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OpenTrials
Completed

NCT Number: NCT01291589

HIV Prevention in Very High Risk Men Who Have Sex With Men

The purpose of this study is to pilot test an innovative program development project in an open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention on ten (10) HIV-infected men who have sex with men who report very high levels (>10 episodes) of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant partners).

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fenway Community Health

Boston, Massachusetts, 02215, United States

About this study

This is an innovative program development project that will, over the next year, pilot test, in an open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention on ten (10) HIV-infected men who have sex with men who report very high levels (>10 episodes) of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant partners). That is, to pilot test a novel prevention intervention designed to effect reductions in sexual transmission risk behavior among the riskiest men in the largest HIV risk group in the US. Effecting even modest reductions in the mean number of risk acts in this group will likely have substantial public health significance through the number of averted new HIV infections. Traditional secondary HIV intervention strategies (e.g., Information, Motivation, Behavior change (IMB)) models only have modest effects for HIV-positive MSM and there is evidence to suggest that these effects tend to diminish over time.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years old or older
  • Self-reports as a man who has sex with men (MSM)
  • Self-reports being HIV-infected
  • Reports engaging in 10 episodes or more of unprotected anal intercourse (receptive or insertive) in the past three months with male partners who are not HIV-infected or whose serostatus is unknown.
  • Is capable of completing and fully understanding the informed consent process and the study procedures and assessments in English

Exclusion criteria

  • Unable or unwilling to provide informed consent

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

Treatment will include elements from effective interventions for reducing risky sexual behaviors

Primary outcomes

  1. Decrease in self-reported sexual risk taking

    Time frame: Measured at baseline, 3 months post baseline (12 weeks) and again at 3 months post treatment (up to 24 weeks)

    The potential for an effect will determine the magnitude of the change in self-reported unprotected anal intercourse acts with HIV-uninfected and HIV-unknown status partners in the previous 3 months from baseline assessment to post treatment and follow-up.

Sponsors and collaborators

Lead sponsor

Fenway Community Health

Other

Collaborators

  • Harvard University
  • Massachusetts General Hospital
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Acronym: ENGAGE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2011
Registry last updated
Aug 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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