Restarting HIV prevention for young women using self-testing for STIs

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

This study is testing if giving young women self-testing kits for STIs can help them start taking HIV prevention medication again.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 16 Years to 20 Years
• Sex: Female
• Sponsor: Wits RHI Research Centre Clinical Research Site (other)
• Locations: 1 site (Hillbrow, Gauteng)
• Trial ID: NCT06030856 on ClinicalTrials.gov

What this trial studies

This pilot randomized trial focuses on adolescent girls and young women aged 16 to 20 who have recently discontinued pre-exposure prophylaxis (PrEP) for HIV prevention. Participants are randomly assigned to receive either STI self-test kits with guidance or standard care involving a self-administered behavioral risk assessment. The study aims to assess the feasibility of using at-home STI testing to encourage the re-initiation of PrEP among this population in South Africa. Additionally, qualitative interviews will explore participants' experiences with the testing and assessment process.

Who should consider this trial

Good fit: Ideal candidates are cis-gender adolescent females aged 16-20 who are sexually active and have recently discontinued PrEP.

Not a fit: Patients who are not currently sexually active or who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the uptake of PrEP among young women at risk of HIV by making STI testing more accessible.

How similar studies have performed: Other studies have shown promise in using self-testing for STIs to improve health outcomes, making this approach both relevant and potentially impactful.

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.

Where this trial is running

Hillbrow, Gauteng

• Wits RHI Research Centre — Hillbrow, Gauteng, South Africa (RECRUITING)

Study contacts

• Study coordinator: Thesla Palanee-Phillips

Conditions: HIV Prevention, Pre-Exposure Prophylaxis, HIV, Sexually Transmitted Infection