Evidence map›Paper›PMID 34143779›Full record

Trial reportPLoS medicine2021

PrEP uptake, persistence, adherence, and effect of retrospective drug level feedback on PrEP adherence among young women in southern Africa: Results from HPTN 082, a randomized controlled trial.

Connie Celum, Sybil Hosek, Mandisa Tsholwana, Sheetal Kassim, Shorai Mukaka, Bonnie J Dye, Subash Pathak, Nyaradzo Mgodi, Linda-Gail Bekker, Deborah J Donnell and 12 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PLoS medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 138 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
138citing papers in PubMed, 3 pooled it
7.5field-weighted citation impact, top 2% of its field
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.

NCT02732730 phase4completednot on this map

Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study

TypeinterventionalSponsorHIV Prevention Trials NetworkRan2016 to 2018Enrolled451ConditionsHIVArmsTruvada, Drug level counseling at Weeks 8 and 13
NCT06446752 phase3active not recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 3 Randomized, Observer-Blind, Placebo-Controlled Study to Assess Efficacy of Meningococcal Group B (rMenB+OMV NZ (Bexsero)) in Preventing Gonococcal Infection Among South African Cis-Gender Women

TypeinterventionalSponsorUniversity of WashingtonRan2024 to 2027Enrolled1,100ConditionsGonorrhea, Gonorrhea of Pharynx, Gonorrhea of Anus, Gonorrhea of CervixArmsBexsero, Placebo
3 · Its place in the literature

Who cites it

138 citing papers in PubMed, 3 syntheses or guidelines pooled it, 174 citations in OpenAlex.

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78 more citing papers are in PubMed but not listed here.

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

22 authors at 12 institutions in 3 countries.

Connie CelumDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington, United States of America.ORCID 0000-0002-8813-3419
Sybil HosekDepartment of Psychiatry, Stroger Hospital of Cook County, Chicago, Illinois, United States of America.
Mandisa TsholwanaWits RHI, University of Witwatersrand, Johannesburg, South Africa.
Sheetal KassimDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Shorai MukakaUniversity of Zimbabwe, College of Health Sciences Clinical Trials Unit Research Unit, Harare, Zimbabwe.
Bonnie J DyeFamily Health International 360, Durham, North Carolina, United States of America.ORCID 0000-0001-9652-552X
Subash PathakVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Nyaradzo MgodiUniversity of Zimbabwe, College of Health Sciences Clinical Trials Unit Research Unit, Harare, Zimbabwe.ORCID 0000-0002-3085-5259
Linda-Gail BekkerDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Deborah J DonnellVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.ORCID 0000-0002-0587-7480
Ethan WilsonVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.ORCID 0000-0002-9120-3182
Krista YuhaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.ORCID 0000-0001-5254-1149
Peter L AndersonDepartment of Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, United States of America.
Yaw AgyeiDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.ORCID 0000-0001-5614-4108
Heather NobleVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Scott M RoseFamily Health International 360, Durham, North Carolina, United States of America.
Jared M BaetenDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington, United States of America.
Jessica M FogelDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.ORCID 0000-0003-3143-9000
Adeola AdeyeyeNational Institutes of Allergy and Infectious Diseases, National Institutes of Health, Division of AIDS, Rockville, Maryland, United States of America.
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-9070-8699
James RooneyGilead Sciences, Foster City, California, United States of America.
Sinead Delany-MoretlweWits RHI, University of Witwatersrand, Johannesburg, South Africa.ORCID 0000-0003-0376-1019
Fred Hutch Cancer Center · USDesmond Tutu HIV Foundation · ZAFamily Health International 360 · USJohns Hopkins University · USUniversity of the Witwatersrand · ZAUniversity of Washington · USUniversity of Zimbabwe · ZWGilead Sciences (United States) · USJohn H. Stroger, Jr. Hospital of Cook County · USNational Institutes of Health · USUniversity of Cape Town · ZAUniversity of Colorado Anschutz Medical Campus · US

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI MYRON Scott COHEN, Sinead Delany-Moretlwe · 2011 to 2026
$779.5M
SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
University of Cape Town Clinical Trials Unit (UCTCTU)UM1AI069519 · NIAID · UNIVERSITY OF CAPE TOWN · PI Linda-Gail Bekker · 2012 to 2026
$36.3M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Cape Town Clinical Trials Unit (CT-CTU) for HIV/AIDS Prevention & TreatmentU01AI069519 · NIAID · UNIVERSITY OF CAPE TOWN · PI WOOD, ROBIN · 2007 to 2011
$4.6M
NIAID NIH HHS U01 AI069436NIAID NIH HHS U01 AI069519NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069519
6 · The paper itself

Abstract

backgroundPre-exposure prophylaxis (PrEP) is highly effective and an important prevention tool for African adolescent girls and young women (AGYW), but adherence and persistence are challenging. PrEP adherence support strategies for African AGYW were studied in an implementation study. METHODS AND

findingsHIV Prevention Trials Network (HPTN) 082 was conducted in Cape Town, Johannesburg (South Africa) and Harare (Zimbabwe) from October 2016 to October 2018 to evaluate PrEP uptake, persistence, and the effect of drug level feedback on adherence. Sexually active HIV-negative women ages 16-25 were offered PrEP and followed for 12 months; women who accepted PrEP were randomized to standard adherence support (counseling, 2-way SMS, and adherence clubs) or enhanced adherence support with adherence feedback from intracellular tenofovir-diphosphate (TFV-DP) levels in dried blood spots (DBS). PrEP uptake, persistence through 12 months (no PrEP hold or missed visits), and adherence were assessed. The primary outcome was high adherence (TFV-DP ≥700 fmol/punch) at 6 months, compared by study arm. Of 451 women enrolled, median age was 21 years, and 39% had curable sexually transmitted infections (STIs). Most (95%) started PrEP, of whom 55% had uninterrupted PrEP refills through 12 months. Of those with DBS, 84% had detectable TFV-DP levels at month 3, 57% at month 6, and 31% at month 12. At 6 months, 36/179 (21%) of AGYW in the enhanced arm had high adherence and 40/184 (22%) in the standard adherence support arm (adjusted odds ratio [OR] of 0.92; 95% confidence interval [CI] 0.55, 1.34; p = 0.76). Four women acquired HIV (incidence 1.0/100 person-years), with low or undetectable TFV-DP levels at or prior to seroconversion, and none of whom had tenofovir or emtricitabine resistance mutations. The study had limited power to detect a modest effect of drug level feedback on adherence, and there was limited awareness of PrEP at the time the study was conducted.

conclusionsIn this study, PrEP initiation was high, over half of study participants persisted with PrEP through month 12, and the majority of young African women had detectable TFV-DP levels through month 6 with one-fifth having high adherence. Drug level feedback in the first 3 months of PrEP use did not increase the proportion with high adherence at month 6. HIV incidence was 1% in this cohort with 39% prevalence of curable STIs and moderate PrEP adherence. Strategies to support PrEP use and less adherence-dependent formulations are needed for this population.

trial registrationClinicalTrials.gov NCT02732730.

Indexed as

Drug MonitoringFeedback, PsychologicalMedication AdherencePre-Exposure ProphylaxisAdenineAdolescentAdultAnti-HIV AgentsCounselingDried Blood Spot TestingFemaleHealth Knowledge, Attitudes, PracticeHIV InfectionsHumansOrganophosphatesSouth AfricaAdenineAnti-HIV AgentsOrganophosphatestenofovir diphosphate

Identifiers

PMID34143779
PMCPMC8253429
OpenAlexW3170023264

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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.