Clinical trial NCT00710671: Psychosocial Needs of YMSM
Official title: Psychosocial Needs of HIV+ Young Men Who Have Sex With Men (YMSM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV+ YMSM
Keywords: HIV positive
YMSM
risk factors
coping
identity development
psychosocial needs
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2008-07-04
Enrollment: 254
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: An understanding of the most salient risk factors/stressors and resistance factors/coping mechanisms that impact healthy identity development among YMSM living with HIV.
timeFrame: To be determined in analysis
measure: 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.
timeFrame: To be determined in analysis
measure: 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.
timeFrame: To be determined in analysis
measure: Identification of additional psychosocial/developmental needs of YMSM living with HIV (in addition to healthy identity development and future life goals).
timeFrame: To be determined in analysis
measure: 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.
timeFrame: To be determined in analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hopsital of Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Teatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Chicago
country: United States
facility: John Stroger Jr. Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of MD School of Medicine
state: Maryland
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: Adolescent Trials Network
name: Gary W Harper
role: STUDY_CHAIR
References: