Pre-exposure Prophylaxis Adherence Intervention for MSM (PrEPare)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Kenneth H. Mayer, MD, Fenway Community Health

ClinicalTrials.gov Identifier:

NCT01632397

First received: May 8, 2012

Last updated: June 28, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2012

Last Updated Date

June 28, 2012

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adherence to PrEP over time [ Time Frame: At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months) ] [ Designated as safety issue: No ]

This is primarily a feasiblity pilot RCT. However, the primary eventual endpoint is PrEP adherence measured daily via electronic medication adherence monitoring (Wisepill™).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01632397 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sexual Risk Compensation [ Time Frame: At each of the 9 study visits spread over up to six months. ] [ Designated as safety issue: No ]

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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Pre-exposure Prophylaxis Adherence Intervention for MSM

Official Title ^ICMJE

Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM

Brief 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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Medication Adherence

Intervention ^ICMJE

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

Study Arm (s)

Experimental: CBT-based counseling
Cognitive behavioral based intervention to promote PrEP adherence.

Intervention: Behavioral: CBT-based counseling
Active Comparator: Health education and supportive counseling
Time matched supportive counseling

Intervention: Behavioral: Health education and supportive counseling

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01632397

Other Study ID Numbers ^ICMJE

1R34MH095584-01

Has Data Monitoring Committee

Yes

Responsible Party

Kenneth H. Mayer, MD, Fenway Community Health

Study Sponsor ^ICMJE

Fenway Community Health

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kenneth Mayer, MD

Fenway Health

Information Provided By

Fenway Community Health

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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