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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: May 15, 2014
Last verified: May 2014
  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
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
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.
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.

  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
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: 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: May 15, 2014
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 September 22, 2014