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Pilot Test of a Couple-Based Medication Adherence Intervention for HIV-Positive Women and Their Male Partners in South Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03809364
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : February 7, 2019
Human Sciences Research Council
University of Washington
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jennifer Belus, University of Maryland, College Park

Brief Summary:
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 preliminary efficacy of the CBI on HIV-positive women's ART adherence, men's HIV testing, and HIV-positive men's linkage to care will be compared to a control condition of referrals to usual HIV care.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: START Together Not Applicable

Detailed Description:
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 "90-90-90" goal. 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 10 weeks thereafter.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: START Together
Couples randomized to START Together will receive the manualized treatment to enhance women's medication adherence. The treatment is anticipated to be 4 sessions in length and conducted weekly.
Behavioral: START Together
Behavioral intervention using a cognitive behavioral couple therapy (CBCT) framework designed to improve the couple's communication and problem-solving behavior.

No Intervention: Standard of Care (SOC)
Couples randomized to SOC will receive referrals to local HIV clinics to support medication adherence (for women) or other HIV-related issues (for men).

Primary Outcome Measures :
  1. HIV medication adherence for women [ Time Frame: Change from baseline assessment to approximately 10 weeks follow-up ]
    Viral load in dried blood spots

Secondary Outcome Measures :
  1. Engagement in healthcare for men [ Time Frame: Change from baseline assessment to approximately 10 weeks follow-up ]
    Dichotomous engagement in care (yes/no) will be measured by clinic records review. If clinic records are unavailable, participant self-report will be used.

  2. Relationship quality (women and men) [ Time Frame: Change from baseline assessment to approximately 6 weeks follow-up ]
    Total score on the Relationship Quality Index (RQI) from the Couple Functionality Assessment Tool (CFAT). Total scores range from 0 to 100, with higher scores indicating greater relationship quality.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 18 or over
  • HIV-positive women
  • Currently in a committed, heterosexual, monogamous romantic relationship with a male partner for at least 6 months
  • Both partners willing to participate in treatment to support women's ART adherence
  • Reside in Vulindlela, or neighboring community, KwaZulu-Natal, South Africa
  • Women only: must be HIV-positive and not taking ART or having difficulty maintaining ART adherence (i.e., not virally suppressed)
  • Able to comfortably communicate in either Zulu or English
  • Willing to have intervention sessions audio-recorded (if randomized to the intervention group)

Exclusion Criteria:

  • Report of moderate or severe relationship violence
  • Previously participated in a couple-based HIV prevention or treatment program

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Responsible Party: Jennifer Belus, Postdoctoral Fellow, University of Maryland, College Park Identifier: NCT03809364     History of Changes
Other Study ID Numbers: 395623
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Belus, University of Maryland, College Park:
Couple-based intervention
Antiretroviral therapy
South Africa
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases