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

NCT00267436 | Completed Phase 1

• 2 other identifiers: CDC-NCHSTP-U65/CCU523908U65/CCU523908-01
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Prevention; STD Prevention

Keywords

adaptation; HIV prevention; HIV positive; evidence based interventions; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• 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)

  7/2006-2/2007

Secondary Outcomes (1)

• Behavioral intentions and attitudes for condom use; disclosure of HIV status; self reported STD diagnosis; medication adherence; links to care.

  7/2006-2/2007

Interventions

Community PROMISE BEHAVIORAL

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.

Also known as: AIDS Community Demonstration Project

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Minneapolis Urban League;: collaborator
• University of Minnesota: collaborator
• AIDS Action Committee of Massachusetts: collaborator
• The Fenway Institute: collaborator

Study Sites (2)

AIDS Action Committee

Boston, Massachusetts, 02118, United States

Location

Minneapolis Urban League

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jennifer S Galbraith

  Centers for Disease Control and Prevention

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: December 21, 2005
• Study Start: July 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: April 13, 2012

Record last verified: 2012-04

Locations

US (2)