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

December 20, 2005
September 10, 2012
November 2005
April 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Document the resources and activities required to adapt and implement the Healthy Relationships intervention model for young sero-positive MSM of color
  • Measure the effectiveness of the newly-adapted intervention
  • Assess CDC’s guidance for adapting effective behavioral interventions for new populations.
Complete list of historical versions of study NCT00267410 on ClinicalTrials.gov Archive Site
Optimize service delivery [ Time Frame: 11/2005-12/2009 ] [ Designated as safety issue: No ]
Optimize service delivery
Not Provided
Not Provided
 
Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT), Harlem United Community AIDS Center
Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT), Harlem United Community AIDS Center

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for adapting evidence-based behavioral interventions to fit new conditions or populations and to pilot CDC-developed draft guidance for adaptation.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).

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Sexually Transmitted Diseases
  • HIV Infections
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
June 2009
April 2009   (final data collection date for primary outcome measure)

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.
Male
18 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00267410
CDC-CGH-4869, CA 2 U65/CCU223844-0101
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Not Provided
Principal Investigator: Soraya Elcock Harlem United Community AIDS Center
Centers for Disease Control and Prevention
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP