Addressing Young Men's Substance Use and HIV Risk (Get REAL)

This study has been completed.
Sponsor:
Collaborators:
Mazzoni Center
Information provided by (Responsible Party):
Jennifer Lauby, Public Health Management Corporation
ClinicalTrials.gov Identifier:
NCT00325702
First received: May 11, 2006
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

This project will develop, implement, and evaluate a community-level intervention for Black and White substance-using MSM between the ages of 15 and 29. The intervention is designed to change both social norms and risk behavior using persuasive media communication and interpersonal networking as primary intervention strategies.

Qualitative data from focus groups and interviews will inform the development of the intervention. The effects of the intervention will be assessed through annual interviews with young Black and White MSM in Philadelphia where the intervention will be implemented and in Baltimore, our comparison community.


Condition Intervention
HIV
Behavioral: community-level intervention for young MSM

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Addressing Young Men's Substance Use and HIV Risk

Resource links provided by NLM:


Further study details as provided by Public Health Management Corporation:

Primary Outcome Measures:
  • drug use
  • risk behaviors

Enrollment: 761
Study Start Date: October 2006
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: community-level intervention for young MSM
    The community-level intervention includes small media in the form of role model stories, peer outreach and web-based intervention
Detailed Description:

Young men who have sex with men (YMSM) have unique needs for targeted and tailored HIV prevention messages. HIV infection rates among MSM remain high, particularly among men under the age of 30 and for Black YMSM, whose HIV infection rates are over four times those of White YMSM. The use of drugs and alcohol has been linked to increased sexual risk for HIV among MSM yet no intervention addressing substance use and sexual risk within this population has been rigorously evaluated.

This project will develop, implement, and evaluate a community-level intervention for Black and White substance-using MSM between the ages of 15 and 29. The intervention, implemented with the collaboration of a community service organization, the Mazzoni Center, will be designed to change both social norms and risk behavior using persuasive media communication and interpersonal networking as primary intervention strategies. The proposed project aims to: 1) examine patterns and contexts of episodic substance use among YMSM; 2) compare patterns of substance use for Black and White YMSM, and differences by age, sexual identity and socio-economic status; 3) clarify the association between patterns and contexts of substance use and sexual risk behaviors; 4) evaluate the efficacy of a community-level intervention for substance-using YMSM to decrease sexual risk for HIV, through strengthening social norms, increasing perceived risk, and enhancing self-efficacy and positive attitudes to HIV prevention; 5) measure the differential impact of intervention messages on sexual risk behavior for subgroups of YMSM; 6) determine if a reduction in substance use leads to a decrease in sexual risk behaviors.

During the formative research phase, qualitative data will be obtained through focus groups and in-depth interviews to refine the conceptual model and the media materials. The intervention evaluation will collect quantitative data from YMSM in both Philadelphia PA and the comparison community of Baltimore MD, using geocoding and census tract data to control for demographic and socio-economic differences. A Solomon four-group design will be used to collect data from panel and cross-sectional samples in intervention and comparison communities. Four annual waves of interviews (baseline, 12, 24, and 36 months) will enable us to examine exposure to the intervention, changes in norms and behavior, and long-term intervention effects. A total of 650 men will be interviewed in Philadelphia and 400 in Baltimore. The data will be analyzed using multivariate techniques, including generalized linear model (GLM) repeated measures analysis and cumulative logit models. The study results will provide needed information on substance use and sexual risk of Black and White YMSM and have direct implications for implementing effective interventions to this high-risk population.

  Eligibility

Ages Eligible for Study:   15 Years to 29 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Black or White race
  • sex with a man in the past 12 months
  • episodic use of alcohol and drugs in past 30 days

Exclusion Criteria:

-

  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: NCT00325702

Locations
United States, Pennsylvania
Philadelphia Health Management Corporation
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Public Health Management Corporation
Mazzoni Center
Investigators
Principal Investigator: Jennifer L Lauby, PhD Philadelphia Health Managment Corporation
  More Information

No publications provided

Responsible Party: Jennifer Lauby, Principal Investigator, Public Health Management Corporation
ClinicalTrials.gov Identifier: NCT00325702     History of Changes
Other Study ID Numbers: R01 DA018084-01A2, R01DA018084
Study First Received: May 11, 2006
Last Updated: October 17, 2011
Health Authority: United States: Federal Government

Keywords provided by Public Health Management Corporation:
HIV
prevention

ClinicalTrials.gov processed this record on September 14, 2014