Clinical trial NCT05231707: Simunye: A Couples-focused Intervention for HIV Prevention and Care in South Africa
Official title: A Couples-focused Intervention for HIV Prevention and Care in South Africa
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV
Couples
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Human Sciences Research Council
First posted: 2022-02-09
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Virologic suppression change
timeFrame: Baseline and every 6 months for 24 months
Secondary outcomes:
measure: Behavioral indicators of engagement in HIV care
timeFrame: Baseline and every 6 months for 24 months
Other outcomes:
Locations:
city: Sweetwaters
country: South Africa
facility: Human Sciences Research Council
state: KwaZulu Natal
Study officials:
affiliation: University of Michigan
name: Lynae Darbes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: