ClinicalTrials.gg
CompletedNCT04222504Updated May 22, 2026

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

An interventional study of Provision of sexual health preventative services in the salon setting in Pre-Exposure Prophylaxis, STI and Contraceptive Usage, sponsored by Massachusetts General Hospital. Completed at 1 site in South Africa. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
436
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Pre-Exposure Prophylaxis
  • STI
  • Contraceptive Usage
03

In context

Sexually Transmitted Diseases

523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.

This study's enrollment of 436 is close to the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.

Browse Sexually Transmitted Diseases studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Symptoms of acute viral syndrome
  • Known pregnancy at baseline
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
436 participants (actual)

Study arms

  • 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

  • No intervention
    Control Salon

    No Intervention

Interventions

  • BehavioralProvision 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.

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

06

What researchers measure

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.

    Time frame: Months 4 to 16

07

Study locations

1 site
  • Adrenergy Research Innovations
    Durban, South Africa
08

References and documents

Publications

  • 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. PubMed 40192662 ↗
  • 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. PubMed 39922997 ↗
  • 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. PubMed 39806604 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04222504
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Adrenergy Research Innovations
Responsible party
Ingrid V. Bassett, MD, MPH (Professor of Medicine, Massachusetts General Hospital) — Principal investigator
First posted
Jan 10, 2020
Start date
Feb 8, 2021
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026
Last update
May 22, 2026

Study contacts

Ingrid V. Bassett, MD, MPH
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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