<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/NCT03826199</url>
  </required_header>
  <id_info>
    <org_study_id>K01TW011187</org_study_id>
    <nct_id>NCT03826199</nct_id>
  </id_info>
  <brief_title>Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)</brief_title>
  <acronym>PrEP-PP</acronym>
  <official_title>Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Desmond Tutu HIV Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      The overarching goal of this proposal is to evaluate the feasibility and acceptability of&#xD;
      integrating PrEP into antenatal and postnatal care, to describe the cascade in women&#xD;
      initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP&#xD;
      cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1)&#xD;
      Evaluate the feasibility and acceptability of integrating PrEP into antenatal and&#xD;
      postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and&#xD;
      adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate&#xD;
      attrition and associated factors across the PrEP cascade.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 23, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</primary_completion_date>
  <phase>Phase 4</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>Open label cohort study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PrEP Retention</measure>
    <time_frame>18 months</time_frame>
    <description>number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PrEP Adherence</measure>
    <time_frame>3 months</time_frame>
    <description>number of women taking PrEP who have &gt;80 percent levels at &gt;40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PrEP Initiation</measure>
    <time_frame>18 months</time_frame>
    <description>number of women who initiate PrEP over time/ total number of women in active cohort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP Adherence (Peri-sexual)</measure>
    <time_frame>3 months</time_frame>
    <description>number of women taking PrEP who have &gt;80 percent levels at &gt;40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time when women report condomless sex in past week= PrEP adherence rate (peri-sexual)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP Adherence (Subjective, Self-reported)</measure>
    <time_frame>3 months</time_frame>
    <description>number of women taking PrEP, who self-report taking their medication daily (and pill count to confirm this) during periods of sexual risk over time / total woman time on PrEP in active cohort = PrEP adherence rate (subjective)</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Hiv</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TDF-FTC</intervention_name>
    <description>We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.</description>
    <other_name>PrEP</other_name>
    <other_name>Truvada</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counselling on PrEP in antenatal and postnatal care</intervention_name>
    <description>Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Documented HIV-negative according to two fingerpick rapid tests (per routine antenatal&#xD;
             care protocol in this setting), confirmed with a 4th generation antigen HIV test at&#xD;
             study enrollment&#xD;
&#xD;
          2. No previous exposure triple-drug antiretroviral therapy&#xD;
&#xD;
          3. Age 18 years or older&#xD;
&#xD;
          4. Lives within 20 kilometers of a clinic&#xD;
&#xD;
          5. Without psychiatric or medical contraindications to PrEP use&#xD;
&#xD;
          6. Able to provide informed consent for research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Failure to meet any of the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only pregnant women will be included</gender_description>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gugulethu Midwife Obstetric Unit</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <results_first_submitted>January 5, 2023</results_first_submitted>
  <results_first_submitted_qc>March 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2023</results_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Dvora Joseph Davey, PhD, MPH</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pre-exposure prophylaxis</keyword>
  <keyword>PrEP</keyword>
  <keyword>pregnancy</keyword>
  <keyword>prevention of mother to child transmission</keyword>
  <keyword>PMTCT</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
  </intervention_browse>
  <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>November 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03826199/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pregnant Women Offered PrEP</title>
          <description>Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>200 pregnant women enrolled in formative study and followed for 12 months postpartum</population>
      <group_list>
        <group group_id="B1">
          <title>Pregnant Women Offered PrEP</title>
          <description>Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="190"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25" lower_limit="22" upper_limit="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>PrEP Retention</title>
        <description>number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP</description>
        <time_frame>18 months</time_frame>
        <population>Participants who were retained on PrEP study and were on PrEP</population>
        <group_list>
          <group group_id="O1">
            <title>Pregnant Women Offered PrEP</title>
            <description>Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Retention</title>
          <description>number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP</description>
          <population>Participants who were retained on PrEP study and were on PrEP</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PrEP Adherence</title>
        <description>number of women taking PrEP who have &gt;80 percent levels at &gt;40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)</description>
        <time_frame>3 months</time_frame>
        <population>Women who were adherent on PrEP at 3 months per DBS measure of TFV-DP (equivalent to 2+ days/week by pregnant or postpartum)</population>
        <group_list>
          <group group_id="O1">
            <title>Pregnant Women Offered PrEP</title>
            <description>Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Adherence</title>
          <description>number of women taking PrEP who have &gt;80 percent levels at &gt;40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)</description>
          <population>Women who were adherent on PrEP at 3 months per DBS measure of TFV-DP (equivalent to 2+ days/week by pregnant or postpartum)</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PrEP Initiation</title>
        <description>number of women who initiate PrEP over time/ total number of women in active cohort</description>
        <time_frame>18 months</time_frame>
        <population>Pregnant women who enrolled in study and were offered PrEP</population>
        <group_list>
          <group group_id="O1">
            <title>Pregnant Women Offered PrEP</title>
            <description>Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Initiation</title>
          <description>number of women who initiate PrEP over time/ total number of women in active cohort</description>
          <population>Pregnant women who enrolled in study and were offered PrEP</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PrEP Adherence (Peri-sexual)</title>
        <description>number of women taking PrEP who have &gt;80 percent levels at &gt;40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time when women report condomless sex in past week= PrEP adherence rate (peri-sexual)</description>
        <time_frame>3 months</time_frame>
        <population>78 DBS drawn from participants on PrEP at 3m visit</population>
        <group_list>
          <group group_id="O1">
            <title>Pregnant Women Offered PrEP</title>
            <description>Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Adherence (Peri-sexual)</title>
          <description>number of women taking PrEP who have &gt;80 percent levels at &gt;40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time when women report condomless sex in past week= PrEP adherence rate (peri-sexual)</description>
          <population>78 DBS drawn from participants on PrEP at 3m visit</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PrEP Adherence (Subjective, Self-reported)</title>
        <description>number of women taking PrEP, who self-report taking their medication daily (and pill count to confirm this) during periods of sexual risk over time / total woman time on PrEP in active cohort = PrEP adherence rate (subjective)</description>
        <time_frame>3 months</time_frame>
        <population>Participants who started PrEP at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Pregnant Women Offered PrEP</title>
            <description>Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Adherence (Subjective, Self-reported)</title>
          <description>number of women taking PrEP, who self-report taking their medication daily (and pill count to confirm this) during periods of sexual risk over time / total woman time on PrEP in active cohort = PrEP adherence rate (subjective)</description>
          <population>Participants who started PrEP at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="194"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>We collected data every study visit (quarterly) until 12 months postpartum (up to 18 months from baseline enrollment in study)</time_frame>
      <desc>Adverse events included all pregnancy and birth outcomes in the cohort</desc>
      <group_list>
        <group group_id="E1">
          <title>Pregnant Women Offered PrEP</title>
          <description>Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Stillbirth</sub_title>
                <description>Pregnancy loss at &gt;20 weeks gestation</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Miscarriage</sub_title>
                <description>Pregnancy loss at &lt;=20 weeks gestation</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Infant low birthweight or preterm</sub_title>
                <description>LBW &lt;2500 grams; preterm born &lt;37 weeks gestation</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dvora Joseph Davey</name_or_title>
      <organization>UCLA</organization>
      <phone>3107011526</phone>
      <email>dvoradavey@ucla.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03826199
org study id: K01TW011187
nct id: NCT03826199
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The overarching goal of this proposal is to evaluate the feasibility and acceptability of
      integrating PrEP into antenatal and postnatal care, to describe the cascade in women
      initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP
      cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1)
      Evaluate the feasibility and acceptability of integrating PrEP into antenatal and
      postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and
      adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate
      attrition and associated factors across the PrEP cascade.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open label cohort study
primary purpose: Prevention
masking: None (Open Label)
measure: PrEP Retention
time frame: 18 months
description: number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP
measure: PrEP Adherence
time frame: 3 months
description: number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)
measure: PrEP Initiation
time frame: 18 months
description: number of women who initiate PrEP over time/ total number of women in active cohort
measure: PrEP Adherence (Peri-sexual)
time frame: 3 months
description: number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time when women report condomless sex in past week= PrEP adherence rate (peri-sexual)
measure: PrEP Adherence (Subjective, Self-reported)
time frame: 3 months
description: number of women taking PrEP, who self-report taking their medication daily (and pill count to confirm this) during periods of sexual risk over time / total woman time on PrEP in active cohort = PrEP adherence rate (subjective)
intervention type: Drug
intervention name: TDF-FTC
description: We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.
other name: PrEP
other name: Truvada
intervention type: Behavioral
intervention name: Counselling on PrEP in antenatal and postnatal care
description: Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.
criteria: 
gender: Female
gender based: Yes
gender description: Only pregnant women will be included
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Dvora Joseph Davey, PhD, MPH
investigator title: Principal Investigator
mesh term: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 