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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00252109
Other study ID # CDC-NCHSTP-U65/CCU623818
Secondary ID U65/CCU623818-01
Status Completed
Phase N/A
First received November 10, 2005
Last updated August 15, 2012
Start date July 2004
Est. completion date January 2009

Study information

Verified date August 2012
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT) is a supplement to the Centers for Disease Control and Prevention (CDC) Community Based Organization Program Announcement 04064 (PA 04064). The purpose of ADAPT is to improve the understanding of the processes needed for adapting evidence-based behavioral interventions to fit new conditions or populations and to pilot the CDC-developed adaptation guidance. The ADAPT project responds to concerns from the field that existing interventions do not address the HIV prevention needs of their specific population. This project seeks to develop guidance for agencies to engage in the evidence-based adaptation of interventions previously shown to be effective in evaluation settings for use in real world applications.

The New Orleans AIDS Task Force (NO/AIDS) is one of five grantees funded to use the adaptation guidance to adapt an intervention packaged by the CDC's Replicating Effective Programs and disseminated by CDC's Diffusion of Effective Behavioral Interventions. The agency will adapt Jeff Kelly's Popular Opinion Leader (POL) intervention (Kelly, 2004; Kelly et al., 1991) for use in Internet venues with seropositive men who identify ethnically/racially as other than White/Caucasian who have sex with other men (men who have sex with men [MSM] of color).

Kelly's POL intervention is a community-level, evidence-based HIV prevention intervention that originally targeted gay and bisexual men in smaller cities throughout the United States. Kelly's intervention seeks to identify and enlist the support of well-known and well-liked opinion leaders to take on risk reduction advocacy roles. Opinion leaders attend sessions to learn how to engage in risk reduction conversations with people in their own social networks. The opinion leaders help to reshape social norms to encourage safer sex by helping to create a social environment in which MSM feel comfortable and empowered to make decisions to avoid high-risk sexual behaviors.


Description:

In 2000, NO/AIDS was funded by the CDC to conduct community mobilization. Two components of that program were Kelly's POL and outreach in Internet chat rooms. Kelly's POL targeted traditional venues frequented by MSM, such as gay bars. Online outreach in chat rooms was modeled after standard street outreach, where outreach workers provide HIV/AIDS, sexually transmitted disease and risk reduction information and referrals. Since the agency started online outreach, the Internet has continued to grow and it has become a mainstream venue for MSM to seek sexual partners online while maintaining their anonymity (Benotsch et al., 2002; Bull et al., 2001). With this trend, the agency realized that the online MSM community needed to be targeted by multiple behavior change interventions comparable to those implemented in other at risk venues. The agency included implementation of Kelly's POL online in chat rooms frequented by MSM as one of the interventions to be funded through the CDC's PA 04064 (the parent grant). As of August 2004, the agency has been funded under the parent grant to conduct Kelly's POL online in chat rooms that serve New Orleans, Louisiana, and the Southeastern U.S. region. This parent grant project shall be referred to as South POL. Supplemental PA 04064 funding for ADAPT will be used to further adapt South POL to target seropositive MSM of color. The supplement grant project shall be referred to as South POL+.

The South POL+ intervention has three main goals: first, to adapt the intervention for use with adult seropositive MSM of color based on formative evaluation findings; second, to evaluate and monitor the process of adapting the intervention utilizing the CDC-developed Adaptation Guidance; and third, to conduct implementation monitoring and evaluation and evaluation of the implementation of the adapted intervention.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date January 2009
Est. primary completion date September 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Seropositive

- Men who have sex with other men

- African American

- At least 18 years of age

- Report having sexual contact with a man (any type of sexual contact in which either partner achieved orgasm) within the last year

- Those who frequent viable venues for recruiting pre-and post-implementation questionnaire respondents

Exclusion Criteria:

- MSM who are not willing to identify themselves to study staff as seropositive Hispanic MSM may be excluded.

- Those under 18 years of age will be excluded from participation due to the study design precluding direct applicability of hypotheses and intervention to both adults and children due to different cognitive development, HIV prevalence levels, and social networks.

- Serious mental illness which makes the individual unsuitable for participation

- Under the influence of drugs or alcohol which makes the individual unsuitable for participation

- Anyone who does not meet the inclusion criteria

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Popular Opinion Leader
Popular opinion leaders of social networks are identified and attend 4 sessions to prepare them to have casual conversations with persons in the social networks that are meant to shift social norms to embrace safer behaviors (e.g., increased condom use, fewer sexual partners)

Locations

Country Name City State
United States New Orleans AIDS Task Force New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative data collected during online focus groups to discuss risky sexual behavior engaged in by men who have sex with men (MSM) of color and access online venues primarily frequented by MSM in the New Orleans LA area. Fall/winter 2006 No
Secondary Development of Popular Opinion Leader behavioral HIV prevention intervention materials adapted for use online use with men who have sex with men (MSM) of color and who access online venues primarily frequented by MSM in the New Orleans LA area. Spring 2007 No
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