Clinical Trials Logo
  1. Home
  2. HIV Prevention
  3. NCT06030856

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

HIV Prevention Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06030856
Study type Interventional
Source Wits RHI Research Centre Clinical Research Site
Contact Thesla Palanee-Phillips
Phone 11 358 5471
Email TPalanee@wrhi.ac.za
Status Recruiting
Phase N/A
Start date July 5, 2023
Completion date August 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Recruiting NCT03112369 - Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use N/A
Not yet recruiting NCT03642314 - HIV Self-testing in Implementation PrEP Study N/A
Completed NCT01810315 - Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity Phase 1
Completed NCT00984971 - Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet Phase 1
Completed NCT00142935 - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1 N/A
Active, not recruiting NCT03255915 - PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study) Early Phase 1
Active, not recruiting NCT05037513 - Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky N/A
Recruiting NCT05087680 - An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South N/A
Recruiting NCT05804461 - Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico N/A
Active, not recruiting NCT03148171 - Project WERK (Wellness Encouragement Respect Kinship) N/A
Completed NCT04791007 - OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults Early Phase 1
Recruiting NCT05412433 - Clinic-based HIV Identification and Prevention Project Using Electronic Resources N/A
Active, not recruiting NCT03977181 - The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms N/A
Recruiting NCT05165745 - Stick2PrEP Cisgender Women and Trans Individuals N/A
Completed NCT03719053 - Single Dose Truvada Study Phase 1
Recruiting NCT03856580 - Long-acting Biomedical HIV Prevention in Transgender Women N/A
Completed NCT02750540 - Optimization of a Tenofovir Enema for HIV Prevention Phase 1
Completed NCT01386294 - Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection Phase 3
Completed NCT00993811 - The Shang Ring: A Novel Male Circumcision Device for HIV Prevention Phase 1