NCT01632397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

2.5 years

First QC Date

May 8, 2012

Last Update Submit

February 8, 2016

Conditions

Medication Adherence

Keywords

PrEPHIVAdherenceMSMMen having sex with men

Outcome Measures

Primary Outcomes (1)

  • 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 (Wisepillâ„¢).

    At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months)

Secondary Outcomes (1)

  • Sexual Risk Compensation

    At each of the 9 study visits spread over up to six months.

Study Arms (2)

CBT-based counseling

EXPERIMENTAL

Cognitive behavioral based intervention to promote PrEP adherence.

Behavioral: CBT-based counseling

Health education and supportive counseling

ACTIVE COMPARATOR

Time matched supportive counseling

Behavioral: Health education and supportive counseling

Interventions

CBT-based counselingBEHAVIORAL

Cognitive Behavior Therapy for PrEP adherence

CBT-based counseling
Health education and supportive counselingBEHAVIORAL

Time matched general supportive therapy of the type commonly available from community therapists.

Health education and supportive counseling

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fenway Institute

Boston, Massachusetts, 02215, United States

Location

Related Links

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Kenneth Mayer, MD

    Fenway Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Research Director, Co-Chair of The Fenway Institute

Study Record Dates

First Submitted

May 8, 2012

First Posted

July 2, 2012

Study Start

August 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 9, 2016

Record last verified: 2016-02

Locations

US(1)