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

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.

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Key information

Conditions

Pre-exposure Prophylaxis Behavior Communicable Diseases Contraception Behavior Contraceptive Usage Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Reproductive Behavior STI Sexually Transmitted Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Adrenergy Research Innovations

Durban, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Provision of sexual health preventative services in the salon setting

Behavioral

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.

Other names: PrEP (combined tenofovir/emtricitabine), STI testing, Hormonal birth control (Oral, Injectable)

Primary outcomes

Uptake of Preventative Sexual Health Services

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

Adrenergy Research Innovations
National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Jan 10, 2020
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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