Pre-exposure Prophylaxis Adherence Intervention for MSM

Medication Adherence Clinical Trial

— PrEPare  

Official title:

Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632397
• Other study ID #: 1R34MH095584-01
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2012
• Last updated: February 8, 2016
• Start date: August 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2016
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Behavioral:
• CBT-based counseling
Cognitive Behavior Therapy for PrEP adherence
• Health education and supportive counseling
Time matched general supportive therapy of the type commonly available from community therapists.

Locations

Country	Name	City	State
United States	The Fenway Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Fenway Community Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to PrEP over time	This is primarily a feasiblity pilot RCT. However, the primary eventual endpoint is PrEP adherence measured daily via electronic medication adherence monitoring (Wisepill™).	At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months)	No
Secondary	Sexual Risk Compensation	This is primarily a feasiblity RCT. Sexual risk compensation is defined as a potential change in sexual risk taking behaviors (unprotected anal sex). This is measured daily with text message assessments for sexual risk as well as at each study visit with self-report measure(s).	At each of the 9 study visits spread over up to six months.	No

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