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

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Behavioral: START Together

• Registration Number: NCT03809364
• Lead Sponsor: 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 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

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.

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-18
• Study Start: 2021-11-01
• Primary Completion: 2022-10-11
• Study Completion: 2022-12-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• Report of moderate or severe relationship violence past year
• Either partner previously participated in a couple-based HIV prevention or treatment program

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
START Together	START Together	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Human Sciences Research Council; 🇿🇦 Pietermaritzburg, KwaZulu-Natal, South Africa