C2P - Phase III: MPowerment and Community Promise

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00381784
First received: September 26, 2006
Last updated: June 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Behavioral: Printed materials
Behavioral: Peer advocates
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Connect-To-Protect® Phase III: Local Evaluation of Community Promise Connect-To-Protect® Phase III: Local Evaluation of Mpowerment

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Successful delivery of a CDC-endorsed community-level HIV prevention program [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: July 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Community PROMISE
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
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.
Other Name: No other names.
Experimental: Mpowerment
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

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.

Other Name: There are no other names.

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

Ages Eligible for Study:   12 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381784

Locations
United States, California
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90054
University of California at San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Childrens Hospital National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
USF Peds Division of Infectious Disease
Tampa, Florida, United States, 33606
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Investigators
Study Chair: Jonathan Ellen, MD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00381784     History of Changes
Other Study ID Numbers: ATN 041
Study First Received: September 26, 2006
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
YMSM
HIV/AIDS
Condom use
Drug users
Minority women

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 16, 2014