Inconsistent Counselor Fidelity in Delivering an Evidence-Based Adherence Intervention During a PrEP Trial.

Evidence-based adherence counseling interventions must be delivered with fidelity to ensure that their effectiveness is retained, but little is known regarding how counselors in biomedical HIV trials deliver these interventions. Forty-two counselors from the MTN-025/HOPE Study, which was conducted in 14 sites in sub-Saharan Africa, participated. They completed a quantitative assessment and consented for their HOPE counseling session ratings to be analyzed.

Culturally-Based Challenges to and Recommendations for Delivering Adherence Counseling in a Multicultural Biomedical HIV Prevention Trial in Four African Countries.

Research is needed to identify how to effectively tailor evidence-based interventions across cultures with limited resources, particularly for behavioral components in large HIV prevention trials. Through surveys and interviews with counselors of sub-Saharan African women during an open-label microbicide trial (MTN-025), we examined language, education, and cultural barriers in delivering a motivational interviewing-based adherence counseling intervention (i.e.

Adherence in the CAPRISA 004 tenofovir gel microbicide trial.

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.

Impact of an adherence intervention on the effectiveness of tenofovir gel in the CAPRISA 004 trial.

High adherence is important in microbicide trials, but no adherence interventions to date have demonstrated empiric improvements in microbicide adherence or effectiveness. Approximately midway during the CAPRISA 004 trial, we implemented a novel adherence intervention (Adherence Support Program-ASP), based on an Information-Motivation-Behavioral Skills model and incorporating a Motivational Interviewing approach. We assessed the impact of the ASP on adherence and tenofovir gel effectiveness using a before-and-after comparison.

Disclosure of microbicide gel use to sexual partners: influence on adherence in the CAPRISA 004 trial.

Young women in sub-Saharan Africa are disproportionately affected by HIV, making the development of women initiated and controlled methods of prevention, including microbicides, a priority. Adherence is pivotal to microbicide efficacy and partner related factors are known to impact adherence. An analysis of disclosure of gel use to sexual partners and adherence in CAPRISA 004 women was conducted to better understand this relationship.

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

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.

Stabilizing HIV prevalence masks high HIV incidence rates amongst rural and urban women in KwaZulu-Natal, South Africa.

Background: In mature generalized human immunodeficiency virus (HIV) epidemics, as survival from accessing antiretroviral treatment (ART) increases, HIV prevalence data may be suboptimal and difficult to interpret without HIV incidence rates.

Objective: To determine the HIV incidence rate among rural and urban women in KwaZulu-Natal, South Africa.

Methods: We conducted a prospective cohort study from March 2004 to May 2007.