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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

September 26, 2006
June 23, 2014
July 2006
March 2011   (final data collection date for primary outcome 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. [ 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.
  • Evaluation includes process and outcome monitoring activities conducted by ATN/C2P program staff and peer advocates.
Complete list of historical versions of study NCT00381784 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
C2P - Phase III: MPowerment and Community Promise
Connect-To-Protect® Phase III: Local Evaluation of Community Promise Connect-To-Protect® Phase III: Local Evaluation of Mpowerment

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Printed materials
  • 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.
    Intervention: Behavioral: Peer advocates
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
12 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00381784
ATN 041
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Jonathan Ellen, MD Johns Hopkins University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP