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| Sponsor: | Centers for Disease Control and Prevention |
|---|---|
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00267410 |
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for adapting evidence-based behavioral interventions to fit new conditions or populations and to pilot CDC-developed draft guidance for adaptation.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: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT), Harlem United Community AIDS Center |
| Estimated Enrollment: | 176 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
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for adapting evidence-based behavioral interventions to fit new conditions or populations and to pilot CDC-developed draft guidance for adaptation.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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Soraya Elcock | 212-803-2880 |
| United States, New York | |
| Harlem United Community AIDS Center | Recruiting |
| New York, New York, United States, 10027 | |
| Contact: Rashi Rohatgi 212-803-2850 ext 830 rrohatgi@harlemunited.org | |
| Principal Investigator: | Soraya Elcock | Harlem United Community AIDS Center |
More Information
| Responsible Party: | Centers for Disease Control and Prevention ( Jennifer Galbraith/ Behavioral Scientist ) |
| Study ID Numbers: | CDC-NCHSTP-U65/CCU223844, CA 2 U65/CCU223844-0101 |
| Study First Received: | December 20, 2005 |
| Last Updated: | January 6, 2010 |
| ClinicalTrials.gov Identifier: | NCT00267410 History of Changes |
| Health Authority: | United States: Federal Government |
|
HIV Adaptation Behavioral interventions |
Seropositive MSM HIV Seronegativity |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Genital Diseases, Male |
Immunologic Deficiency Syndromes Genital Diseases, Female Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |