Clinical trial NCT00381784: C2P - Phase III: MPowerment and Community Promise
Official title: Connect-To-Protect® Phase III: Local Evaluation of Community Promise Connect-To-Protect® Phase III: Local Evaluation of Mpowerment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: YMSM
HIV/AIDS
Condom use
Drug users
Minority women
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2006-09-28
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 4 years
Secondary outcomes:
measure: Successful delivery of a CDC-endorsed community-level HIV prevention program
timeFrame: 4 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Washington
country: United States
facility: Childrens Hospital National Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: USF Peds Division of Infectious Disease
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: Johns Hopkins University
name: Jonathan Ellen, MD
role: STUDY_CHAIR
References: