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

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ClinicalTrials.gov Identifier: NCT05231707
Recruitment Status : Recruiting
First Posted : February 9, 2022
Last Update Posted : May 5, 2022
Sponsor:
Collaborators:
University of California, San Francisco
Human Sciences Research Council
Information provided by (Responsible Party):
Robert Stephenson, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: A couples-focused intervention for HIV prevention and care in South Africa Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 544 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Couples-focused Intervention for HIV Prevention and Care in South Africa
Actual Study Start Date : April 29, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender only
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05231707


Contacts
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Contact: Jayelin N Parker, MPH 2488609446 jayelinp@umich.edu

Locations
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South Africa
Human Sciences Research Council Recruiting
Sweetwaters, KwaZulu Natal, South Africa, 3201
Contact: Alastair van Heerden, PhD       avanheerden@hsrc.ac.za   
Contact: Sphamandla Mpisane    +27 76 580 9526    SPMpisane@hsrc.ac.za   
Sponsors and Collaborators
University of Michigan
University of California, San Francisco
Human Sciences Research Council
Investigators
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Principal Investigator: Rob B Stephenson, PhD Center for Sexuality and Health Disparities
Principal Investigator: Lynae Darbes, PhD Center for Sexuality and Health Disparities
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Responsible Party: Robert Stephenson, Chair, Department of Systems, Population and Leadership, University of Michigan
ClinicalTrials.gov Identifier: NCT05231707    
Other Study ID Numbers: HUM00203672
First Posted: February 9, 2022    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Stephenson, University of Michigan:
HIV
Couples
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases