Evidence map›Paper›PMID 40299387›Full record

ArticleJAMA network open2025

Consensus on Adolescent and Young Adult HIV Research Consent in Low- and Middle-Income Countries.

Suzanne Day, Sonam J Shah, Ujunwa F Onyeama, Lauren Fidelak, Ucheoma Nwaozuru, Stuart Rennie, Abdulhammed Opeyemi Babatunde, Weiming Tang, Elzette Rousseau, Chisom Obiezu-Umeh and 11 more

Abstract readConsensus Statement
In one paragraph

Article in JAMA network open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

21 authors.

Suzanne DayDepartment of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill.
Sonam J ShahInstitute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill.
Ujunwa F OnyeamaDepartment of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.
Lauren FidelakDepartment of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.
Ucheoma NwaozuruDepartment of Implementation Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.
Stuart RennieDepartment of Social Medicine, University of North Carolina at Chapel Hill.
Abdulhammed Opeyemi BabatundeMedicine and Surgery, Faculty of Clinical Sciences, University of Ibadan, Ibadan, Nigeria.
Weiming TangDepartment of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill.
Elzette RousseauThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, Republic of South Africa.
Chisom Obiezu-UmehDepartment of Behavioral Science & Health Education, College for Public Health and Social Justice, St Louis University, St Louis, Missouri.
Kelechi Prince ChimaClinical Sciences Department, Nigerian Institute of Medical Research, Lagos, Nigeria.
Nadia A Sam-AguduInternational Research Center of Excellence, Institute of Human Virology Nigeria, Abuja, Nigeria.
Erin C WilsonSan Francisco Department of Public Health, San Francisco, California.
Seema K ShahDepartment of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Susan NkengasongClinical Research Department, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Titilola Gbaja-BiamilaDepartment of Behavioral Science & Health Education, College for Public Health and Social Justice, St Louis University, St Louis, Missouri.
Bill G KapogiannisNational Institutes of Health, Bethesda, Maryland.
Linda-Gail BekkerThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, Republic of South Africa.
Juliet IwelunmorDepartment of Behavioral Science & Health Education, College for Public Health and Social Justice, St Louis University, St Louis, Missouri.
Oliver EzechiClinical Sciences Department, Nigerian Institute of Medical Research, Lagos, Nigeria.
Joseph D TuckerDepartment of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill.

Funding

Strategic antiretroviral therapy and HIV testing for youth in rural Africa (SATURN)UG3HD096915 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2018 to 2019
$3.4M
Data-informed Stepped Care (DiSC) to Improve Adolescent HIV OutcomesUH3HD096906 · NICHD · UNIVERSITY OF WASHINGTON · PI JOHN-STEWART, GRACE C., KOHLER, PAMELA · 2020 to 2022
$3.1M
ITEST: Innovative Tools to Expand Youth-Friendly HIV Self-TestingUG3HD096929 · NICHD · SAINT LOUIS UNIVERSITY · PI EZECHI, OLIVER CHUKWUJEKWU, IWELUNMOR, JULIET · 2018 to 2019
$2.3M
CombinADO: a combination intervention strategy to improve health outcomes for adolescents living with HIVUG3HD096926 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI ABRAMS, ELAINE JANINE · 2018 to 2019
$2.2M
Developing and Testing a Multi-level Package of Interventions for an Integrated Care Delivery Model of HIV Prevention and Treatment Targeting Adolescent Girls in ZambiaUG3HD096908 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI SUBRAMANIAN, SUJHA · 2018 to 2019
$2.1M
Intensive Combination Approach to Rollback the Epidemic (iCARE) in Nigerian AdolescentsUG3HD096920 · NICHD · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GAROFALO, ROBERT, TAIWO, BABAFEMI O · 2018 to 2020
$2.0M
Data-informed Stepped Care (DiSC) to Improve Adolescent HIV OutcomesUG3HD096906 · NICHD · UNIVERSITY OF WASHINGTON · PI JOHN-STEWART, GRACE C., KOHLER, PAMELA · 2018 to 2019
$1.9M
Mentoring Multidisciplinary Global HIV Patient-Oriented ResearchK24AI143471 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph David Tucker · 2019 to 2026
$1.4M
Multilevel Comprehensive HIV Prevention for South African Adolescent Girls and Young WomenUG3HD096875 · NICHD · UNIVERSITY OF ILLINOIS AT CHICAGO · PI BEKKER, LINDA-GAIL GAIL, DONENBERG, GERI R · 2018 to 2019
$1.2M
The BeT intervention to reduce HIV prevention and care disparities among young transwomen in Rio De JaneiroUG3HD096914 · NICHD · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI GRINSZTEJN, BEATRIZ, MEEK, ERIN CATHERINE · 2018 to 2019
$540k
NIAID NIH HHS K24 AI143471NICHD NIH HHS UG3 HD096875NICHD NIH HHS UG3 HD096906NICHD NIH HHS UG3 HD096908NICHD NIH HHS UG3 HD096914NICHD NIH HHS UG3 HD096915NICHD NIH HHS UG3 HD096920NICHD NIH HHS UG3 HD096926NICHD NIH HHS UG3 HD096929NICHD NIH HHS UH3 HD096906
6 · The paper itself

Abstract

Importance: Many adolescents and young adults (AYAs) in low- and middle-income countries (LMICs) are excluded from HIV research because of challenges with informed consent for study participation, which makes it difficult to understand and improve the lives of AYAs living with HIV and AIDS in a wide variety of settings. Objective: To help increase the inclusion of AYAs in HIV research, we developed a consensus statement on practical strategies for improving AYA consent in HIV research in LMICs. Evidence Review: The VOICE (HIV Youth Informed Consent & Ethics in Research) Working Group included AYAs, researchers, community organizers, advocates, research ethics committee members, parents of AYAs, and bioethicists who drafted initial statement items using data from a global open call and scoping review. An adapted Delphi process was then used to develop consensus statement items. The process involved 3 rounds of online Likert-scale questionnaires and a hybrid (online and in-person) consensus summit in Lagos, Nigeria, in 2022, with the total study period lasting from August 23, 2021, to February 10, 2023. Findings: Thirty-five people participated in the final round of the Delphi process, including 14 individuals younger than 35 years (40.0%), 25 HIV researchers (71.4%), and 32 people who worked in an LMIC (91.4%). Twenty-five items reached a predefined threshold for consensus (≥80% agreement). Strong consensus emerged for formal mechanisms (eg, cocreation, crowdsourcing, or youth advisory boards) for AYA engagement in and education about research as well as for strategies to enhance parental and guardian involvement in HIV research when safe and appropriate. Capacity strengthening can allow AYAs to review research protocols, join ethical review committees, and advocate for regulatory change. Two items in the statement (alternatives to parental consent and raising awareness among research ethics committees about AYA-independent consent) required further refinement to reach the agreement threshold for inclusion. Conclusions and Relevance: Greater engagement of both AYAs and parents may help to enhance consent processes and increase the inclusion of AYAs in LMIC HIV research studies. The resulting consensus statement provides practical strategies for implementing improved consent processes for AYA research participation at the organizational, community, and policy levels, which may help foster greater inclusion of AYAs in HIV research and address existing data gaps.

Indexed as

Biomedical ResearchDeveloping CountriesHIV InfectionsInformed ConsentAdolescentAdultDelphi TechniqueFemaleHumansMaleNigeriaYoung Adult

Identifiers

PMID40299387
PMCPMC12764374

What OpenQuestion holds

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Registered trials

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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.