HIV InfectionsNCT00252109
ADAPT-POL New Orleans: Adaptation of Prevention Techniques With Popular Opinion Leader
An observational study of HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Popular Opinion Leader
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men who have sex with men (MSM) of color who access Websites and chat rooms primarily frequented by MSM in the New Orleans, LA area.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New Orleans AIDS Task Force
New Orleans, Louisiana, 70119
About this study
Official title: New Orleans AIDS Task Force Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT) With Popular Opinion Leader (POL)
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.
Read the detailed 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.
- Conditions
- HIV Infections
- Being tested
- Popular Opinion Leader
- Keywords
- HIV, Seropositive, MSM, African American, Popular Opinion Leader
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Popular Opinion LeaderBehavioural
Also called Adapted POL intervention also known locally as SouthPOL+.
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Fall/winter 2006
Secondary outcomes (1)
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.
Measured: Spring 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startJul 2004
- Primary completionSep 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Vel S. McKleroy, MPH, BSW, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252109
- Sponsor's protocol ID
- CDC-NCHSTP-U65/CCU623818
- Other IDs
- U65/CCU623818-01-1
- Status last verified
- Aug 2012
- First submitted
- 10 Nov 2005
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Orleans AIDS Task Force Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT) With Popular Opinion Leader (POL)
- ClinicalTrials.gov ID
- NCT00252109
- Acronym / sponsor ID
- CDC-NCHSTP-U65/CCU623818
- Conditions
- HIV Infections
- Keywords
- HIV, Seropositive, MSM, African American, Popular Opinion Leader
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Jul 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 11 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men who have sex with men (MSM) of color who access Websites and chat rooms primarily frequented by MSM in the New Orleans, LA area.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Popular Opinion LeaderAlso: Adapted POL intervention also known locally as SouthPOL+.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) | Behavioural | – |
Primary outcome
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.
Time frame: Fall/winter 2006
1 secondary outcome
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.
Time frame: Spring 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vel S. McKleroy, MPH, BSW principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Fall/winter 2006). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.