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OpenTrials
Completed

NCT Number: NCT01632397

Pre-exposure Prophylaxis Adherence Intervention for 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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

The Fenway Institute

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-based counseling

Behavioral

Cognitive Behavior Therapy for PrEP adherence

Health education and supportive counseling

Behavioral

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

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. Sexual Risk Compensation

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

    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).

Sponsors and collaborators

Lead sponsor

Fenway Community Health

Other

Registry information

Official study title

Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM

Acronym: PrEPare

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2012
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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