Trial reportThe Journal of adolescent health : official publication of the Society for Adolescent Medicine2017
Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV.
Trial report in The Journal of adolescent health : official publication of the Society for Adolescent Medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Missing assent: a global systematic review of ethical practices in HIV research with men who have sex with men (MSM) under 18.BMC medical ethics · 2026Pooled it
- Ethical Aspects of Involving Adolescents in HIV Research: A Systematic Review of the Empiric Literature.The Journal of pediatrics · 2023Pooled it
- Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents' Willingness to Participate.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2023Trial
- Ethical Implications of Study Terminations.Pediatrics · 2025Article
- Challenges in Arranging to Waive Parental Consent in HIV Prevention Studies of Adolescent Men Who have Sex with Men: The Case of HPTN 078.Journal of homosexuality · 2024Article
- Ethical and methodological challenges conducting participative research with transgender and gender-diverse young people: a systematic review.International journal of transgender health · 2024Review
- Biobanking and consenting to research: a qualitative thematic analysis of young people's perspectives in the North East of England.BMC medical ethics · 2023Article
- Adolescents, Sensitive Topics, and Appropriate Access to Biomedical Prevention Research.The American journal of bioethics : AJOB · 2023Article
- Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics.AIDS research and human retroviruses · 2022Article
- Pre-Exposure Prophylaxis (PrEP) for HIV Infection in Cisgender and Transgender Women in the U.S.: A Narrative Review of the Literature.Archives of sexual behavior · 2021Review
- Research Participation of Minor Adolescents in Foster Care.Journal of pediatric and adolescent gynecology · 2021Review
- Mind the Gap: HIV Prevention Among Young Black Men Who Have Sex with Men.Current HIV/AIDS reports · 2020Review
- Adolescent and Parent Perceptions about Participation in Biomedical Sexual Health Trials.Ethics & human research · 2020Article
- Innovative Approaches to Obtain Minors' Consent for Biomedical HIV Prevention Trials: Multi-Site Quasi-Experimental Study of Adolescent and Parent Perspectives.JMIR research protocols · 2020Article
- Avoiding a Tyranny of the Majority: Public Deliberation as Citizen Science, Sensitive Issues, and Vulnerable Populations.The American journal of bioethics : AJOB · 2019Article
- Do confidentiality concerns impact pre-exposure prophylaxis willingness in emergency department adolescents and young adults?The American journal of emergency medicine · 2019Article
- Advancing HIV Biomedical Prevention Research for At-Risk Adolescents.Journal of acquired immune deficiency syndromes (1999) · 2018Article
- Potential Impact of HIV Preexposure Prophylaxis Among Black and White Adolescent Sexual Minority Males.American journal of public health · 2018Article
- "I think the parent should be there because no one was born alone": Kenyan adolescents' perspectives on parental involvement in HIV research.African journal of AIDS research : AJAR · 2018Article
- Contrasting Comprehension of HIV Research by Adolescents, Young Adults, and Caregivers in Western Kenya: A Cross-sectional Analysis.The Journal of the Association of Nurses in AIDS Care : JANACArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
purposeThere is a persistent HIV epidemic among sexual and gender minority adolescents in the U.S. Oral pre-exposure prophylaxis (PrEP) is an efficacious prevention strategy, but not yet approved for minors. Minors' access to biomedical HIV prevention technologies is impeded by the ethical and legal complexities of consent to research participation. We explore autonomous consent and study experiences among minor and adult participants in Project PrEPare, a Phase II safety study of PrEP for HIV prevention.
methodsData for this mixed-methods descriptive study were collected via self-administered web-survey and in-depth telephone interviews in early 2016. Eligible participants were previously enrolled in Project PrEPare. We attempted to contact 191 participants; 74 were reached and expressed interest in participating and 58 enrolled.
resultsParticipants nearly universally felt well informed, understood the study, and freely volunteered with the clear understanding they could withdraw any time. All felt supported by study staff, but a small minority wished for more support during enrollment. Minors were more likely than adults to indicate a wish for more support in decision-making, and adults expressed higher satisfaction with their decision compared to minors. There was no association between elements of consent and Project PrEPare study outcomes.
conclusionsParticipants had an overwhelmingly positive experience in a Phase II safety study of PrEP for HIV prevention. Some minors wished for more support during the decision-making process, but none consulted their parents about the decision. Our results support the inclusion of decisional supports in consent processes for adolescents, while also protecting their privacy.
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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.