<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/NCT03832530</url>
  </required_header>
  <id_info>
    <org_study_id>2017P001853</org_study_id>
    <nct_id>NCT03832530</nct_id>
  </id_info>
  <brief_title>Periconception PrEP for HIV-exposed Ugandan Women</brief_title>
  <official_title>Adherence to Periconception HIV Risk-reduction Among Uninfected Women in Rural Uganda</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mbarara University of Science and Technology</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this mixed-methods research study, the study team will offer comprehensive safer&#xD;
      conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk&#xD;
      partner and personal or partner plans for pregnancy in rural Uganda to evaluate prevalence&#xD;
      and determinants of uptake and adherence (tenofovir plasma concentration &gt;40ng/mL, opening&#xD;
      pill device to take &gt;80% of dispensed pills) to PrEP and other safer conceptions strategies&#xD;
      among Ugandan women exposed to HIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study plans to enroll 150 HIV-uninfected women with an HIV-positive or HIV-serostatus&#xD;
      unknown partner and personal or partner pregnancy plans. Eligible women will participate in&#xD;
      comprehensive safer conception counseling including offering daily, oral TDF/FTC as PrEP. The&#xD;
      primary outcomes are to evaluate uptake of and adherence to periconception PrEP among&#xD;
      HIV-exposed women in rural Uganda.&#xD;
&#xD;
      To accomplish this, women will participate in quarterly study visits, HIV and pregnancy&#xD;
      testing, questionnaires and safer conception/adherence group counseling sessions.&#xD;
      Participants will be eligible to initiate PrEP at any time during the first 6 months of the&#xD;
      9-month study follow-up period. Participants who initiate PrEP will use an electronic pill&#xD;
      cap to measure daily adherence and will be asked to give blood samples to measure plasma TFV&#xD;
      at quarterly study visits.&#xD;
&#xD;
      For women who become pregnant in the first 9 months, investigators will follow them up&#xD;
      through completion of pregnancy to evaluate PrEP use, pregnancy and infant outcomes.&#xD;
&#xD;
      Study duration will be a maximum 19 month follow-up period (through pregnancy outcome) .&#xD;
&#xD;
      Investigators will offer objective sexually transmitted infection (STI) testing to all&#xD;
      participants in order to measure the prevalence, incidence, and factors associated with STIs.&#xD;
      Investigators will compare incidence among women who choose and who do not choose PrEP.&#xD;
      Investigators will also measure the number of episodes of condomless sex each month as a&#xD;
      mediator variable for STI development.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Safer conception counseling</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Uptake of PrEP</measure>
    <time_frame>9 months</time_frame>
    <description>Measure prevalence (measured by the proportion of women who collect the first 3 month supply of drug) TDF/FTC PrEP for safer conception</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to PrEP, daily pill taking behavior</measure>
    <time_frame>9 months</time_frame>
    <description>We will measure the proportion of women who achieve daily adherence to at least 80% of PrEP through electronic pill count measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to PrEP, plasma levels</measure>
    <time_frame>9 months</time_frame>
    <description>We will measure the proportion of women who achieve TFV plasma levels consistent with taking medication (detectable) and taking enough medication to confer protection (=&gt;40ng/mL).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>HIV Prevention</condition>
  <arm_group>
    <arm_group_label>HIV-uninfected women</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A sample of 150 women, aged 18-35, likely to be fertile based on reproductive health history, with reported personal or partner desire to have a child in the next year and who self-reports having a relationship with a partner she reports as HIV-infected or likely to be HIV-infected (e.g. taking medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied that he is &quot;sick&quot; but has not disclosed). All women are offered comprehensive safe conception counseling -- this is the intervention -- inclusive of daily oral TDF/FTC as PrEP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Safer conception counseling inclusive of periconception PrEP</intervention_name>
    <description>Observational evaluation of factors associated with uptake of and adherence to daily, oral TDF/FTC PrEP and other safer conception methods (including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive during follow-up) over 9 month. Maximum 19 month follow-up period (through pregnancy outcome).</description>
    <arm_group_label>HIV-uninfected women</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Self Report Inclusion Criteria:&#xD;
&#xD;
          1. Female&#xD;
&#xD;
          2. Aged 18-35&#xD;
&#xD;
          3. Likely to be fertile based on reproductive health history [55]&#xD;
&#xD;
          4. Reported personal or partner desire to have a child in the next year [56-59]&#xD;
&#xD;
          5. With a partner she reports as HIV-infected or likely to be HIV-infected (e.g. taking&#xD;
             medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied&#xD;
             that he is &quot;sick&quot; but has not disclosed).&#xD;
&#xD;
          6. Live within 60km of clinic. Not planning on relocating to an area incompatible with&#xD;
             ability to attend quarterly clinic over a 9-month follow-up period&#xD;
&#xD;
        Objective Inclusion Criteria:&#xD;
&#xD;
          1. HIV-negative (onsite rapid testing)&#xD;
&#xD;
          2. Not currently pregnant (onsite urine b-hcg testing)&#xD;
&#xD;
          3. Fluent in English or local language&#xD;
&#xD;
          4. Otherwise able to participate in the informed consent process&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Currently pregnant&#xD;
&#xD;
          2. HIV-positive&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mbarara University of Science and Technology</name>
      <address>
        <city>Mbarara</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>May 22, 2021</last_update_submitted>
  <last_update_submitted_qc>May 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Lynn T Matthews</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>PrEP</keyword>
  <keyword>conception</keyword>
  <keyword>prevention</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03832530/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03832530
org study id: 2017P001853
nct id: NCT03832530
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
In this mixed-methods research study, the study team will offer comprehensive safer
      conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk
      partner and personal or partner plans for pregnancy in rural Uganda to evaluate prevalence
      and determinants of uptake and adherence (tenofovir plasma concentration >40ng/mL, opening
      pill device to take >80% of dispensed pills) to PrEP and other safer conceptions strategies
      among Ugandan women exposed to HIV.
The study plans to enroll 150 HIV-uninfected women with an HIV-positive or HIV-serostatus
      unknown partner and personal or partner pregnancy plans. Eligible women will participate in
      comprehensive safer conception counseling including offering daily, oral TDF/FTC as PrEP. The
      primary outcomes are to evaluate uptake of and adherence to periconception PrEP among
      HIV-exposed women in rural Uganda.

      To accomplish this, women will participate in quarterly study visits, HIV and pregnancy
      testing, questionnaires and safer conception/adherence group counseling sessions.
      Participants will be eligible to initiate PrEP at any time during the first 6 months of the
      9-month study follow-up period. Participants who initiate PrEP will use an electronic pill
      cap to measure daily adherence and will be asked to give blood samples to measure plasma TFV
      at quarterly study visits.

      For women who become pregnant in the first 9 months, investigators will follow them up
      through completion of pregnancy to evaluate PrEP use, pregnancy and infant outcomes.

      Study duration will be a maximum 19 month follow-up period (through pregnancy outcome) .

      Investigators will offer objective sexually transmitted infection (STI) testing to all
      participants in order to measure the prevalence, incidence, and factors associated with STIs.
      Investigators will compare incidence among women who choose and who do not choose PrEP.
      Investigators will also measure the number of episodes of condomless sex each month as a
      mediator variable for STI development.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Safer conception counseling
primary purpose: Prevention
masking: None (Open Label)
measure: Uptake of PrEP
time frame: 9 months
description: Measure prevalence (measured by the proportion of women who collect the first 3 month supply of drug) TDF/FTC PrEP for safer conception
measure: Adherence to PrEP, daily pill taking behavior
time frame: 9 months
description: We will measure the proportion of women who achieve daily adherence to at least 80% of PrEP through electronic pill count measurement
measure: Adherence to PrEP, plasma levels
time frame: 9 months
description: We will measure the proportion of women who achieve TFV plasma levels consistent with taking medication (detectable) and taking enough medication to confer protection (=>40ng/mL).
arm group label: HIV-uninfected women
arm group type: Experimental
description: A sample of 150 women, aged 18-35, likely to be fertile based on reproductive health history, with reported personal or partner desire to have a child in the next year and who self-reports having a relationship with a partner she reports as HIV-infected or likely to be HIV-infected (e.g. taking medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied that he is "sick" but has not disclosed). All women are offered comprehensive safe conception counseling -- this is the intervention -- inclusive of daily oral TDF/FTC as PrEP.
intervention type: Behavioral
intervention name: Safer conception counseling inclusive of periconception PrEP
description: Observational evaluation of factors associated with uptake of and adherence to daily, oral TDF/FTC PrEP and other safer conception methods (including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive during follow-up) over 9 month. Maximum 19 month follow-up period (through pregnancy outcome).
arm group label: HIV-uninfected women
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: Uganda
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Lynn T Matthews
investigator title: Principal Investigator
provided document: 