The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms

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.

Conditions

• PrEP
• HIV Prevention
• Adolescence
• Cost-effectiveness

Interventions

BEHAVIORAL

Group-based Community Health Club

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.

BEHAVIORAL

Individual-based Adherence Support

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Desmond Tutu HIV Centre

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Foundation for Professional Development (Pty) Ltd

  lead OTHER

Principal Investigators

• Andrew Medina-Marino, PhD · Foundation for Professional Development

• Linda-Gail Bekker, MBChB, DTMH, DCH, FCP, PhD · Desmund Tutu HIV Centre

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

25 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-26

Primary Completion

2021-11-20

Completion

2021-11-20

Countries

• South Africa

Study Locations