Adolescent Willingness to Participate in a Reproductive Health Clinical Trial at Baseline and One Year Follow-up

Background: Adolescents’ willingness to participate (WTP) may be influenced by developmental characteristics, which change over time. We evaluated whether demographics, previous research experience, and changes in both sexual experiences and attitudes about parental involvement in research were associated with change in WTP at one-year follow-up. 

Methods: Adolescents (N = 340) were recruited with their parents into a study assessing WTP in a hypothetical microbicide safety study and 294 adolescents returned one-year later. Parental involvement was measured using two scales assessing attitudes about learning test results/behaviors and enrollment/permissions. Sexual experience was coded as no experience, kissing/having a romantic partner, touching genitals/oral/anal sex or penile-vaginal intercourse.   Separate analyses evaluated change from WTP to not willing, and not willing to WTP. Logistic regression models were used to evaluate associations.

Results: At baseline, the sample was 63% female, 69% Hispanic, had a mean age of 15.5 years (range: 14 - 17) and 15% reported previous research experience. With regard to change in sexual experience over one year, 71% remained the same, 26% reported more experience, and 3% reported less.  Of the 294 adolescents, 174 agreed to participate at baseline. Of those that agreed at baseline, 25% disagreed at follow-up. In bivariate and multivariable analyses, males (p < 0.01) and those reporting higher levels of sexual experience (p < 0.05) were more likely to change to not willing at follow-up.  Of those that disagreed at baseline (n = 120), 31% agreed at follow-up. In bivariate and multivariable analyses, those who were non-Hispanic (p < 0.01) and reported higher levels of sexual experience (p < 0.001) were more likely to change to WTP.

Conclusions: WTP was relatively stable at one year follow up for the adolescent population studied. Understanding the adolescents that did change their attitudes about WTP at one year, especially those who reported new sexual experiences, is important for recruitment and retention of adolescents in clinical trials for reproductive health.