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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Human Sciences Research Council
Coordinator of this site? Confirm its status
SweetwatersSouth AfricaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.