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Community-based Venues for Delivery of Healthcare Services: Proof of Concept Pilot

Community-based Venues for Delivery of Healthcare Services in Umlazi, South Africa: Proof of Concept Pilot Conducted in Hair Salons

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04222504
Enrollment
436
Registered
2020-01-10
Start date
2021-02-08
Completion date
2026-03-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Usage, Pre-Exposure Prophylaxis, STI

Brief summary

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.

Interventions

BEHAVIORALProvision of sexual health preventative services in the salon setting

Participants at intervention salons will be offered a choice of receiving daily PrEP and/or contraceptives (oral and injectables). Participants that elect to receive at least PrEP or contraceptives will also be offered STI testing. Follow-up visits will be planned for 3, 6, 9, and 12-months. 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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER
National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Adrenergy Research Innovations
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Female * 18 years or older * English or Zulu speaking * Able and willing to consent

Exclusion criteria

* Symptoms of acute HIV viral syndrome * Known pregnancy at baseline

Design outcomes

Primary

MeasureTime frameDescription
Uptake of Preventative Sexual Health ServicesMonths 4 to 16We will measure uptake of the intervention as the proportion of eligible women who agree to salon-based contraception (first-time users and new users) and separately to salon-based PrEP.

Countries

South Africa

Contacts

PRINCIPAL_INVESTIGATORIngrid V. Bassett, MD, MPH

Massachusetts General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026