title: Enrollment of adolescents aged 16-17 years old in microbicide trials: an evidence-based approach.
abstract: OBJECTIVE
  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.
authors.affiliation: Population Council, Washington, DC.
authors.forename: Katie D
authors.initials: KD
authors.lastname: Schenk
authors.affiliation: Population Council, New York, New York. Electronic address: bfriedland@popcouncil.org.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Friedland
authors.affiliation: Population Council, Washington, DC.
authors.forename: Michelle
authors.initials: M
authors.lastname: Chau
authors.affiliation: Population Council, New York, New York.
authors.forename: Marie
authors.initials: M
authors.lastname: Stoner
authors.affiliation: Population Council, New York, New York.
authors.forename: Marlena Gehret
authors.initials: MG
authors.lastname: Plagianos
authors.affiliation: Population Council, New York, New York; Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Skoler-Karpoff
authors.affiliation: Medical Research Council, Durban, South Africa; Wits Reproductive Health and HIV Institute, Johannesburg, South Africa; Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Thesla
authors.initials: T
authors.lastname: Palanee
authors.affiliation: Medunsa Campus, University of Limpopo, Soshanguve, South Africa.
authors.forename: Khatija
authors.initials: K
authors.lastname: Ahmed
authors.affiliation: Medunsa Campus, University of Limpopo, Soshanguve, South Africa.
authors.forename: Mary Jane Malebo
authors.initials: MJ
authors.lastname: Rathlagana
authors.affiliation: Medical Research Council, Durban, South Africa.
authors.forename: Pamela Nombali
authors.initials: PN
authors.lastname: Mthembu
authors.affiliation: University of Cape Town, Cape Town, South Africa.
authors.forename: Nomampondomise
authors.initials: N
authors.lastname: Ngcozela
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000294:Adolescent Behavior; D000328:Adult; D000367:Age Factors; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D019317:Evidence-Based Medicine / Q000941:ethics / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000453:epidemiology*; D006801:Humans; D053208:Kaplan-Meier Estimate; D018579:Patient Selection / Q000941:ethics; D011247:Pregnancy; D011253:Pregnancy in Adolescence / Q000706:statistics & numerical data; D016016:Proportional Hazards Models; D035842:Research Subjects / Q000706:statistics & numerical data*; D012309:Risk-Taking; D012725:Sexual Behavior / Q000706:statistics & numerical data*; D012749:Sexually Transmitted Diseases / Q000453:epidemiology*; D013019:South Africa / Q000453:epidemiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents
keywords: Adolescents; Carraguard; Clinical trial design; HIV prevention; Microbicides; South Africa