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

Contraceptive Usage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222504
• Other study ID #: 2019P003869
• Secondary ID: K24AI141036BFC44
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive Usage
• Pre-Exposure Prophylaxis
• STI

Intervention

Behavioral:
• Provision 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.

Locations

Country	Name	City	State
South Africa	Adrenergy Research Innovations	Durban

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	AIDS Healthcare Foundation, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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