Practice brief: adolescents and HIV clinical trials: ethics, culture, and context.

Full Abstract

One quarter of HIV infections globally occur among young people 15 to 24 years of age, and more than half of all new infections are in people younger than 25 years. Clearly, there is a need to identify and implement effective HIV prevention strategies among at-risk teens. Some of the most effective options for slowing the epidemic are biomedical, and several promising methods are in development, including microbicides, vaccines, and preexposure prophylaxis (PREP, or the daily use of antiretrovirals to prevent the acquisition of HIV). There is widespread reluctance to enroll minors in such biomedical prevention trials because of concerns about vulnerability related to physical maturity, experiential maturity, and diminished autonomy as well as legal and social challenges that vary across and within nations. However, excluding minors from trials misses an important opportunity to evaluate the effectiveness, acceptability, and safety of innovative interventions under the best conditions for identifying and resolving potential problems. The challenges of including minors in HIV prevention trials are highlighted through the example of one rural South African community that has been particularly devastated by the HIV epidemic.

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Author information

Author/s: MacQueen, Kathleen M (KM); Karim, Quarraisha Abdool (QA);

Affiliation: Family Health International, Research Triangle Park, NC, USA.

Grants: 1 U19 AI51794 (Agency:United States NIAID) ; D43 TW000231-12 (Agency:United States FIC) ; D43 TW00231 (Agency:United States FIC) ; U19 AI051794-01 (Agency:United States NIAID)

Journal and publication information

Publication Type: Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.; Review

Journal: The Journal of the Association of Nurses in AIDS Care : JANAC (J Assoc Nurses AIDS Care), published in United States. (Language: eng)

Reference: -2007 Mar-Apr; vol 18 (issue 2) : pp 78-82

Dates: Created 2007/04/03; Completed 2007/05/30; Revised 2008/03/04;

PMID: 17403499, status: MEDLINE (last retrieval date: 11/6/2008)

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adolescent - legislation & jurisprudence
Adolescent Behavior - ethnology
Adolescent Psychology
Attitude to Health - ethnology
Clinical Trials as Topic - ethics; legislation & jurisprudence; psychology
HIV Infections - ethnology; prevention & control
Health Knowledge, Attitudes, Practice
Humans

Minors - legislation & jurisprudence; psychology
Patient Selection - ethics
Personal Autonomy
Research Subjects - psychology
Sexual Behavior - ethnology
South Africa - epidemiology
Vulnerable Populations - ethnology; legislation & jurisprudence
World Health

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