Simunye: A Couples-focused Intervention for HIV Prevention and Care in South Africa

NCT ID: NCT05231707

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 544 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2026-05-01

Brief Summary

From a sample of 272 male-female couples (544 individuals, 272 men and 272 women) recruited from rural KaZulu-Natal, South Africa, couples will be randomized to receive either individual a package of dyadic counseling and testing (intervention arm) or an attention matched control. The research examines the impact of a package of dyadic counseling and testing on viral suppression and engagement in HIV care among sero-discordant and concordant positive male-female couples in KwaZulu-Natal, South Africa.

Detailed Description

South Africa remains one of the countries mostly heavily impacted by the HIV epidemic, with an overall estimated adult HIV prevalence of 18% to 30% among female antenatal clinic attendees. There is now substantial evidence that more than 80% of new infections occur within primary male-female partnerships. The high rates of new infections among primary partnerships are attributed to a combination of low levels of HIV testing and a high prevalence of outside sex partners. Recent work by Darbes (MPI), in KwaZulu-Natal (KZN) - the site of the proposed new research - found that among a sample of 330 heterosexual couples, 49% of men and 41% of women had no previous HIV testing history. In 20% of couples, neither partner had ever tested for HIV, despite living in a region with one of the highest adult HIV prevalence globally. Beyond the low levels of HIV testing, recent work also demonstrates significant deficits across the continuum of care in South Africa: recent work by Haber in KZN shows that only 45% of HIV-positive individuals are linked to care, 35% initiate ART, and 33% reach viral suppression. There is increasing evidence of efficacy for couples' focused HIV prevention interventions. Couples HIV Testing and Counseling (CHTC) is a proven strategy to reduce the risk of HIV transmission between partners. However, CHTC focuses only on the first stage of the cascade of HIV care - testing - are there are no interventions that allow couples to pass through the cascade of care together. Using a randomized controlled trial design with 272 couples, we aim to address this gap in HIV prevention and care literature by comparing a package of dyadic focused HIV testing and counseling interventions, against an attention matched control. The proposed RCT will test the efficacy of the dyadic intervention for achieving gains in viral suppression and engagement in HIV care. Heterosexual couples represent a significant yet over- looked risk group in South Africa, and innovative solutions are urgently needed to improve progression across the continuum of HIV care.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

For couples who are prevalent sero-discordant, this will be a CHTC session. For couples who are prevalent concordant HIV-positive, the first visit will be the first Partner Steps session. For couples in which one or both do not know their sero-status or have not tested for HIV in the past 12 months, the first session will be a CHTC session.

Group Type: EXPERIMENTAL

A couples-focused intervention for HIV prevention and care in South Africa

Intervention Type: BEHAVIORAL

From a sample of 272 male-female couples (544 individuals, 272 men and 272 women) recruited from rural KaZulu-Natal, South Africa, couples will be randomized to receive either individual a package of dyadic counseling and testing (intervention arm) or an attention matched control.

Attention Matched Control

Participants in the control group will receive an intervention, with the same number of sessions as couples of the same sero-status in the intervention condition, delivered via one-on-one couples counseling sessions (i.e., one couple with one counselor).

Group Type: ACTIVE_COMPARATOR

A couples-focused intervention for HIV prevention and care in South Africa

Intervention Type: BEHAVIORAL

From a sample of 272 male-female couples (544 individuals, 272 men and 272 women) recruited from rural KaZulu-Natal, South Africa, couples will be randomized to receive either individual a package of dyadic counseling and testing (intervention arm) or an attention matched control.

Interventions

A couples-focused intervention for HIV prevention and care in South Africa

From a sample of 272 male-female couples (544 individuals, 272 men and 272 women) recruited from rural KaZulu-Natal, South Africa, couples will be randomized to receive either individual a package of dyadic counseling and testing (intervention arm) or an attention matched control.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. both aged between 18-50

2. report being a cis-gender male and a cis-gender female

3. report being in a relationship with each other for at least 6 months

4. are not in a polygamous marriage and 5) report being sexually active with their partner.

1. have never initiated ART

2. not currently on ART (but can have been on it before)

3. if already on ART, that they have missed 3 doses of medication in the past 30 days

Exclusion Criteria

1. Couples in which one or both members report experiencing or perpetrating severe IPV in the prior 6 months

2. Below age 18 or above age 50

3. Report being transgender

4. Report not being a relationship at all or for <6 months

5. Are in a polyamorous marriage

6. Are not sexual active with participating partner

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Human Sciences Research Council

OTHER_GOV

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Lynae Darbes

Professor of Nursing, School of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynae Darbes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Human Sciences Research Council

Sweetwaters, KwaZulu-Natal, South Africa

Countries

South Africa

Other Identifiers

HUM00203672

Identifier Type: -

Identifier Source: org_study_id