49. Adolescent Willingness to Participate in Reproductive Health Clinical Trials

Abstract

The development of new biomedical options for the prevention of sexually transmitted infections (STIs) will require clinical trials with adolescent participation. This study evaluated the association of demographics, sexual experience, family characteristics, and perceptions of clinical trial privacy on adolescents' willingness to participate (WTP) in a hypothetical trial evaluating topical microbicide safety. Adolescents (n = 300), ages 14 to 17 years, were recruited with their parents to enroll in a study regarding WTP in a hypothetical topical microbicide safety trial. Adolescents were interviewed about demographics (age, gender, Hispanic ethnicity), sexual experience, family characteristics (selected scales of the family environment scale (FES) and three parental monitoring scales), previous participation in a research study, and beliefs about parental involvement during clinical trial participation. Adolescents were presented a hypothetical trial similar to typical Phase 1 studies, and were asked if they would agree to participate if offered participation today (a 6 point Likert scale was divided into agree versus disagree for analytical purposes). Age was categorized into 14-15 versus 16-17 years. Sexual experience was divided into no experience beyond a romantic partner and/or kissing versus reports of touching genitals, oral/anal/penile-vaginal intercourse. Chi square analyses or logistic regressions were used to evaluate whether individual or groups of variables were associated with WTP. Significant variables were placed in a common model. The characteristics of participants was as follows: 62% female, 75% Hispanic, 55% 16-17 years, 65% no sexual experience beyond a romantic partner and/or kissing. Fifty-nine percent reported some level of likelihood of participating in the clinical trial. Typically, these trials are not offered to anyone who is not sexually experienced; however, 103 of 194 (53%) sexually inexperienced adolescents agreed to participate. In individual/group models, significant predictors of WTP were age (p = 0.02), sexual experience (p < 0.01), indirect monitoring (p < 0.01), and parental involvement during clinical trial participation (p = 0.03). Adolescents who were older, had more sexual experience, who had less indirect monitoring, and wanted less parental involvement during research participation were more likely to agree to participate. Gender, Hispanic ethnicity, selected FES scale scores, direct monitoring, direct monitoring with peers, and previous research experience were not associated with WTP. When sexual experience was left out of the common model, only indirect monitoring stayed in the model (p < 0.01). As might be expected, adolescents with greater sexual experience were more likely to agree to be in a study involving placing a product in the vagina or on the penis; however, many adolescents who had not experienced penile-vaginal sex were still willing to participate. Other associations suggested that willingness to participate is not associated with demographics but rather with evidence of increased autonomy (less indirect monitoring, beliefs in less parental involvement in the study) or a possible surrogate for autonomy (age). Understanding how to engage a full range of adolescents in reproductive health trials will enhance the development of products that can be used safely and effectively among all adolescents.