University of Alabama at Birmingham researchers will be involved in the enrollment and implementation of the NIH-funded Microbicide Network DESIRE study — Developing and Evaluating Short-acting Innovations for Rectal Use — which will systematically examine placebo methods for delivering drugs to help prevent HIV during anal sex. UAB is one of only seven sites worldwide to be involved.
“We know that personal preferences play a key role in HIV prevention, and we want to evaluate the safety, acceptability, tolerability of and adherence to three placebo dosage forms that will help administer preventive drugs in the future,” said Craig Hoesley, M.D., principal investigator of the study, senior associate dean for Medical Education in UAB’s School of Medicine and professor in the Division of Infectious Diseases. “What we conclude from this research will make a significant impact in providing a safe, acceptable and tolerable medication that will help prevent HIV in vulnerable populations.”
The crossover study is multi-site and randomized-sequenced at 1:1:1:1:1:1. It is a three-period, open-label study in which a placebo rectal insert, placebo rectal douche and placebo rectal suppository will be administered to participants. Each dosage form will be used for approximately four weeks, and there will be a one-week washout period between each dosage form’s application period.
Behavioral questionnaires will be administered throughout the four-month study to obtain participant feedback about each product. Participants will include heathy, HIV-negative cisgender men, transgender men and transgender women who have sex with men.
In addition to the United States, this study will be conducted in Malawi, Peru, South Africa and Thailand. UAB is currently enrolling patients for the study. Interested individuals may call 205-996-4405 to see if they qualify. Enrolled participants will receive up to $700.