Pre-exposure Prophylaxis Adherence Intervention for MSM

Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM

Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.

Inclusion Criteria:

• male sex at birth
• being 18 years old or older
• testing HIV-negative at screening
• evidence of high risk for HIV acquisition defined by having unprotected anal sex (insertive or receptive) with an HIV-positive male partner OR at least a total of three episodes of unprotected anal sex with at least two partners in the last three months
• medically cleared to take the study drug (ambulatory performance >=60 on Karnofsky scale, adequate renal function, negative glucose and protein in urine, adequate hepatic function, adequate hematologic function)
• able to understand and speak English (for consenting and counseling).

Exclusion Criteria:

• participants who are not able to consent due to psychiatric or cognitive concerns
• those who have already been prescribed PrEP
• having a history of or current medical conditions that would preclude taking the study drug (e.g., previously diagnosed active and serious infections, acute or chronic hepatitis B, history of pathological bone fractures not related to trauma)
• receiving ongoing therapy with ART, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion, or other investigational agents
• receiving or possibly receiving antiretroviral drugs for an anti-HIV vaccine in a clinical trial
• active alcohol or drug use that would interfere with study participation
• having other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures