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

September 29, 2023 updated by: Lynae Darbes, University of Michigan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

544

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
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.
Active Comparator: Attention Matched Control
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and every 6 months for 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral indicators of engagement in HIV care
Time Frame: Baseline and every 6 months for 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

University of California, San Francisco
Human Sciences Research Council

Investigators

  • Principal Investigator: Lynae Darbes, Ph.D., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00203672

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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