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

Not Applicable

Recruiting

• Conditions: Pre-Exposure Prophylaxis; STI; Contraceptive Usage

• Registration Number: NCT04222504
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-10
• Study Start: 2021-02-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Uptake of Preventative Sexual Health Services	Months 4 to 16	We 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.

Trial Locations

Locations (1)

Adrenergy Research Innovations; 🇿🇦 Durban, South Africa