HIV PreventionPhase 1/2NCT00267436
Adopting and Demonstrating the Adaptation of Prevention Techniques: Community PROMISE PLUS
A Phase 1/2 study testing Community PROMISE in people with HIV Prevention and STD Prevention, run by Centers for Disease Control and Prevention at 2 sites in United States.
Trial summary
This project will pilot test a step-by-step guide developed by CDC for organizations to engage in evidence-based adaptation of interventions previously shown to be effective in research settings for use in real world applications. 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 Prevention, STD Prevention
- What is being tested?
- Community PROMISE
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 574 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to Feb 2007
- Phase
- Phase 1/2
- 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
Who may be able to join
- HIV+ cohort
- Self-reports as HIV+ (for CP PLUS cohort)
- Self-report that they had sex with men in the past 3 years (MSP) or 1 year (Boston)
- Self-reports as a resident of the identified geographic areas.
- Identifies as African American
- 18 years of age, or older.
Show all 13Show fewer
- HIV- cohort
- HIV- or unknown status only, has engaged in risky sexual contact (defined as those who self-report engaging in unprotected anal or vaginal intercourse within the past year)
- Self-report that they had sex with men in the past 3 years (MSP) or 1 year (Boston)
- Identifies as African American (MSP); No racial/ethnic criteria however AA will be over-sampled and will be at least 20% of sample
- 18 years of age, or older.
- Self-reports as a resident of the identified geographic areas.
- Engage in risky sex (defined as individuals who self-report engaging in unprotected anal or vaginal intercourse within the past year.
Who cannot join
- Inability to complete informed consent process due to (a) substantial cognitive impairment. (b) non-English speaking; (c) under the influence of drugs or alcohol
- Under 18 years of age
- Plans to relocate within 12 months after baseline interview
- Anyone who does not meet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AIDS Action Committee
Boston, Massachusetts, 02118
Minneapolis Urban League
Minneapolis, Minnesota, 55455
About this study
Official title: Adopting and Demonstrating the Adaptation of Prevention Techniques: Community PROMISE Positives Leading and Utilizing Strategies (ADAPT CP PLUS)
This project will pilot test a step-by-step guide developed by CDC for organizations to engage in evidence-based adaptation of interventions previously shown to be effective in research settings for use in real world applications. The second purpose of the program is to evaluate the adapted intervention to determine if it is effective in changing behavior of HIV+ African American men who have sex with other men.
Read the detailed description
During the ADAPT project both sites will adapt the original Community Promise intervention to specifically address the HIV prevention needs of sero-positive, African American men who have sex with men (HIV+ AAMSM) in either Boston, MA or Minneapolis/St. Paul (MSP), MN. The adapted intervention will be referred to as Community PROMISE, Positives Leading and Utilizing Strategies (CP PLUS).
In the first two months of the ADAPT project, the Boston and MSP sites will conduct formative evaluation activities (i.e., a comprehensive literature review, focus groups, and individual interviews) to assess the needs of the target population and organizational capacities to serve them. Results will be used to inform the adaptation of the original intervention to ensure that CP PLUS meet the expressed needs of the target population.
Process data will also be collected from various sources throughout the life of the project. Process data will be collected through staff meetings, interviews with staff, focus groups with peer advocates, and an expert panel consultation. Process data will be extremely useful for ensuring program objectives are met, improving CP PLUS, and providing information for providers in other locales who may be interested in adapting this intervention to serve this target population.
The Boston and MSP sites will also conduct outcome monitoring through collection of data concerning risk behaviors pre- and post-intervention implementation (follow-up at 6-8 months post and 11-13 months post [Boston only]) to determine if the adapted intervention has met its outcome objectives. Outcome monitoring will also be conducted for the "parent" intervention at both sites for HIV- or unknown status men who have sex with men.
In addition to the project activities, the organization will be examining the utility of the CDC draft guidance. The Boston and MSP sites are two of five case studies throughout the United States that will detail the challenges, successes and lessons learned from adapting an intervention packaged by CDC's Replicating Effective Programs (REP) and disseminated by Diffusing Effective Behavioral Interventions (DEBI) to a specific population. These findings will help other community-based organizations and Health Departments effectively adapt and tailor group, individual and community-level interventions.
- Conditions
- HIV Prevention, STD Prevention
- Being tested
- Community PROMISE
- Keywords
- adaptation, HIV prevention, HIV positive, evidence based interventions, HIV Seronegativity
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community PROMISEBehavioural
Also called AIDS Community Demonstration Project
The Community PROMISE begins with a community assessment to identify HIV risk factors. Once risk factors have been identified, individuals from the targeted at-risk community are recruited and trained to be peer advocates. Trained peer advocates interview members of the community about their behavior. Role model stories are written based on the interviews. Role model stories are personal accounts from individuals in the target population which explain how and why they took steps to practice HIV risk-reduction behaviors and the positive effects the choice has had on their lives. Each week, peer advocates distribute role model stories and supplies, such as condoms, to 10 to 20 members of their social networks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual activities with main and casual partners in past 30 days to 6 months (i.e., unprotected insertive and receptive anal/vaginal sex and protected insertive and receptive anal/vaginal sex)
Measured: 7/2006-2/2007
Secondary outcomes (1)
Behavioral intentions and attitudes for condom use; disclosure of HIV status; self reported STD diagnosis; medication adherence; links to care.
Measured: 7/2006-2/2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startJul 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Minneapolis Urban League;, University of Minnesota, AIDS Action Committee of Massachusetts, The Fenway Institute
- Investigators
- Jennifer S Galbraith, Study director, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267436
- Sponsor's protocol ID
- CDC-NCHSTP-U65/CCU523908
- Other IDs
- U65/CCU523908-01
- Status last verified
- Apr 2012
- First submitted
- 20 Dec 2005
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adopting and Demonstrating the Adaptation of Prevention Techniques: Community PROMISE Positives Leading and Utilizing Strategies (ADAPT CP PLUS)
- ClinicalTrials.gov ID
- NCT00267436
- Acronym / sponsor ID
- CDC-NCHSTP-U65/CCU523908
- Conditions
- HIV Prevention, STD Prevention
- Keywords
- adaptation, HIV prevention, HIV positive, evidence based interventions, HIV Seronegativity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Minneapolis Urban League;, University of Minnesota, AIDS Action Committee of Massachusetts, The Fenway Institute
- Study start
- Jul 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 21 Dec 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.
This project will pilot test a step-by-step guide developed by CDC for organizations to engage in evidence-based adaptation of interventions previously shown to be effective in research settings for use in real world applications. The second purpose of the program is to evaluate the adapted intervention to determine if it is effective in changing behavior of HIV+ African American men who have sex with other men.
Detailed description
During the ADAPT project both sites will adapt the original Community Promise intervention to specifically address the HIV prevention needs of sero-positive, African American men who have sex with men (HIV+ AAMSM) in either Boston, MA or Minneapolis/St. Paul (MSP), MN. The adapted intervention will be referred to as Community PROMISE, Positives Leading and Utilizing Strategies (CP PLUS).
In the first two months of the ADAPT project, the Boston and MSP sites will conduct formative evaluation activities (i.e., a comprehensive literature review, focus groups, and individual interviews) to assess the needs of the target population and organizational capacities to serve them. Results will be used to inform the adaptation of the original intervention to ensure that CP PLUS meet the expressed needs of the target population.
Process data will also be collected from various sources throughout the life of the project. Process data will be collected through staff meetings, interviews with staff, focus groups with peer advocates, and an expert panel consultation. Process data will be extremely useful for ensuring program objectives are met, improving CP PLUS, and providing information for providers in other locales who may be interested in adapting this intervention to serve this target population.
The Boston and MSP sites will also conduct outcome monitoring through collection of data concerning risk behaviors pre- and post-intervention implementation (follow-up at 6-8 months post and 11-13 months post [Boston only]) to determine if the adapted intervention has met its outcome objectives. Outcome monitoring will also be conducted for the "parent" intervention at both sites for HIV- or unknown status men who have sex with men.
In addition to the project activities, the organization will be examining the utility of the CDC draft guidance. The Boston and MSP sites are two of five case studies throughout the United States that will detail the challenges, successes and lessons learned from adapting an intervention packaged by CDC's Replicating Effective Programs (REP) and disseminated by Diffusing Effective Behavioral Interventions (DEBI) to a specific population. These findings will help other community-based organizations and Health Departments effectively adapt and tailor group, individual and community-level interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- HIV+ cohort
- Self-reports as HIV+ (for CP PLUS cohort)
- Self-report that they had sex with men in the past 3 years (MSP) or 1 year (Boston)
- Self-reports as a resident of the identified geographic areas.
- Identifies as African American
Key exclusion criteria (4 listed)
- Inability to complete informed consent process due to (a) substantial cognitive impairment. (b) non-English speaking; (c) under the influence of drugs or alcohol
- Under 18 years of age
- Plans to relocate within 12 months after baseline interview
- Anyone who does not meet 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 |
|---|---|---|
| Community PROMISEAlso: AIDS Community Demonstration ProjectThe Community PROMISE begins with a community assessment to identify HIV risk factors. Once risk factors have been identified, individuals from the targeted at-risk community are recruited and trained to be peer advocates. Trained peer advocates interview members of the community about their behavior. Role model stories are written based on the interviews. Role model stories are personal accounts from individuals in the target population which explain how and why they took steps to practice HIV risk-reduction behaviors and the positive effects the choice has had on their lives. Each week, peer advocates distribute role model stories and supplies, such as condoms, to 10 to 20 members of their social networks. | Behavioural | – |
Primary outcome
Sexual activities with main and casual partners in past 30 days to 6 months (i.e., unprotected insertive and receptive anal/vaginal sex and protected insertive and receptive anal/vaginal sex)
Time frame: 7/2006-2/2007
1 secondary outcome
Behavioral intentions and attitudes for condom use; disclosure of HIV status; self reported STD diagnosis; medication adherence; links to care.
Time frame: 7/2006-2/2007
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 13 Apr 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.
Jennifer S Galbraith study director
Centers for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Community PROMISE in people with HIV Prevention and STD Prevention, run by Centers for Disease Control and Prevention at 2 sites 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 13 inclusion and 4 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 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sexual activities with main and casual partners in past 30 days to 6 months (i.e., unprotected insertive and receptive anal/vaginal sex and protected insertive and receptive anal/vaginal sex) (time frame: 7/2006-2/2007). 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 13 Apr 2012.