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

October 3, 2018 updated by: Public Health Management Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

761

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Philadelphia Health Management Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
drug use
risk behaviors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health Management Corporation

Collaborators

National Institute on Drug Abuse (NIDA)
Mazzoni Center

Investigators

  • Principal Investigator: Jennifer L Lauby, PhD, Philadelphia Health Managment Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 11, 2006

First Submitted That Met QC Criteria

May 11, 2006

First Posted (Estimate)

May 15, 2006

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA018084-01A2 (U.S. NIH Grant/Contract)
  • R01DA018084 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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