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

NCT05231707 | Completed DMC

• 2 other identifiers: HUM00203672R01MH123392
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV; Couples

Outcome Measures

Primary Outcomes (1)

• Virologic suppression change

  A blood draw will be conducted to provide a measure of viral load at each visit to look for changes between visits. The outcome will be a binary outcome of detectable versus undetectable viral load.

  Baseline and every 6 months for 24 months

Secondary Outcomes (1)

• Behavioral indicators of engagement in HIV care

  Baseline and every 6 months for 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

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

Attention Matched Control

ACTIVE COMPARATOR

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).

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Cisgender only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• both aged between 18-50
• report being a cis-gender male and a cis-gender female
• report being in a relationship with each other for at least 6 months
• are not in a polygamous marriage and 5) report being sexually active with their partner.
• have never initiated ART
• not currently on ART (but can have been on it before)
• if already on ART, that they have missed 3 doses of medication in the past 30 days

You may not qualify if:

• Couples in which one or both members report experiencing or perpetrating severe IPV in the prior 6 months
• Below age 18 or above age 50
• Report being transgender
• Report not being a relationship at all or for \<6 months
• Are in a polyamorous marriage
• Are not sexual active with participating partner

Sponsors & Collaborators

• University of Michigan: lead
• University of California, San Francisco: collaborator
• Human Sciences Research Council: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Human Sciences Research Council

Sweetwaters, KwaZulu-Natal, 3201, South Africa

Location

Related Publications (1)

• Darbes LA, Chibi B, Tesfay N, Dilworth SE, Humphries H, Merrill L, Conroy AA, Johnson MO, Neilands TB, Gutin SA, van Heerden A. Couple-based intervention for HIV prevention, care and treatment in South Africa: a study protocol for a randomised controlled trial of Simunye. BMJ Open. 2026 May 5;16(5):e114075. doi: 10.1136/bmjopen-2025-114075.

  PMID: 42086273 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; 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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Lynae Darbes, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing, School of Nursing

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: April 29, 2022
• Primary Completion: December 31, 2025
• Study Completion: May 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)