HIV+ YMSMNCT00710671
Psychosocial Needs of YMSM
An observational study of HIV+ YMSM, run by University of North Carolina, Chapel Hill at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 years, men only
- Conditions the study is for
- HIV+ YMSM
- How many people
- 254 participants
- Where
- 14 sitesUnited States
- Study dates
- Mar 2008to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Male, HIV+ participants from ages 16-24 who have had sex with another male in the past year and accquired HIV behaviorally.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of MD School of Medicine
Baltimore, Maryland, 21201
John Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
Children's Memorial Hospital
Chicago, Illinois, 60614
Children's Diagnostic and Teatment Center
Fort Lauderdale, Florida, 33316
Children's Hopsital of Los Angeles
Los Angeles, California, 90027
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Miami
Miami, Florida, 33101
Tulane Medical Center
New Orleans, Louisiana, 70112
Mount Sinai Medical Center
New York, New York, 10128
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California at San Francisco
San Francisco, California, 94118
University of South Florida College of Medicine
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
- Conditions
- HIV+ YMSM
- Keywords
- HIV positive, YMSM, risk factors, coping, identity development, psychosocial needs
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
An understanding of the most salient risk factors/stressors and resistance factors/coping mechanisms that impact healthy identity development among YMSM living with HIV.
Measured: To be determined in analysis
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.
Measured: To be determined in analysis
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.
Measured: To be determined in analysis
Identification of additional psychosocial/developmental needs of YMSM living with HIV (in addition to healthy identity development and future life goals).
Measured: To be determined in analysis
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.
Measured: To be determined in analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV+ YMSMStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gary W Harper, Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710671
- Sponsor's protocol ID
- ATN 070
- Status last verified
- Feb 2016
- First submitted
- 2 Jul 2008
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Needs of HIV+ Young Men Who Have Sex With Men (YMSM)
- ClinicalTrials.gov ID
- NCT00710671
- Acronym / sponsor ID
- ATN 070
- Conditions
- HIV+ YMSM
- Keywords
- HIV positive, YMSM, risk factors, coping, identity development, psychosocial needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male, HIV+ participants from ages 16-24 who have had sex with another male in the past year and accquired HIV behaviorally.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary W Harper study chair
Adolescent Trials Network
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV+ YMSM, run by University of North Carolina, Chapel Hill at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: To be determined in analysis). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.