Suchergebnisse

ABSTRACTGiven the burden of HIV and other sexually transmitted infections among adolescents who are legal minors, it is critical that they be included in biomedical sexual health trials to ensure that new prevention and treatment interventions are safe, effective, and acceptable for their use. However, adolescents are often not well represented in clinical trials. We provide an overview of the available evidence regarding adolescent and parent willingness for adolescents to participate in biomedical sexual health trials, parental involvement in the permission‐consent process, management of differences and discord among adolescents and parents, and parental involvement throughout the study period. We also outline recommendations for current practice and areas for future research.

A greater understanding of participant views regarding reimbursement will help investigators plan studies that have better potential for reaching target enrollment, maximize efficient recruitment, maintain scientific integrity, and enhance retention over time. As part of a clinical trial in the area of sexual health, healthy women's perceptions of reimbursement for research participation were investigated. Semi-structured, audio-recorded, qualitative interviews were conducted immediately upon women's completion of the clinical trial to enable a participant-driven understanding of perceptions about monetary reimbursement. Audio-recordings were transcribed and analyzed using framework analysis. Women (N = 30) had a mean age of 29.5 ± 5.7 years (range 22–45 years). Sixty-three percent of participants (n = 19) were non-Hispanic (white n = 13, black n = 4, and Asian n = 2), while the remaining were Hispanic (n = 11). Seventy-three percent (n = 22) reported previous participation in research. In general, women viewed reimbursement as a benefit to research participation, the amount of which should reflect time, the inconvenience to the research subject, and the potential for unknown risks in the short- and long-term. They believed reimbursement should take into account the degree of risk of the study, with investigations of experimental products offering greater reimbursement. Women believed that monetary reimbursement is unlikely to coerce an individual to volunteer for a study involving procedures or requirements that they found unacceptable. The results of this study can be used to provide guidance to those planning and evaluating reimbursement for research participation.

The objective of this study is to understand the resolution of discordance between adolescent–parent dyads about participation in research. Adolescent (14-17 years) and parent dyads were recruited from NYC pediatric clinics to assess attitudes toward research participation. A subset of dyads participated in videotaped discussions about participation in a hypothetical study. Videos from dyads that held strongly discordant opinions about participation ( n = 30) were content-coded and analyzed using a thematic framework approach. Strategies used to resolve discordance included asserting authority, granting autonomy, or recognizing inaccurate assumptions using a variety of communication behaviors. Missed opportunities to enroll initially discordant dyads may be avoided by allowing time for adolescents and parents to elicit information, clarify a situation, or convince the other.

Little is known about how adolescents' and parents' thoughts about participation in clinical trials change over time. In this study, adolescent (14-17 years)–parent dyads were asked about willingness to participate in a hypothetical reproductive health study. A year later, they were asked how their thoughts about the study had changed. Qualitative responses were coded and analyzed using framework analysis. Thirty-two percent of adolescents and 18% of parents reported changes in thoughts; reasons included general changes in perception, clearer understanding, new knowledge or experiences, increased maturity/age of adolescents, and changes in participants independent of the study. Adolescents and parents may benefit from learning about studies multiple times, and investigators should account for development and new experiences to optimize adolescent research enrollment.