NCT00381784

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable hiv-infections

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2016

Enrollment Period

4.7 years

First QC Date

September 26, 2006

Last Update Submit

March 2, 2017

Conditions

HIV Infections

Keywords

YMSMHIV/AIDSCondom useDrug usersMinority women

Outcome Measures

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.

    4 years

Secondary Outcomes (1)

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

    4 years

Study Arms (2)

Community PROMISE

EXPERIMENTAL

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

Mpowerment

EXPERIMENTAL

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

Interventions

Printed materialsBEHAVIORAL

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.

Also known as: No other names.
Community PROMISE
Peer advocatesBEHAVIORAL

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.

Also known as: There are no other names.
Mpowerment

Eligibility Criteria

Age12 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Childrens Hospital of Los Angeles

Los Angeles, California, 90054, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Childrens Hospital National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

USF Peds Division of Infectious Disease

Tampa, Florida, 33606, United States

Location

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University Pediatric Hospital

San Juan, 00936, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeDrug Misuse

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jonathan Ellen, MD

    Johns Hopkins University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 28, 2006

Study Start

July 1, 2006

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 3, 2017

Record last verified: 2016-03

Locations

US(6)PR(1)