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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05231707
• Other study ID #: HUM00203672
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: Lynae Darbes, Ph.D.
• Phone: 5104594164
• Email: lynaed[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 544
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

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:

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
South Africa	Human Sciences Research Council	Sweetwaters	KwaZulu Natal

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Human Sciences Research Council, University of California, San Francisco

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline and every 6 months for 24 months