6 research outputs found

    HIV incidence in young girls in KwaZulu-Natal, South Africa - public health imperative for their inclusion in HIV biomedical intervention trials.

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    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

    Adherence in the CAPRISA 004 tenofovir gel microbicide trial.

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    CAPRISA, 2014.High adherence is key to microbicide effectiveness. Here we provide a description of adherence interventions and the adherence rates achieved in the CAPRISA 004 Tenofovir Gel Trial. Adherence support for the before-and-after dosing strategy (BAT 24) was provided at enrolment and at each monthly study visit. This initially comprised individual counselling and was replaced midway by a structured theory-based adherence support program (ASP) based on motivational interviewing. The 889 women were followed for an average of 18 months and attended a total of 17031 monthly visits. On average women reported 5 sex acts and returned 5.9 empty applicators per month. The adherence rate based on applicator count in relation to all reported sex acts was 72.2% compared to the 82.0% self-reported adherence during the last sex act. Adherence support activities, which achieve levels of adherence similar to or better than those achieved by the CAPRISA 004 ASP, will be critical to the success of future microbicide trials
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