Adolescent and Adult Participation in an HIV Vaccine Trial Preparedness Cohort in South Africa

• Published in: Journal of adolescent health Vol. 43; no. 1; pp. 8 - 14
• Main Authors: Middelkoop, Keren, M.B.ChB, Myer, Landon, M.A., M.Phil., Ph.D, Mark, Daniella, B.Soc.Sc. (Hons), M.Soc.Sc, Mthimunye, Sibonisile P, Smit, Joalida, B.A. (Hons), M.A, Wood, Robin, B.M., B.Ch., F.C.P., M.Med, Bekker, Linda-Gail, M.B.Ch.B., F.C.P., Ph.D
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.07.2008; Elsevier
• Subjects: Adolescent; Adolescents; Adult; Adults; AIDS Vaccines - therapeutic use; Biological and medical sciences; Clinical Trials as Topic; Cohort Studies; Female; General populations; HIV; HIV Infections - immunology; HIV Infections - prevention & control; HIV vaccines; Human immunodeficiency virus; Human viral diseases; Humans; Immunization; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunopathology; Infectious diseases; Male; Medical sciences; Patient Dropouts; Patient Participation; Pediatrics; Prevention and actions; Public health. Hygiene; Public health. Hygiene-occupational medicine; South Africa; Surveys and Questionnaires; Treponema pallidum; Trials; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Willingness; South Africa; Africa; HIV; Adolescents; HIV vaccines; Human; Immunopathology; Participation; Vaccination; Retroviridae; AIDS; Immune deficiency; Lentivirus; Infection; Virus; Viral disease; Adolescent; Adult; Clinical trial; Human immunodeficiency virus; Public health
• ISSN: 1054-139X; 1879-1972
• DOI: 10.1016/j.jadohealth.2007.11.144

Abstract Purpose The importance of involving adolescents in HIV prevention trials has been recognized, but there have been few experiences reported from sub-Saharan Africa. We analyzed adult and adolescent data from a cohort study conducted to assess the feasibility of involving adolescents and adults in HIV vaccine-related studies. Methods Two hundred HIV-negative participants aged 16 to 40 years were enrolled, including 86 (43%) adolescents. At baseline, sexual risk behavior and willingness to participate (WTP) in future HIV vaccine trials questionnaires were administered. Three monthly HIV counseling, pregnancy, HIV and syphilis tests were performed. Risk questionnaires were repeated at 6 months and WTP at 12 months. Results No significant difference in retention between adults (83%) and adolescents (87%) was noted ( p = .58). Initially, more adults (40%) reported WTP compared to adolescents (13%) ( p < .001). At the end of the study both groups reported higher levels of WTP; increasing to 40% among adolescents. HIV incidence during the study was 9.2 infections per 100 person-years (95% confidence interval [CI]: 4.4–19.2) among adolescents compared to 5.8 (95% CI 2.6–12.9) in adults ( p = .42). Conclusions Retention of high-risk HIV-negative adolescents in a cohort study is feasible. Following education, adolescents reported improved WTP. The high HIV incidence rate in adolescents highlights the importance of including this group in prevention trials.