Skip to main content
OpenTrials
Completed

NCT Number: NCT00381784

C2P - Phase III: MPowerment and Community Promise

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Drug Misuse Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

12 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Pediatric Hospital, San Juan, Puerto Rico

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Printed materials

Behavioral

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 names: No other names.

Peer advocates

Behavioral

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 names: There are no other names.

Primary outcomes

  1. 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 outcomes

  1. Successful delivery of a CDC-endorsed community-level HIV prevention program

    Time frame: 4 years

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Connect-To-Protect® Phase III: Local Evaluation of Community Promise Connect-To-Protect® Phase III: Local Evaluation of Mpowerment

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Sep 28, 2006
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.