Pre-exposure Prophylaxis Adherence Intervention for MSM (PrEPare)

Fenway Community Health

Status and phase

Completed

Phase 4

Conditions

Medication Adherence

Treatments

Behavioral: CBT-based counseling

Behavioral: Health education and supportive counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT01632397

1R34MH095584-01

Details and patient eligibility

About

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.

Enrollment

103 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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