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

• Published in: Journal of adolescent health 2014-06, Vol.54 (6), p.654-662
• Main Authors: Schenk, Katie D., Ph.D, Friedland, Barbara A., M.P.H, Chau, Michelle, M.P.H, Stoner, Marie, M.P.H, Plagianos, Marlena Gehret, M.S, Skoler-Karpoff, Stephanie, M.P.H, Palanee, Thesla, Ph.D, Ahmed, Khatija, FCPath, Rathlagana, Mary Jane Malebo, Mthembu, Pamela Nombali, Ngcozela, Nomampondomise
• Format: Article
• Language: English
• Subjects: Administration, Intravaginal; Adolescent; Adolescent Behavior; Adolescents; Adult; Age Factors; Anti-Infective Agents - administration & dosage; Biological and medical sciences; Carraguard; Clinical trial design; Evidence-Based Medicine - ethics; Evidence-Based Medicine - methods; Feasibility Studies; Female; Health; HIV; HIV Infections - epidemiology; HIV prevention; Humans; Infection; Kaplan-Meier Estimate; Medical sciences; Microbicides; Patient Selection - ethics; Pediatrics; Pregnancy; Pregnancy in Adolescence - statistics & numerical data; Prevention and actions; Proportional Hazards Models; Public health. Hygiene; Public health. Hygiene-occupational medicine; Research Subjects - statistics & numerical data; Risk behaviour; Risk-Taking; Safe sexual practices; Sexual Behavior - statistics & numerical data; Sexually Transmitted Diseases - epidemiology; South Africa; South Africa - epidemiology; Specific populations (family, woman, child, elderly...); Treatment Outcome; Young Adult
• ISSN: 1054-139X; 1879-1972
• DOI: 10.1016/j.jadohealth.2014.01.014

Abstract Purpose This article explores the ethics and feasibility of enrolling adolescent females in microbicide trials using data from 16- to 17-year-old participants of the Phase 3 trial of the candidate vaginal microbicide, Carraguard. Methods Secondary analysis was conducted to compare health, behavioral, and operational outcomes between 16- to 17-year-olds and 18- to 19-year-olds screened for and enrolled in the trial. Analytical approaches included Kaplan–Meier survival analysis, Cox proportional hazards modeling, and generalized estimating equations for nonsurvival end points. Results Results reveal no significant differences between the two age groups for health (sexually transmitted infection, adverse event), risk behavior, or operational (adherence, follow-up) outcomes. However, data suggest that after 1 year of trial participation, human immunodeficiency virus (HIV) and pregnancy incidence were higher and increased more rapidly for the 16- to 17-year-olds than for 18- to 19-year-olds; this finding is entirely consistent with other incidence data for HIV infection among South African youth and cannot be attributed to study participation without a comparison outside the trial. Conclusions Data from the Carraguard trial provide no evidence that inclusion of 16- to 17-year-olds in the trial had any detrimental effect on trial participants or on the conduct of research. These data provide an argument motivating the inclusion of sexually active adolescents aged 16–17 years into future trials in order to avoid delaying access to an effective product for adolescents at high risk of HIV acquisition. Careful support for adolescent-inclusive protocols (including appropriate counseling) must be incorporated into study design.