Status:
UNKNOWN
PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk
Lead Sponsor:
Wits RHI Research Centre Clinical Research Site
Collaborating Sponsors:
University of Alabama at Birmingham
University of California, San Francisco
Conditions:
HIV Prevention
Eligibility:
FEMALE
16-20 years
Phase:
NA
Brief Summary
This is a pilot randomized trial among 50 AGYW (aged ≥16≤18 years), who discontinued PrEP use within the past 6 months, assigned in a 1:1 ratio to receive: 1) STI self-test kits (Neisseria gonorrhoea ...
Detailed Description
The PALESA study aims to determine the feasibility of conducting a randomized controlled trial (RCT) to determine the impact of decentralized sexually transmitted infection (STI) point of care (POC) s...
Eligibility Criteria
Inclusion
- For the full cohort, all participants must:
- Be cis-gender adolescent females (16-20 years of age)
- Be literate
- Currently sexually active
- Be willing to participate in in-person and virtual study visits
- Not be pregnant or planning to be pregnant for the next 6 months
- Be HIV-negative but not ready to initiate PrEP at the screening and enrolment visit
- Have used PrEP with subsequent discontinuation within the last 6 months
- Have no contraindications to oral PrEP per self-report
- Have no indication of possible acute HIV infection, according to South African PrEP guidelines
- Have their own personal smart phone
- Willing to provide written informed consent/assent to participate in this study
- For the subset invited to qualitative interviews, all participants must be:
- • Willing to participate in an IDI at/before their month 6 visit (study exit visit)
Exclusion
- Potential AGYW participants who meet any of the following criteria will be excluded from the study:
- At Screening and Enrollment, parent/guardian (for those participants \<18 years) is unwilling to provide written informed consent
- At Screening and Enrollment, is already participating in another research study involving drugs, medical devices, or vaccines for STI prevention or treatment.
- Is not willing to comply with study procedures
- As determined by the PIs/designee, any current or historical physical health, mental health or social issue or condition that the site investigator or designee determines should exclude participation.
- Has any other condition that, in the opinion of the PIs/designee, would preclude informed consent, make study participation unsafe, or otherwise interfere with achieving the study objectives.
Key Trial Info
Start Date :
July 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06030856
Start Date
July 5 2023
End Date
August 1 2024
Last Update
September 11 2023
Active Locations (1)
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1
Wits RHI Research Centre
Hillbrow, Gauteng, South Africa, 2038