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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.
Full 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
Enrollment
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Inclusion criteria
For the full cohort, all participants must:
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 criteria
Potential AGYW participants who meet any of the following criteria will be excluded from the study:
Primary purpose
Allocation
Interventional model
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50 participants in 2 patient groups
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Central trial contact
Krishnaveni Reddy; Thesla Palanee-Phillips
Data sourced from clinicaltrials.gov
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