Evidence map›Paper›PMID 42387521›Full record

ArticleBMC medical ethics2026

Ethical complexities in contraceptive mandates for adolescent clinical trial participation: a qualitative analysis of U.S. adolescents' perspectives.

Margaret Waltz, Anne Drapkin Lyerly, Hadas Clementine Baron, Rita Vanessa Masese, Suzanne Day

Abstract read
In one paragraph

Article in BMC medical ethics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Margaret WaltzDepartment of Social Medicine, Center for Bioethics, The University of North Carolina at Chapel Hill, 333 South Columbia Street, Chapel Hill, North Carolina, 27599, USA. margaret_waltz@med.unc.edu.
Anne Drapkin LyerlyDepartment of Social Medicine, Center for Bioethics, The University of North Carolina at Chapel Hill, 333 South Columbia Street, Chapel Hill, North Carolina, 27599, USA.
Hadas Clementine BaronDepartment of Social Medicine, Center for Bioethics, The University of North Carolina at Chapel Hill, 333 South Columbia Street, Chapel Hill, North Carolina, 27599, USA.
Rita Vanessa MaseseDepartment of Social Medicine, Center for Bioethics, The University of North Carolina at Chapel Hill, 333 South Columbia Street, Chapel Hill, North Carolina, 27599, USA.
Suzanne DayDepartment of Medicine, Division of Infectious Diseases, The University of North Carolina at Chapel Hill, 130 Mason Farm Road, Chapel Hill, North Carolina, 27514, USA.

Funding

The PHASES Project: Pregnancy and HIV/AIDS-Seeking Equitable StudyR01AI108368 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAY, SUZANNE LOUISE, LYERLY, ANNE DRAPKIN · 2015 to 2024
$6.4M
National Institute of Allergy and Infectious Diseases R01AI108368NIAID NIH HHS R01 AI108368
6 · The paper itself

Abstract

backgroundClinical trials often require women and girls of childbearing potential to adhere to contraceptive mandates, typically requiring the use of two forms of contraceptives for the duration of the study. Understanding adolescent perspectives on contraceptive mandates within HIV prevention and treatment trials is critical for evaluating whether and when such requirements are ethically justified and, if so, how they might be appropriately applied in trials involving this group.

methodsWe conducted semi-structured interviews with adolescents age 15-24 in the U.S. on their perspectives about contraceptive requirements. Interviews were audio-recorded and transcribed verbatim. We used Nvivo qualitative analysis software to code transcripts, and then conducted thematic analysis to identify emergent patterns in adolescents' perceptions of the advantages and disadvantages of requiring contraception use for adolescent participants of HIV research studies.

resultsForty adolescents were interviewed in total. Overall, most participants expressed support for a contraceptive requirement. Regardless of their stance, perceived advantages and disadvantages of such requirements stood in tension, including the ability to prevent pregnancy and desires to become pregnant, desirable health benefits and concerning side effects, and voluntary participation and violated decisional autonomy.

conclusionOur findings illustrate that although contraceptive mandates are intended to facilitate and promote inclusion in research, they can simultaneously work to restrict adolescent participation in research and limit access to its potential benefits. In doing so, these requirements risk undermining their ethical justification and obstructing the generation of data needed to advance health outcomes for adolescents.

Indexed as

Clinical Trials as TopicContraceptionContraceptive AgentsResearch SubjectsAdolescentDecision MakingFemaleHIV InfectionsHumansInterviews as TopicMalePregnancyPregnancy in AdolescenceQualitative ResearchUnited StatesYoung AdultContraceptive AgentsAdolescentsClinical trialsContraceptionHIV

Identifiers

PMID42387521
PMCPMC13587296

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.