C2P - Phase III: MPowerment and Community Promise

HIV Infections Clinical Trial

Official title:

Connect-To-Protect® Phase III: Local Evaluation of Community Promise Connect-To-Protect® Phase III: Local Evaluation of Mpowerment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381784
• Other study ID #: ATN 041
• Status: Completed
• Phase: N/A
• First received: September 26, 2006
• Last updated: March 2, 2017
• Start date: July 2006
• Est. completion date: March 2011

Study information

• Verified date: March 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

Community Promise:

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.

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:

Inclusion Criteria

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 (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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Puerto Rico	University Pediatric Hospital	San Juan
United States	University of Maryland	Baltimore	Maryland
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	Childrens Hospital of Los Angeles	Los Angeles	California
United States	University of California at San Francisco	San Francisco	California
United States	USF Peds Division of Infectious Disease	Tampa	Florida
United States	Childrens Hospital National Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The goal of PROMISE and Mpowerment is to effect community change through diffusion of health-promoting information via naturally occurring social networks. Data collection is process evaluation data only.		4 years
Secondary	Successful delivery of a CDC-endorsed community-level HIV prevention program	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.	4 years

External Links

•   ATN website