Clinical trial NCT00267410: Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT), Harlem United Community AIDS Center
Official title: Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT), Harlem United Community AIDS Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
HIV Infections
Keywords: HIV
Adaptation
Behavioral interventions
Seropositive
MSM
HIV Seronegativity
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-12-21
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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for adapting evidence-based behavioral interventions to fit new conditions or populations and to pilot CDC-developed draft guidance for adaptation.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

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for adapting evidence-based behavioral interventions to fit new conditions or populations and to pilot CDC-developed draft guidance for adaptation.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

Primary outcomes:
measure: Document the resources and activities required to adapt and implement the Healthy Relationships intervention model for young sero-positive MSM of color
timeFrame: 11/2005-9/2007
measure: Measure the effectiveness of the newly-adapted intervention
timeFrame: 11/2005-9/2009
measure: Assess CDC's guidance for adapting effective behavioral interventions for new populations.
timeFrame: 11/2005-11/2007
Secondary outcomes:
measure: Optimize service delivery
timeFrame: 11/2005-12/2009
Other outcomes:
Locations:
city: New York
country: United States
facility: Harlem United Community AIDS Center
state: New York
Study officials:
affiliation: Harlem United Community AIDS Center
name: Soraya Elcock
role: PRINCIPAL_INVESTIGATOR
References: