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

• ClinicalTrials.gov Identifier: NCT03809364
• Recruitment Status: Active, not recruiting
• First Posted: January 18, 2019
• Last Update Posted: November 10, 2022
• Sponsor: University of Maryland, College Park
• Collaborators: Human Sciences Research Council; University of Washington; Canadian Institutes of Health Research (CIHR); Swiss Tropical & Public Health Institute
• Information provided by (Responsible Party): Jennifer Belus, University of Maryland, College Park

Study Description

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.

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 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Study Start Date: November 1, 2021
• Actual Primary Completion Date: October 11, 2022
• Estimated Study Completion Date: December 15, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.
3. Percentage of couples assigned to START Together who complete all treatment sessions [ Time Frame: Approximately 8 weeks post-randomization ]
   Acceptability of START Together intervention
4. Average number of START Together sessions attended [ Time Frame: Approximately 8 weeks post-randomization ]
   Acceptability of START Together intervention
5. 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.
6. 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

Secondary Outcome Measures :

1. 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)
2. 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
3. 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
4. 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.
5. 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.
6. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: HIV-positive women are the target study participants. They will participate in treatment with their male partners.
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

South Africa

Human Sciences Research Council

Pietermaritzburg, KwaZulu-Natal, South Africa

Sponsors and Collaborators

University of Maryland, College Park

Human Sciences Research Council

University of Washington

Canadian Institutes of Health Research (CIHR)

Swiss Tropical & Public Health Institute

More Information

Publications:

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.

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.

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.

• Responsible Party: Jennifer Belus, Postdoctoral Fellow, University of Maryland, College Park
• ClinicalTrials.gov Identifier: NCT03809364
• Other Study ID Numbers: 395623
• First Posted: January 18, 2019
• Last Update Posted: November 10, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases