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

May 19, 2026 updated by: Ingrid V. Bassett, MD, MPH, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Durban, South Africa
        • Adrenergy Research Innovations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Salons
Intervention: Behavioral: Provision of sexual health preventative services in the salon setting
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.

Other Names:
  • PrEP (combined tenofovir/emtricitabine)
  • STI testing
  • Hormonal birth control (Oral, Injectable)
No Intervention: Control Salon
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Months 4 to 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

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

Investigators

  • Principal Investigator: Ingrid V. Bassett, MD, MPH, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P003869
  • K24AI141036 (U.S. NIH Grant/Contract)
  • BFC449/19 (Other Identifier: UKZN Biomedical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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