- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710671
Psychosocial Needs of YMSM
February 27, 2017 updated by: University of North Carolina, Chapel Hill
Psychosocial Needs of HIV+ Young Men Who Have Sex With Men (YMSM)
The proposed study will use both qualitative and quantitative research methods (mixed methods) to gather data that will support the eventual development of interventions for young men who have sex with men (YMSM) living with behaviorally acquired HIV infection.
The overall goal of the study is to gain an understanding of the psychosocial/developmental needs of YMSM by focusing on two critical developmental issues-identity development and future life goals.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
254
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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California
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Los Angeles, California, United States, 90027
- Children's Hopsital of Los Angeles
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San Francisco, California, United States, 94118
- University of California at San Francisco
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Children's Diagnostic and Teatment Center
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Miami, Florida, United States, 33101
- University of Miami
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Tampa, Florida, United States, 33606
- University of South Florida College of Medicine
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Illinois
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Chicago, Illinois, United States, 60612
- John Stroger Jr. Hospital of Cook County
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Chicago, Illinois, United States, 60614
- Children's Memorial Hospital
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, United States, 21201
- University of MD School of Medicine
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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New York, New York, United States, 10128
- Mount Sinai Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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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
16 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Male, HIV+ participants from ages 16-24 who have had sex with another male in the past year and accquired HIV behaviorally.
Description
Inclusion Criteria:
Potential participants must meet all of the following inclusion criteria in order to participate in the study:
- Biologically male at birth and identifies as male at time of study participation;
- HIV-infected as documented by medical record review or verbal verification with referring professional;
- Between the age of 16 years, 0 days to 24 years, 364 days at the time of informed consent/assent;
- HIV infection occurred through sexual or substance use behavior of the participant;
- Ability to understand both written and spoken English; and
- History of at least one sexual encounter involving either anal or oral penetration (either receptive or insertive) with a male partner during the 12 months prior to enrollment.
Exclusion Criteria:
- Acquired HIV through perinatal infection;
- Transfusion acquired HIV infection;
- Presence of serious psychiatric symptoms (active hallucinations, thought disorder) that would impair participants' ability to complete the study measures;
- Visibly distraught (suicidal, homicidal, exhibiting violent behavior); or
- Intoxicated
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
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
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Phase 1
Male, HIV+ participants from ages 16-24 who have had sex with another male in the past year and acquired HIV behaviorally.
Participants will be drawn from four participating AMTU sites.
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Phase 2
Male, HIV+ participants from ages 16-24 who have had sex with another male in the past year and acquired HIV behaviorally.
Participants will be drawn from all fifteen AMTU sites.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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An understanding of the most salient risk factors/stressors and resistance factors/coping mechanisms that impact healthy identity development among YMSM living with HIV.
Time Frame: To be determined in analysis
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To be determined in analysis
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An understanding of the association between ethnic identity, sexual identity, and identity as a young man living with HIV and the health behaviors of substance use, sexual activity, and adherence to healthcare among YMSM living with HIV.
Time Frame: To be determined in analysis
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To be determined in analysis
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An understanding of the most salient risk factors/stressors and resistance factors/coping mechanisms that negatively impact the future life goals of YMSM living with HIV.
Time Frame: To be determined in analysis
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To be determined in analysis
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Identification of additional psychosocial/developmental needs of YMSM living with HIV (in addition to healthy identity development and future life goals).
Time Frame: To be determined in analysis
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To be determined in analysis
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Development of recommendations for interventions aimed at facilitating healthy identity development, constructing future life goals, and addressing additional psychosocial/developmental needs among YMSM living with HIV.
Time Frame: To be determined in analysis
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To be determined in analysis
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Gary W Harper, Adolescent Trials Network
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
March 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
July 2, 2008
First Submitted That Met QC Criteria
July 2, 2008
First Posted (Estimate)
July 4, 2008
Study Record Updates
Last Update Posted (Actual)
February 28, 2017
Last Update Submitted That Met QC Criteria
February 27, 2017
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- ATN 070
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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Institute of HIV Research and Innovation Foundation...amfAR, The Foundation for AIDS Research; The US NIH through the International...RecruitingChemSex Users for YMSMThailand
-
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-
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-
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-
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