Human Immunodeficiency VirusNCT05231707
Simunye: A Couples-focused Intervention for HIV Prevention and Care in South Africa
A study testing A couples-focused intervention for HIV prevention and care in South Africa in people with Human Immunodeficiency Virus, run by University of Michigan at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- A couples-focused intervention for HIV prevention and care in South Africa
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 1 siteSouth Africa
- Study dates
- 29 Apr 2022to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Human Sciences Research Council
Sweetwaters, KwaZulu-Natal, 3201
About this study
Official title: 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. 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.
Read the 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
- Being tested
- A couples-focused intervention for HIV prevention and care in South Africa
- Keywords
- HIV, Couples
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A couples-focused intervention for HIV prevention and care in South AfricaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: A couples-focused intervention for HIV prevention and care in South Africa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and every 6 months for 24 months
Secondary outcomes (1)
Behavioral indicators of engagement in HIV care
Engagement in care is conceptualized as including linkage to care and retention in HIV care. For HIV-positive partners who report no engagement in HIV care at baseline, linkage to care is defined as attending at least one clinical care appointment, having at least one CD4 test performed, and having at least one viral load test performed within 6 months of the baseline visit
Measured: Baseline and every 6 months for 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start29 Apr 2022
- Primary completion31 Dec 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Human Sciences Research Council, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lynae Darbes, University of Michigan
- Investigators
- Lynae Darbes, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231707
- Sponsor's protocol ID
- HUM00203672
- Other IDs
- R01MH123392
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42086273
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Couples-focused Intervention for HIV Prevention and Care in South Africa
- ClinicalTrials.gov ID
- NCT05231707
- Acronym / sponsor ID
- HUM00203672
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, Couples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Human Sciences Research Council, National Institute of Mental Health (NIMH)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: A couples-focused intervention for HIV prevention and care in South AfricaFor 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. |
| Attention Matched Control | Active comparator | Behavioral: A couples-focused intervention for HIV prevention and care in South AfricaParticipants 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
- For those individuals who already know that they are HIV-positive, the inclusion criteria will be that they report one of the following conditions:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A couples-focused intervention for HIV prevention and care in South AfricaFrom 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. | Behavioural | Attention Matched Control, Intervention |
Primary outcome
Virologic suppression change
Time frame: Baseline and every 6 months for 24 months
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.
1 secondary outcome
Behavioral indicators of engagement in HIV care
Time frame: Baseline and every 6 months for 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 42086273Darbes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynae Darbes, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A couples-focused intervention for HIV prevention and care in South Africa in people with Human Immunodeficiency Virus, run by University of Michigan at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic suppression change (time frame: Baseline and every 6 months for 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05231707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.