Inclusion of Adolescents in Clinical Trials for Sexually Transmitted Infections: A Review of Existing Registered Studies

doi:10.1016/j.jadohealth.2016.01.007

Journal of Adolescent Health

Volume 58, Issue 5, May 2016, Pages 576-578

https://doi.org/10.1016/j.jadohealth.2016.01.007 Get rights and content

Abstract

Purpose

Despite their heightened risk of sexually transmitted infections, minor adolescents (<18 years old) are often excluded from clinical trials. The results of trials of adults should not be assumed to generalize to minors.

Methods

Two public clinical trial registries were first searched using microbicide or PrEP with STD, STI, HIV, or HSV and with gel, ring, or film, and then searched using prevention/sexually transmitted diseases with gel. Studies were classified based on the information provided in the registry.

Results

The searches yielded 111 unique studies. Only 9.0% (n = 10) included minors. They were under-represented in Phase 0–II studies and over-represented in studies of individuals infected with human immunodeficiency virus.

Conclusions

Minor adolescents should be included during all stages of development and before they have acquired an infection. Future studies should examine the challenges of including minor adolescents in trials and how to overcome these barriers.

Section snippets

Methods

Two electronic databases were used: (1) Clinicaltrials.gov (the registry of the National Institutes of Health) and (2) the International Standard Registered Clinical/Social Study Number, the primary clinical trial registry recognized by World Health Organization and International Committee of Medical Journal Editors. The search terms were (microbicide or PrEP) with the terms (STD or STI or HIV or HSV [representing herpes simplex virus]) with (Gel OR ring OR film [representing varied

Results

The search of clinicaltrails.gov yielded 133 studies of which 30 were excluded. Of the 30 studies that were excluded, 13 were duplicates, seven were withdrawn before enrollment of participants, three focused on topics that were unrelated, six were studies that included children (<10 years old), and one did not specify an age range. The International Standard Registered Clinical/Social Study Number search produced an additional eight studies that met criteria, for a total sample size of 111

Discussion

Based on a review of these two clinical trial registries, our results confirm that minor adolescents are under-represented in clinical trials. Highlighting the exclusion of minor adolescents should increase awareness and focus on efforts to develop solutions.

Although researchers might be hesitant to include minor adolescents in the first early phase studies, it seems imperative that they be included in later early phase studies to establish safety. Minor adolescents are over-represented in

Acknowledgments

Findings of the study will be presented as an oral platform at the Society for Adolescent Health and Medicine Annual Meeting in Washington, D.C., in March 2016. L.F.H. wrote the first draft of this article. All authors of this research article have directly participated in the planning, execution, or analysis of this study. No payment was provided to any of the authors to produce this article. If this publication is accepted, it will not be published elsewhere including electronically in the

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Cited by (13)

Adolescent–Parent Dyadic Retention in an Interview Study and Changes in Willingness to Participate in a Hypothetical Microbicide Safety Study
2018, Journal of Pediatric and Adolescent Gynecology
Citation Excerpt :
Inclusion of adolescents in sexual health biomedical trials is necessary to ensure that new products are safe and effective for them.1,2
In this study we describe adolescent and parent retention and changes in willingness to participate (WTP) in research among adolescents, parents, and adolescent–parent dyads.
Adolescent–parent dyads were recruited to participate in a longitudinal study to assess research participation attitudes using simultaneous individual interviews of the adolescent and parent with a return visit 1 year later using the same interview.
Adolescents (14-17 years old) and their parents.
None.
The relationship between participant characteristics and dyad retention was assessed. WTP was measured on a Likert scale and dichotomized (willing/unwilling) to assess changes in WTP attitudes over time for adolescents, parents, and dyads.
Eighty-three percent of the 300 dyads were retained. Dyads in which there was successful contact with the parent before follow-up were more likely to be retained (odds ratio, 4.88; 95% confidence interval, 2.57-9.26). For adolescents at baseline, 59% were willing to participate and 55% were willing to participate at follow-up (McNemar S = 0.91; P = .34). For parents at baseline, 51% were willing to participate and 57% were willing to participate at follow-up (McNemar S = 5.12; P = .02). For dyads at baseline, 57% were concordant (in either direction) and 70% of dyads were concordant at follow-up (McNemar S = 10.56; P = .001).
Over 1 year, parent contact might positively influence successful adolescent retention. Parents become more willing to let their adolescents participate over time, with dyads becoming more concordant about research participation.
Medical students reflect on the future of Pre-Exposure Prophylaxis use among adolescents and young adults
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Adolescent and Parent Willingness to Participate in Microbicide Safety Studies
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This study was not designed to address this issue, and phase I clinical trials have typically required parental consent. So because of the continued high rate of STIs in adolescents and the need for novel biomedical options, it is crucial to promote adolescent inclusion in clinical trials now.24 Studies such as the hypothetical phase I study presented to these participants often have a small number of subjects; our study supports there should be a sufficient number of adolescents able to participate even if parental consent is required.
To understand adolescents' and parents' willingness to participate (WTP) in a hypothetical phase I prevention study of sexually transmitted infections, discordance within adolescent-parent dyads, and expectations of each other during decision-making.
Adolescent-parent dyads were recruited to participate in a longitudinal study about research participation attitudes.
Adolescents (14-17 years old) and their parents (n = 301 dyads) participated.
None.
Individual interviews at baseline assessed WTP on a 6-level Likert scale. WTP was dichotomized (willing/unwilling) to assess discordance.
WTP was reported by 60% (182 of 301) of adolescents and 52% (156 of 300) of parents. In bivariate analyses, older adolescent age, sexual experience, and less involvement of parents in research processes were associated with higher level of WTP for adolescents; only sexual experience remained in the multivariable analysis. For parents, older adolescent age, perceived adolescent sexual experience, and conversations about sexual health were significant; only conversations remained. Dyadic discordance (44%, 132 of 300) was more likely in dyads in which the parent reported previous research experience, and less likely when parents reported higher family expressiveness. Adolescents (83%, 248 of 299) and parents (88%, 263 of 300) thought that the other would have similar views, influence their decision (adolescents 66%, 199 of 300; parents 75%, 224 of 300), and listen (adolescents 90%, 270 of 300; parents 96%, 287 of 300). There were no relationships between these perceptions and discordance.
Inclusion of adolescents in phase I clinical trials is necessary to ensure that new methods are safe, effective, and acceptable for them. Because these trials currently require parental consent, strategies that manage adolescent-parent discordance and support adolescent independence and parental guidance are critically needed.
Ethical considerations for involving adolescents in biomedical HIV prevention research
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Case 27-2021: A 16-Year-Old Boy Seeking Human Immunodeficiency Virus Prophylaxis
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2020, JAMA Pediatrics

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: Conflicts of Interest: All named authors have no potential conflicts of interest, real or perceived, to disclose.

: Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

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Adolescent health briefInclusion of Adolescents in Clinical Trials for Sexually Transmitted Infections: A Review of Existing Registered Studies

Abstract

Purpose

Methods

Results

Conclusions

Section snippets

Methods

Results

Discussion

Acknowledgments

J Pediatr Adolesc Gynecol

J Adolesc Health

J Adolesc Health

J Assoc Nurses AIDS Care

Sexually transmitted infections among U.S. women and men: Prevalence and incidence estimates, 2008

Sex Transm Dis

Adolescent health brief
Inclusion of Adolescents in Clinical Trials for Sexually Transmitted Infections: A Review of Existing Registered Studies