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

Mass General Brigham

Status: Active, not recruiting

Conditions: STI; Pre-Exposure Prophylaxis; Contraceptive Usage

Treatments: Behavioral: Provision of sexual health preventative services in the salon setting

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04222504

K24AI141036 (U.S. NIH Grant/Contract)

BFC449/19 (Other Identifier)

2019P003869

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Intervention Salons

Experimental group

Description:

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

Treatment:

Behavioral: Provision of sexual health preventative services in the salon setting

Control Salon

No Intervention group

Description:

No Intervention