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

This study has been completed.
Sponsor:
Collaborators:
Minneapolis Urban League;
University of Minnesota - Clinical and Translational Science Institute
AIDS Action Committee of Massachusetts
The Fenway Institute
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00267436
First received: December 20, 2005
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
HIV Prevention
STD Prevention
Behavioral: Community PROMISE
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adopting and Demonstrating the Adaptation of Prevention Techniques: Community PROMISE Positives Leading and Utilizing Strategies (ADAPT CP PLUS)

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Sexual activities with main and casual partners in past 30 days to 6 months (i.e., unprotected insertive and receptive anal/vaginal sex and protected insertive and receptive anal/vaginal sex) [ Time Frame: 7/2006-2/2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavioral intentions and attitudes for condom use; disclosure of HIV status; self reported STD diagnosis; medication adherence; links to care. [ Time Frame: 7/2006-2/2007 ] [ Designated as safety issue: No ]

Enrollment: 574
Study Start Date: July 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: 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.
    Other Name: AIDS Community Demonstration Project
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  • Anyone who does not meet inclusion criteria
  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: NCT00267436

Locations
United States, Massachusetts
AIDS Action Committee
Boston, Massachusetts, United States, 02118
United States, Minnesota
Minneapolis Urban League
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Minneapolis Urban League;
University of Minnesota - Clinical and Translational Science Institute
AIDS Action Committee of Massachusetts
The Fenway Institute
Investigators
Study Director: Jennifer S Galbraith Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Jennifer Galbraith/ Behavioral Scientist, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00267436     History of Changes
Other Study ID Numbers: CDC-NCHSTP-U65/CCU523908, U65/CCU523908-01
Study First Received: December 20, 2005
Last Updated: April 12, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
adaptation
HIV prevention
HIV positive
evidence based interventions
HIV Seronegativity

ClinicalTrials.gov processed this record on August 18, 2014