C2P - Phase III: MPowerment and Community Promise

NCT ID: NCT00381784

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2011-03-31

Brief Summary

One of the objectives of the C2P coalition is the successful delivery of a CDC-endorsed community-level HIV prevention program aimed at changing the risk profiles of youth. This protocol (ATN 041) describes the program, Community PROMISE (Peers Reaching Out and Modeling Intervention Strategies) or MPowerment, and plans for adapting and implementing it. There are a total of 4 interventions that a community can implement.

Detailed Description

Community Promise: Role model stories comprise the "heart" of printed materials distributed throughout the target community. The role model stories are brief publications that depict personal accounts from individuals in the population of focus who have made or are planning to make a risk-reducing behavioral change. The messages in the role model stories are reinforced by interpersonal communication with trained peer advocates.

MPowerment: is a community level HIV/STD prevention program that relies on peer advocates from the community to lead outreach activities including discussion groups (M-groups), venue-based outreach, social events and a publicity campaign. Sites will adapt MPowerment for local use remaining faithful to the core elements.

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Community PROMISE

Community PROMISE is a community level HIV/STD prevention program that relies on role model stories and peer advocates from the community. Sites will adapt PROMISE for local use remaining faithful to the core elements.

Group Type: EXPERIMENTAL

Printed materials

Intervention Type: BEHAVIORAL

Role model stories comprise the "heart" of printed materials distributed throughout the target community. The role model stories are brief publications that depict personal accounts from individuals in the population of focus who have made or are planning to make a risk-reducing behavioral change. Depending on the population they are meant to reach and what behavior they are trying to influence, the stories may include examples of people who now carry condoms with them, talked to a partner about condom use, use condoms consistently, avoid sharing needles, or exhibited other risk reduction behaviors.

Mpowerment

MPowerment is a community level HIV/STD prevention program that relies on peer advocates from the community to lead outreach activities including discussion groups (Mgroups), venue-based outreach, social events and a publicity campaign. Sites will adapt MPowerment for local use remaining faithful to the core elements.

Group Type: EXPERIMENTAL

Peer advocates

Intervention Type: BEHAVIORAL

Core Element 1 Core group of young gay men and additional volunteers recruited from the community. The core group and volunteers comprise the "peer advocates" who design and carry out all program activities.

Core Element 2 Designated space where most social events and meetings are held; also serves as a drop in center where young men can meet and socialize during specified hours.

Core Element 3 Social events to attract young gay men and to promote safer sex. Core Element 4 Teams of young gay men go to locations frequented by young gay men to discuss and promote safer sex, deliver appealing informational literature on HIV risk reduction and distribute condoms.

Core Element 5 Meetings of eight to 10 young gay men to discuss factors contributing to unsafe sex among men. Men practice safer sex negotiation and correct condom use skills.

Core Element 6 Publicity campaigns that attract men to the program by word of mouth and through articles and advertisements in gay newspapers.

Interventions

Printed materials

Role model stories comprise the "heart" of printed materials distributed throughout the target community. The role model stories are brief publications that depict personal accounts from individuals in the population of focus who have made or are planning to make a risk-reducing behavioral change. Depending on the population they are meant to reach and what behavior they are trying to influence, the stories may include examples of people who now carry condoms with them, talked to a partner about condom use, use condoms consistently, avoid sharing needles, or exhibited other risk reduction behaviors.

Intervention Type: BEHAVIORAL

Peer advocates

Core Element 1 Core group of young gay men and additional volunteers recruited from the community. The core group and volunteers comprise the "peer advocates" who design and carry out all program activities.

Core Element 2 Designated space where most social events and meetings are held; also serves as a drop in center where young men can meet and socialize during specified hours.

Core Element 3 Social events to attract young gay men and to promote safer sex. Core Element 4 Teams of young gay men go to locations frequented by young gay men to discuss and promote safer sex, deliver appealing informational literature on HIV risk reduction and distribute condoms.

Core Element 5 Meetings of eight to 10 young gay men to discuss factors contributing to unsafe sex among men. Men practice safer sex negotiation and correct condom use skills.

Core Element 6 Publicity campaigns that attract men to the program by word of mouth and through articles and advertisements in gay newspapers.

Intervention Type: BEHAVIORAL

Other Intervention Names

No other names.; There are no other names.

Eligibility Criteria

Inclusion Criteria

1. Adolescents and young adults who provide verbal confirmation that their age is within

2. the range of 12 through 24 years, inclusive.

3. Gender will reflect that of the population of focus.

4. Must report having engaged in voluntary sexual activity within the past 12 months (vaginal, anal and/or oral sex).

5. Ability to understand and willingness to provide informed consent/assent.

1. Male adolescents and young adults who provide verbal confirmation that their age is within the range of 12 through 24 years, inclusive.

2. Must report having engaged in voluntary sexual activity within the past 12 months (anal and/or oral sex) with a man.

3. Ability to understand and willingness to provide informed consent/assent.

Exclusion Criteria

1. Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood, or exhibiting manic, suicidal, or violent behavior).

2. Visibly intoxicated or under the influence of psychoactive agents

3. Clinically presents as acutely ill.

MPowerment:

1. Visibly distraught and/or visibly emotionally unstable (i.e., depressive mood,

2. or exhibiting manic, suicidal, or violent behavior, etc.).

3. Visibly intoxicated or under the influence of psychoactive agents.

4. Clinically presents as acutely ill.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Ellen, MD

Role: STUDY_CHAIR

Johns Hopkins University

Locations

Childrens Hospital of Los Angeles

Los Angeles, California, United States

University of California at San Francisco

San Francisco, California, United States

Childrens Hospital National Medical Center

Washington D.C., District of Columbia, United States

USF Peds Division of Infectious Disease

Tampa, Florida, United States

Stroger Hospital of Cook County

Chicago, Illinois, United States

University of Maryland

Baltimore, Maryland, United States

University Pediatric Hospital

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Related Links

http://www.atnonline.org

ATN website

Other Identifiers

ATN 041

Identifier Type: -

Identifier Source: org_study_id