CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 480 enrolled
Drug / intervention
Group-based Community Health Club +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03977181
NCT03977181N/ACompleted

Leveraging Community-based Platforms to Improve Access and Adherence to PrEP for Young Women in South Africa

Foundation for Professional Development (Pty) Ltd·interventional·Posted Jun 6, 2019·Updated Apr 27, 2025

In Brief

A clinical study evaluating Group-based Community Health Club and Individual-based Adherence Support for PrEP and 3 related conditions. Completed, enrolled 480 participants across 1 site.

Detailed Summary

The investigators aim to 1) speed up access to and delivery of PrEP to young women, and 2) compare interventions to support and maximize the prevention-effective use of PrEP. Specifically, the investigators aim to answer the following two questions: 1) how can the study use existing community-based platforms to identify and deliver PrEP to those in need? and 2) which adherence support interventions are most likely to engender effective use of PrEP? The investigators propose to answer these questions by leveraging existing community-based HIV testing platforms in South Africa and use a mixed methods approach to optimize the PrEP cascade and evaluate a community-based PrEP adherence program for young women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Africa

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 6, 2019
Enrollment StartOct 26, 2018
Primary CompletionNov 20, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.1 years ago

Interventions

Group-based Community Health Clubbehavioral

GBHCs will be facilitated by trained Lay Health Counsellors (LHC). GBHCs will consist of a maximum 20 participants. GBHC sessions will held multiple times a month in each study area, allowing for flexibility for study participants. Sessions will be held at a safe and secure, centrally located area within the study community, and will be regularly monitored and assessed by the study coordinator. Participants will be invited to join a club-specific WhatsApp group to facilitate group communication and adherence support throughout the month. They will also be invited to partner up with another participant to provide mutual peer support. Permission will be sought from group-based adherence support participants before they are added to WhatsApp groups. Group adherence counsellors assigned will be members of WhatsApp groups, and will monitor all shared content to ensure that no inappropriate content or private information is shared in the group.

Individual-based Adherence Supportbehavioral

IAS participants will be matched to a LHC and will schedule IAS sessions once-a-month for the duration of the study. These sessions will be held at a centralized location within the study community. The sessions will be semi-structured to allow for participant-driven discussion of any adherence challenges and key-messages. The adherence curriculum will also explore motivations for PrEP and adherence and focus on practical adherence tips, environmental cues, integration of PrEP within daily routines, short-term goal-setting, problem-solving, safe PrEP disclosure and social support, risk reduction counselling, partner communication, and HIV risk perception. A subset of IAS sessions will be audio-recorded for quality assurance by investigators and the study coordinator. These recordings are for training purposes only and will not form part of the dataset. Consent for recording IAS sessions will be sought from participants during the pre-enrolment consent process.