C2P - Phase III: MPowerment and Community Promise

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Printed materials
* Behavioral: Peer advocates


Participation Criteria
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Eligibility Criteria
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Community Promise: Inclusion Criteria Adolescents and young adults who provide verbal confirmation that their age is within the range of 12 through 24 years, inclusive. Gender will reflect that of the population of focus. Must report having engaged in voluntary sexual activity within the past 12 months (vaginal, anal and/or oral sex). Ability to understand and willingness to provide informed consent/assent. Exclusion Criteria Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood, or exhibiting manic, suicidal, or violent behavior). Visibly intoxicated or under the influence of psychoactive agents Clinically presents as acutely ill. MPowerment: Inclusion Criteria Male adolescents and young adults who provide verbal confirmation that their age is within the range of 12 through 24 years, inclusive. Must report having engaged in voluntary sexual activity within the past 12 months (anal and/or oral sex) with a man. Ability to understand and willingness to provide informed consent/assent. Exclusion Criteria Visibly distraught and/or visibly emotionally unstable (i.e., depressive mood, or exhibiting manic, suicidal, or violent behavior, etc.). Visibly intoxicated or under the influence of psychoactive agents. Clinically presents as acutely ill.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community PROMISE<br>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. | Behavioral: Printed materials<br>* 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.<br>* Other names: No other names.;|
| Experimental: Mpowerment<br>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. | Behavioral: Peer advocates<br>* 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.<br>* Other names: There are no other names.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YMSM, HIV/AIDS, Condom use, Drug users, Minority women