Enrollment of Adolescents Aged 16–17 Years Old in Microbicide Trials: An Evidence-Based Approach

Schenk, Katie D.; Friedland, Barbara; Chau, Michelle M.; Stoner, Marie; Plagianos, Marlena; Skoler-Karpoff, Stephanie; Palanee, Thesla; Ahmed, Khatija; Rathlagana, Mary Jane Malebo; Mthembu, Pamela Nombali; Ngcozela, Nomampondomise

doi:10.1016/j.jadohealth.2014.01.014

Cited by 18 publications

(14 citation statements)

References 32 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Throughout the focus groups, youth indicated an understanding of the health-related benefits, side effects, and limitations of PrEP for preventing HIV and STIs. Although we did not directly address this question, consistent with other studies (Grov, Whitfield, Rendina, Ventuneac, & Parsons, 2015; Schenk et al, 2014), there was no indication that youth believed taking PrEP would lead to an increase in unsafe sexual behaviors (i.e., risk disinhibition; Eaton & Kalichman, 2007). In fact, many described how participation would provide them information to help them better protect their sexual health (Dellar et al, 2014; Protogerou & Johnson, 2014).…”

Section: Discussionsupporting

confidence: 47%

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth

Fisher

Arbeit

Dumont

et al. 2016

Journal of Empirical Research on Human Research Ethics

View full text Add to dashboard Cite

This project examined the attitudes of sexual and gender minority youth (SGMY) toward guardian permission for a pre-exposure prophylaxis (PrEP) adherence trial and their preparedness to provide informed, rational and voluntary self-consent. Sixty sexually active SGMY (ages 14–17) participated in online survey and asynchronous focus group questions after watching a video describing a PrEP adherence study. Youth responses highlighted guardian permission as a significant barrier to research participation, especially for those not “out” to families. Youth demonstrated understanding of research benefits, medical side effects, confidentiality risks, and random assignment and felt comfortable asking questions and declining participation. Reasoning about participation indicated consideration of health risks and benefits, personal sexual behavior, ability to take pills everyday, logistics, and post-trial access to PrEP. Results demonstrate youth’s ability to self-consent to age- and population- appropriate procedures, and underscore the value of empirical studies for informing IRB protections of SGMY research participants.

show abstract

Section: Discussionsupporting

confidence: 47%

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth

Fisher

Arbeit

Dumont

et al. 2016

Journal of Empirical Research on Human Research Ethics

View full text Add to dashboard Cite

show abstract

“…However, they acknowledge that adolescent inclusion in clinical trials may require some modifications to trial design or implementation (i.e. training in youth-friendly counselling and further consideration of informed consent and compensation issues) to support their participation [24]. …”

Section: Discussionmentioning

confidence: 99%

Comparing patterns of sexual risk among adolescent and young women in a mixed‐method study in Tanzania: implications for adolescent participation in HIV prevention trials

Tolley

Kaaya

Kaale

et al. 2014

Journal of the International AIDS Society

View full text Add to dashboard Cite

IntroductionDespite the disproportionate impact of HIV on women, and adolescents in particular, those below age 18 years are underrepresented in HIV prevention trials due to ethical, safety and logistical concerns. This study examined and compared the sexual risk contexts of adolescent women aged 15–17 to young adult women aged 18–21 to determine whether adolescents exhibited similar risk profiles and the implications for their inclusion in future trials.MethodsWe conducted a two-phase, mixed-method study to assess the opportunities and challenges of recruiting and retaining adolescents (aged 15–17) versus young women (18–21) in Tanzania. Phase I, community formative research (CFR), used serial in-depth interviews with 11 adolescent and 12 young adult women from a range of sexual risk contexts in preparation for a mock clinical trial (MCT). For Phase II, 135 HIV-negative, non-pregnant adolescents and young women were enrolled into a six-month MCT to assess and compare differences in sexual and reproductive health (SRH) outcomes, including risky sexual behaviour, incident pregnancy, sexually transmitted infections (STIs), reproductive tract infections (RTIs) and HIV.ResultsIn both research phases, adolescents appeared to be at similar, if not higher, risk than their young adult counterparts. Adolescents reported earlier sexual debut, and similar numbers of lifetime partners, pregnancy and STI/RTI rates, yet had lower perceived risk. Married women in the CFR appeared at particular risk but were less represented in the MCT. In addition, adolescents were less likely than their older counterparts to have accessed HIV testing, obtained gynaecological exams or used protective technologies.ConclusionsAdolescent women under 18 are at risk of multiple negative SRH outcomes and they underuse preventive services. Their access to new technologies such as vaginal microbicides or pre-exposure prophylaxis (PrEP) may similarly be compromised unless greater effort is made to include them in clinical trial research.

show abstract

“…[16] Participants nearly universally felt adequately informed and they understood the basic premise of the study. This is consistent with prior research showing that adolescents are capable of understanding the concepts of randomization and placebo, but may need extra time and interaction (e.g.…”

Section: Discussionmentioning

confidence: 99%

Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV

Knopf

Ott

Liu

et al. 2017

Journal of Adolescent Health

View full text Add to dashboard Cite

Purpose There 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 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. Methods Data 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, 58 enrolled. Results Participants 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. Conclusion Participants 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.

show abstract

Enrollment of Adolescents Aged 16–17 Years Old in Microbicide Trials: An Evidence-Based Approach

Cited by 18 publications

References 32 publications

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth

Comparing patterns of sexual risk among adolescent and young women in a mixed‐method study in Tanzania: implications for adolescent participation in HIV prevention trials

Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV

Contact Info

Product

Resources

About