NCT05231707Completed
Simunye: A Couples-focused Intervention for HIV Prevention and Care in South Africa
A Couples-focused Intervention for HIV Prevention and Care in South Africa
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 544 (actual)
- First submitted
- 28 Jan 2022
- Start date
- 29 Apr 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Michigan
- Diseases
- HIV
- NCT number
- NCT05231707
What you commit to
- Study type: Interventional
- Participants enrolled: 544
- From 29 Apr 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Couples in which one or both members report experiencing or perpetrating severe IPV in the prior 6 months
Age
- Below age 18 or above age 50
Other
- 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
Who the study is looking for
- 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.
- Serostatus Inclusion Criteria:
- For those individuals who already know that they are HIV-positive, the inclusion criteria will be that they report one of the following conditions:
- 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
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Human Sciences Research Council Coordinator of this site? Confirm its status | Sweetwaters | South Africa | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.