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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01291589
Acronym
ENGAGE
Enrollment
14
Registered
2011-02-08
Start date
2011-11-30
Completion date
2012-09-30
Last updated
2016-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk Reduction Behavior

Keywords

HIV-infected, MSM, HIV prevention

Brief summary

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).

Detailed description

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.

Interventions

BEHAVIORALCognitive-behavioral therapy

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

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Harvard University
CollaboratorOTHER
National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Fenway Community Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decrease in self-reported sexual risk takingMeasured 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026