- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02128594
Serosorting Intervention for HIV Negative MSM
May 27, 2015 updated by: University of Connecticut
Men who have sex with men make up a majority of incident HIV infections, however few effective interventions to prevent HIV transmission among this group exist.
African American men who have sex with men (AAMSM) are disproportionately infected with STI/HIV and little is understood about how the role of stigma impacts their linkage and retention to health care during treatment.
Effective strategies for reducing HIV related risk taking are urgently needed to prevent further spread of the HIV epidemic.
The proposed research will test a behavioral intervention, which can be used during routine public health services, designed to reduce HIV risks posed by sexual partner selection strategies.
The proposed research will also identify treatment barriers among MSM who test HIV/STI positive.
Effective strategies for reducing social barriers to health care treatment rely on a comprehensive and thorough investigation into social barriers that affect AAMSM to effectively engage in medical care.
These areas of research will be focused on for the current trial.
Study Overview
Detailed Description
Men who have sex with men continue to make up a majority of incident HIV infections.
Despite alarmingly high rates of HIV infection, there are few effective interventions to prevent HIV transmission among these men.
This five year study, proposed by a New/Early Stage Investigator, consists of a randomized controlled trial to test a behavioral intervention designed to reduce risks for HIV/AIDS posed by sexual partner selection strategies, specifically serosorting, among at-risk HIV negative men who have sex with men in Atlanta, GA.
Serosorting - limiting unprotected sexual partners to those of the same HIV status- has emerged as a risk reduction strategy with little input from public health agencies.
It is commonly practiced among men who have sex with men to avoid HIV infection.
However, engaging in serosorting is a predictor of HIV transmission rather than a reliable form of prevention.
Serosorting is ineffective due to several factors, including: multiple flaws in the ability to be certain of own or partner's HIV statuses, the failure of routine HIV tests to detect acute HIV infection, elevated infectiousness due to acute HIV infection, and increased risk for contracting other STIs that can facilitate HIV transmission.
We are therefore proposing to test a brief, single-session, Conflict Theory of Decision Making based intervention for use in public health settings.
This project uses a novel theory of informed decision making to guide an intervention designed for use in routine services, i.e., HIV post-test counseling.
An intervention to address the needs of men who test HIV negative fits well with current efforts to scale up HIV testing, also referred to as seek, test and treat.
The proposed research builds on the strengths of a pilot tested, behavioral intervention for addressing serosorting among men who have sex with men.
Following screening, informed consent, baseline assessments, and HIV testing (we predict 70 men will test HIV positive), 600 HIV-negative participants will be randomly assigned to receive one of two intervention arms: (a) a serosorting, partner selection intervention, or (b) a time-match, CDC based, post-HIV test counseling, standard-of-care.
Participants will be followed over 12-months and assessments will include measures of serosorting beliefs, decisional balance, knowledge of acute HIV infection, HIV status disclosure, and biological (incident STI) and behavioral outcomes (sexual behaviors).
This study will test the hypotheses that a brief, single session, serosorting intervention will result in less risk-related serosorting beliefs, greater knowledge/awareness of HIV transmission risk taking, increased HIV status disclosure, reductions in number of sex partners, unprotected sex acts, and incident STIs among intervention participants more so than the control group participants.
Moreover, we will test the hypothesis that the intervention will be cost saving when tested in cost-effectiveness analyses.
If shown effective, the intervention model will be ready for immediate dissemination to HIV testing services.
In a subset of participants, we will test how stigma affects linkage, engagement and retention in care for participants who test HIV/STI positive.
Study Type
Interventional
Enrollment (Actual)
600
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
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- SHARE Project
-
-
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men who have sex with men
- Reside in study area (Atlanta, GA)
- At least 18 years of age
- Other criteria may apply
Exclusion Criteria:
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard of Care
Standard of care
|
Single session, behavioral intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sexually Transmitted Disease
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa A Eaton, PhD, University of Connecticut
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2012
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
April 29, 2014
First Submitted That Met QC Criteria
April 30, 2014
First Posted (Estimate)
May 1, 2014
Study Record Updates
Last Update Posted (Estimate)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 27, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- H10-299
- R01MH094230 (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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