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

Study Overview
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Brief Summary
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The investigators propose to offer a package of evidence-based health services to women in three 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 three salons will serve as controls, 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 200 clients uptake PrEP. Two hundred participants will be recruited in control salons.

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

Conditions
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STI, Pre-Exposure Prophylaxis, Contraceptive Usage

Intervention / Treatment
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* Behavioral: Provision of sexual health preventative services in the salon setting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Salons<br>Intervention: Behavioral: Provision of sexual health preventative services in the salon setting | Behavioral: Provision of sexual health preventative services in the salon setting<br>* 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.<br>* Other names: Hormonal birth control (Oral, Injectable);|
| No Intervention: Control Salons<br>No Intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of Preventative Sexual Health Services | 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. | Months 4 to 16 |