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

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
community-level intervention for young MSM
Sponsored by
Public Health Management Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, prevention

Eligibility Criteria

15 Years - 29 Years (Child, Adult)MaleAccepts Healthy Volunteers

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: -

Sites / Locations

  • Philadelphia Health Management Corporation

Outcomes

Primary Outcome Measures

drug use
risk behaviors

Secondary Outcome Measures

Full Information

First Posted
May 11, 2006
Last Updated
October 3, 2018
Sponsor
Public Health Management Corporation
Collaborators
National Institute on Drug Abuse (NIDA), Mazzoni Center
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1. Study Identification

Unique Protocol Identification Number
NCT00325702
Brief Title
Addressing Young Men's Substance Use and HIV Risk
Acronym
Get REAL
Official Title
Addressing Young Men's Substance Use and HIV Risk
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Public Health Management Corporation
Collaborators
National Institute on Drug Abuse (NIDA), Mazzoni Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
761 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
community-level intervention for young MSM
Intervention Description
The community-level intervention includes small media in the form of role model stories, peer outreach and web-based intervention
Primary Outcome Measure Information:
Title
drug use
Title
risk behaviors

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Lauby, PhD
Organizational Affiliation
Philadelphia Health Managment Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia Health Management Corporation
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Addressing Young Men's Substance Use and HIV Risk

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