ArticleSexually transmitted infections2010
Enrolment of young adolescents in a microbicide acceptability study.
Article in Sexually transmitted infections, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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
4 citing papers in PubMed.
- Adolescent and Parent Willingness to Participate in Microbicide Safety Studies.Journal of pediatric and adolescent gynecology · 2017Article
- Inclusion of Adolescents in Clinical Trials for Sexually Transmitted Infections: A Review of Existing Registered Studies.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2016Article
- Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity.PloS one · 2012Article
- Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents.AJOB empirical bioethicsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
backgroundClinical trials of microbicides should include adolescent participants. There may be unique challenges including obtaining informed consent, meeting eligibility criteria and adherence to study demands. We report on our experience enrolling young adolescents in a microbicide surrogate acceptability study and the implication of our experience for other types of clinical trials.
methodsAdolescent females were enrolled in a microbicide surrogate acceptability study for 6 months which required parental consent. They were asked to use the product every time they had coitus. They had face-to-face interviews at intake, 3 and 6 months, and completed weekly phone diaries.
resultsOf the 208 enrolled, 95 participants were between 14 and 17 years. Ten were pregnant at intake, and 15 did not have sex during the study. Of the remaining 70 adolescents, 46 (66%) used the product at least once during the 6-month period, and all but seven attended a face-to-face interview after intake.
conclusionsIt will be possible to include young adolescents in clinical studies, even if parental consent is required. However, there will be challenges, and researchers need to anticipate those challenges and reduce barriers to enrolling young adolescents.
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What OpenQuestion holds
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.