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Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT), Harlem United Community AIDS Center

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00267410
First received: December 20, 2005
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

This project will pilot test a step-by-step guide for community-based organizations to engage in evidence-based adaptation of interventions previously shown to be effective in research settings for use in real world applications. The main purpose of this program is to improve understanding of the processes needed for adapting evidence-based behavioral interventions to fit new conditions or populations and to pilot CDC-developed draft guidance for adaptation. The second purpose of the program is to increase the number of effective behavioral HIV prevention interventions for 18-24 year old sero-positive men of color who have sex with other men (MSM of color).


Condition Intervention
Sexually Transmitted Diseases
HIV Infections
Behavioral: Healthy Relationships

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 (ADAPT), Harlem United Community AIDS Center

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Document the resources and activities required to adapt and implement the Healthy Relationships intervention model for young sero-positive MSM of color [ Time Frame: 11/2005-9/2007 ] [ Designated as safety issue: No ]
  • Measure the effectiveness of the newly-adapted intervention [ Time Frame: 11/2005-9/2009 ] [ Designated as safety issue: No ]
  • Assess CDC's guidance for adapting effective behavioral interventions for new populations. [ Time Frame: 11/2005-11/2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Optimize service delivery [ Time Frame: 11/2005-12/2009 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: November 2005
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Healthy Relationships
    "Healthy Relationships," grounded in the social cognitive theory, is a five-session, group-level intervention originally designed for HIV-positive heterosexual individuals seeking skills-building and support around risk reduction, as well as disclosure of status and sexual preference. Through clip media and active role-plays, the intervention promotes the development of decision-making and problem-solving tools, empowering participants to make voluntary and informed decisions around disclosure and safer sex practices. This model was formally disseminated to AIDS Service Organizations as part of CDC's strategic plan - Advancing HIV Prevention, New Strategies for a Changing Epidemic - which focused on innovative strategies to recruit individuals into HIV testing, as well as a movement towards secondary prevention efforts.
Detailed Description:

The Adopting and Demonstrating the Adaptation of Prevention Techniques project (referred to as ADAPTATION throughout this protocol) responds to concerns from the field that existing interventions do not address the HIV prevention needs of diverse and often unstudied populations. This project will pilot test a step-by-step guide for community-based organizations to engage in evidence-based adaptation of interventions previously shown to be effective in research settings for use in real world applications. The main purpose of this program is to improve understanding of the processes needed for adapting evidence-based behavioral interventions to fit new conditions or populations and to pilot CDC-developed draft guidance for adaptation. The second purpose of the program is to increase the number of effective behavioral HIV prevention interventions for 18-24 year old sero-positive men of color who have sex with other men (MSM of color).

Harlem United Community AIDS Center is one of five sites originally funded through Program Announcement 04064 and selected to receive a supplement to conduct adaptation activities. Under Program Announcement 04064, Harlem United, a community-based organization with over 16 years of experience providing quality HIV services to the Harlem and South Bronx communities, was funded to implement a multi-faceted, HIV prevention program. The program combines rapid testing, access to care, and an evidenced-based, group-level behavioral intervention (i.e., Healthy Relationships) for sero-positive, heterosexual men and women of color. Healthy Relationships is a five-session, small group-level intervention for persons living with HIV/AIDS that promotes the development of decision-making and problem-solving skills that enable participants to make informed and safe decisions about disclosure and behaviors. Preliminary evaluation efforts suggest that this service model is effective in reducing risk behaviors among the general population, but its appropriateness and effectiveness for specific sub-populations has yet to be fully demonstrated. The original research for Healthy Relationships was conducted in Atlanta, Georgia. Approximately half of the participants identified as gay and the study population had a mean age of 40 years. Harlem United will adapt the Healthy Relationships intervention for young sero-positive MSM of color between the ages of 18-24 who reside in Harlem, New York. Further adaptation also may include adding decision-making for disclosure with needle sharing partners.

The goal of Harlem United's ADAPTATION project is to evaluate efforts to adapt and implement the Healthy Relationships intervention for young sero-positive MSM of color by: 1) documenting the resources and activities required to adapt and implement the Healthy Relationships intervention model for young sero-positive MSM of color; 2) optimizing service delivery; 3) measuring the effectiveness of the newly-adapted intervention; and 4) assessing CDC's guidance for adapting effective behavioral interventions for new populations.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MSM, at least 18 years old;
  • HIV-positive; and
  • Self-identified African Americans, English speaking African-born individuals and Latinos.

Exclusion Criteria:

  • Non-English speaking;
  • Under 18 years of age;
  • Serious mental illness which makes them unsuitable for interviewing (accommodation will be made for HIV-related cognitive deficits & related illnesses);
  • Inebriated;
  • Has been interviewed before; and
  • Anyone who does not meet the 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: NCT00267410

Locations
United States, New York
Harlem United Community AIDS Center
New York, New York, United States, 10027
Sponsors and Collaborators
Investigators
Principal Investigator: Soraya Elcock Harlem United Community AIDS Center
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00267410     History of Changes
Other Study ID Numbers: CDC-CGH-4869, CA 2 U65/CCU223844-0101
Study First Received: December 20, 2005
Last Updated: September 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
HIV
Adaptation
Behavioral interventions
Seropositive
MSM
HIV Seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Immune System Diseases
Immunologic Deficiency Syndromes
Infection
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 19, 2014