NCT03977181

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2021

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

3.1 years

First QC Date

May 23, 2019

Last Update Submit

April 24, 2025

Conditions

PrEPHIV PreventionAdolescenceCost-effectiveness

Keywords

PrEPHIV PreventionAdherence SupportAdolescenceSouth Africa

Outcome Measures

Primary Outcomes (2)

  • The cost per adolescent girl and young women on pre-exposure prophylaxis

    Itemized cost menus

    10 months

  • The incremental cost-effectiveness ratio per incidence HIV case averted

    Dynamic infectious disease model of HIV

    10 months

Study Arms (3)

Health Club

EXPERIMENTAL

A group-based community health club akin to an ART adherence club

Behavioral: Group-based Community Health Club

One-on-one

EXPERIMENTAL

One-on-one adherence counselling and support

Behavioral: Individual-based Adherence Support

Medication pick-up

NO INTERVENTION

Community-based medication dispensary

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.

Health Club
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.

One-on-one

Eligibility Criteria

Age16 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified as female (regardless of assigned sex at birth)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buffalo City Metro

East London, Eastern Cape, 5217, South Africa

Location

Related Publications (5)

  • de Vos L, Krogstad Mudzingwa E, Fynn L, Atujuna M, Webb Mazinyo E, Kodi K, Hosek S, Katz IT, Celum C, Bekker LG, Daniels J, Medina-Marino A. Study-to-Clinic Transition and Daily Oral PrEP Access Experiences Among AGYW in Eastern Cape, South Africa: Insights from the Community PrEP Study. AIDS Behav. 2025 Aug;29(8):2574-2587. doi: 10.1007/s10461-025-04718-7. Epub 2025 Apr 17.

    PMID: 40240718DERIVED

  • Krogstad Mudzingwa E, de Vos L, Atujuna M, Fynn L, Mugore M, Mabandla S, Hosek S, Celum C, Bekker LG, Daniels J, Medina-Marino A. High study participation but diverging adherence levels: qualitatively unpacking PrEP use among adolescent girls and young women over two years in Eastern Cape, South Africa. J Behav Med. 2024 Apr;47(2):320-333. doi: 10.1007/s10865-023-00462-2. Epub 2023 Dec 11.

    PMID: 38081955DERIVED

  • de Vos L, Mudzingwa EK, Fynn L, Atujuna M, Mugore M, Gandhi M, Celum C, Hosek S, Bekker LG, Daniels J, Medina-Marino A. Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa. J Int AIDS Soc. 2023 Sep;26(9):e26175. doi: 10.1002/jia2.26175.

    PMID: 37758649DERIVED

  • Mudzingwa EK, de Vos L, Atujuna M, Fynn L, Mugore M, Hosek S, Celum C, Bekker LG, Daniels J, Medina-Marino A. Factors influencing adolescent girls and young women's uptake of community-based PrEP services following home-based HIV testing in Eastern Cape, South Africa: a qualitative study. AIDS Behav. 2022 Nov;26(11):3726-3739. doi: 10.1007/s10461-022-03702-9. Epub 2022 Jun 2.

    PMID: 35653046DERIVED

  • Medina-Marino A, Bezuidenhout D, Hosek S, Barnabas RV, Atujuna M, Bezuidenhout C, Ngwepe P, Peters RPH, Little F, Celum CL, Daniels J, Bekker LG. The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa-study protocol. Trials. 2021 Jul 26;22(1):489. doi: 10.1186/s13063-021-05402-6.

    PMID: 34311754DERIVED

Study Officials

  • Andrew Medina-Marino, PhD

    Foundation for Professional Development

    PRINCIPAL INVESTIGATOR

  • Linda-Gail Bekker, MBChB, DTMH, DCH, FCP, PhD

    Desmund Tutu HIV Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The allocation of study arm is concealed to study staff during randomization
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Investigators 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; or Arm 3) community-based medication dispensary.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

June 6, 2019

Study Start

October 26, 2018

Primary Completion

November 20, 2021

Study Completion

November 20, 2021

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Access Criteria
Based on contractual agreement

Locations

ZA(1)