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

Wits RHI Research Centre Clinical Research Site

Status: Enrolling

Conditions: HIV Prevention

Treatments: Device: STI test kits (NG, CT and TV) for home use; Behavioral: Self Administered Behavioural Risk Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06030856

PALESA

Details and patient eligibility

About

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: 50 estimated patients

Sex: Female

Ages: 16 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

STI test kits for home use coupled with self-administered behavioural risk assessment

Experimental group

Description:

The adolescent will receive STI test kits (NG, CT and TV) for home use coupled with self-administered behavioural risk assessment at the screening and enrolment visit.

Treatment:

Device: STI test kits (NG, CT and TV) for home use

Behavioral: Self Administered Behavioural Risk Assessment

Self-administered behavioural risk assessment only (standard of care)

Active Comparator group

Description:

The adolescent will receive a self-administered behavioural risk assessment at the screening and enrolment visit

Treatment:

Behavioral: Self Administered Behavioural Risk Assessment