- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02116049
Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners
April 6, 2015 updated by: University of South Florida
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
340
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- University of South Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline, Week 7, Week 12, Week 24, Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to 52 Weeks in HIV Transmission Risk
Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52
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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)
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Baseline, Week 7, Week 12, Week 24, Week 52
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to 52 Weeks in the reported obstacles to disclosure
Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52
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Reasons for non-disclosure (obstacles) are measured at the encounter level (last five encounters during the prior 30 day period)
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Baseline, Week 7, Week 12, Week 24, Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julianne M Serovich, PhD, University of South Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
April 7, 2014
First Submitted That Met QC Criteria
April 14, 2014
First Posted (Estimate)
April 16, 2014
Study Record Updates
Last Update Posted (Estimate)
April 7, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MH082639
- R01MH082639 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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