STI Research: Recruiting an Unbiased Sample

Abstract 

Purpose

Although minors may legally consent for clinical care of sexually transmitted infections (STI) in all states, research participation often requires parental consent. We examined whether age, race, and parental barriers differed between those adolescents who accepted versus refused enrollment in a minimal risk STI research study.

Methods

A cross-sectional sample (age 13–21 years, sexually active females, presenting to an Emergency Department) was approached to participate in an STI study. Participation required an interview regarding symptoms and sexual history, a vaginal swab and urine sample for STI testing, and parental consent for those under age 18 years. Demographics, enrollment, and reasons for ineligibility or refusal were recorded.

Results

Of 466 females approached, 240 (52%) met eligibility criteria, and 139 (58%) of those eligible refused enrollment. Reasons for refusal included: 32 (23%) lack of parental confidentiality or consent, 65 (47%) no reason, 23 (17%) time constraints, and 19 (13%) other reasons. Parental barriers were only cited by those under age 18. Reasons for refusal did not differ by race. In unadjusted and adjusted analyses, enrollees were more likely to be black and age ≥ 18 than nonenrollees. An interaction between age and race is shown in stratified logistic regression analyses: The association of age ≥ 18 with enrollment was highly significant for white/other females (odds ratio [OR] 12.5, 95% confidence interval [CI] 3.0–52.7) but not for Black females (OR 1.5, 95% CI .77–3.0).

Conclusions

Requiring parental consent appears to preclude participation in minimal risk STI research, especially for younger non-black females.

Keywords: Adolescent, STI, Research, Recruitment, Bias