Psychosocial Needs of YMSM
This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00710671
First received: July 2, 2008
Last updated: December 14, 2012
Last verified: October 2012
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Purpose
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.
| Condition |
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HIV+ YMSM |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Psychosocial Needs of HIV+ Young Men Who Have Sex With Men (YMSM) |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 254 |
| Study Start Date: | March 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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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Eligibility| Ages Eligible for Study: | 16 Years to 24 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710671
Locations
| United States, California | |
| Children's Hopsital of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94118 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Children's Diagnostic and Teatment Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| University of Miami | |
| Miami, Florida, United States, 33101 | |
| University of South Florida College of Medicine | |
| Tampa, Florida, United States, 33606 | |
| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| John Stroger Jr. Hospital of Cook County | |
| Chicago, Illinois, United States, 60612 | |
| United States, Louisiana | |
| Tulane Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| University of MD School of Medicine | |
| Baltimore, Maryland, United States, 21201 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10128 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Gary W Harper | Adolescent Trials Network |
More Information
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00710671 History of Changes |
| Other Study ID Numbers: | ATN 070 |
| Study First Received: | July 2, 2008 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
HIV positive YMSM risk factors |
coping identity development psychosocial needs |
ClinicalTrials.gov processed this record on May 16, 2013