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

NCT06030856 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-09-11

No results posted yet for this study

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.

Conditions

  • HIV Prevention

Interventions

DEVICE

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

The adolescent randomized to the at-home STI testing arm will be provided with in-person instruction at enrollment and flyers (in English and isiZulu) with printed step-by-step instructions for kit use. Information will include details on how to store the kits, criteria for adequate specimen collection and preparation, how to run the test, and how to interpret the test results. Video-based instructions with accompanying text subtitles and audio options may also be provided for home use.

BEHAVIORAL

Self Administered Behavioural Risk Assessment

Self Administered assessment to determine risk of HIV, STIs and pregnancy

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-05
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • South Africa

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06030856 on ClinicalTrials.gov