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California State University, Long Beach

Study of the Safety and Efficacy of Daily Oral Antiretroviral Use For the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana

Dr. Malotte serves as a consultant/co-investigator for a study taking place in Botswana, Africa. The Centers for Disease Control and Prevention (CDC) has funded BOTUSA, a collaboration between the Government of Botswana and CDC, to conduct a Phase II/III safety and efficacy trial to determine whether antiretroviral medication taken as daily oral prophylaxis (pre-exposure prophylaxis or PrEP) is safe on a long-term basis and whether it significantly reduces the rate of acquisition of HIV infection. The trial is being conducted with heterosexually active young adult men and women in Gaborone and Francistown. Participants in this study will be randomized to receive either the antiretroviral medication or its placebo and will be followed for any adverse effects of the agent, any changes in their sexual risk behavior, and HIV incidence. Results of this study will determine whether the antiretroviral is safe and effective as long-term prophylaxis against HIV infection among those exposed sexually when used in addition to standard risk reduction methods.

Dr. Malotte assisted in the development of risk-reduction and adherence counseling guidelines and provided initial training in these guidelines. Using the developed protocols and materials, he continues to provide 1) periodic observation and evaluation of counselors in the performance of their counseling tasks including: HIV risk reduction, medication adherence, partner notification, and support for persons becoming HIV infected during the trial, 2) periodic retraining of counseling staff, and 3) training counseling staff hired to replace counselors who leave. Dr. Malotte makes two trips to Botswana a year to work with counseling staff, and conduct evaluation, (re)training, and data analysis. He also spends some of his time from California providing ongoing consultation, materials revision, and paper writing.