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NCT04222504
Community-based Venues for Delivery of Healthcare Services: Proof of Concept Pilot
NA trial testing Provision of sexual health preventative services in the salon setting in Pre-Exposure Prophylaxis in 436 participants. Completed in 31 March 2026.
31 March 2026
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 436 |
| Start date | 8 February 2021 |
| Primary completion | 31 March 2026 |
| Estimated completion | 31 March 2026 |
| Sites | 1 location across South Africa |
Drugs / interventions tested
- Provision of sexual health preventative services in the salon setting
Conditions studied
- Pre-Exposure Prophylaxis — all drugs for Pre-Exposure Prophylaxis →
- STI — all drugs for STI →
- Contraceptive Usage — all drugs for Contraceptive Usage →
Sponsor
Massachusetts General Hospital
Who can join
18 and older, female only, with Pre-Exposure Prophylaxis or STI. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators propose to offer a package of evidence-based health services to women in two hair salons in the Umlazi township of Durban. Based on community feedback in previous survey and qualitative work, the package has been designed to include daily PrEP, family planning/contraceptives, and STI screening. Interested salon clients at intervention salons will elect which services to use. An additional salon will serve as control, offering no health services to clients. Surveys will be conducted in both salon groups. Attendance at follow-up visits for monitoring and medication refill will be encouraged using text message reminders, WhatsApp support groups, and lottery-based incentives for free salon services. Recruitment in intervention salons will conclude when 100 clients uptake PrEP, not inclusive of clients who enroll at intervention salons who accept other services through the study. Approximately 250 participants will be recruited in control salons. The study team anticipates an overall total enrollment of 500.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A pilot cluster randomized controlled trial assessing uptake of PrEP and contraception in hair salons in South Africa.
Bassett IV, Yan J, Govere S, Shezi S, et al · · 2025 · cited 3× · PMID 39922997 · DOI 10.1186/s12889-025-21718-3 -
Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial.
Govere SM, Jarolimova J, Yan J, Shezi S, et al · · 2024 · cited 2× · PMID 39806604 · DOI 10.1136/bmjopen-2023-083621 -
Sexually Transmitted Infection Testing Integrated With HIV Prevention and Contraceptive Services in Hair Salons in Urban South Africa.
Jarolimova J, Yan J, Govere S, Shezi S, et al · · 2025 · PMID 40192662 · DOI 10.1097/qai.0000000000003677
Verify or expand the search:
- PubMed search for NCT04222504
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pre-Exposure Prophylaxis
Currently open trials in the same condition.
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- NCT06576648 — Thailand HIV and Stigma Reduction Study · NA · recruiting
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- NCT06415357 — Zambia Healthy Choices Project for Emerging Adults Living With HIV · NA · active not recruiting
- NCT05262426 — Developing mHealth to Promote PrEP Use Among Thai Young Vulnerable Adolescents and Emerging Adults · NA · active not recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
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- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
- NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting
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 NCT04222504 (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 Massachusetts General Hospital
- Last refreshed: 7 April 2026
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/NCT04222504.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing