<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/NCT01683461</url>
  </required_header>
  <id_info>
    <org_study_id>07-1070</org_study_id>
    <secondary_id>R01HD050134</secondary_id>
    <nct_id>NCT01683461</nct_id>
  </id_info>
  <brief_title>Efficacy of HIV Post-Test Support for ANC in South Africa</brief_title>
  <acronym>SAHAPS</acronym>
  <official_title>Efficacy of HIV Posttest Support for ANC in South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of KwaZulu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled intervention trial with 1,500 pregnant and postpartum women&#xD;
      to examine the efficacy of an enhanced model of ongoing post-test support for women attending&#xD;
      antenatal and postnatal care in KwaZulu-Natal, South Africa. Through the intervention, the&#xD;
      investigators will tailor voluntary counseling and testing (VCT) for HIV to the ANC setting&#xD;
      and provide a continuum of psychosocial support for pregnant women through: (1) a&#xD;
      standardized health education video before HIV pre-test counseling; (2) HIV pre- and&#xD;
      post-test counseling sessions that prepare women for decisions related to testing, serostatus&#xD;
      disclosure and anti-retroviral (ARV) prophylaxis and help women plan strategies for sexual&#xD;
      risk behavior change; (3) two additional post-test counseling sessions postpartum focusing on&#xD;
      legal education and referral, partner testing, sexual risk behavior change and family&#xD;
      planning decisions and; (4) an active referral system to post-test support groups run by a&#xD;
      clinically trained staff psychologist and (5) an active referral system to legal services run&#xD;
      by a lawyer at the clinic.&#xD;
&#xD;
      Through this intervention trial the investigators will be testing the following hypotheses:&#xD;
&#xD;
      H1: Women receiving the intervention will have significantly lower sexual risk of HIV at 14&#xD;
      weeks and 9-months post-partum as compared to women in the control arm. Sexual risk of HIV&#xD;
      will be measured by: STI incidence (Trichomonas vaginalis, Neisseria gonorrhea and&#xD;
      Chlamydia), consistent condom use, unprotected sex in past 30 days, and unprotected sex since&#xD;
      delivery.&#xD;
&#xD;
      H2: Women receiving the intervention will report significantly better outcomes related to&#xD;
      prevention of mother to child transmission (PMTCT) service uptake at 14 weeks and 9 months&#xD;
      post-partum as compared to women in the control arm. PMTCT service uptake will be measured by&#xD;
      acceptance of HIV VCT among HIV-positive and HIV-negative women; acceptance of ARVs,&#xD;
      adherence to national infant feeding guidelines, and family planning use among HIV-positive&#xD;
      women.&#xD;
&#xD;
      H3: Women in the intervention arm will report significantly better psychosocial outcomes at&#xD;
      14 weeks and 9 months post-partum as compared to women in the control arm. Psychosocial&#xD;
      outcomes will be measured by: perceived social support, emotional distress, and partner&#xD;
      violence among HIV-positive and HIV-negative women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Incidence of sexually transmitted disease</measure>
    <time_frame>14 weeks post-partum</time_frame>
    <description>The investigators are using biologic markers of three STIs (Trichomonas vaginalis, Neisseria gonorrhea and Chlamydia). All women are tested for STIs at baseline and 14-weeks post-partum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Condom use</measure>
    <time_frame>14 weeks and 9 months post-partum</time_frame>
    <description>The investigators are measuring consistent condom use, unprotected sex in the past 30 days, unprotected sex since delivery (at 9 months post-partum)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1500</enrollment>
  <condition>HIV</condition>
  <condition>Acquired Immunodeficiency Syndrome</condition>
  <arm_group>
    <arm_group_label>Enhanced Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in the intervention arm receive: (1) a standardized health education video before HIV pre-test counseling; (2) HIV pre- and post-test counseling sessions that prepare women for decisions related to testing, serostatus disclosure and anti-retroviral (ARV) prophylaxis and help women plan strategies for sexual risk behavior change; (3) two additional post-test counseling sessions postpartum focused on legal education and referral, partner testing, sexual risk behavior change and family planning decisions and; (4) an active referral system to post-test support groups run by a clinically trained staff psychologist and (5) an active referral system to legal services run by a lawyer at the clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women in the control arm receive the standard of care in terms of HIV counseling and testing during pregnancy. The standard of care for HIV counseling adheres to guidelines provided by the US Centers for Disease Control and the World Health Organization. Women receive one individual pre-test counseling session immediately before they are tested for HIV, and one individual post-test counseling session the same day that they are tested.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Counseling</intervention_name>
    <description>Women in the enhanced counseling arm receive the following intervention package: a video prior to their HIV pre-test counseling session that prepares them for decisions they will have to make regarding HIV testing and PMTCT participation, a pre-test counseling session and post-test counseling session with their nurse midwife/counselor, and two additional post-test counseling sessions with the same nurse midwife at 6 and 10 weeks postpartum. Women in the enhanced counseling arm also have access to ongoing support groups and legal support if needed at the clinic.</description>
    <arm_group_label>Enhanced Counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Women in the standard of care arm receive HIV pre and post-test counseling at their first antenatal visit. The counseling provided to them adheres to international guidelines for HIV counseling and testing developed by US CDC and the World Health Organization.</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Eligible women:&#xD;
&#xD;
          1. are at least 18 years old,&#xD;
&#xD;
          2. are not pregnant,&#xD;
&#xD;
          3. have never tested for HIV or had most recently tested negative for HIV at least 3&#xD;
             months prior to recruitment,&#xD;
&#xD;
          4. report having a primary partner who they have been with for at least 6 months,&#xD;
&#xD;
          5. plan to live in Durban for at least the next year,&#xD;
&#xD;
          6. plan to take their infant to the clinic for immunization visits,&#xD;
&#xD;
          7. are able to communicate in English or Zulu, and&#xD;
&#xD;
          8. do not need critical care for a high risk pregnancy that clinic staff is unable to&#xD;
             provide.&#xD;
&#xD;
        Exclusion Criteria: Women are ineligible if they:&#xD;
&#xD;
          1. are younger than 18 years;&#xD;
&#xD;
          2. are not pregnant;&#xD;
&#xD;
          3. have previously tested positive for HIV;&#xD;
&#xD;
          4. do not have a primary partner defined as someone they have been with for at least 6&#xD;
             months;&#xD;
&#xD;
          5. are not planning to reside in Durban for the next one year;&#xD;
&#xD;
          6. are unable to communicate in English or Zulu;&#xD;
&#xD;
          7. require care for high risk pregnancy that can not be provided by the clinic staff.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne Maman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dhayendre Moodley, MMedSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of KwaZulu</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of KwaZulu-Natal</name>
      <address>
        <city>Durban</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>September 10, 2012</last_update_submitted>
  <last_update_submitted_qc>September 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of North Carolina, Chapel Hill</investigator_affiliation>
    <investigator_full_name>Suzanne Maman</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>AIDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <!-- 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/NCT01683461
org study id: 07-1070
secondary id: R01HD050134
nct id: NCT01683461
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is a randomized controlled intervention trial with 1,500 pregnant and postpartum women
      to examine the efficacy of an enhanced model of ongoing post-test support for women attending
      antenatal and postnatal care in KwaZulu-Natal, South Africa. Through the intervention, the
      investigators will tailor voluntary counseling and testing (VCT) for HIV to the ANC setting
      and provide a continuum of psychosocial support for pregnant women through: (1) a
      standardized health education video before HIV pre-test counseling; (2) HIV pre- and
      post-test counseling sessions that prepare women for decisions related to testing, serostatus
      disclosure and anti-retroviral (ARV) prophylaxis and help women plan strategies for sexual
      risk behavior change; (3) two additional post-test counseling sessions postpartum focusing on
      legal education and referral, partner testing, sexual risk behavior change and family
      planning decisions and; (4) an active referral system to post-test support groups run by a
      clinically trained staff psychologist and (5) an active referral system to legal services run
      by a lawyer at the clinic.

      Through this intervention trial the investigators will be testing the following hypotheses:

      H1: Women receiving the intervention will have significantly lower sexual risk of HIV at 14
      weeks and 9-months post-partum as compared to women in the control arm. Sexual risk of HIV
      will be measured by: STI incidence (Trichomonas vaginalis, Neisseria gonorrhea and
      Chlamydia), consistent condom use, unprotected sex in past 30 days, and unprotected sex since
      delivery.

      H2: Women receiving the intervention will report significantly better outcomes related to
      prevention of mother to child transmission (PMTCT) service uptake at 14 weeks and 9 months
      post-partum as compared to women in the control arm. PMTCT service uptake will be measured by
      acceptance of HIV VCT among HIV-positive and HIV-negative women; acceptance of ARVs,
      adherence to national infant feeding guidelines, and family planning use among HIV-positive
      women.

      H3: Women in the intervention arm will report significantly better psychosocial outcomes at
      14 weeks and 9 months post-partum as compared to women in the control arm. Psychosocial
      outcomes will be measured by: perceived social support, emotional distress, and partner
      violence among HIV-positive and HIV-negative women.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of sexually transmitted disease
time frame: 14 weeks post-partum
description: The investigators are using biologic markers of three STIs (Trichomonas vaginalis, Neisseria gonorrhea and Chlamydia). All women are tested for STIs at baseline and 14-weeks post-partum.
measure: Condom use
time frame: 14 weeks and 9 months post-partum
description: The investigators are measuring consistent condom use, unprotected sex in the past 30 days, unprotected sex since delivery (at 9 months post-partum)
arm group label: Enhanced Counseling
arm group type: Experimental
description: Women in the intervention arm receive: (1) a standardized health education video before HIV pre-test counseling; (2) HIV pre- and post-test counseling sessions that prepare women for decisions related to testing, serostatus disclosure and anti-retroviral (ARV) prophylaxis and help women plan strategies for sexual risk behavior change; (3) two additional post-test counseling sessions postpartum focused on legal education and referral, partner testing, sexual risk behavior change and family planning decisions and; (4) an active referral system to post-test support groups run by a clinically trained staff psychologist and (5) an active referral system to legal services run by a lawyer at the clinic.
arm group label: Standard of Care
arm group type: Active Comparator
description: Women in the control arm receive the standard of care in terms of HIV counseling and testing during pregnancy. The standard of care for HIV counseling adheres to guidelines provided by the US Centers for Disease Control and the World Health Organization. Women receive one individual pre-test counseling session immediately before they are tested for HIV, and one individual post-test counseling session the same day that they are tested.
intervention type: Behavioral
intervention name: Enhanced Counseling
description: Women in the enhanced counseling arm receive the following intervention package: a video prior to their HIV pre-test counseling session that prepares them for decisions they will have to make regarding HIV testing and PMTCT participation, a pre-test counseling session and post-test counseling session with their nurse midwife/counselor, and two additional post-test counseling sessions with the same nurse midwife at 6 and 10 weeks postpartum. Women in the enhanced counseling arm also have access to ongoing support groups and legal support if needed at the clinic.
arm group label: Enhanced Counseling
intervention type: Behavioral
intervention name: Standard of Care
description: Women in the standard of care arm receive HIV pre and post-test counseling at their first antenatal visit. The counseling provided to them adheres to international guidelines for HIV counseling and testing developed by US CDC and the World Health Organization.
arm group label: Standard of Care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suzanne Maman, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Dhayendre Moodley, MMedSc, PhD
role: Principal Investigator
affiliation: University of KwaZulu
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: University of North Carolina, Chapel Hill
investigator full name: Suzanne Maman
investigator title: Associate Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Immunologic Deficiency Syndromes