<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/NCT03256435</url>
  </required_header>
  <id_info>
    <org_study_id>1611001642</org_study_id>
    <secondary_id>5R34MH109371-03</secondary_id>
    <nct_id>NCT03256435</nct_id>
  </id_info>
  <brief_title>Retention in PrEP Care for African American MSM in Mississippi</brief_title>
  <official_title>PrEP Uptake, Adherence, and Retention for African American MSM in Mississippi</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</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>
      Innovative and novel HIV prevention interventions are urgently needed for African American&#xD;
      (AA) young men who have sex with men (YMSM) in the South, and in Mississippi in particular.&#xD;
      HIV pre-exposure prophylaxis (PrEP) is a newer HIV prevention strategy that consists of a&#xD;
      daily oral antiretroviral pill taken on an ongoing basis by HIV-uninfected but at-risk&#xD;
      individuals. Although acceptability studies have demonstrated high interested in PrEP in the&#xD;
      US, uptake remains limited. To date, studies of PrEP initiation have largely been limited to&#xD;
      settings in which PrEP is provided free of charge. Barriers to PrEP initiation and retention&#xD;
      in PrEP care in real world settings are likely more complex, since payment for PrEP can be a&#xD;
      substantial financial burden.&#xD;
&#xD;
      The ADAPT_ITT approach (an approach to adapting behavioral interventions to new populations:&#xD;
      Assessment, Decision, Administration, Production, Topical Experts - Integration, Training,&#xD;
      Testing) will be used to develop and pilot test a RAMP (Retain African American Men in PrEP)&#xD;
      intervention that aims to promote PrEP adherence and retention in care in Jackson, MS and&#xD;
      focuses on recruiting AA YMSM in a city with some of the highest HIV infection rates in the&#xD;
      country. This study will include formative research to understand the cultural and social&#xD;
      contexts that influence AA YMSM's PrEP use patterns and the acceptability of our proposed&#xD;
      intervention. Results from these qualitative interviews will inform the study intervention&#xD;
      which will be tested and refined in a dynamic open pilot evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Men who have sex with men (MSM) bear a disproportionate burden of the HIV epidemic in the&#xD;
      United States (US), and the number of new HIV diagnoses among MSM is increasing every year.&#xD;
      Despite HIV incidence remaining relatively stable overall, HIV incidence is increasing among&#xD;
      MSM, and among Black/African American (hereafter AA) young MSM (YMSM) in particular. Black/AA&#xD;
      MSM represent less than 1% of the population but account for 25% of new HIV diagnoses.&#xD;
      Compared to MSM of other races, AA MSM are 3 times more likely to be HIV infected. Among&#xD;
      YMSM, the disparities are greatest; AA MSM aged 20-29 have an HIV prevalence of 34%, whereas&#xD;
      White MSM in the same age range have an HIV prevalence of 5.5%. Additionally, the American&#xD;
      South accounts for 46% of new HIV diagnoses in the US and 45% of new AIDS diagnoses.&#xD;
      Mississippi is ranked 7th in the country in HIV case rates, with an overall rate of 20.7 per&#xD;
      100,000 persons; however, some census tracts have rates of 2-5%, which is comparable to some&#xD;
      sub-Saharan African countries. There are alarming racial disparities related to HIV/AIDS; in&#xD;
      Mississippi, AAs comprise 37% of the population but accounted for 76% of HIV infection&#xD;
      reported in 2013. Between 2011 and 2013, the number of infections among MSM in Mississippi&#xD;
      increased 43%, with an even sharper increase among AA YMSM, who have among the highest rates&#xD;
      of infection in the nation.&#xD;
&#xD;
      Given the disproportionate burden of HIV, worse HIV outcomes, and current social climate,&#xD;
      innovative and novel HIV prevention interventions are urgently needed for AA YMSM in the&#xD;
      South, and in Mississippi in particular. HIV pre-exposure prophylaxis (PrEP) is a newer HIV&#xD;
      prevention strategy that consists of a daily oral antiretroviral pill taken on an ongoing&#xD;
      basis by HIV-uninfected but at-risk individuals. Its efficacy has been well established in&#xD;
      randomized controlled trials and open-label studies for MSM and other groups. Although&#xD;
      acceptability studies have demonstrated high interest in PrEP in the US, uptake remains&#xD;
      limited. To date, studies of PrEP initiation have largely been limited to settings in which&#xD;
      PrEP is provided free of charge. Barriers to PrEP initiation and retention in PrEP care in&#xD;
      real world settings are likely more complex, since payment for PrEP can be a substantial&#xD;
      financial burden. Although most health insurance programs are covering the cost of PrEP, and&#xD;
      the industry-sponsored PrEP Medication Assistance Program exists to assist people who do not&#xD;
      have insurance, these programs require patient and clinician awareness, sufficient staffing&#xD;
      and appropriate infrastructure.&#xD;
&#xD;
      A body of evidence is only beginning to emerge related to PrEP adherence and little is known&#xD;
      about retention in PrEP care, most of which is in the context of either RCTs or open-label&#xD;
      studies in which PrEP is provided free of charge. The efficacy of PrEP is closely tied to&#xD;
      adherence, and evidence suggests that efficacy decreases exponentially with fewer doses of&#xD;
      PrEP per week; maximum efficacy is achieved when 6-7 doses are taken per week, but PrEP&#xD;
      provides high protection with at least 4 doses per week. In an open label study of PrEP&#xD;
      uptake and adherence in MSM, 71% of participants receiving PrEP had drug detected after&#xD;
      initiation of PrEP. AA YMSM in Jackson, MS face many challenges to optimal adherence and&#xD;
      retention in care, including inconsistent routines, socioeconomic challenges, and logistical&#xD;
      difficulty in returning for follow-up visits. MSM may not want to disclose use of PrEP to&#xD;
      family or friends, due to the potential for unintended disclosure of sexual orientation,&#xD;
      which may result in reduced social support for PrEP adherence or returning for care.&#xD;
      Understanding barriers and facilitators to adherence and retention in care for AA YMSM, and&#xD;
      subsequently the development of interventions to improve them, will be necessary to ensure&#xD;
      maximum PrEP effectiveness.&#xD;
&#xD;
      The ADAPT_ITT approach will be used to develop and pilot test a RAMP intervention that aims&#xD;
      to promote PrEP adherence and retention in care in Jackson, MS and focuses on recruiting AA&#xD;
      YMSM in a city with some of the highest HIV infection rates in the country. This study will&#xD;
      include formative research to understand the cultural and social contexts that influence AA&#xD;
      YMSM's PrEP use patterns and the acceptability of our proposed intervention. Results from&#xD;
      these qualitative interviews will inform the study intervention which will be tested and&#xD;
      refined in a dynamic open pilot evaluation.&#xD;
&#xD;
      Qualitative interviews (Phase 1) will &quot;assess&quot; individual, interpersonal and structural&#xD;
      contexts of sexual risk behavior, anticipated adoption and use of new prevention&#xD;
      technologies, barriers and facilitators to PrEP initiation and adherence, and optimal content&#xD;
      and format for a PrEP initiation and adherence intervention. Using results of the qualitative&#xD;
      interviews and input from key opinion leaders, the investigators will &quot;decide&quot; on&#xD;
      intervention components and structure of the intervention package. The investigators will&#xD;
      then &quot;adapt&quot; the Life-Steps intervention to be responsive to the unique context and complex&#xD;
      needs of AA YMSM in Jackson, and &quot;produce&quot; a draft of the intervention manual. Our study team&#xD;
      is made up of &quot;topical experts&quot; who will all have a central role in developing the&#xD;
      intervention manual. Moreover, the open pilot evaluation (Phase 2) will be used to obtain&#xD;
      further input on the draft intervention manual and protocol. After &quot;integrating&quot; the feedback&#xD;
      obtained from the open pilot evaluation and exit interviews into the intervention manual and&#xD;
      protocol, study staff will be &quot;trained&quot; in all final study procedures, and a provisional&#xD;
      theory-based intervention to overcome barriers to PrEP adherence and retention, and reduce&#xD;
      sexual risk behavior, among AA YMSM will be &quot;tested&quot; in a pilot Randomized Control Trial&#xD;
      (RCT) (Phase 3). This intervention will have broad generalizability for AA YMSM across the&#xD;
      South and the country as PrEP programs expand nationwide.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2016</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of PrEP drug in blood samples</measure>
    <time_frame>measured at 3 months</time_frame>
    <description>Blood samples will be collected from participants at 3- and 6-month assessments to test for the presence of detectable levels of Emtricitabine/Tenofovir (FTC/TDF). Samples will be processed and shipped to Dr. Peter Anderson's lab at the University of Colorado Anschutz for analysis of the quantification (drug levels) of detectable serum levels of FTC and TDF.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of PrEP drug in blood samples</measure>
    <time_frame>measured at 6 months</time_frame>
    <description>Blood samples will be collected from participants at 3- and 6-month assessments to test for the presence of detectable levels of Emtricitabine/Tenofovir (FTC/TDF). Samples will be processed and shipped to Dr. Peter Anderson's lab at the University of Colorado Anschutz for analysis of the quantification (drug levels) of detectable serum levels of FTC and TDF.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported adherence</measure>
    <time_frame>measured at 3 months</time_frame>
    <description>Self-reported adherence (with interviews) will supplement biological monitoring data at 3-month intervals, as well at the time of the intervention sessions (for both those in the intervention and comparison condition)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported adherence</measure>
    <time_frame>measured at 6 months</time_frame>
    <description>Self-reported adherence (with interviews) will supplement biological monitoring data at 3-month intervals, as well at the time of the intervention sessions (for both those in the intervention and comparison condition)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PrEP Retention in Care over time</measure>
    <time_frame>measured at 3 months</time_frame>
    <description>This study will employ the Center for Disease Control (CDC) guidelines for retention in PrEP care, which include PrEP clinical visits every 3 to 6 months. &quot;Retention in care&quot; is defined as two PrEP follow up visits by month 8 of enrollment. While participants will only be randomized after attending the first PrEP clinic visit and receive a prescription from the study clinician for FTC/TDF, it is possible that they will not fill the prescription. The investigators will obtain a medical release from the participants in order that, at each assessment time-point, the study clinician can follow up with the pharmacy to determine whether or not the prescription was filled and picked up, and the date it was picked up (to assess time to initiation). Moreover, attendance at follow up clinic visits (months 3 and 6) will be calculated to assess retention in PrEP clinical care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP Retention in Care over time</measure>
    <time_frame>measured at 6 months</time_frame>
    <description>This study will employ the Center for Disease Control (CDC) guidelines for retention in PrEP care, which include PrEP clinical visits every 3 to 6 months. &quot;Retention in care&quot; is defined as two PrEP follow up visits by month 8 of enrollment. While participants will only be randomized after attending the first PrEP clinic visit and receive a prescription from the study clinician for FTC/TDF, it is possible that they will not fill the prescription. The investigators will obtain a medical release from the participants in order that, at each assessment time-point, the study clinician can follow up with the pharmacy to determine whether or not the prescription was filled and picked up, and the date it was picked up (to assess time to initiation). Moreover, attendance at follow up clinic visits (months 3 and 6) will be calculated to assess retention in PrEP clinical care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual risk behavior/behavioral adjustment</measure>
    <time_frame>measured at baseline</time_frame>
    <description>This study will use the AIDS-Risk Behavior Assessment (ARBA), a validated computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to 3 types of sexual behavior (anal, oral, vaginal) and assess detailed partner-by-partner sexual risk information by partner type (transactional, casual, main) and by HIV-status, protected/unprotected sex, and whether in the context of substance use in the prior 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual risk behavior/behavioral adjustment</measure>
    <time_frame>measured at 3 months</time_frame>
    <description>This study will use the AIDS-Risk Behavior Assessment (ARBA), a validated computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to 3 types of sexual behavior (anal, oral, vaginal) and assess detailed partner-by-partner sexual risk information by partner type (transactional, casual, main) and by HIV-status, protected/unprotected sex, and whether in the context of substance use in the prior 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual risk behavior/behavioral adjustment</measure>
    <time_frame>measured at 6 months</time_frame>
    <description>This study will use the AIDS-Risk Behavior Assessment (ARBA), a validated computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to 3 types of sexual behavior (anal, oral, vaginal) and assess detailed partner-by-partner sexual risk information by partner type (transactional, casual, main) and by HIV-status, protected/unprotected sex, and whether in the context of substance use in the prior 3 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Preventive Medicine</condition>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RAMP PrEP initiation, adherence, and retention intervention package as well as standard of care (access to a financial advocate and clinical staff to support, facilitate, and assist in linkage to the established PrEP clinic at Open Arms and to facilitate initiation of, and obtaining, PrEP medications)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care (access to a financial advocate and clinical staff to support, facilitate, and assist in linkage to the established PrEP clinic at Open Arms and to facilitate initiation of, and obtaining, PrEP medications)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RAMP PrEP initiation, adherence, and retention intervention</intervention_name>
    <description>The intervention arm will receive facilitated strengths-based case management (SBCM)-delivered by trained interventionists-to help navigate the PrEP medical care system and support the participant and health care staff in meeting the challenges faced with obtaining PrEP medication (e.g., overcoming insurance barriers or barriers with co-pays). This also includes facilitated integration into the PrEP clinic and obtaining monthly PrEP prescription refills.</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-35 years of age&#xD;
&#xD;
          -  assigned male sex at birth&#xD;
&#xD;
          -  African American race&#xD;
&#xD;
          -  report having sex with another person assigned male at birth who identifies as a man&#xD;
             within the last year&#xD;
&#xD;
          -  report behavioral risk for HIV infection (consistent with the CDC guidelines for&#xD;
             prescribing PrEP: unprotected anal intercourse (UAI) with at least one HIV-infected or&#xD;
             unknown serostatus partner in the preceding 6 months)&#xD;
&#xD;
          -  HIV-uninfected by antibody test&#xD;
&#xD;
          -  able to understand and speak English (for consenting and counseling).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to provide informed consent, including people with severe mental illness&#xD;
             requiring immediate treatment or with mental illness limiting their ability to&#xD;
             participate&#xD;
&#xD;
          -  for aims 2 and 3 only, participants who are positive for Hepatitis B antigen or&#xD;
             diagnosed with renal insufficiency (Glomerular Filtration Rate&lt;50)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy S Nunn, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Open Arms Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>April 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>November 19, 2021</last_update_submitted>
  <last_update_submitted_qc>November 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03256435
org study id: 1611001642
secondary id: 5R34MH109371-03
nct id: NCT03256435
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Innovative and novel HIV prevention interventions are urgently needed for African American
      (AA) young men who have sex with men (YMSM) in the South, and in Mississippi in particular.
      HIV pre-exposure prophylaxis (PrEP) is a newer HIV prevention strategy that consists of a
      daily oral antiretroviral pill taken on an ongoing basis by HIV-uninfected but at-risk
      individuals. Although acceptability studies have demonstrated high interested in PrEP in the
      US, uptake remains limited. To date, studies of PrEP initiation have largely been limited to
      settings in which PrEP is provided free of charge. Barriers to PrEP initiation and retention
      in PrEP care in real world settings are likely more complex, since payment for PrEP can be a
      substantial financial burden.

      The ADAPT_ITT approach (an approach to adapting behavioral interventions to new populations:
      Assessment, Decision, Administration, Production, Topical Experts - Integration, Training,
      Testing) will be used to develop and pilot test a RAMP (Retain African American Men in PrEP)
      intervention that aims to promote PrEP adherence and retention in care in Jackson, MS and
      focuses on recruiting AA YMSM in a city with some of the highest HIV infection rates in the
      country. This study will include formative research to understand the cultural and social
      contexts that influence AA YMSM's PrEP use patterns and the acceptability of our proposed
      intervention. Results from these qualitative interviews will inform the study intervention
      which will be tested and refined in a dynamic open pilot evaluation.
Men who have sex with men (MSM) bear a disproportionate burden of the HIV epidemic in the
      United States (US), and the number of new HIV diagnoses among MSM is increasing every year.
      Despite HIV incidence remaining relatively stable overall, HIV incidence is increasing among
      MSM, and among Black/African American (hereafter AA) young MSM (YMSM) in particular. Black/AA
      MSM represent less than 1% of the population but account for 25% of new HIV diagnoses.
      Compared to MSM of other races, AA MSM are 3 times more likely to be HIV infected. Among
      YMSM, the disparities are greatest; AA MSM aged 20-29 have an HIV prevalence of 34%, whereas
      White MSM in the same age range have an HIV prevalence of 5.5%. Additionally, the American
      South accounts for 46% of new HIV diagnoses in the US and 45% of new AIDS diagnoses.
      Mississippi is ranked 7th in the country in HIV case rates, with an overall rate of 20.7 per
      100,000 persons; however, some census tracts have rates of 2-5%, which is comparable to some
      sub-Saharan African countries. There are alarming racial disparities related to HIV/AIDS; in
      Mississippi, AAs comprise 37% of the population but accounted for 76% of HIV infection
      reported in 2013. Between 2011 and 2013, the number of infections among MSM in Mississippi
      increased 43%, with an even sharper increase among AA YMSM, who have among the highest rates
      of infection in the nation.

      Given the disproportionate burden of HIV, worse HIV outcomes, and current social climate,
      innovative and novel HIV prevention interventions are urgently needed for AA YMSM in the
      South, and in Mississippi in particular. HIV pre-exposure prophylaxis (PrEP) is a newer HIV
      prevention strategy that consists of a daily oral antiretroviral pill taken on an ongoing
      basis by HIV-uninfected but at-risk individuals. Its efficacy has been well established in
      randomized controlled trials and open-label studies for MSM and other groups. Although
      acceptability studies have demonstrated high interest in PrEP in the US, uptake remains
      limited. To date, studies of PrEP initiation have largely been limited to settings in which
      PrEP is provided free of charge. Barriers to PrEP initiation and retention in PrEP care in
      real world settings are likely more complex, since payment for PrEP can be a substantial
      financial burden. Although most health insurance programs are covering the cost of PrEP, and
      the industry-sponsored PrEP Medication Assistance Program exists to assist people who do not
      have insurance, these programs require patient and clinician awareness, sufficient staffing
      and appropriate infrastructure.

      A body of evidence is only beginning to emerge related to PrEP adherence and little is known
      about retention in PrEP care, most of which is in the context of either RCTs or open-label
      studies in which PrEP is provided free of charge. The efficacy of PrEP is closely tied to
      adherence, and evidence suggests that efficacy decreases exponentially with fewer doses of
      PrEP per week; maximum efficacy is achieved when 6-7 doses are taken per week, but PrEP
      provides high protection with at least 4 doses per week. In an open label study of PrEP
      uptake and adherence in MSM, 71% of participants receiving PrEP had drug detected after
      initiation of PrEP. AA YMSM in Jackson, MS face many challenges to optimal adherence and
      retention in care, including inconsistent routines, socioeconomic challenges, and logistical
      difficulty in returning for follow-up visits. MSM may not want to disclose use of PrEP to
      family or friends, due to the potential for unintended disclosure of sexual orientation,
      which may result in reduced social support for PrEP adherence or returning for care.
      Understanding barriers and facilitators to adherence and retention in care for AA YMSM, and
      subsequently the development of interventions to improve them, will be necessary to ensure
      maximum PrEP effectiveness.

      The ADAPT_ITT approach will be used to develop and pilot test a RAMP intervention that aims
      to promote PrEP adherence and retention in care in Jackson, MS and focuses on recruiting AA
      YMSM in a city with some of the highest HIV infection rates in the country. This study will
      include formative research to understand the cultural and social contexts that influence AA
      YMSM's PrEP use patterns and the acceptability of our proposed intervention. Results from
      these qualitative interviews will inform the study intervention which will be tested and
      refined in a dynamic open pilot evaluation.

      Qualitative interviews (Phase 1) will "assess" individual, interpersonal and structural
      contexts of sexual risk behavior, anticipated adoption and use of new prevention
      technologies, barriers and facilitators to PrEP initiation and adherence, and optimal content
      and format for a PrEP initiation and adherence intervention. Using results of the qualitative
      interviews and input from key opinion leaders, the investigators will "decide" on
      intervention components and structure of the intervention package. The investigators will
      then "adapt" the Life-Steps intervention to be responsive to the unique context and complex
      needs of AA YMSM in Jackson, and "produce" a draft of the intervention manual. Our study team
      is made up of "topical experts" who will all have a central role in developing the
      intervention manual. Moreover, the open pilot evaluation (Phase 2) will be used to obtain
      further input on the draft intervention manual and protocol. After "integrating" the feedback
      obtained from the open pilot evaluation and exit interviews into the intervention manual and
      protocol, study staff will be "trained" in all final study procedures, and a provisional
      theory-based intervention to overcome barriers to PrEP adherence and retention, and reduce
      sexual risk behavior, among AA YMSM will be "tested" in a pilot Randomized Control Trial
      (RCT) (Phase 3). This intervention will have broad generalizability for AA YMSM across the
      South and the country as PrEP programs expand nationwide.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Presence of PrEP drug in blood samples
time frame: measured at 3 months
description: Blood samples will be collected from participants at 3- and 6-month assessments to test for the presence of detectable levels of Emtricitabine/Tenofovir (FTC/TDF). Samples will be processed and shipped to Dr. Peter Anderson's lab at the University of Colorado Anschutz for analysis of the quantification (drug levels) of detectable serum levels of FTC and TDF.
measure: Presence of PrEP drug in blood samples
time frame: measured at 6 months
description: Blood samples will be collected from participants at 3- and 6-month assessments to test for the presence of detectable levels of Emtricitabine/Tenofovir (FTC/TDF). Samples will be processed and shipped to Dr. Peter Anderson's lab at the University of Colorado Anschutz for analysis of the quantification (drug levels) of detectable serum levels of FTC and TDF.
measure: Self-reported adherence
time frame: measured at 3 months
description: Self-reported adherence (with interviews) will supplement biological monitoring data at 3-month intervals, as well at the time of the intervention sessions (for both those in the intervention and comparison condition)
measure: Self-reported adherence
time frame: measured at 6 months
description: Self-reported adherence (with interviews) will supplement biological monitoring data at 3-month intervals, as well at the time of the intervention sessions (for both those in the intervention and comparison condition)
measure: PrEP Retention in Care over time
time frame: measured at 3 months
description: This study will employ the Center for Disease Control (CDC) guidelines for retention in PrEP care, which include PrEP clinical visits every 3 to 6 months. "Retention in care" is defined as two PrEP follow up visits by month 8 of enrollment. While participants will only be randomized after attending the first PrEP clinic visit and receive a prescription from the study clinician for FTC/TDF, it is possible that they will not fill the prescription. The investigators will obtain a medical release from the participants in order that, at each assessment time-point, the study clinician can follow up with the pharmacy to determine whether or not the prescription was filled and picked up, and the date it was picked up (to assess time to initiation). Moreover, attendance at follow up clinic visits (months 3 and 6) will be calculated to assess retention in PrEP clinical care.
measure: PrEP Retention in Care over time
time frame: measured at 6 months
description: This study will employ the Center for Disease Control (CDC) guidelines for retention in PrEP care, which include PrEP clinical visits every 3 to 6 months. "Retention in care" is defined as two PrEP follow up visits by month 8 of enrollment. While participants will only be randomized after attending the first PrEP clinic visit and receive a prescription from the study clinician for FTC/TDF, it is possible that they will not fill the prescription. The investigators will obtain a medical release from the participants in order that, at each assessment time-point, the study clinician can follow up with the pharmacy to determine whether or not the prescription was filled and picked up, and the date it was picked up (to assess time to initiation). Moreover, attendance at follow up clinic visits (months 3 and 6) will be calculated to assess retention in PrEP clinical care.
measure: Sexual risk behavior/behavioral adjustment
time frame: measured at baseline
description: This study will use the AIDS-Risk Behavior Assessment (ARBA), a validated computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to 3 types of sexual behavior (anal, oral, vaginal) and assess detailed partner-by-partner sexual risk information by partner type (transactional, casual, main) and by HIV-status, protected/unprotected sex, and whether in the context of substance use in the prior 3 months.
measure: Sexual risk behavior/behavioral adjustment
time frame: measured at 3 months
description: This study will use the AIDS-Risk Behavior Assessment (ARBA), a validated computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to 3 types of sexual behavior (anal, oral, vaginal) and assess detailed partner-by-partner sexual risk information by partner type (transactional, casual, main) and by HIV-status, protected/unprotected sex, and whether in the context of substance use in the prior 3 months.
measure: Sexual risk behavior/behavioral adjustment
time frame: measured at 6 months
description: This study will use the AIDS-Risk Behavior Assessment (ARBA), a validated computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to 3 types of sexual behavior (anal, oral, vaginal) and assess detailed partner-by-partner sexual risk information by partner type (transactional, casual, main) and by HIV-status, protected/unprotected sex, and whether in the context of substance use in the prior 3 months.
arm group label: Treatment Arm
arm group type: Experimental
description: RAMP PrEP initiation, adherence, and retention intervention package as well as standard of care (access to a financial advocate and clinical staff to support, facilitate, and assist in linkage to the established PrEP clinic at Open Arms and to facilitate initiation of, and obtaining, PrEP medications)
arm group label: Control Arm
arm group type: No Intervention
description: Standard of care (access to a financial advocate and clinical staff to support, facilitate, and assist in linkage to the established PrEP clinic at Open Arms and to facilitate initiation of, and obtaining, PrEP medications)
intervention type: Behavioral
intervention name: RAMP PrEP initiation, adherence, and retention intervention
description: The intervention arm will receive facilitated strengths-based case management (SBCM)-delivered by trained interventionists-to help navigate the PrEP medical care system and support the participant and health care staff in meeting the challenges faced with obtaining PrEP medication (e.g., overcoming insurance barriers or barriers with co-pays). This also includes facilitated integration into the PrEP clinic and obtaining monthly PrEP prescription refills.
arm group label: Treatment Arm
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amy S Nunn, ScD
role: Principal Investigator
affiliation: Brown University
facility: 
country: United States
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: No