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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Behavioral: START Together


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both partners aged 18 or over HIV-positive woman diagnosed ≥ 3 months prior to study entry HIV-positive woman demonstrates difficulty with HIV treatment engagement, defined as either self-reported ART adherence difficulties, evidence of missed clinic visits over the past year (collected from medical records), or evidence of being not virally suppressed (≥ 50 copies/mL) in the past year In a committed, heterosexual, monogamous romantic relationship for at least 6 months Both partners willing to participate in treatment to support women's ART adherence Both partners reside in Vulindlela, or neighboring community, KwaZulu-Natal, South Africa Willing to have intervention sessions audio-recorded (if randomized to the intervention group) Able to comfortably communicate in either isiZulu or English Exclusion Criteria: Report of moderate or severe relationship violence past year Either partner previously participated in a couple-based HIV prevention or treatment program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: START Together<br>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. | Behavioral: START Together<br>* Behavioral intervention using a cognitive behavioral couple therapy (CBCT) framework designed to improve the couple's communication and problem-solving behavior.<br>|
| No Intervention: Standard of Care (SOC)<br>Couples randomized to SOC will receive referrals to local HIV clinics to support medication adherence (for women) or other HIV-related issues (for men). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of couples assigned to START Together who agree to enroll in the intervention | Feasibility of START Together intervention | Approximately 8 weeks post-randomization | 
| Average score on the 14-item Applied Mental Health Research group's feasibility subscale | Feasibility of START Together intervention. Higher scores indicate greater feasibility. | Approximately 8 weeks post-randomization | 
| Percentage of couples assigned to START Together who complete all treatment sessions | Acceptability of START Together intervention | Approximately 8 weeks post-randomization | 
| Average number of START Together sessions attended | Acceptability of START Together intervention | Approximately 8 weeks post-randomization | 
| Average score on the 15-item Applied Mental Health Research group's acceptability subscale | Acceptability of START Together intervention. Higher scores indicate greater acceptability. | Approximately 8 weeks post-randomization | 
| Average percentage of session content and process items that were completed correctly by the interventionist | START Together intervention fidelity | Approximately 8 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral suppression for women | Viral load in dried blood spots or based on clinic records (past 30 days) | Change from baseline assessment to approximately 12 weeks post-randomization | 
| HIV medication adherence for women | Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence | Change from baseline assessment to approximately 8 weeks post-randomization | 
| HIV medication adherence for women | Self-report using the Ira Wilson adherence measure. Higher scores indicate better adherence | Change from baseline assessment to approximately 12 weeks post-randomization | 
| Engagement in HIV care for men | Dichotomous engagement in care (yes/no) will be measured by clinic records review. If clinic records are unavailable, participant self-report will be used. | Change from baseline assessment to approximately 12 weeks post-randomization | 
| Relationship functioning (women and men) | 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. | Change from baseline assessment to approximately 8 weeks post-randomization | 
| Relationship functioning (women and men) | 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. | Change from baseline assessment to approximately 12 weeks post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Couple-based intervention, Antiretroviral therapy, South Africa