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

NCT04222504 | Active Not Recruiting

• 3 other identifiers: 2019P003869K24AI141036BFC449/19
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-Exposure Prophylaxis; STI; Contraceptive Usage

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Salons

EXPERIMENTAL

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

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

Control Salon

NO INTERVENTION

No Intervention

Interventions

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.

Also known as: PrEP (combined tenofovir/emtricitabine), STI testing, Hormonal birth control (Oral, Injectable)

Intervention Salons

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years or older
• English or Zulu speaking
• Able and willing to consent

You may not qualify if:

• Symptoms of acute HIV viral syndrome
• Known pregnancy at baseline

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Adrenergy Research Innovations: collaborator

Study Sites (1)

Adrenergy Research Innovations

Durban, South Africa

Location

Related Publications (3)

• Jarolimova J, Yan J, Govere S, Shezi S, Ngcobo LM, Sagar S, Zionts D, Dube N, Parker RA, Bassett IV. Sexually Transmitted Infection Testing Integrated With HIV Prevention and Contraceptive Services in Hair Salons in Urban South Africa. J Acquir Immune Defic Syndr. 2025 Aug 1;99(4):359-367. doi: 10.1097/QAI.0000000000003677.

  PMID: 40192662 DERIVED

• Bassett IV, Yan J, Govere S, Shezi S, Ngcobo LM, Sagar S, Jarolimova J, Zionts D, Khumalo A, Zwane Z, Psaros C, Dube N, Parker RA. A pilot cluster randomized controlled trial assessing uptake of PrEP and contraception in hair salons in South Africa. BMC Public Health. 2025 Feb 8;25(1):524. doi: 10.1186/s12889-025-21718-3.

  PMID: 39922997 DERIVED

• Govere SM, Jarolimova J, Yan J, Shezi S, Ngcobo LM, Sagar S, Zionts D, Dube N, Parker RA, Psaros C, Bassett I. Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial. BMJ Open. 2024 Dec 20;14(12):e083621. doi: 10.1136/bmjopen-2023-083621.

  PMID: 39806604 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Contraception Behavior

Interventions

Emtricitabine; Hormonal Contraception; Injections

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Reproductive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Contraception; Reproductive Techniques; Therapeutics; Drug Administration Routes; Drug Therapy

Study Officials

• Ingrid V. Bassett, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: February 8, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)