Clinical trial NCT03977181: The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms
Official title: Leveraging Community-based Platforms to Improve Access and Adherence to PrEP for Young Women in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PrEP
HIV Prevention
Adolescence
Cost-effectiveness
Keywords: PrEP
HIV Prevention
Adherence Support
Adolescence
South Africa
Lead sponsor: Foundation for Professional Development (Pty) Ltd
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institutes of Health (NIH)
name: Desmond Tutu HIV Centre
name: University of Washington
First posted: 2019-06-06
Enrollment: 480
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The cost per adolescent girl and young women on pre-exposure prophylaxis
timeFrame: 10 months
measure: The incremental cost-effectiveness ratio per incidence HIV case averted
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: East London
country: South Africa
facility: Buffalo City Metro
state: Eastern Cape
Study officials:
affiliation: Foundation for Professional Development
name: Andrew Medina-Marino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Desmund Tutu HIV Centre
name: Linda-Gail Bekker, MBChB, DTMH, DCH, FCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.