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

NCT ID: NCT04222504

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-08

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pre-Exposure Prophylaxis STI Contraceptive Usage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Salons

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

Group Type EXPERIMENTAL

Provision of sexual health preventative services in the salon setting

Intervention Type 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.

Control Salon

No Intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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PrEP (combined tenofovir/emtricitabine) STI testing Hormonal birth control (Oral, Injectable)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Adrenergy Research Innovations

UNKNOWN

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ingrid V. Bassett, MD, MPH

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingrid V. Bassett, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Adrenergy Research Innovations

Durban, , South Africa

Site Status

Countries

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South Africa

References

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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.

Reference Type DERIVED
PMID: 39922997 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39806604 (View on PubMed)

Other Identifiers

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K24AI141036

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BFC449/19

Identifier Type: OTHER

Identifier Source: secondary_id

2019P003869

Identifier Type: -

Identifier Source: org_study_id