Clinical trial NCT02116049: Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners
Official title: Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Disclosure, intervention
HIV
prevention
Disclosure Intervention
Attention Control Case Management
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-04-16
Enrollment: 340
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* HIV-positive
* Male
* 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:

* Women
* 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

Primary outcomes:
measure: Change from baseline to 52 Weeks in the number/proportion of sex partners disclosed to
timeFrame: Baseline, Week 7, Week 12, Week 24, Week 52
Secondary outcomes:
measure: Change from baseline to 52 Weeks in HIV Transmission Risk
timeFrame: Baseline, Week 7, Week 12, Week 24, Week 52
Other outcomes:
measure: Change from baseline to 52 Weeks in the reported obstacles to disclosure
timeFrame: Baseline, Week 7, Week 12, Week 24, Week 52
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Julianne M Serovich, PhD
role: PRINCIPAL_INVESTIGATOR
References: