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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
NA trial testing START Together in Human Immunodeficiency Virus in 40 participants. Completed in 15 December 2022.
11 October 2022
Quick facts
| Lead sponsor | University of Maryland, College Park |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 November 2021 |
| Primary completion | 11 October 2022 |
| Estimated completion | 15 December 2022 |
| Sites | 1 location across South Africa |
Drugs / interventions tested
- START Together
Conditions studied
- Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT03809364
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03809364 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Maryland, College Park
- Last refreshed: 27 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03809364.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing