Evidence map›Paper›PMID 34311754›Full record

ArticleTrials2021

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.

Andrew Medina-Marino, Dana Bezuidenhout, Sybil Hosek, Ruanne V Barnabas, Millicent Atujuna, Charl Bezuidenhout, Phuti Ngwepe, Remco P H Peters, Francesca Little, Connie L Celum and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03977181 (Leveraging Community-based Platforms to Improve Access and Adherence to PrEP for Young Women in South Africa), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03977181 nacompletednot on this map

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

TypeinterventionalSponsorFoundation for Professional Development (Pty) LtdRan2018 to 2021Enrolled480ConditionsPrEP, HIV Prevention, Adolescence, Cost-effectivenessArmsGroup-based Community Health Club, Individual-based Adherence Support
3 · Its place in the literature

Who cites it

23 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Andrew Medina-MarinoResearch Unit, Foundation for Professional Development, 10 Rochester Rd, Vincent, East London, Buffalo City Metro, Eastern Cape Province, South Africa. andrewmedinamarino@gmail.com.ORCID http://orcid.org/0000-0002-0095-4141
Dana BezuidenhoutResearch Unit, Foundation for Professional Development, 10 Rochester Rd, Vincent, East London, Buffalo City Metro, Eastern Cape Province, South Africa.
Sybil HosekDivision of Child and Adolescent Psychiatry, Department of Psychiatry, Stroger Hospital of Cook County, Chicago, IL, USA.
Ruanne V BarnabasDepartment of Global Health, University of Washington, Seattle, WA, USA.
Millicent AtujunaThe Desmond Tutu HIV Centre, University of Cape Town, Anzio Road, Observatory, Cape Town, South Africa.
Charl BezuidenhoutResearch Unit, Foundation for Professional Development, 10 Rochester Rd, Vincent, East London, Buffalo City Metro, Eastern Cape Province, South Africa.
Phuti NgwepeResearch Unit, Foundation for Professional Development, 10 Rochester Rd, Vincent, East London, Buffalo City Metro, Eastern Cape Province, South Africa.
Remco P H PetersResearch Unit, Foundation for Professional Development, 10 Rochester Rd, Vincent, East London, Buffalo City Metro, Eastern Cape Province, South Africa.
Francesca LittleDepartment of Statistical Sciences, University of Cape Town, Cape Town, South Africa.
Connie L CelumDepartment of Global Health, University of Washington, Seattle, WA, USA.
Joseph DanielsDepartment of Psychiatry and Human Behaviors, Charles R. Drew University of Medicine and Science, Los Angeles, USA.
Linda-Gail BekkerThe Desmond Tutu HIV Centre, University of Cape Town, Anzio Road, Observatory, Cape Town, South Africa. Linda-Gail.Bekker@hiv-research.org.za.

Funding

The Community PrEP StudyR01MH114648 · NIMH · FOUNDATION FOR PROFESSIONAL DEVELOPMENT · PI BEKKER, LINDA-GAIL GAIL, MEDINA-MARINO, ANDREW · 2017 to 2021
$2.4M
NIMH NIH HHS R01 MH114648NIMH NIH HHS R01MH114648
6 · The paper itself

Abstract

backgroundHIV incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP). Unfortunately, AGYW report significant barriers to clinic-based sexual and reproductive health services. Even when AGYW access PrEP as an HIV prevention method, poor prevention-effective use was a serious barrier to achieving its optimal HIV prevention benefits. Determining the acceptability and feasibility of community-based platforms to increase AGYW's access to PrEP, and evaluating behavioural interventions to improve prevention-effective use of PrEP are needed.

methodsWe propose a mixed-methods study among AGYW aged 16-25 years in Eastern Cape Province, South Africa. In the first component, a cross-sectional study will assess the acceptability and feasibility of leveraging community-based HIV counselling and testing (CBCT) platforms to refer HIV-negative, at-risk AGYW to non-clinic-based, same-day PrEP initiation services. In the second component, we will enrol 480 AGYW initiating PrEP via our CBCT platforms into a three-armed (1:1:1) randomized control trial (RCT) that will evaluate the effectiveness of adherence support interventions to improve the prevention-effective use of PrEP. Adherence will be measured over 24 months via tenofovir-diphosphate blood concentration levels. Qualitative investigations will explore participant, staff, and community experiences associated with community-based PrEP services, adherence support activities, study implementation, and community awareness. Costs and scalability of service platforms and interventions will be evaluated. DISCUSSION: This will be the first study to assess the acceptability and feasibility of leveraging CBCT platforms to identify and refer at-risk AGYW to community-based, same-day PrEP initiation services. It will also provide quantitative and qualitative results to inform adherence support activities and services that promote the prevention-effective use of PrEP among AGYW. By applying principles of implementation science, behavioural science, and health economics research, we aim to inform strategies to improve access to and prevention-effective use of PrEP by AGYW.

trial registrationClinicalTrials.gov NCT03977181 . Registered on 6 June 2019-retrospectively registered.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisAdolescentCounselingFemaleHumansRandomized Controlled Trials as TopicSexual BehaviorSouth AfricaAnti-HIV AgentsAdherence support interventionAdolescent girls and young womenCommunity-based delivery platformsCost-effectivenessHIVHIV preventionPrEPRandomized controlled trialSouth Africa

Identifiers

PMID34311754
PMCPMC8314507

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.