Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of South Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT02116049
First received: April 7, 2014
Last updated: April 14, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
HIV
Behavioral: Disclosure Intervention
Behavioral: Attention Control Case Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change from baseline to 52 Weeks in HIV Transmission Risk [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Ordinal measure of HIV transmission risk. The ordinal measure is constructed from information provided by the participant on the last five sexual encounters during the prior 30 days, with the highest risk assigned to encounters involving discordant anal/vaginal intercourse, unprotected, with a discordant partner (XEF)


Other Outcome Measures:
  • Change from baseline to 52 Weeks in the reported obstacles to disclosure [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Reasons for non-disclosure (obstacles) are measured at the encounter level (last five encounters during the prior 30 day period)


Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Attention Control Case Management
Comprehensive Risk Counseling and Services" (CRCS) will be used to guide the case management activities. CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance. These core elements represent the framework of the intervention, and provide enough flexibility to allow implementation that most appropriately serves the needs of clients. This project's case management will mimic the experimental condition with a meeting schedule reflective of the experimental arm plus a booster session at 3 months.
Behavioral: Attention Control Case Management
Comprehensive Risk Counseling and Services (CRCS) will be used to guide the case management activities. CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance.
Experimental: Disclosure Intervention
The experimental condition is a 4-session + 3 month booster intervention. Session 1 includes an introduction to the project, goal setting, assessment of disclosure strategies or tactics utilized, and disclosure triggers. Session 2 focuses on the costs and benefits of disclosing to casual sexual partners and previous best and worst disclosure experiences. Session 3 begins with the delivery of the encouraging messages and review of the disclosure strategies already employed. Session 4 is a continuation of session 3 activities with an additional focus on expanding the participant's repertoire of strategies; discussion of methods of sexual negotiation, and rehearsal. The booster session includes a discussion of what strategies have been used in the preceding months, which strategies worked and how can these be enhanced, which strategies did not work with opportunities for troubleshooting, and an examination of rewards experienced or costs encountered.
Behavioral: Disclosure Intervention
The experimental condition is a 4-session + 3 month booster intervention. Session 1 includes an introduction to the project, goal setting, assessment of disclosure strategies or tactics utilized, and disclosure triggers. Session 2 focuses on the costs and benefits of disclosing to casual sexual partners and previous best and worst disclosure experiences. Session 3 begins with the delivery of the encouraging messages and review of the disclosure strategies already employed. Session 4 is a continuation of session 3 activities with an additional focus on expanding the participant's repertoire of strategies; discussion of methods of sexual negotiation, and rehearsal. The booster session includes a discussion of what strategies have been used in the preceding months, which strategies worked and how can these be enhanced, which strategies did not work with opportunities for troubleshooting, and an examination of rewards experienced or costs encountered.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02116049

Contacts
Contact: Julianne M Serovich, PhD 813-974-1990 jserovich@usf.edu
Contact: Judy A Kimberly, PhD 813-974-6013 jkimberly@usf.edu

Locations
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Judy A Kimberly, PhD    813-974-6013    jkimberly@usf.edu   
Principal Investigator: Julianne M Serovich, PhD         
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Julianne M Serovich, PhD University of South Florida
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02116049     History of Changes
Other Study ID Numbers: MH082639, R01MH082639
Study First Received: April 7, 2014
Last Updated: April 14, 2014
Health Authority: United States: National Institutes of Health

Keywords provided by University of South Florida:
Disclosure, intervention
HIV
prevention
Disclosure Intervention
Attention Control Case Management

ClinicalTrials.gov processed this record on September 18, 2014