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

January 18, 2023 updated by: Foundation for Professional Development (Pty) Ltd

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Worldwide, about 1.9 million people became infected with HIV in 2015, most of whom live in Southern and East Africa. In South Africa, the HIV incidence rate among young women ages 15-24 (2.5%) is four times higher than their male counterparts (0.6%). Recent HIV prevention trials in South Africa documented incidence rates of 5-6% per year in 15-24 year old young women. Given this high incidence of HIV, implementing effective HIV prevention strategies - including PrEP - is crucial to controlling HIV globally.

The proposed study leverages existing community-based HIV counseling and testing platforms in South Africa and evaluates, using a mixed methods approach, a community-based PrEP adherence program for young women whilst optimizing the PrEP cascade. Numerous barriers have been described that delay or block young women from accessing clinic-based health services, especially reproductive health and HIV testing and prevention services. Consequently, reaching young women at large scale with HIV prevention services requires delivery platforms outside of clinic-based facilities. Community-based counseling and testing programs have shown the greatest coverage and potential to achieve high levels of knowledge of HIV serostatus and linkage to HIV care. Using community-based counseling and testing programs, this proposal will deliver PrEP as part of a population-level combination prevention program, which is necessary to substantially reduce HIV incidence.

The investigators propose to answer key research questions through the following; Specific Aims: 1) Assess young women's uptake of PrEP when delivered through large-scale community-based HIV counseling and testing platforms in urban and rural settings in South Africa, 2) Evaluate community-based scalable interventions to achieve prevention-effective adherence to PrEP among young women, and 3) Evaluate the cost per young woman initiated on PrEP and provided adherence support through community-based platforms, and the cost-effectiveness per incident HIV infection averted. In order to achieve Aim 1, the study will leverage from on-going, at-scale CBCT programs and platforms (mobile unit and systematic home-based testing) to identify and link young women to community-based PrEP initiation services. In order to achieve Aim 2, the study will perform a 3-arm randomized controlled trial, with participants randomized to one of the following arms: Arm 1) a group-based community health club akin to an ART adherence club; Arm 2) one-on-one adherence counseling and support; Arm 3) community-based medication dispensary.

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Eastern Cape
      • East London, Eastern Cape, South Africa, 5217
        • Buffalo City Metro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Self-identified as female (regardless of assigned sex at birth)
  • 16 - 25 years of age.
  • HIV negative (confirmed during CBCT testing)
  • At risk for HIV acquisition
  • Express interest in taking PrEP

Exclusion Criteria:

  • Planning to relocate in the next 12 months
  • Positive HIV test at screening or enrolment
  • Pregnant
  • Breastfeeding
  • Current participation in other HIV prevention studies (clinical or behavioural)
  • Current use of ARV drugs for post-exposure prophylaxis (PEP)
  • Presence of any disease or health condition, self-reported or identified by initiation clinician, that may prevent participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Club
A group-based community health club akin to an ART adherence club
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.
Experimental: One-on-one
One-on-one adherence counselling and support
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.
No Intervention: Medication pick-up
Community-based medication dispensary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cost per adolescent girl and young women on pre-exposure prophylaxis
Time Frame: 10 months
Itemized cost menus
10 months
The incremental cost-effectiveness ratio per incidence HIV case averted
Time Frame: 10 months
Dynamic infectious disease model of HIV
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Professional Development (Pty) Ltd

Collaborators

National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
University of Washington
Desmond Tutu HIV Centre

Investigators

  • Principal Investigator: Andrew Medina-Marino, PhD, Foundation for Professional Development
  • Principal Investigator: Linda-Gail Bekker, MBChB, DTMH, DCH, FCP, PhD, Desmund Tutu HIV Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2018

Primary Completion (Actual)

November 20, 2021

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01MH114648 (U.S. NIH Grant/Contract)
  • 1R01MH114648 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Access Criteria

Based on contractual agreement

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PrEP

Clinical Trials on Group-based Community Health Club

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe