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C2P - Phase III: MPowerment and Community Promise

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Printed materials
Peer advocates
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring YMSM, HIV/AIDS, Condom use, Drug users, Minority women

Eligibility Criteria

12 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Childrens Hospital of Los Angeles
  • University of California at San Francisco
  • Childrens Hospital National Medical Center
  • USF Peds Division of Infectious Disease
  • Stroger Hospital of Cook County
  • University of Maryland
  • University Pediatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Community PROMISE

Mpowerment

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 26, 2006
Last Updated
March 2, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00381784
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
YMSM, HIV/AIDS, Condom use, Drug users, Minority women

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community PROMISE
Arm Type
Experimental
Arm 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.
Arm Title
Mpowerment
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Printed materials
Other Intervention Name(s)
No other names.
Intervention Description
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
Intervention Name(s)
Peer advocates
Other Intervention Name(s)
There are no other names.
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Successful delivery of a CDC-endorsed community-level HIV prevention program
Description
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.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Ellen, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
Childrens Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90054
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Childrens Hospital National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
USF Peds Division of Infectious Disease
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Stroger Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University Pediatric Hospital
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

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C2P - Phase III: MPowerment and Community Promise

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