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NCT03809364

Pilot Test of a Couple-Based Medication Adherence Intervention for HIV-Positive Women and Their Male Partners in South Africa

Completed NA Last updated 27 December 2023
What this trial tests

NA trial testing START Together in Human Immunodeficiency Virus in 40 participants. Completed in 15 December 2022.

Timeline
1 November 2021
Primary endpoint
11 October 2022
15 December 2022

Quick facts

Lead sponsorUniversity of Maryland, College Park
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date1 November 2021
Primary completion11 October 2022
Estimated completion15 December 2022
Sites1 location across South Africa

Drugs / interventions tested

Conditions studied

Sponsor

University of Maryland, College Park

Who can join

18 and older, any sex, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to collect quantitative data related to developing and testing a couple-based intervention (CBI) for HIV-positive women's medication adherence in the region of Kwazulu-Natal, South Africa. The CBI, called START (Supporting Treatment for Anti-Retroviral Therapy) Together, will be a manualized intervention focused on women's ART adherence and enhancing the couple's communication and problem-solving behavior. The study focuses on implementation outcomes (feasibility, acceptability, and fidelity) and preliminary efficacy outcomes (women's ART adherence, men's engagement in HIV care, and the couple's relationship functioning), which will be compared to a control condition of referrals to usual HIV care.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Accuracy of measures for antiretroviral adherence in people living with HIV.
    Smith R, Villanueva G, Probyn K, Sguassero Y, et al · · 2022 · cited 34× · PMID 35871531 · DOI 10.1002/14651858.cd013080.pub2
  2. Feasibility and Acceptability Pilot Test of Connecting Latinos en Parejas: A Couples-Based HIV Prevention Intervention for Latino Male Couples.
    Martinez O, Fernandez MI, Yang C, Wu E, et al · · 2023 · cited 6× · PMID 37096329 · DOI 10.1177/15579883231167106
  3. Supporting Treatment for Anti-Retroviral Therapy (START) Together: Protocol for a pilot, randomized, couple-based intervention to promote women's ART adherence and men's engagement in HIV care in KwaZulu-Natal, South Africa.
    Belus JM, van Heerden A, van Rooyen H, Bradley VD, et al · · 2022 · cited 2× · PMID 36105267 · DOI 10.1016/j.conctc.2022.100970
  4. Couple-Based Intervention to Improve HIV Care Engagement for Women and their Partners in KwaZulu-Natal, South Africa: Outcomes of a Pilot Randomized Controlled Trial.
    Belus JM, van Heerden A, Hines AC, Pita TP, et al · · 2025 · cited 1× · PMID 39871688 · DOI 10.1177/23259582241307694

Verify or expand the search:

Other recruiting trials for Human Immunodeficiency Virus

Currently open trials in the same condition.

Other University of Maryland, College Park trials

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing