Objectives&#xD;
  &#xD;
        Our research question is:&#xD;
  &#xD;
        What effect does participation in a culturally-adapted group-level versus an individual-level&#xD;
        intervention have on the use of HIV prevention strategies among at risk African-born women&#xD;
        living in the US?&#xD;
  &#xD;
        The investigators hypothesize that culturally adapted SISTA will be more effective than&#xD;
        culturally adapted S2S in addressing the complex drivers of risk among African-born Black&#xD;
        women because it addresses gender inequality (a primary driver of HIV infection), is peer-led&#xD;
        (promoting patient and stakeholder ownership), and is group-level (fosters a sense of support&#xD;
        and community).&#xD;
  &#xD;
        Subject Selection&#xD;
  &#xD;
        This study will be conducted in MA [Brigham and Women's Hospital (BWH) Clinic and Whittier&#xD;
        Street Health Center (WSHC)] and in NYC [Muslim Women's Institute for Research and&#xD;
        Development (MWIRD)]. All sites have established procedures for referrals to HIV clinical&#xD;
        services including PrEP. In MA, Whittier Street Health Center and Brigham and Women's&#xD;
        Hospital Gynecology Clinic offer HIV and PrEP services; in NYC, MWIRD has an established&#xD;
        relationship with Morris Heights Health Center and African Committee Services, as primary HIV&#xD;
        and PrEP referral centers which offer HIV treatment and PrEP).&#xD;
  &#xD;
        Recruitment Strategy&#xD;
  &#xD;
        Participants will be recruited via listservs of organizations affiliated with BWH clinic,&#xD;
        Whittier Street Health Center (WSHC), Muslim Women's Institute for Research and Development&#xD;
        (MWIRD), via posters, flyers, walk-ins, online social media groups and residents in cities&#xD;
        throughout MA and NYC. In addition, the study will use a referral method where participants&#xD;
        share with their friends the recruitment flyer, which includes contact information for the&#xD;
        study coordinator.&#xD;
  &#xD;
        Randomization Process and Treatment Assignment&#xD;
  &#xD;
        At each site, a blocked 1:1 randomization design with stratification by site and African&#xD;
        region of origin based upon the most common regions of origin of African-born immigrants in&#xD;
        the US (West vs. East) and language (English vs. French) alternating blocks of 2 and 4 to&#xD;
        prevent anticipation of condition will help to ensure balance across arms. The&#xD;
        biostatistician will use a random number generator to devise a randomization log and a set of&#xD;
        numbered randomization. This will be done using REDCap. As participants complete baseline&#xD;
        assessments, sealed opaque envelopes will be used to reveal the assignments. Once randomized,&#xD;
        DADA participants will wait to be scheduled into a session until when at least 4 additional&#xD;
        participants have been randomized to DADA. Participants will also need to wait for assignment&#xD;
        to appropriate groups based upon language requirements (French vs. English). The&#xD;
        investigators anticipate that both interventions will be delivered approximately two weeks&#xD;
        post-enrollment. The participants will be assigned to receive one of two culturally adapted&#xD;
        virtual interventions.&#xD;
  &#xD;
        DADA(Group-Level Intervention). Studies suggest that sexual risk beliefs among African-born&#xD;
        individuals are highly community-oriented and peer influenced. Therefore, virtual group&#xD;
        census will be kept between 5-8 women to enhance opportunities for pro-social, peer feedback&#xD;
        regarding sexual health behavior. Once randomized, participants will wait to be scheduled&#xD;
        until at least 4 additional participants within their site have been randomized to the DADA.&#xD;
        Participants will also need to wait for assignment to appropriate groups based upon language&#xD;
        requirements (French vs English). The investigators anticipate that both interventions will&#xD;
        be delivered approximately two weeks post enrollment. The partially nested design of this&#xD;
        study (participants are nested within groups in one arm of the study) is addressed in&#xD;
        Analytic Plan.&#xD;
  &#xD;
        Study Procedures&#xD;
  &#xD;
        The same study protocol will be used within each site. Research assitants will communicate&#xD;
        with potential participants via email or telephone. If eligible, they will be consented via&#xD;
        telephone and physically when they visit site for testing. They will then be randomized&#xD;
        (using REDCap) to either condition and asked to complete an online survey via REDCap.&#xD;
        Participants will present to WSHC or MWIRD in person for HIV testing via 4th generation assay&#xD;
        and gonorrhea and Chlamydia testing via urine nucleic acid amplification assay within one&#xD;
        week of enrollment. Patient will be consented in person during site visit. BWH clinic, WSHC&#xD;
        and MWIRD have safety protocols in place to perform onsite laboratory testing. The&#xD;
        investigators anticipate that virtual intervention delivery (for both interventions) will&#xD;
        occur approximately two weeks following enrollment which will allow for participant accrual&#xD;
        for SISTA/DADA (group-level intervention) and HIV testing results to return. Participants&#xD;
        will receive stipends to cover their cell phone/data plan costs throughout the duration of&#xD;
        the study to ensure access during follow-up.&#xD;
  &#xD;
        Research assistants will recruit 424 individuals (212 per condition) from community-based&#xD;
        sites throughout MA and NY. HIV testing will be offered at baseline. Women who are found to&#xD;
        be HIV positive will be navigated to care and treatment services and will be excluded from&#xD;
        participation. Women who test positive for Chlamydia and/or Gonorrhea will be referred to&#xD;
        counseling and treatment and still be included in the study. Follow-up for the primary&#xD;
        patient centered outcomes (condom use and PrEP uptake) will occur at 3 and 6 months following&#xD;
        baseline assessment. At baseline and 6 months participants will be offered urine testing for&#xD;
        Chlamydia and gonorrhea and HIV testing (4th generation). Interventions will be delivered at&#xD;
        community-based clinic sites (BWH, WSHC (in MA), and, MWIRD (in NY)) Additional outcomes as&#xD;
        listed below will also be collected at baseline, 3 and 6 months.&#xD;
  &#xD;
        Sample Size and Power&#xD;
  &#xD;
        Sample size calculations for the patient-centered primary outcomes (condom use and PrEP&#xD;
        uptake) are based on previous research. For condom use, in a subset analysis (N=283) of data&#xD;
        including African-born women, 22% of women reported condom use during most episodes&#xD;
        intercourse in past 3 months. Similar data were reported by the National Survey on Family&#xD;
        Growth. These data support using 22% condom use as a baseline estimate. For this study the&#xD;
        condom use outcome will be defined as the proportion of protected sexual intercourse or the&#xD;
        number of days on which the participants had sexual intercourse using a condom divided by the&#xD;
        number of days on which they had sexual intercourse during the 180 days prior to assessment.&#xD;
        The investigators will focus on the 6-month assessment in a conservative estimation of&#xD;
        available power and minimally detectable effect size. Power for differential longitudinal&#xD;
        effects between the DKD (individual intervention) arm and the DADA (group intervention) arm&#xD;
        will be greater as a result of the accounting of within-subject correlation of responses in&#xD;
        the GEE models noted in the Analysis Plan. In a previous RCT, S2S resulted in 26% increased&#xD;
        condom use at 6 months (past 90 days). In previous RCTs, SISTA resulted in increased condom&#xD;
        use at 6 months (40% to 56% increase in the past 90 days). Assuming a 26% increased condom&#xD;
        use from baseline in the DKD arm at 6-months and 40% increased condom use (a modest estimate)&#xD;
        in the DADA arm at 6-months (equal to an odds ratio of 1.90), with 354 participants overall&#xD;
        and 177 per intervention (accounting for 17% drop-out), the sample size will have 80% power&#xD;
        to detect a statistically significant difference with an alpha of 0.05. For PrEP uptake, data&#xD;
        are limited regarding women in the US, therefore, effect size estimates are based on&#xD;
        individual-level intervention trials among Black men who have sex with men (MSM) which&#xD;
        resulted in a 25%-37% increase in PrEP uptake at 1 to 3 months. For African-born women who&#xD;
        are lower risk than Black MSM, the investigators anticipate a lower impact of interventions&#xD;
        on PrEP uptake. A sample size of 177 in each arm would detect a difference of 10% increased&#xD;
        uptake in the DKD arm versus 21% increased uptake in the DADA arm with 80% power. When&#xD;
        applying ITT, there will be a very good power to detect differences of a moderate size or&#xD;
        greater in odds ratio for our two primary outcomes of condom use and PrEP uptake. Possible&#xD;
        location/site clustering may impact detectable differences in primary outcomes. With two&#xD;
        locations (MA and NYC) where condom use and PrEP initiation could vary substantially, there&#xD;
        is a possibility of the need to account for location as a clustering variable. Without&#xD;
        available data in the target population for this trial to measure the likely design effect&#xD;
        (i.e., the sample size inflation factor accounting for site clustering), the investigators&#xD;
        can nonetheless compute how a design effect of a notable size would impact the differences in&#xD;
        proportions that would be detectable with sufficient statistical power.&#xD;
  &#xD;
        The investigators can compute statistical power for the planned Aim2 study based on&#xD;
        simulation using 10,000 Monte Carlo samples and two-sided Fisher's exact tests for our STI&#xD;
        outcome and chi-square tests for our condom use outcome. The investigators will employ a type&#xD;
        1 error rate of 5% in these computations. The investigators propose using a 1:1 randomization&#xD;
        design with randomly permuted blocks of 2 and 4 with stratification by African region of&#xD;
        origin based upon the most common regions of origin of African immigrants in the US (West&#xD;
        versus East). The study will enroll a total of 424 women (212 per arm) which accounts for an&#xD;
        estimated 17% drop-out rate yielding an analysis sample size of 354 and will give adequate&#xD;
        power to detect clinically meaningful differences in study outcomes between the two arms.&#xD;
        With clustering by site (3 sites) taken into consideration, an analysis sample size of 177 in&#xD;
        each arm will detect differences of 10.6% STI in the Dada Kwa Dada arm versus 2% in the DADA&#xD;
        arm as statistically significant assuming an intraclass correlation coefficient (ICC) of&#xD;
        0.005 design effect of 1.3. With n=177 in each arm for analysis, for condom use the&#xD;
        investigators can detect a difference between arms of 26% vs. 42.1% assuming an ICC of 0.005&#xD;
        and a design effect of 1.3. Thus, for both primary outcomes, our sample size of 212 per&#xD;
        group/424 total enrolled with 17% loss to follow-up, should provide adequate statistical&#xD;
        power to detect clinically meaningful differences in outcomes while accounting for site-level&#xD;
        clustering.&#xD;
  &#xD;
        Internal and External Validity: To ensure internal validity, the investigators will minimize&#xD;
        selection bias with a block randomization design (described above) and control for attrition&#xD;
        bias by analyzing the data according to the ITT approach. Multivariable analysis methods will&#xD;
        be used to adjust for the effects of confounders. Performance bias will be minimized by&#xD;
        taping the intervention and ongoing supervision. To minimize contamination, patients&#xD;
        receiving the intervention will be asked not to share the information with other individuals.&#xD;
        To ensure external validity the investigators will recruit from diverse African populations&#xD;
        throughout MA and NYC, base the intervention in real-world settings, and institute practices&#xD;
        to minimize drop-out. Our eligibility criteria is inclusive of diverse women, some of whom&#xD;
        will be moderate versus high HIV/STI risk. The study is involving stakeholders who will be&#xD;
        engaged in future scale-up and documenting resource needs. The study will also solicit input&#xD;
        from patients and stakeholders. Measures of validity will be documented in all reports.&#xD;
  &#xD;
        Heterogeneity of Treatment Effects (HTE). Determining whether or not the effect of the&#xD;
        interventions varies across participant subgroups is important for future implementation. The&#xD;
        investigators will estimate the effects of each condition in clinically relevant subgroups&#xD;
        (e.g. regional West versus East African, time since immigration (≥10 years vs &lt;10 years). The&#xD;
        investigators will not look at HTE based upon immigration status because the sensitivity of&#xD;
        that information will make missing data highly likely. Without information on a specific&#xD;
        likely magnitude or direction of potential HTE, the investigators cannot examine statistical&#xD;
        power for a definitive scenario. However, the investigators compute the minimal difference in&#xD;
        between-strata odds ratio for our primary outcome, condom use, that would be statistically&#xD;
        significant with 80% power at an alpha of 0.05 assuming two strata of equal size given an&#xD;
        overall sample size of 424. These stratum-specific odds ratios average to 1.91, the odds&#xD;
        ratio detectable with 80% power in our overall analysis. With n=212 per stratum, the minimal&#xD;
        difference in odds ratios required for statistically significant HTE with 80% power would be&#xD;
        for odds ratios of 4.03 and 1.06, constituting very sizable heterogeneity. The investigators&#xD;
        thus expect our statistical testing of interaction as noted above, will be underpowered with&#xD;
        respect to HTE and will consider any clinically meaningful, but statistically non-significant&#xD;
        stratum specific observed differences, to be of hypothesis generating relevance that could be&#xD;
        examined in larger study in the future.&#xD;
  &#xD;
        Analytic Plan&#xD;
  &#xD;
        The investigators will use an intention-to-treat (ITT) protocol in which participants will be&#xD;
        analyzed in their original assigned treatment conditions irrespective of the number of&#xD;
        follow-up sessions attended. The investigators will specifically examine the balance in&#xD;
        salient variables at baseline between intervention arms using descriptive statistics only and&#xD;
        not with hypothesis testing as per the 2010 CONSORT guidelines. From these analyses, the&#xD;
        investigators will identify variables as potential confounding variables to be included in&#xD;
        subsequent multivariable analyses of our trial endpoints. Next, in initial unadjusted&#xD;
        analyses to determine the differences between study conditions, the investigators will use&#xD;
        t-tests for continuous variables and cross-tabulations with chi-square testing for&#xD;
        categorical outcome variables separately at each of the time points, 3 and 6-months. As our&#xD;
        primary statistical analyses, however, the investigators will employ models for repeated&#xD;
        measures of our outcomes of interest to obtain adjusted mean differences or odds ratios over&#xD;
        the 6-month period via linear and logistic generalized estimating equation (GEE) regression&#xD;
        models. The fitted GEE parameters will be interpreted as adjusted odds ratios in logistic&#xD;
        models and adjusted mean differences in linear models. Each model will include, if necessary,&#xD;
        sociodemographic variables as covariates as well as terms representing an interaction between&#xD;
        treatment and time period. These models will also include study site as a covariate so that&#xD;
        site-level heterogeneity of intervention effects over time can be formally estimated and&#xD;
        tested. In addition to study site, based on a priori theoretical and clinical consideration&#xD;
        the investigators will extend the main effects only models to examine potential effect&#xD;
        modification by participant age. In addition to our ITT-based analyses, the investigators&#xD;
        will analyze the data in an &quot;as treated&quot; manner by dividing the DADA arm into subgroups by&#xD;
        level of dose/compliance. The DADA group-level intervention will be designed as a two, 3hr,&#xD;
        two days sessions and adherence to the entire session may vary. Therefore, the investigators&#xD;
        will generate adherence-adjusted estimates of the effectiveness of DADA versus DKD.&#xD;
        Heteroscedastic partially nested mixed-effects models, which model the clustering in only one&#xD;
        arm will be used given the comparison of the group-level (DADA intervention) with the&#xD;
        individual-level (DKD Intervention). Our statistical testing in all analyses will employ a&#xD;
        2-sided type I error rate of 5% and 95% confidence intervals will be generated.&#xD;
  &#xD;
        Monitoring and Quality Assurance&#xD;
  &#xD;
        Process (Acceptability and Feasibility) Evaluation: To ensure that the interventions are&#xD;
        acceptable in routine care and can be feasibly incorporated into Community Based&#xD;
        Organizations (CBO) operations, using IRBs # 2020P001558 and # 2021P001486. The&#xD;
        investigators/research assistants have conducted virtual post-intervention interviews during&#xD;
        pilot with all participants and facilitators. Acceptability has been assessed using the&#xD;
        Information Systems Success Model (ISSM) and has been adapted in assessing facilitators and&#xD;
        participants' perception of the intervention using four domains (1) information quality, (2)&#xD;
        delivery quality, (3) perceived usefulness and (4) overall satisfaction with the intervention&#xD;
        using Likert scales. Mean scores will be reported for each domain. Intervention participants&#xD;
        will also be asked open-ended questions, such as &quot;What did you like most/least about the&#xD;
        intervention?&quot;. The investigators have also evaluated intervention feasibility with feedback&#xD;
        (post-intervention forms) from the facilitator on intervention session flow, content, and&#xD;
        whether key elements were covered adequately. The intervention facilitators took notes on&#xD;
        perceived effectiveness of the facilitation manual and videos. Feasibility has been assessed&#xD;
        to determine if the interventions are practical in specific situations and settings.&#xD;
        Qualitative data will be discussed and relevant changes will be made to the interventions.&#xD;
        The interventions will be considered feasible and acceptable if post-session feedback is&#xD;
        highly positive (high mean ISSM scores) and if any identified barriers to implementation can&#xD;
        be (and are) addressed. Data collected during the pilot test will result in the final adapted&#xD;
        interventions.&#xD;
  &#xD;
        Fidelity Assessment. A critical component of the RCT will be the assessment of intervention&#xD;
        fidelity. Adherence to the content of the intervention strategies will be determined by: (1)&#xD;
        Content: Was each of the intervention components implemented as planned?; (2) Coverage: What&#xD;
        proportion of the target group participated in the intervention?; (3) Frequency/Duration:&#xD;
        Were the intervention components implemented as often and for as long as planned?. A random&#xD;
        sample of 10 intervention delivery recordings will also be selected and reviewed to assess&#xD;
        fidelity. If an implemented intervention adheres completely to the content, frequency,&#xD;
        duration, and coverage prescribed by its designers, then fidelity can be said to be high.&#xD;
        Moderators of fidelity will also be determined, such as intervention complexity, facilitation&#xD;
        strategies, quality of delivery and patient responsiveness.&#xD;
  &#xD;
        Data Management: Ojikutu(PI) has ultimate responsibility for data management and safeguarding&#xD;
        and will provide trainings to the study team. All study data will be stored in a&#xD;
        password-protected database that is backed up through a secure offsite connection [REDCap&#xD;
        (Research Electronic Data Capture) is a secure, HIPAA compliant web-based application hosted&#xD;
        by Partners HealthCare Research Computing]. All study data will be identified by a unique&#xD;
        identification (ID) code and kept separately from study samples, results, informed consent&#xD;
        and locator information. A list connecting the name of the participant and participant ID&#xD;
        code will be maintained in a locked cabinet in locked offices at BWH, WSHC and MWIRD and with&#xD;
        the study PI (only accessible to the Site PIs and the study site coordinator). Self-reported&#xD;
        study data will be collected at community-based sites by unique ID code via REDCap and&#xD;
        transmitted via password-protected, encrypted flash drives. De-identified data will be&#xD;
        uploaded to REDCap. These data will not be shared with individuals who are not part of the&#xD;
        project team, and no data shared with the study team will contain participant names. The site&#xD;
        coordinators will have access to these files and will locate the participant at baseline and&#xD;
        12 months by name/birth date, link them to the unique ID code and enter results into REDCap.&#xD;
        All linking files and identifiable information will be destroyed within a year after study&#xD;
        completion. Frederica Williams (Co-I) and Nurah Amatulllah (Co-I) will re-check the entry of&#xD;
        these data to ensure accuracy. Though blinding is not possible, the study team will be&#xD;
        blinded to the data and results until the end of the trial to avoid bias.&#xD;
  &#xD;
        The investigators propose a single, independent, trained mental health provider (e.g.&#xD;
        licensed clinical social worker) who has no conflict of interest with the study team and who&#xD;
        has research experience serve as an independent monitor for the study. This study has&#xD;
        identified Dr. Christina Psaros who has exceeded these qualifications to serve in this&#xD;
        capacity as independent monitor. To allow effective monitoring, Dr. Psaros will be provided&#xD;
        with periodic reports every 3 months which include subject enrollment, subject retention, the&#xD;
        number of patients who drop out of the study with reasons for dropping out, and a listing of&#xD;
        all adverse events (AEs) that are plausibly related to study procedures. Dr. Psaros will make&#xD;
        a recommendation regarding the continuation, modification, or termination of the study. All&#xD;
        communications from the independent monitor will be shared with the study institutional&#xD;
        review board (IRB), as well as Patient-Centered Outcomes Research Institute (PCORI). Any&#xD;
        unexpected, serious adverse events that occur during the course of this investigation and&#xD;
        follow-up period will be reported by telephone by the PI, Ojikutu, within the next business&#xD;
        day to the study IRB and the independent study monitor. The telephone report will be followed&#xD;
        within 3 business days by a written report, which will contain: subject's ID#, the title and&#xD;
        date of serious adverse event, and narrative explanation (e.g., how the research staff was&#xD;
        notified of the event, dates of consent, study screening for inclusion/exclusion, whether the&#xD;
        participant participated in the intervention, dates and circumstances of the&#xD;
        hospitalization/death, whether alcohol or drugs were known to be involved, and participant&#xD;
        status at last research contact). In consultation with the IRB and independent monitor, the&#xD;
        PI will address whether there is a need to redesign or amend the protocol, and/or to inform&#xD;
        current and future subjects of a change in description of risk (e.g., in consent form and&#xD;
        protocol).&#xD;
  &#xD;
        Preventing and Handling Missing Data: Trial design that limits the likelihood of missing data&#xD;
        is a priority of our study team. Incentives will offered, the follow-up periods are frequent,&#xD;
        and strategies are in place to continually engage participants. If the study have high&#xD;
        retention and find statistically significant differences between respondents and&#xD;
        non-respondents at follow-up, the investigators will construct and employ inverse predicted&#xD;
        probability nonresponse weights. If item nonresponse is substantial, the investigators will&#xD;
        address it using multiple imputation techniques. This approach is one of the statistically&#xD;
        principled methods noted in a recent New England Journal of Medicine (NEJM) editorial on the&#xD;
        need for such approaches in the analysis of data from RCTs with missing values. This approach&#xD;
        assumes that data are missing either completely at random (MCAR) or at random (MAR) as a&#xD;
        function of non-missing data on available variables in the dataset. The investigators will&#xD;
        implement this process using proc Multiple Imputation (MI) in Statistical Analysis System&#xD;
        (SAS). The investigators will generate 20 imputed datasets and will conduct our&#xD;
        intent-to-treat analyses per our analysis plan, saving results across datasets so they can be&#xD;
        combined using proc mianalyze in SAS. The investigators will also consider the possibility&#xD;
        that data are missing in a non-ignorable fashion. Should more or less affected subjects be&#xD;
        lost-to-follow-up the investigators will randomly impute data in sensitivity analyses under&#xD;
        various alternative scenarios employing multiple imputation with the combination of analytic&#xD;
        results noted above.&#xD;
  &#xD;
        Reporting of Subject Enrollment and Follow-up: Consistent with the CONSORT statement, the&#xD;
        investigators will record the number of patients approached, screened, ineligible, and&#xD;
        refusing participation. The investigators will record subject attrition and note all adverse&#xD;
        events. Whenever a participant drops out of the study, the specific reason for dropout, who&#xD;
        decided that the participant would drop out, and whether the dropout involved intervention&#xD;
        participation, data collection, or both will be documented. All participants included will be&#xD;
        accounted for in CONSORT diagram. All post-randomization exclusions will be documented and&#xD;
        accompanied by a rationale for exclusion.&#xD;
  &#xD;
        Clinical monitoring structure/site monitoring plan: The study team consists of members who&#xD;
        are primarily responsible for overseeing the study implementation in the BWH main campus and&#xD;
        at 2 field clinic sites. Each of the clinics has a site PI who is responsible for supervising&#xD;
        site staff, ensuring that all study activities occur, and data management. The site PI will&#xD;
        oversee the site recruitment, intervention implementation, data collection, facilitation,&#xD;
        administration and reporting to BWH. Each site will also have a project coordinator and a&#xD;
        research assistant to coordinate operational responsibilities for the substantive direction&#xD;
        of the project at the site in collaboration with other site research staff. They will assist&#xD;
        in upholding effective strategies and coordination for sample screening, recruitment,&#xD;
        retention, scheduling, data collection, blood draws, testing, sample handling, medical&#xD;
        records, reporting, and participate in study meetings other study activities. Additionally,&#xD;
        will organize blood draws and testing of the study participants in collaboration with Quest&#xD;
        Diagnostics laboratory.&#xD;
  &#xD;
        Data Sensitivity: All data will be labeled with a unique identification (ID) number.&#xD;
        Participant names will only appear (1) on participant consent forms which will be stored in&#xD;
        locked file cabinets at BWH, WSHC and MWIRD and in the PI's office and are only accessible to&#xD;
        the site PIs and coordinating project staff, and (2) on a master list for participant&#xD;
        tracking, which links participants' identification numbers to their names, telephone numbers,&#xD;
        and street addresses and will be kept in a locked room in a locked office on a single&#xD;
        password protected encrypted computer at BWH, WSHC and MWIRD. A hard copy of the master list&#xD;
        will be kept in a locked file cabinet that is only accessible to the site PI and coordinating&#xD;
        project staff. The master list will be destroyed following completion of data collection&#xD;
        (i.e., after all participants have completed the last follow-up self-report survey).&#xD;
        Consequently, it will not be possible to determine the identity of respondents from any of&#xD;
        the research material.&#xD;
  &#xD;
        Disposition of Data After the Study: Hard and soft copies of raw data, including participant&#xD;
        identifiable information and computer files with de-identified data will be kept in locked&#xD;
        files in the PI's office; all linking files and identifiable information will be destroyed&#xD;
        within a year after study completion. Audiofiles of participant interviews will be destroyed&#xD;
        following confirmation of the accuracy of the transcription. De-identified information will&#xD;
        be destroyed a reasonable amount of time after publication of the final reports and articles.&#xD;
  &#xD;
        Data Integrity: The investigators have several mechanisms in place to ensure data integrity&#xD;
        and confidentiality. All study staff will be trained to promote standardized and objective&#xD;
        collection and recording of participant information. Assessments are edited by the study&#xD;
        coordinator at each site for legibility, consistency, and completeness. All data will be&#xD;
        stored in a password-protected database that is backed up through a secure offsite&#xD;
        connection. All paper files are stored in locked file cabinets, and electronic files are&#xD;
        stored in password-protected files. Furthermore, both paper and electronic files are&#xD;
        identified only by participant ID numbers. Confidentiality policies and procedures are&#xD;
        reviewed with all new staff and reviewed annually with current staff. A federal Certificate&#xD;
        of Confidentiality will be obtained for this project.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 25, 2023</start_date>
    <completion_date type="Anticipated">September 3, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 3, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>In this study, we have a two-arm parallel assignment, with each arm receiving a different intervention (individual-level vs. group-level).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of participants who used condom during their last sexual intercourse</measure>
      <time_frame>3-month and 6-months after intervention</time_frame>
      <description>Condom use at last sexual intercourse (Self-report yes/no) change from baseline to each followup)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants who obtained PrEP prescriptions.</measure>
      <time_frame>3-months and 6-months after intervention</time_frame>
      <description>Participants who obtained prescription for PrEP (Self-report/medical record review)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants who are willing to take PrEP in the next 12 months.</measure>
      <time_frame>3-months and 6-months after intervention</time_frame>
      <description>Participants who reported that they were extremely unlikely, very unlikely, somewhat unlikely, not sure, somewhat likely, very likely or extremely likely willing to take PrEP.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants who took PrEP through pill or injection.</measure>
      <time_frame>3-months and 6-months after intervention</time_frame>
      <description>Participants who took daily PrEP pills or PrEP injection.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants who tested positive for STI.</measure>
      <time_frame>6-months after intervention</time_frame>
      <description>New diagnosis for HIV, Chlamydia trachomatis and Neisseria gonorrhea.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants who accepted HIV testing.</measure>
      <time_frame>6-months after intervention</time_frame>
      <description>Participants who accepted HIV testing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with intention to get tested for HIV in the next 6 months.</measure>
      <time_frame>6-months after intervention</time_frame>
      <description>Participants who reported that they were very unlikely, somewhat unlikely, somewhat likely or very likely to get tested for HIV in the next 6 months.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">424</enrollment>
    <condition>HIV</condition>
    <condition>Other STIs</condition>
    <arm_group>
      <arm_group_label>Individual-level intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Virtual one-on-one session</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group-level intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Virtual group sessions</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dada Kwa Dada (individual-level)</intervention_name>
      <description>Dada Kwa Dada (DKD) intervention is an adapted version of Sister to Sister (S2S) intervention (a brief, health profession-led, individual-level intervention proven to increase condom use and decrease STIs among African American women). Intervention is a 1hr to 1.5hrs session and offered in English or French.</description>
      <arm_group_label>Individual-level intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>DADA (group-level)</intervention_name>
      <description>DADA intervention is an adapted version of Sisters Informing Sisters about Topics on AIDS (SISTA) intervention (a peer-led, group-level intervention proven to increase condom use and decrease STIs among African American women). This is a 6hrs intervention implemented in two three-hour sessions and offered in English or French.</description>
      <arm_group_label>Group-level intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  HIV-negative&#xD;
  &#xD;
            -  Born in an African country&#xD;
  &#xD;
            -  Currently living in Greater Boston Area or New York City&#xD;
  &#xD;
            -  Cis-gender woman&#xD;
  &#xD;
            -  Self-reported Black or mixed-Black race&#xD;
  &#xD;
            -  Fluent in English or French&#xD;
  &#xD;
            -  Ages between 18 and 45&#xD;
  &#xD;
            -  Report of condomless vaginal or anal sex with one or more male(s) in the last 3 months&#xD;
               prior to enrollment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Cis-gender man, transgender woman, transgender man, Pregnant woman&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Cis-gender women</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bisola O. Ojikutu, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Brigham and Women's Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Gray M. Maganga, MS</last_name>
      <role>Study Director</role>
      <affiliation>Brigham and Women's Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Laura Bogart, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>RAND Corporation Inc</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Khady Diouf, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Brigham and Women's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Principal Investigator</last_name>
      <phone>917-287-2710</phone>
      <email>bojikutu@bwh.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Study Director</last_name>
      <phone>415-810-0675</phone>
      <email>gmaganga@bwh.harvard.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Brigham and Women's Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Whittier Street Health Center</name>
        <address>
          <city>Roxbury</city>
          <state>Massachusetts</state>
          <zip>02120</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Frederica Williams, MS, MBA</last_name>
        <phone>617-989-3221</phone>
        <email>Frederica.Williams@wshc.org</email>
      </contact>
      <contact_backup>
        <last_name>Nadya Nadhir, MD, MPH</last_name>
        <phone>617-989-3221</phone>
        <email>Nadya.Nadhir@wshc.org</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Muslim Women's Insitute for Research and Development</name>
        <address>
          <city>Bronx</city>
          <state>New York</state>
          <zip>10452</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nurah Amatullah, PhD</last_name>
        <phone>718-960-2262</phone>
        <email>namatullah@mwird.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
      <investigator_full_name>Bisola O. Ojikutu, M.D.</investigator_full_name>
      <investigator_title>Associate Professor of Medicine</investigator_title>
    </responsible_party>
    <keyword>HIV</keyword>
    <keyword>African-born women</keyword>
    <keyword>Condom use</keyword>
    <keyword>Pre-exposure Prophylaxis</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06022809
  org study id: 2023P001336
  secondary id: 125110
  nct id: NCT06022809
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The HIV diagnosis rate among African-born Black women is the highest of all Black individuals
        living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis
        (PrEP) are two effective means of decreasing HIV risk among women, but they remain suboptimal
        among Black women.
  
        The specific aims of this study are:
  
          1. To culturally adapt two widely utilized, evidence-based HIV prevention interventions
             originally designed for US born Black women (Sister-to-Sister (S2S) and Sisters
             Informing Sisters about Topics on AIDS (SISTA)) for use by African-born women
  
          2. To conduct a randomized controlled comparative effectiveness trial (RCT) to determine
             the effectiveness of adapted versions of S2S versus SISTA on increasing condom use and
             PrEP uptake among African-born women.
  
        The adapted versions of these interventions will be given new names that resonate with the
        African culture. The adapted version of S2S intervention will be called "Dada Kwa Dada (DKD)"
        intervention while the adapted version of SISTA intervention will be called "DADA"
        intervention. "DADA" means "Sister" in Swahili and other languages in Eastern and Western
        Africa.
  Background and Significance
  
        African immigrants comprise a growing share of the US Black population, particularly in the
        Northeast. The population of African-born individuals in the US has doubled every decade
        since 1970; in 2015, there were 2.1 million African-born individuals in the US, more than 50%
        are female. Most are from Eastern (Ethiopia, Kenya and Somalia) and Western sub-Saharan
        Africa (Nigeria, Ghana and Liberia). Approximately one-third of the Black population within
        US cities are non-US born. One-third of new HIV diagnoses among African-born individuals
        occur in the Northeast, as opposed to the South where the majority of newly diagnosed US born
        Black individuals reside.
  
        Among Black individuals in the US, African-born women have the highest rate of new HIV
        diagnoses due to heterosexual transmission. In 2014, the HIV diagnosis rate among
        African-born Black women was 400% higher than US born Black women. The rate of new HIV
        diagnoses among all Black women has decreased significantly, however the disparity between
        African-born and US born Black women increased. More than half of African-born Black
        individuals newly diagnosed with HIV are women (60.7%) compared to US born (27.0% women).
  
        A significant proportion of HIV transmission cases among African-born women occurs
        post-immigration, here in the US. In a qualitative analysis conducted by our team in MA and
        NYC, 62% of HIV-infected African-born women believed that they contracted HIV in the US.
        Utilizing data on length of time in US, HIV testing, and life history, Wiewel et al concluded
        that 34% of HIV-infected African-born individuals were most likely infected in the US.
  
        HIV risk among African-born Black women is due to complex cultural, psychosocial, and
        structural issues. PrEP is an effective HIV prevention strategy in women, and education about
        PrEP will be added to both interventions. Though African-born Black women are at-risk, there
        are no evidence-based interventions to address PrEP use, and little is known about its use
        among African-born women.
  
        The key evidence gap is the lack of culturally adapted evidence-based interventions to
        address the HIV/STI prevention needs of at-risk African-born Black women. Current
        evidence-based interventions do not address cultural norms regarding sexual partnerships,
        HIV-related stigma, immigration challenges, PrEP education or culturally determined sexual
        practices such as "dry sex" which increases HIV risk. Formative data collected through
        Tulumbe! have revealed that culturally adapted interventions are needed to reduce HIV risk
        and will fill this critical gap.
  
        Significance
  
        This study is designed to address a critical gap and to inform an important decisional
        dilemma by adapting two HIV/STI prevention interventions and compare their effectiveness
        among African-born Black women.
  
        S2S (a brief, health profession-led, individual-level intervention proven to increase condom
        use and decrease STIs) is the only Centers for Disease Control and Prevention (CDC) High
        Impact HIV Prevention Intervention (HIP) culturally tailored for heterosexually active US
        born Black women.
  
        SISTA (a peer-led, group-level intervention also proven to increase condom use and decrease
        STIs) is also culturally tailored for heterosexually active US born Black women and utilizes
        the Theory of Gender and Power to overcome gender inequality, which may address many of the
        drivers of HIV risk among African-born Black women.
  
        Specific Aims and Objectives
  
        Our research question is:
  
        What effect does participation in a culturally-adapted group-level versus an individual-level
        intervention have on the use of HIV prevention strategies among at risk African-born women
        living in the US?
  
        The investigators hypothesize that culturally adapted SISTA will be more effective than
        culturally adapted S2S in addressing the complex drivers of risk among African-born Black
        women because it addresses gender inequality (a primary driver of HIV infection), is peer-led
        (promoting patient and stakeholder ownership), and is group-level (fosters a sense of support
        and community).
  
        Subject Selection
  
        This study will be conducted in MA [Brigham and Women's Hospital (BWH) Clinic and Whittier
        Street Health Center (WSHC)] and in NYC [Muslim Women's Institute for Research and
        Development (MWIRD)]. All sites have established procedures for referrals to HIV clinical
        services including PrEP. In MA, Whittier Street Health Center and Brigham and Women's
        Hospital Gynecology Clinic offer HIV and PrEP services; in NYC, MWIRD has an established
        relationship with Morris Heights Health Center and African Committee Services, as primary HIV
        and PrEP referral centers which offer HIV treatment and PrEP).
  
        Recruitment Strategy
  
        Participants will be recruited via listservs of organizations affiliated with BWH clinic,
        Whittier Street Health Center (WSHC), Muslim Women's Institute for Research and Development
        (MWIRD), via posters, flyers, walk-ins, online social media groups and residents in cities
        throughout MA and NYC. In addition, the study will use a referral method where participants
        share with their friends the recruitment flyer, which includes contact information for the
        study coordinator.
  
        Randomization Process and Treatment Assignment
  
        At each site, a blocked 1:1 randomization design with stratification by site and African
        region of origin based upon the most common regions of origin of African-born immigrants in
        the US (West vs. East) and language (English vs. French) alternating blocks of 2 and 4 to
        prevent anticipation of condition will help to ensure balance across arms. The
        biostatistician will use a random number generator to devise a randomization log and a set of
        numbered randomization. This will be done using REDCap. As participants complete baseline
        assessments, sealed opaque envelopes will be used to reveal the assignments. Once randomized,
        DADA participants will wait to be scheduled into a session until when at least 4 additional
        participants have been randomized to DADA. Participants will also need to wait for assignment
        to appropriate groups based upon language requirements (French vs. English). The
        investigators anticipate that both interventions will be delivered approximately two weeks
        post-enrollment. The participants will be assigned to receive one of two culturally adapted
        virtual interventions.
  
        DADA(Group-Level Intervention). Studies suggest that sexual risk beliefs among African-born
        individuals are highly community-oriented and peer influenced. Therefore, virtual group
        census will be kept between 5-8 women to enhance opportunities for pro-social, peer feedback
        regarding sexual health behavior. Once randomized, participants will wait to be scheduled
        until at least 4 additional participants within their site have been randomized to the DADA.
        Participants will also need to wait for assignment to appropriate groups based upon language
        requirements (French vs English). The investigators anticipate that both interventions will
        be delivered approximately two weeks post enrollment. The partially nested design of this
        study (participants are nested within groups in one arm of the study) is addressed in
        Analytic Plan.
  
        Study Procedures
  
        The same study protocol will be used within each site. Research assitants will communicate
        with potential participants via email or telephone. If eligible, they will be consented via
        telephone and physically when they visit site for testing. They will then be randomized
        (using REDCap) to either condition and asked to complete an online survey via REDCap.
        Participants will present to WSHC or MWIRD in person for HIV testing via 4th generation assay
        and gonorrhea and Chlamydia testing via urine nucleic acid amplification assay within one
        week of enrollment. Patient will be consented in person during site visit. BWH clinic, WSHC
        and MWIRD have safety protocols in place to perform onsite laboratory testing. The
        investigators anticipate that virtual intervention delivery (for both interventions) will
        occur approximately two weeks following enrollment which will allow for participant accrual
        for SISTA/DADA (group-level intervention) and HIV testing results to return. Participants
        will receive stipends to cover their cell phone/data plan costs throughout the duration of
        the study to ensure access during follow-up.
  
        Research assistants will recruit 424 individuals (212 per condition) from community-based
        sites throughout MA and NY. HIV testing will be offered at baseline. Women who are found to
        be HIV positive will be navigated to care and treatment services and will be excluded from
        participation. Women who test positive for Chlamydia and/or Gonorrhea will be referred to
        counseling and treatment and still be included in the study. Follow-up for the primary
        patient centered outcomes (condom use and PrEP uptake) will occur at 3 and 6 months following
        baseline assessment. At baseline and 6 months participants will be offered urine testing for
        Chlamydia and gonorrhea and HIV testing (4th generation). Interventions will be delivered at
        community-based clinic sites (BWH, WSHC (in MA), and, MWIRD (in NY)) Additional outcomes as
        listed below will also be collected at baseline, 3 and 6 months.
  
        Sample Size and Power
  
        Sample size calculations for the patient-centered primary outcomes (condom use and PrEP
        uptake) are based on previous research. For condom use, in a subset analysis (N=283) of data
        including African-born women, 22% of women reported condom use during most episodes
        intercourse in past 3 months. Similar data were reported by the National Survey on Family
        Growth. These data support using 22% condom use as a baseline estimate. For this study the
        condom use outcome will be defined as the proportion of protected sexual intercourse or the
        number of days on which the participants had sexual intercourse using a condom divided by the
        number of days on which they had sexual intercourse during the 180 days prior to assessment.
        The investigators will focus on the 6-month assessment in a conservative estimation of
        available power and minimally detectable effect size. Power for differential longitudinal
        effects between the DKD (individual intervention) arm and the DADA (group intervention) arm
        will be greater as a result of the accounting of within-subject correlation of responses in
        the GEE models noted in the Analysis Plan. In a previous RCT, S2S resulted in 26% increased
        condom use at 6 months (past 90 days). In previous RCTs, SISTA resulted in increased condom
        use at 6 months (40% to 56% increase in the past 90 days). Assuming a 26% increased condom
        use from baseline in the DKD arm at 6-months and 40% increased condom use (a modest estimate)
        in the DADA arm at 6-months (equal to an odds ratio of 1.90), with 354 participants overall
        and 177 per intervention (accounting for 17% drop-out), the sample size will have 80% power
        to detect a statistically significant difference with an alpha of 0.05. For PrEP uptake, data
        are limited regarding women in the US, therefore, effect size estimates are based on
        individual-level intervention trials among Black men who have sex with men (MSM) which
        resulted in a 25%-37% increase in PrEP uptake at 1 to 3 months. For African-born women who
        are lower risk than Black MSM, the investigators anticipate a lower impact of interventions
        on PrEP uptake. A sample size of 177 in each arm would detect a difference of 10% increased
        uptake in the DKD arm versus 21% increased uptake in the DADA arm with 80% power. When
        applying ITT, there will be a very good power to detect differences of a moderate size or
        greater in odds ratio for our two primary outcomes of condom use and PrEP uptake. Possible
        location/site clustering may impact detectable differences in primary outcomes. With two
        locations (MA and NYC) where condom use and PrEP initiation could vary substantially, there
        is a possibility of the need to account for location as a clustering variable. Without
        available data in the target population for this trial to measure the likely design effect
        (i.e., the sample size inflation factor accounting for site clustering), the investigators
        can nonetheless compute how a design effect of a notable size would impact the differences in
        proportions that would be detectable with sufficient statistical power.
  
        The investigators can compute statistical power for the planned Aim2 study based on
        simulation using 10,000 Monte Carlo samples and two-sided Fisher's exact tests for our STI
        outcome and chi-square tests for our condom use outcome. The investigators will employ a type
        1 error rate of 5% in these computations. The investigators propose using a 1:1 randomization
        design with randomly permuted blocks of 2 and 4 with stratification by African region of
        origin based upon the most common regions of origin of African immigrants in the US (West
        versus East). The study will enroll a total of 424 women (212 per arm) which accounts for an
        estimated 17% drop-out rate yielding an analysis sample size of 354 and will give adequate
        power to detect clinically meaningful differences in study outcomes between the two arms.
        With clustering by site (3 sites) taken into consideration, an analysis sample size of 177 in
        each arm will detect differences of 10.6% STI in the Dada Kwa Dada arm versus 2% in the DADA
        arm as statistically significant assuming an intraclass correlation coefficient (ICC) of
        0.005 design effect of 1.3. With n=177 in each arm for analysis, for condom use the
        investigators can detect a difference between arms of 26% vs. 42.1% assuming an ICC of 0.005
        and a design effect of 1.3. Thus, for both primary outcomes, our sample size of 212 per
        group/424 total enrolled with 17% loss to follow-up, should provide adequate statistical
        power to detect clinically meaningful differences in outcomes while accounting for site-level
        clustering.
  
        Internal and External Validity: To ensure internal validity, the investigators will minimize
        selection bias with a block randomization design (described above) and control for attrition
        bias by analyzing the data according to the ITT approach. Multivariable analysis methods will
        be used to adjust for the effects of confounders. Performance bias will be minimized by
        taping the intervention and ongoing supervision. To minimize contamination, patients
        receiving the intervention will be asked not to share the information with other individuals.
        To ensure external validity the investigators will recruit from diverse African populations
        throughout MA and NYC, base the intervention in real-world settings, and institute practices
        to minimize drop-out. Our eligibility criteria is inclusive of diverse women, some of whom
        will be moderate versus high HIV/STI risk. The study is involving stakeholders who will be
        engaged in future scale-up and documenting resource needs. The study will also solicit input
        from patients and stakeholders. Measures of validity will be documented in all reports.
  
        Heterogeneity of Treatment Effects (HTE). Determining whether or not the effect of the
        interventions varies across participant subgroups is important for future implementation. The
        investigators will estimate the effects of each condition in clinically relevant subgroups
        (e.g. regional West versus East African, time since immigration (≥10 years vs <10 years). The
        investigators will not look at HTE based upon immigration status because the sensitivity of
        that information will make missing data highly likely. Without information on a specific
        likely magnitude or direction of potential HTE, the investigators cannot examine statistical
        power for a definitive scenario. However, the investigators compute the minimal difference in
        between-strata odds ratio for our primary outcome, condom use, that would be statistically
        significant with 80% power at an alpha of 0.05 assuming two strata of equal size given an
        overall sample size of 424. These stratum-specific odds ratios average to 1.91, the odds
        ratio detectable with 80% power in our overall analysis. With n=212 per stratum, the minimal
        difference in odds ratios required for statistically significant HTE with 80% power would be
        for odds ratios of 4.03 and 1.06, constituting very sizable heterogeneity. The investigators
        thus expect our statistical testing of interaction as noted above, will be underpowered with
        respect to HTE and will consider any clinically meaningful, but statistically non-significant
        stratum specific observed differences, to be of hypothesis generating relevance that could be
        examined in larger study in the future.
  
        Analytic Plan
  
        The investigators will use an intention-to-treat (ITT) protocol in which participants will be
        analyzed in their original assigned treatment conditions irrespective of the number of
        follow-up sessions attended. The investigators will specifically examine the balance in
        salient variables at baseline between intervention arms using descriptive statistics only and
        not with hypothesis testing as per the 2010 CONSORT guidelines. From these analyses, the
        investigators will identify variables as potential confounding variables to be included in
        subsequent multivariable analyses of our trial endpoints. Next, in initial unadjusted
        analyses to determine the differences between study conditions, the investigators will use
        t-tests for continuous variables and cross-tabulations with chi-square testing for
        categorical outcome variables separately at each of the time points, 3 and 6-months. As our
        primary statistical analyses, however, the investigators will employ models for repeated
        measures of our outcomes of interest to obtain adjusted mean differences or odds ratios over
        the 6-month period via linear and logistic generalized estimating equation (GEE) regression
        models. The fitted GEE parameters will be interpreted as adjusted odds ratios in logistic
        models and adjusted mean differences in linear models. Each model will include, if necessary,
        sociodemographic variables as covariates as well as terms representing an interaction between
        treatment and time period. These models will also include study site as a covariate so that
        site-level heterogeneity of intervention effects over time can be formally estimated and
        tested. In addition to study site, based on a priori theoretical and clinical consideration
        the investigators will extend the main effects only models to examine potential effect
        modification by participant age. In addition to our ITT-based analyses, the investigators
        will analyze the data in an "as treated" manner by dividing the DADA arm into subgroups by
        level of dose/compliance. The DADA group-level intervention will be designed as a two, 3hr,
        two days sessions and adherence to the entire session may vary. Therefore, the investigators
        will generate adherence-adjusted estimates of the effectiveness of DADA versus DKD.
        Heteroscedastic partially nested mixed-effects models, which model the clustering in only one
        arm will be used given the comparison of the group-level (DADA intervention) with the
        individual-level (DKD Intervention). Our statistical testing in all analyses will employ a
        2-sided type I error rate of 5% and 95% confidence intervals will be generated.
  
        Monitoring and Quality Assurance
  
        Process (Acceptability and Feasibility) Evaluation: To ensure that the interventions are
        acceptable in routine care and can be feasibly incorporated into Community Based
        Organizations (CBO) operations, using IRBs # 2020P001558 and # 2021P001486. The
        investigators/research assistants have conducted virtual post-intervention interviews during
        pilot with all participants and facilitators. Acceptability has been assessed using the
        Information Systems Success Model (ISSM) and has been adapted in assessing facilitators and
        participants' perception of the intervention using four domains (1) information quality, (2)
        delivery quality, (3) perceived usefulness and (4) overall satisfaction with the intervention
        using Likert scales. Mean scores will be reported for each domain. Intervention participants
        will also be asked open-ended questions, such as "What did you like most/least about the
        intervention?". The investigators have also evaluated intervention feasibility with feedback
        (post-intervention forms) from the facilitator on intervention session flow, content, and
        whether key elements were covered adequately. The intervention facilitators took notes on
        perceived effectiveness of the facilitation manual and videos. Feasibility has been assessed
        to determine if the interventions are practical in specific situations and settings.
        Qualitative data will be discussed and relevant changes will be made to the interventions.
        The interventions will be considered feasible and acceptable if post-session feedback is
        highly positive (high mean ISSM scores) and if any identified barriers to implementation can
        be (and are) addressed. Data collected during the pilot test will result in the final adapted
        interventions.
  
        Fidelity Assessment. A critical component of the RCT will be the assessment of intervention
        fidelity. Adherence to the content of the intervention strategies will be determined by: (1)
        Content: Was each of the intervention components implemented as planned?; (2) Coverage: What
        proportion of the target group participated in the intervention?; (3) Frequency/Duration:
        Were the intervention components implemented as often and for as long as planned?. A random
        sample of 10 intervention delivery recordings will also be selected and reviewed to assess
        fidelity. If an implemented intervention adheres completely to the content, frequency,
        duration, and coverage prescribed by its designers, then fidelity can be said to be high.
        Moderators of fidelity will also be determined, such as intervention complexity, facilitation
        strategies, quality of delivery and patient responsiveness.
  
        Data Management: Ojikutu(PI) has ultimate responsibility for data management and safeguarding
        and will provide trainings to the study team. All study data will be stored in a
        password-protected database that is backed up through a secure offsite connection [REDCap
        (Research Electronic Data Capture) is a secure, HIPAA compliant web-based application hosted
        by Partners HealthCare Research Computing]. All study data will be identified by a unique
        identification (ID) code and kept separately from study samples, results, informed consent
        and locator information. A list connecting the name of the participant and participant ID
        code will be maintained in a locked cabinet in locked offices at BWH, WSHC and MWIRD and with
        the study PI (only accessible to the Site PIs and the study site coordinator). Self-reported
        study data will be collected at community-based sites by unique ID code via REDCap and
        transmitted via password-protected, encrypted flash drives. De-identified data will be
        uploaded to REDCap. These data will not be shared with individuals who are not part of the
        project team, and no data shared with the study team will contain participant names. The site
        coordinators will have access to these files and will locate the participant at baseline and
        12 months by name/birth date, link them to the unique ID code and enter results into REDCap.
        All linking files and identifiable information will be destroyed within a year after study
        completion. Frederica Williams (Co-I) and Nurah Amatulllah (Co-I) will re-check the entry of
        these data to ensure accuracy. Though blinding is not possible, the study team will be
        blinded to the data and results until the end of the trial to avoid bias.
  
        The investigators propose a single, independent, trained mental health provider (e.g.
        licensed clinical social worker) who has no conflict of interest with the study team and who
        has research experience serve as an independent monitor for the study. This study has
        identified Dr. Christina Psaros who has exceeded these qualifications to serve in this
        capacity as independent monitor. To allow effective monitoring, Dr. Psaros will be provided
        with periodic reports every 3 months which include subject enrollment, subject retention, the
        number of patients who drop out of the study with reasons for dropping out, and a listing of
        all adverse events (AEs) that are plausibly related to study procedures. Dr. Psaros will make
        a recommendation regarding the continuation, modification, or termination of the study. All
        communications from the independent monitor will be shared with the study institutional
        review board (IRB), as well as Patient-Centered Outcomes Research Institute (PCORI). Any
        unexpected, serious adverse events that occur during the course of this investigation and
        follow-up period will be reported by telephone by the PI, Ojikutu, within the next business
        day to the study IRB and the independent study monitor. The telephone report will be followed
        within 3 business days by a written report, which will contain: subject's ID#, the title and
        date of serious adverse event, and narrative explanation (e.g., how the research staff was
        notified of the event, dates of consent, study screening for inclusion/exclusion, whether the
        participant participated in the intervention, dates and circumstances of the
        hospitalization/death, whether alcohol or drugs were known to be involved, and participant
        status at last research contact). In consultation with the IRB and independent monitor, the
        PI will address whether there is a need to redesign or amend the protocol, and/or to inform
        current and future subjects of a change in description of risk (e.g., in consent form and
        protocol).
  
        Preventing and Handling Missing Data: Trial design that limits the likelihood of missing data
        is a priority of our study team. Incentives will offered, the follow-up periods are frequent,
        and strategies are in place to continually engage participants. If the study have high
        retention and find statistically significant differences between respondents and
        non-respondents at follow-up, the investigators will construct and employ inverse predicted
        probability nonresponse weights. If item nonresponse is substantial, the investigators will
        address it using multiple imputation techniques. This approach is one of the statistically
        principled methods noted in a recent New England Journal of Medicine (NEJM) editorial on the
        need for such approaches in the analysis of data from RCTs with missing values. This approach
        assumes that data are missing either completely at random (MCAR) or at random (MAR) as a
        function of non-missing data on available variables in the dataset. The investigators will
        implement this process using proc Multiple Imputation (MI) in Statistical Analysis System
        (SAS). The investigators will generate 20 imputed datasets and will conduct our
        intent-to-treat analyses per our analysis plan, saving results across datasets so they can be
        combined using proc mianalyze in SAS. The investigators will also consider the possibility
        that data are missing in a non-ignorable fashion. Should more or less affected subjects be
        lost-to-follow-up the investigators will randomly impute data in sensitivity analyses under
        various alternative scenarios employing multiple imputation with the combination of analytic
        results noted above.
  
        Reporting of Subject Enrollment and Follow-up: Consistent with the CONSORT statement, the
        investigators will record the number of patients approached, screened, ineligible, and
        refusing participation. The investigators will record subject attrition and note all adverse
        events. Whenever a participant drops out of the study, the specific reason for dropout, who
        decided that the participant would drop out, and whether the dropout involved intervention
        participation, data collection, or both will be documented. All participants included will be
        accounted for in CONSORT diagram. All post-randomization exclusions will be documented and
        accompanied by a rationale for exclusion.
  
        Clinical monitoring structure/site monitoring plan: The study team consists of members who
        are primarily responsible for overseeing the study implementation in the BWH main campus and
        at 2 field clinic sites. Each of the clinics has a site PI who is responsible for supervising
        site staff, ensuring that all study activities occur, and data management. The site PI will
        oversee the site recruitment, intervention implementation, data collection, facilitation,
        administration and reporting to BWH. Each site will also have a project coordinator and a
        research assistant to coordinate operational responsibilities for the substantive direction
        of the project at the site in collaboration with other site research staff. They will assist
        in upholding effective strategies and coordination for sample screening, recruitment,
        retention, scheduling, data collection, blood draws, testing, sample handling, medical
        records, reporting, and participate in study meetings other study activities. Additionally,
        will organize blood draws and testing of the study participants in collaboration with Quest
        Diagnostics laboratory.
  
        Data Sensitivity: All data will be labeled with a unique identification (ID) number.
        Participant names will only appear (1) on participant consent forms which will be stored in
        locked file cabinets at BWH, WSHC and MWIRD and in the PI's office and are only accessible to
        the site PIs and coordinating project staff, and (2) on a master list for participant
        tracking, which links participants' identification numbers to their names, telephone numbers,
        and street addresses and will be kept in a locked room in a locked office on a single
        password protected encrypted computer at BWH, WSHC and MWIRD. A hard copy of the master list
        will be kept in a locked file cabinet that is only accessible to the site PI and coordinating
        project staff. The master list will be destroyed following completion of data collection
        (i.e., after all participants have completed the last follow-up self-report survey).
        Consequently, it will not be possible to determine the identity of respondents from any of
        the research material.
  
        Disposition of Data After the Study: Hard and soft copies of raw data, including participant
        identifiable information and computer files with de-identified data will be kept in locked
        files in the PI's office; all linking files and identifiable information will be destroyed
        within a year after study completion. Audiofiles of participant interviews will be destroyed
        following confirmation of the accuracy of the transcription. De-identified information will
        be destroyed a reasonable amount of time after publication of the final reports and articles.
  
        Data Integrity: The investigators have several mechanisms in place to ensure data integrity
        and confidentiality. All study staff will be trained to promote standardized and objective
        collection and recording of participant information. Assessments are edited by the study
        coordinator at each site for legibility, consistency, and completeness. All data will be
        stored in a password-protected database that is backed up through a secure offsite
        connection. All paper files are stored in locked file cabinets, and electronic files are
        stored in password-protected files. Furthermore, both paper and electronic files are
        identified only by participant ID numbers. Confidentiality policies and procedures are
        reviewed with all new staff and reviewed annually with current staff. A federal Certificate
        of Confidentiality will be obtained for this project.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: In this study, we have a two-arm parallel assignment, with each arm receiving a different intervention (individual-level vs. group-level).
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Proportion of participants who used condom during their last sexual intercourse
  time frame: 3-month and 6-months after intervention
  description: Condom use at last sexual intercourse (Self-report yes/no) change from baseline to each followup)
  measure: Proportion of participants who obtained PrEP prescriptions.
  time frame: 3-months and 6-months after intervention
  description: Participants who obtained prescription for PrEP (Self-report/medical record review)
  measure: Proportion of participants who are willing to take PrEP in the next 12 months.
  time frame: 3-months and 6-months after intervention
  description: Participants who reported that they were extremely unlikely, very unlikely, somewhat unlikely, not sure, somewhat likely, very likely or extremely likely willing to take PrEP.
  measure: Proportion of participants who took PrEP through pill or injection.
  time frame: 3-months and 6-months after intervention
  description: Participants who took daily PrEP pills or PrEP injection.
  measure: Proportion of participants who tested positive for STI.
  time frame: 6-months after intervention
  description: New diagnosis for HIV, Chlamydia trachomatis and Neisseria gonorrhea.
  measure: Proportion of participants who accepted HIV testing.
  time frame: 6-months after intervention
  description: Participants who accepted HIV testing.
  measure: Proportion of participants with intention to get tested for HIV in the next 6 months.
  time frame: 6-months after intervention
  description: Participants who reported that they were very unlikely, somewhat unlikely, somewhat likely or very likely to get tested for HIV in the next 6 months.
  arm group label: Individual-level intervention
  arm group type: Active Comparator
  description: Virtual one-on-one session
  arm group label: Group-level intervention
  arm group type: Experimental
  description: Virtual group sessions
  intervention type: Behavioral
  intervention name: Dada Kwa Dada (individual-level)
  description: Dada Kwa Dada (DKD) intervention is an adapted version of Sister to Sister (S2S) intervention (a brief, health profession-led, individual-level intervention proven to increase condom use and decrease STIs among African American women). Intervention is a 1hr to 1.5hrs session and offered in English or French.
  arm group label: Individual-level intervention
  intervention type: Behavioral
  intervention name: DADA (group-level)
  description: DADA intervention is an adapted version of Sisters Informing Sisters about Topics on AIDS (SISTA) intervention (a peer-led, group-level intervention proven to increase condom use and decrease STIs among African American women). This is a 6hrs intervention implemented in two three-hour sessions and offered in English or French.
  arm group label: Group-level intervention
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Cis-gender women
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bisola O. Ojikutu, MD, MPH
  role: Principal Investigator
  affiliation: Brigham and Women's Hospital
  last name: Gray M. Maganga, MS
  role: Study Director
  affiliation: Brigham and Women's Hospital
  last name: Laura Bogart, PhD
  role: Study Chair
  affiliation: RAND Corporation Inc
  last name: Khady Diouf, MD
  role: Study Chair
  affiliation: Brigham and Women's Hospital
  last name: Principal Investigator
  phone: 917-287-2710
  email: bojikutu@bwh.harvard.edu
  last name: Study Director
  phone: 415-810-0675
  email: gmaganga@bwh.harvard.edu
  facility: 
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  country: United States
  citation: Demeke HB, Johnson AS, Wu B, Nwangwu-Ike N, King H, Dean HD. Differences Between U.S.-Born and Non-U.S.-Born Black Adults Reported with Diagnosed HIV Infection: United States, 2008-2014. J Immigr Minor Health. 2019 Feb;21(1):30-38. doi: 10.1007/s10903-018-0699-4.
  PMID: 29374815
  citation: Adimora AA, Ramirez C, Auerbach JD, Aral SO, Hodder S, Wingood G, El-Sadr W, Bukusi EA; HIV Prevention Trials Network Women at Risk Committee. Preventing HIV infection in women. J Acquir Immune Defic Syndr. 2013 Jul;63 Suppl 2(0 2):S168-73. doi: 10.1097/QAI.0b013e318298a166.
  PMID: 23764631
  citation: Weller S, Davis K. Condom effectiveness in reducing heterosexual HIV transmission. Cochrane Database Syst Rev. 2001;(3):CD003255. doi: 10.1002/14651858.CD003255.
  PMID: 11687062
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  PMID: 23553347
  citation: Little RJ, D'Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, Frangakis C, Hogan JW, Molenberghs G, Murphy SA, Neaton JD, Rotnitzky A, Scharfstein D, Shih WJ, Siegel JP, Stern H. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012 Oct 4;367(14):1355-60. doi: 10.1056/NEJMsr1203730. No abstract available.
  PMID: 23034025
  responsible party type: Principal Investigator
  investigator affiliation: Brigham and Women's Hospital
  investigator full name: Bisola O. Ojikutu, M.D.
  investigator title: Associate Professor of Medicine
  sharing ipd: No