Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-29 @ 12:03 PM
Study NCT ID:
NCT04222504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2020-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-based Venues for Delivery of Healthcare Services: Proof of Concept Pilot
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Community-based Venues for Delivery of Healthcare Services in Umlazi, South Africa: Proof of Concept Pilot Conducted in Hair Salons
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K24AI141036 | NIH | None | https://reporter.nih.gov/quic… | View |
| BFC449/19 | OTHER | UKZN Biomedical Research Ethics Committee | View |