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HIV Prevention in Very High Risk Men Who Have Sex With Men (ENGAGE)

F

Fenway Community Health

Status and phase

Completed
Phase 1

Conditions

Risk Reduction Behavior

Treatments

Behavioral: Cognitive-behavioral therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01291589
2P30AI060354-07

Details and patient eligibility

About

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).

Full 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.

Enrollment

14 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Cognitive-behavioral counseling
Experimental group
Treatment:
Behavioral: Cognitive-behavioral therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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