<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/NCT03809364</url>
  </required_header>
  <id_info>
    <org_study_id>395623</org_study_id>
    <nct_id>NCT03809364</nct_id>
  </id_info>
  <brief_title>Pilot Test of a Couple-Based Medication Adherence Intervention for HIV-Positive Women and Their Male Partners in South Africa</brief_title>
  <official_title>Supporting Treatment for Anti-Retroviral Therapy (START) Together: Development of a Couple-based Medication Adherence Intervention for HIV-positive Women and Their Male Partners in Sweetwaters, South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, College Park</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Human Sciences Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swiss Tropical &amp; Public Health Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, College Park</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect quantitative data related to developing and testing a&#xD;
      couple-based intervention (CBI) for HIV-positive women's medication adherence in the region&#xD;
      of Kwazulu-Natal, South Africa. The CBI, called START (Supporting Treatment for&#xD;
      Anti-Retroviral Therapy) Together, will be a manualized intervention focused on women's ART&#xD;
      adherence and enhancing the couple's communication and problem-solving behavior. The study&#xD;
      focuses on implementation outcomes (feasibility, acceptability, and fidelity) and preliminary&#xD;
      efficacy outcomes (women's ART adherence, men's engagement in HIV care, and the couple's&#xD;
      relationship functioning), which will be compared to a control condition of referrals to&#xD;
      usual HIV care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      South Africa (SA) has one of the highest global HIV burdens with clear gender disparities.&#xD;
      For men, 57% of HIV-related deaths occur among persons who have never sought HIV care. Women,&#xD;
      in comparison, have high rates of HIV testing and are linked to care through antenatal&#xD;
      services, but only 45% are virally suppressed on antiretroviral therapy (ART). Thus, tailored&#xD;
      interventions for HIV are needed. In order to end the AIDS epidemic, the ambitious &quot;90-90-90&quot;&#xD;
      goal was developed by UNAIDS to test, treat, and maintain medication adherence for 73% of&#xD;
      HIV-positive individuals. Separate gender-specific interventions have been developed along&#xD;
      the HIV care cascade to treat the different needs of men and women. However, no study to date&#xD;
      has used one intervention to concurrently meet the unique HIV-related needs for women and&#xD;
      men. Couple-based interventions (CBIs) can achieve this goal. CBIs are more efficacious than&#xD;
      interventions delivered to individuals in enhancing a number of HIV protective behaviors. HIV&#xD;
      is also primarily transmitted in the context of stable heterosexual relationships in&#xD;
      sub-Saharan Africa; about 50% of new infections occur in serodiscordant relationships, making&#xD;
      the use of a CBI especially relevant. The purpose of this study is to strengthen the HIV care&#xD;
      cascade in SA by developing a CBI that concurrently addresses the needs of women and men to&#xD;
      meet the UNAIDS' HIV goals. This study will be conducted in the province of KwaZulu-Natal,&#xD;
      SA. HIV-positive women who are in a heterosexual relationship and non-adherent to ART will be&#xD;
      recruited to participate in the study with their male partners. Twenty couples will be&#xD;
      recruited and randomized to either receive the START Together program or to the control&#xD;
      condition and followed for 12 weeks thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 1, 2021</start_date>
  <completion_date type="Anticipated">December 15, 2022</completion_date>
  <primary_completion_date type="Actual">October 11, 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of couples assigned to START Together who agree to enroll in the intervention</measure>
    <time_frame>Approximately 8 weeks post-randomization</time_frame>
    <description>Feasibility of START Together intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average score on the 14-item Applied Mental Health Research group's feasibility subscale</measure>
    <time_frame>Approximately 8 weeks post-randomization</time_frame>
    <description>Feasibility of START Together intervention. Higher scores indicate greater feasibility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of couples assigned to START Together who complete all treatment sessions</measure>
    <time_frame>Approximately 8 weeks post-randomization</time_frame>
    <description>Acceptability of START Together intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average number of START Together sessions attended</measure>
    <time_frame>Approximately 8 weeks post-randomization</time_frame>
    <description>Acceptability of START Together intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average score on the 15-item Applied Mental Health Research group's acceptability subscale</measure>
    <time_frame>Approximately 8 weeks post-randomization</time_frame>
    <description>Acceptability of START Together intervention. Higher scores indicate greater acceptability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average percentage of session content and process items that were completed correctly by the interventionist</measure>
    <time_frame>Approximately 8 weeks post-randomization</time_frame>
    <description>START Together intervention fidelity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Viral suppression for women</measure>
    <time_frame>Change from baseline assessment to approximately 12 weeks post-randomization</time_frame>
    <description>Viral load in dried blood spots or based on clinic records (past 30 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV medication adherence for women</measure>
    <time_frame>Change from baseline assessment to approximately 8 weeks post-randomization</time_frame>
    <description>Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV medication adherence for women</measure>
    <time_frame>Change from baseline assessment to approximately 12 weeks post-randomization</time_frame>
    <description>Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement in HIV care for men</measure>
    <time_frame>Change from baseline assessment to approximately 12 weeks post-randomization</time_frame>
    <description>Dichotomous engagement in care (yes/no) will be measured by clinic records review. If clinic records are unavailable, participant self-report will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship functioning (women and men)</measure>
    <time_frame>Change from baseline assessment to approximately 8 weeks post-randomization</time_frame>
    <description>Total score and subscales (relationship building, open communication, and couple-level problem-solving) of the South Africa Healthy Relationships Questionnaire. Higher scores indicate better relationship functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship functioning (women and men)</measure>
    <time_frame>Change from baseline assessment to approximately 12 weeks post-randomization</time_frame>
    <description>Total score and subscales (relationship building, open communication, and couple-level problem-solving) of the South Africa Healthy Relationships Questionnaire. Higher scores indicate better relationship functioning.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>START Together</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Couples randomized to START Together will receive the manualized treatment to enhance women's medication adherence. The treatment is 5 sessions in length and conducted weekly. Sessions are 60 - 75 minutes. Couples have the option of completing up to 3 additional booster sessions. Total treatment therefore ranges between 5 to 8 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (SOC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Couples randomized to SOC will receive referrals to local HIV clinics to support medication adherence (for women) or other HIV-related issues (for men).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>START Together</intervention_name>
    <description>Behavioral intervention using a cognitive behavioral couple therapy (CBCT) framework designed to improve the couple's communication and problem-solving behavior.</description>
    <arm_group_label>START Together</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both partners aged 18 or over&#xD;
&#xD;
          -  HIV-positive woman diagnosed ≥ 3 months prior to study entry&#xD;
&#xD;
          -  HIV-positive woman demonstrates difficulty with HIV treatment engagement, defined as&#xD;
             either self-reported ART adherence difficulties, evidence of missed clinic visits over&#xD;
             the past year (collected from medical records), or evidence of being not virally&#xD;
             suppressed (≥ 50 copies/mL) in the past year&#xD;
&#xD;
          -  In a committed, heterosexual, monogamous romantic relationship for at least 6 months&#xD;
&#xD;
          -  Both partners willing to participate in treatment to support women's ART adherence&#xD;
&#xD;
          -  Both partners reside in Vulindlela, or neighboring community, KwaZulu-Natal, South&#xD;
             Africa&#xD;
&#xD;
          -  Willing to have intervention sessions audio-recorded (if randomized to the&#xD;
             intervention group)&#xD;
&#xD;
          -  Able to comfortably communicate in either isiZulu or English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Report of moderate or severe relationship violence past year&#xD;
&#xD;
          -  Either partner previously participated in a couple-based HIV prevention or treatment&#xD;
             program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>HIV-positive women are the target study participants. They will participate in treatment with their male partners.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Human Sciences Research Council</name>
      <address>
        <city>Pietermaritzburg</city>
        <state>KwaZulu-Natal</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <reference>
    <citation>Crepaz N, Tungol-Ashmon MV, Vosburgh HW, Baack BN, Mullins MM. Are couple-based interventions more effective than interventions delivered to individuals in promoting HIV protective behaviors? A meta-analysis. AIDS Care. 2015;27(11):1361-6. doi: 10.1080/09540121.2015.1112353. Epub 2015 Nov 25.</citation>
    <PMID>26608175</PMID>
  </reference>
  <reference>
    <citation>Anglemyer A, Horvath T, Rutherford G. Antiretroviral therapy for prevention of HIV transmission in HIV-discordant couples. JAMA. 2013 Oct 16;310(15):1619-20. doi: 10.1001/jama.2013.278328.</citation>
    <PMID>24129466</PMID>
  </reference>
  <reference>
    <citation>Bor J, Rosen S, Chimbindi N, Haber N, Herbst K, Mutevedzi T, Tanser F, Pillay D, Barnighausen T. Mass HIV Treatment and Sex Disparities in Life Expectancy: Demographic Surveillance in Rural South Africa. PLoS Med. 2015 Nov 24;12(11):e1001905; discussion e1001905. doi: 10.1371/journal.pmed.1001905. eCollection 2015 Nov.</citation>
    <PMID>26599699</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, College Park</investigator_affiliation>
    <investigator_full_name>Jennifer Belus</investigator_full_name>
    <investigator_title>Postdoctoral Fellow</investigator_title>
  </responsible_party>
  <keyword>Couple-based intervention</keyword>
  <keyword>Antiretroviral therapy</keyword>
  <keyword>South Africa</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>
  </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/NCT03809364
org study id: 395623
nct id: NCT03809364
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to collect quantitative data related to developing and testing a
      couple-based intervention (CBI) for HIV-positive women's medication adherence in the region
      of Kwazulu-Natal, South Africa. The CBI, called START (Supporting Treatment for
      Anti-Retroviral Therapy) Together, will be a manualized intervention focused on women's ART
      adherence and enhancing the couple's communication and problem-solving behavior. The study
      focuses on implementation outcomes (feasibility, acceptability, and fidelity) and preliminary
      efficacy outcomes (women's ART adherence, men's engagement in HIV care, and the couple's
      relationship functioning), which will be compared to a control condition of referrals to
      usual HIV care.
South Africa (SA) has one of the highest global HIV burdens with clear gender disparities.
      For men, 57% of HIV-related deaths occur among persons who have never sought HIV care. Women,
      in comparison, have high rates of HIV testing and are linked to care through antenatal
      services, but only 45% are virally suppressed on antiretroviral therapy (ART). Thus, tailored
      interventions for HIV are needed. In order to end the AIDS epidemic, the ambitious "90-90-90"
      goal was developed by UNAIDS to test, treat, and maintain medication adherence for 73% of
      HIV-positive individuals. Separate gender-specific interventions have been developed along
      the HIV care cascade to treat the different needs of men and women. However, no study to date
      has used one intervention to concurrently meet the unique HIV-related needs for women and
      men. Couple-based interventions (CBIs) can achieve this goal. CBIs are more efficacious than
      interventions delivered to individuals in enhancing a number of HIV protective behaviors. HIV
      is also primarily transmitted in the context of stable heterosexual relationships in
      sub-Saharan Africa; about 50% of new infections occur in serodiscordant relationships, making
      the use of a CBI especially relevant. The purpose of this study is to strengthen the HIV care
      cascade in SA by developing a CBI that concurrently addresses the needs of women and men to
      meet the UNAIDS' HIV goals. This study will be conducted in the province of KwaZulu-Natal,
      SA. HIV-positive women who are in a heterosexual relationship and non-adherent to ART will be
      recruited to participate in the study with their male partners. Twenty couples will be
      recruited and randomized to either receive the START Together program or to the control
      condition and followed for 12 weeks thereafter.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of couples assigned to START Together who agree to enroll in the intervention
time frame: Approximately 8 weeks post-randomization
description: Feasibility of START Together intervention
measure: Average score on the 14-item Applied Mental Health Research group's feasibility subscale
time frame: Approximately 8 weeks post-randomization
description: Feasibility of START Together intervention. Higher scores indicate greater feasibility.
measure: Percentage of couples assigned to START Together who complete all treatment sessions
time frame: Approximately 8 weeks post-randomization
description: Acceptability of START Together intervention
measure: Average number of START Together sessions attended
time frame: Approximately 8 weeks post-randomization
description: Acceptability of START Together intervention
measure: Average score on the 15-item Applied Mental Health Research group's acceptability subscale
time frame: Approximately 8 weeks post-randomization
description: Acceptability of START Together intervention. Higher scores indicate greater acceptability.
measure: Average percentage of session content and process items that were completed correctly by the interventionist
time frame: Approximately 8 weeks post-randomization
description: START Together intervention fidelity
measure: Viral suppression for women
time frame: Change from baseline assessment to approximately 12 weeks post-randomization
description: Viral load in dried blood spots or based on clinic records (past 30 days)
measure: HIV medication adherence for women
time frame: Change from baseline assessment to approximately 8 weeks post-randomization
description: Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence
measure: HIV medication adherence for women
time frame: Change from baseline assessment to approximately 12 weeks post-randomization
description: Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence
measure: Engagement in HIV care for men
time frame: Change from baseline assessment to approximately 12 weeks post-randomization
description: Dichotomous engagement in care (yes/no) will be measured by clinic records review. If clinic records are unavailable, participant self-report will be used.
measure: Relationship functioning (women and men)
time frame: Change from baseline assessment to approximately 8 weeks post-randomization
description: Total score and subscales (relationship building, open communication, and couple-level problem-solving) of the South Africa Healthy Relationships Questionnaire. Higher scores indicate better relationship functioning.
measure: Relationship functioning (women and men)
time frame: Change from baseline assessment to approximately 12 weeks post-randomization
description: Total score and subscales (relationship building, open communication, and couple-level problem-solving) of the South Africa Healthy Relationships Questionnaire. Higher scores indicate better relationship functioning.
arm group label: START Together
arm group type: Experimental
description: Couples randomized to START Together will receive the manualized treatment to enhance women's medication adherence. The treatment is 5 sessions in length and conducted weekly. Sessions are 60 - 75 minutes. Couples have the option of completing up to 3 additional booster sessions. Total treatment therefore ranges between 5 to 8 sessions.
arm group label: Standard of Care (SOC)
arm group type: No Intervention
description: Couples randomized to SOC will receive referrals to local HIV clinics to support medication adherence (for women) or other HIV-related issues (for men).
intervention type: Behavioral
intervention name: START Together
description: Behavioral intervention using a cognitive behavioral couple therapy (CBCT) framework designed to improve the couple's communication and problem-solving behavior.
arm group label: START Together
criteria: 
gender: All
gender based: Yes
gender description: HIV-positive women are the target study participants. They will participate in treatment with their male partners.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: South Africa
citation: Crepaz N, Tungol-Ashmon MV, Vosburgh HW, Baack BN, Mullins MM. Are couple-based interventions more effective than interventions delivered to individuals in promoting HIV protective behaviors? A meta-analysis. AIDS Care. 2015;27(11):1361-6. doi: 10.1080/09540121.2015.1112353. Epub 2015 Nov 25.
PMID: 26608175
citation: Anglemyer A, Horvath T, Rutherford G. Antiretroviral therapy for prevention of HIV transmission in HIV-discordant couples. JAMA. 2013 Oct 16;310(15):1619-20. doi: 10.1001/jama.2013.278328.
PMID: 24129466
citation: Bor J, Rosen S, Chimbindi N, Haber N, Herbst K, Mutevedzi T, Tanser F, Pillay D, Barnighausen T. Mass HIV Treatment and Sex Disparities in Life Expectancy: Demographic Surveillance in Rural South Africa. PLoS Med. 2015 Nov 24;12(11):e1001905; discussion e1001905. doi: 10.1371/journal.pmed.1001905. eCollection 2015 Nov.
PMID: 26599699
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, College Park
investigator full name: Jennifer Belus
investigator title: Postdoctoral Fellow
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No