C2P - Phase III: MPowerment and Community Promise

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Printed materials; Behavioral: Peer advocates

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00381784

ATN 041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 12 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Community PROMISE

Experimental group

Description:

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.

Treatment:

Behavioral: Printed materials

Mpowerment

Experimental group

Description:

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.

Treatment:

Behavioral: Peer advocates