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

December 20, 2023 updated by: University of Maryland, College Park

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu-Natal
      • Pietermaritzburg, KwaZulu-Natal, South Africa
        • Human Sciences Research Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of couples assigned to START Together who agree to enroll in the intervention
Time Frame: Approximately 8 weeks post-randomization
Feasibility of START Together intervention
Approximately 8 weeks post-randomization
Average score on the 14-item Applied Mental Health Research group's feasibility subscale
Time Frame: Approximately 8 weeks post-randomization
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
Time Frame: Approximately 8 weeks post-randomization
Acceptability of START Together intervention
Approximately 8 weeks post-randomization
Average number of START Together sessions attended
Time Frame: Approximately 8 weeks post-randomization
Acceptability of START Together intervention
Approximately 8 weeks post-randomization
Average score on the 15-item Applied Mental Health Research group's acceptability subscale
Time Frame: Approximately 8 weeks post-randomization
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
Time Frame: Approximately 8 weeks post-randomization
START Together intervention fidelity
Approximately 8 weeks post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral suppression for women
Time Frame: Change from baseline assessment to approximately 12 weeks post-randomization
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
Time Frame: Change from baseline assessment to approximately 8 weeks post-randomization
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
Time Frame: Change from baseline assessment to approximately 12 weeks post-randomization
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
Time Frame: 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.
Change from baseline assessment to approximately 12 weeks post-randomization
Relationship functioning (women and men)
Time Frame: Change from baseline assessment to approximately 8 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.
Change from baseline assessment to approximately 8 weeks post-randomization
Relationship functioning (women and men)
Time Frame: 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.
Change from baseline assessment to approximately 12 weeks post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, College Park

Collaborators

Canadian Institutes of Health Research (CIHR)
University of Washington
Swiss Tropical & Public Health Institute
Human Sciences Research Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

October 11, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 395623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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