title: HIV incidence in young girls in KwaZulu-Natal, South Africa--public health imperative for their inclusion in HIV biomedical intervention trials.
abstract: Young women are particularly vulnerable for acquiring HIV yet they are often excluded from clinical trials testing new biomedical intervention. We assessed the HIV incidence and feasibility of enrolling a cohort of young women for potential participation in future clinical trials. Between March 2004 and May 2007, 594 HIV uninfected 14-30 year old women were enrolled into a longitudinal HIV risk reduction study in KwaZulu-Natal, South Africa. The overall HIV prevalence at screening in young girls below the age of 18 years was 27.6 % compared to 52.0 % in the women above 18 years, p < 0.001. HIV incidence was 4.7 [95 % Confidence interval (CI) 1.5-10.9) and 6.9 (95 % CI 4.8-9.6)/100 women years (wy), p = 0.42 and pregnancy rates were 23.7 (95 % CI 14.9-35.9) and 16.4 (95 % CI 12.9-20.6)/100 wy, p = 0.29, in the women below and above 18 years respectively. Retention was similar in both groups (71.0 vs. 71.5 %, p = 0.90). This study demonstrates that the inclusion of young girls between the ages of 14 and 17 years in longitudinal studies is feasible and their inclusion in clinical trials would maintain scientific integrity and power of the study.
authors.affiliation: Centre for the AIDS Programme of Research in South Africa (CAPRISA), Doris Duke Medical Research Institute, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Congella, Durban 4013, South Africa.
authors.forename: Quarraisha
authors.initials: Q
authors.lastname: Abdool Karim
authors.forename: Ayesha B M
authors.initials: AB
authors.lastname: Kharsany
authors.forename: Janet A
authors.initials: JA
authors.lastname: Frohlich
authors.forename: Lise
authors.initials: L
authors.lastname: Werner
authors.forename: Mukelisiwe
authors.initials: M
authors.lastname: Mlotshwa
authors.forename: Bernadette T
authors.initials: BT
authors.lastname: Madlala
authors.forename: Salim S
authors.initials: SS
authors.lastname: Abdool Karim
mesh_terms: D000293:Adolescent; D035843:Biomedical Research / Q000639:trends*; D002986:Clinical Trials as Topic / Q000639:trends*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000453:epidemiology* / Q000517:prevention & control; D015528:HIV Seroprevalence; D006801:Humans; D015994:Incidence; D018579:Patient Selection; D011247:Pregnancy; D016016:Proportional Hazards Models; D011634:Public Health; D012725:Sexual Behavior; D013019:South Africa / Q000453:epidemiology