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Clinical Trials/NCT02116049
NCT02116049
Completed
Not Applicable

Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners

University of South Florida1 site in 1 country340 target enrollmentAugust 2009
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University of South Florida
Enrollment
340
Locations
1
Primary Endpoint
Change from baseline to 52 Weeks in the number/proportion of sex partners disclosed to
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Men who have sex with men (MSM) remain disproportionately represented in the national HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual behavior or communication that may be perpetuating the spread of HIV. Non-disclosure of an HIV-positive status may be a key factor responsible for male-male HIV transmission. There are no known intervention programs whose primary focus is to help MSM develop requisite skills to disclose their status to casual sexual partners. The development of such interventions is essential because of the numerous repercussions for not disclosing when one is HIV-positive such as legal prosecution and the transmission of HIV. In a previous intervention development study (R21MH067494) the research team created and tested a 4 session intervention found to be promising for increasing disclosure to casual sexual partners. The purpose of the proposed research is to further refine and enhance our HIV disclosure intervention (DI) designed to increase disclosure to casual sexual partners and reduce sexual risk taking behaviors among HIV-positive MSM; assess the relative effectiveness of a disclosure intervention to an attention control case management group (ACCM) for HIV-positive MSM; examine the effects of the intervention over time; explore differential treatment responses to the disclosure intervention and ACCM on the basis of ethnicity, age, and education level as well as examine the mediating effect of baseline frequency of sexual activity, severity of substance abuse at baseline, and stigmatized fear on the relationship between intervention type and the outcome. Finally, the investigators will test how treatment engagement, retention and expectations predict subsequent disclosure and risky sexual outcomes.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • HIV-positive
  • Have sex with other men
  • Over the age of 18
  • Sexually active in the past 90 days
  • 2 or more partners in last 12 months
  • Indicate an interest in learning more about disclosing serostatus to casual sex partners
  • Speak and understand English
  • Plan on living in Tampa area for at least 1 year

Exclusion Criteria

  • HIV-negative
  • Children under the age of 18
  • Men who exclusively have sex with women
  • Those who cannot speak and understand English
  • Those who have not been sexually active or are behaviorally monogamous

Outcomes

Primary Outcomes

Change from baseline to 52 Weeks in the number/proportion of sex partners disclosed to

Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52

Disclosure to sexual partners is measured at the encounter level (last 5 sexual encounters during the prior 30 day period), and as an aggregate (number of partners disclosed to during the prior 30 day period.

Secondary Outcomes

  • Change from baseline to 52 Weeks in HIV Transmission Risk(Baseline, Week 7, Week 12, Week 24, Week 52)

Study Sites (1)

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