Clinical trial NCT06030856: PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Keywords: Pre-Exposure Prophylaxis
HIV
Sexually Transmitted Infection (STI)
Lead sponsor: Wits RHI Research Centre Clinical Research Site
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: University of California, San Francisco
First posted: 2023-09-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants enrolled and retained in the PALESA study
timeFrame: 1 year
measure: Assessing Risk of Acquiring HIV and STIs
timeFrame: 1 year
measure: Number of participants that restarted PrEP
timeFrame: 1 year
measure: PrEP continuation 1 month after re-start
timeFrame: 1 year
measure: Experiences of at-home STI testing, self-administered behavioural risk assessment, and re-starting PrEP
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hillbrow
country: South Africa
facility: Wits RHI Research Centre
state: Gauteng
Study officials:
References: