NCT06030856

PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk

A Pilot Randomized Controlled Trial to Assess a Model of Decentralised STI-Self Testing and Risk Self-Assessment Among Adolescent Girls and Young Women in South Africa to Trigger PrEP Re-start

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Wits RHI Research Centre Clinical Research Site · Academic / Other
• Sex: Female
• Age: 16 Years – 20 Years
• Healthy volunteers: Accepted

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 (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)) with in-person instruction at enrolment and telephone/video-based instructions for home use coupled with self-administered behavioural risk assessment or 2) self-administered behavioural risk assessment only (standard of care). All participants will receive comprehensive sexual and reproductive health (SRH) services during their study visits including choice of family planning method initiation and support, and behavioural HIV/STI risk reduction counselling.

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) self-testing and risk self-assessment interventions to trigger pre-exposure prophylaxis (PrEP) re-start among adolescent girls and young women (AGYW) in South Africa at potential ongoing risk of re- acquiring STIs and HIV. This overall study comprises two components that include a formative research study enrolling \~60 participants for qualitative in-depth interviews (IDIs) (this has been completed) and a prospective cohort study (Pilot randomized controlled trial - RCT) enrolling 50 AGYW with both clinical, diagnostic laboratory and nested qualitative methodologies. The RCT seeks to establish the feasibility of conducting a randomized controlled trial among AGYW in South Africa to determine the impact of decentralized or at-home STI testing \[(for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)\] on restarting PrEP relative to a self-administered behavioural risk assessment. Additionally qualitative interviews will be conducted to assess adolescent girls experiences of at-home STI testing, behavioural risk assessment, and re-starting PrEP while participating in the pilot trial through exit interviews. Objective 1: To determine the feasibility and acceptability of conducting a RCT among South African AGYW to determine the impact of STI self-testing coupled with a self-administered behavioural risk assessment on restarting PrEP relative to a self-administered behavioural risk assessment only Objective 2: To assess AGYW acceptability of and experiences with use at-home STI testing, self-administered behavioural risk assessment, and re-starting PrEP while participating in the pilot RCT

Conditions

• HIV Prevention

Interventions

Type	Name	Description
DEVICE	STI test kits (NG, CT and TV) for home use	The adolescent randomized to the at-home STI testing arm will be provided with in-person instruction at enrollment and flyers (in English and isiZulu) with printed step-by-step instructions for kit use. Information will include details on how to store the kits, criteria for adequate specimen collection and preparation, how to run the test, and how to interpret the test results. Video-based instructions with accompanying text subtitles and audio options may also be provided for home use.
BEHAVIORAL	Self Administered Behavioural Risk Assessment	Self Administered assessment to determine risk of HIV, STIs and pregnancy

Timeline

• Start date: 2023-07-05
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-09-11
• Last updated: 2023-09-11

Locations

1 site across 1 country: South Africa