Adopting and Demonstrating the Adaptation of Prevention Techniques: Community PROMISE PLUS

NCT ID: NCT00267436

Last Updated: 2012-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 574 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2007-02-28

Brief Summary

This project will pilot test a step-by-step guide developed by CDC for organizations to engage in evidence-based adaptation of interventions previously shown to be effective in research settings for use in real world applications. The second purpose of the program is to evaluate the adapted intervention to determine if it is effective in changing behavior of HIV+ African American men who have sex with other men.

Detailed Description

During the ADAPT project both sites will adapt the original Community Promise intervention to specifically address the HIV prevention needs of sero-positive, African American men who have sex with men (HIV+ AAMSM) in either Boston, MA or Minneapolis/St. Paul (MSP), MN. The adapted intervention will be referred to as Community PROMISE, Positives Leading and Utilizing Strategies (CP PLUS).

In the first two months of the ADAPT project, the Boston and MSP sites will conduct formative evaluation activities (i.e., a comprehensive literature review, focus groups, and individual interviews) to assess the needs of the target population and organizational capacities to serve them. Results will be used to inform the adaptation of the original intervention to ensure that CP PLUS meet the expressed needs of the target population.

Process data will also be collected from various sources throughout the life of the project. Process data will be collected through staff meetings, interviews with staff, focus groups with peer advocates, and an expert panel consultation. Process data will be extremely useful for ensuring program objectives are met, improving CP PLUS, and providing information for providers in other locales who may be interested in adapting this intervention to serve this target population.

The Boston and MSP sites will also conduct outcome monitoring through collection of data concerning risk behaviors pre- and post-intervention implementation (follow-up at 6-8 months post and 11-13 months post [Boston only]) to determine if the adapted intervention has met its outcome objectives. Outcome monitoring will also be conducted for the "parent" intervention at both sites for HIV- or unknown status men who have sex with men.

In addition to the project activities, the organization will be examining the utility of the CDC draft guidance. The Boston and MSP sites are two of five case studies throughout the United States that will detail the challenges, successes and lessons learned from adapting an intervention packaged by CDC's Replicating Effective Programs (REP) and disseminated by Diffusing Effective Behavioral Interventions (DEBI) to a specific population. These findings will help other community-based organizations and Health Departments effectively adapt and tailor group, individual and community-level interventions.

Conditions

HIV Prevention; STD Prevention

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Community PROMISE

The Community PROMISE begins with a community assessment to identify HIV risk factors. Once risk factors have been identified, individuals from the targeted at-risk community are recruited and trained to be peer advocates. Trained peer advocates interview members of the community about their behavior. Role model stories are written based on the interviews. Role model stories are personal accounts from individuals in the target population which explain how and why they took steps to practice HIV risk-reduction behaviors and the positive effects the choice has had on their lives. Each week, peer advocates distribute role model stories and supplies, such as condoms, to 10 to 20 members of their social networks.

Intervention Type: BEHAVIORAL

Other Intervention Names

AIDS Community Demonstration Project

Eligibility Criteria

Inclusion Criteria

HIV+ cohort

• Self-reports as HIV+ (for CP PLUS cohort)
• Self-report that they had sex with men in the past 3 years (MSP) or 1 year (Boston)
• Self-reports as a resident of the identified geographic areas.
• Identifies as African American
• 18 years of age, or older.

HIV- cohort

• HIV- or unknown status only, has engaged in risky sexual contact (defined as those who self-report engaging in unprotected anal or vaginal intercourse within the past year)
• Self-report that they had sex with men in the past 3 years (MSP) or 1 year (Boston)
• Identifies as African American (MSP); No racial/ethnic criteria however AA will be over-sampled and will be at least 20% of sample
• 18 years of age, or older.
• Self-reports as a resident of the identified geographic areas.
• Engage in risky sex (defined as individuals who self-report engaging in unprotected anal or vaginal intercourse within the past year.

Exclusion Criteria

• Inability to complete informed consent process due to (a) substantial cognitive impairment. (b) non-English speaking; (c) under the influence of drugs or alcohol
• Under 18 years of age
• Plans to relocate within 12 months after baseline interview

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Minneapolis Urban League;

UNKNOWN

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

AIDS Action Committee of Massachusetts

OTHER

Sponsor Role: collaborator

The Fenway Institute

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Centers for Disease Control and Prevention

Principal Investigators

Jennifer S Galbraith

Role: STUDY_DIRECTOR

Centers for Disease Control and Prevention

Locations

AIDS Action Committee

Boston, Massachusetts, United States

Minneapolis Urban League

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

U65/CCU523908-01

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP-U65/CCU523908

Identifier Type: -

Identifier Source: org_study_id