HIV InfectionsNCT00252083
ADAPT-POL: Planned Parenthood Center of El Paso Adopting and Demonstrating the Adaptation of Prevention Techniques
A study testing Popular Opinion Leader in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
This study will look at the following questions: Was there a significant difference in HIV prevention knowledge, risk reduction attitudes, norms, intentions, self efficacy, number of sexual partners, and incidence of unprotected anal intercourse among seropositive Hispanic men who have sex with men (MSM) after the… 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
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2007
- Phase
- Interventional
- 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 seropositive
- Men who have sex with other men
- Sexual contact to orgasm with a man within past year
- Hispanic
- At least 18 years of age
- 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
Planned Parenthood Center of El Paso
El Paso, Texas, 79902
About this study
Official title: Planned Parenthood Center of El Paso Adopting and Demonstrating the Adaptation of Prevention Techniques With Popular Opinion Leader (ADAPT-POL)
This study will look at the following questions:
- Was there a significant difference in HIV prevention knowledge, risk reduction attitudes, norms, intentions, self efficacy, number of sexual partners, and incidence of unprotected anal intercourse among seropositive Hispanic men who have sex with men (MSM) after the implementation of ADAPT-POL?
Read more
Hypothesis: There will be a significant increase in HIV prevention knowledge, intentions, and self efficacy concerning condom use. There will be a decrease in risk attitudes, norms, number of sexual partners, and incidence of unprotected anal intercourse among seropositive Hispanic MSM after the implementation of ADAPT-POL.
- How is exposure to the intervention and intervention dosage related to the following variables: HIV prevention knowledge, attitudes, intentions, and behaviors concerning unprotected anal intercourse?
Hypothesis: Intervention exposure and dosage are positively correlated with improved HIV prevention knowledge, attitudes, intentions, and behaviors concerning unprotected anal intercourse.
Read the detailed description
The proposed project, Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT), has two main goals: first, to assist the Centers for Disease Control and Prevention (CDC) to better understand the processes needed for adapting evidence-based behavioral interventions to fit new conditions or target populations; second, to utilize the CDC's draft adaptation guidance to adapt Jeff Kelly's Popular Opinion Leader (POL) for use with adult, seropositive Hispanic men who have sex with other men (MSM). The target population will directly participate in all phases of the intervention adaptation process.
ADAPT, known as ADAPT-POL in El Paso, will include formative research and outcome monitoring. Throughout both periods, the ADAPT-POL staff will conduct process monitoring and evaluation to assess the delivery of the intervention, and to help the CDC understand how the draft adaptation guidance procedures work in a real world setting. Representatives of the target population will participate in focus groups, key informant interviews, and community advisor meetings during the formative phase; and potentially serve as popular opinion leaders (POLs) during the implementation phase.
The knowledge obtained during the ADAPT-POL intervention will be diffused to other interventions and programs at the Planned Parenthood Center of El Paso (PPCEP). This will allow PPCEP management and staff to make informed decisions about the adoption of interventions and what steps might be necessary to adapt existing and future PPCEP interventions that target Hispanic populations. At the conclusion of ADAPT activities, the CDC-developed draft adaptation guidance will be revised based on lessons learned.
- Conditions
- HIV Infections
- Being tested
- Popular Opinion Leader
- Keywords
- Seropositive, MSM, Hispanic, Popular Opinion Leader, HIV
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
reduced incidence of unprotected anal intercourse
Measured: 6 months
Secondary outcomes (1)
reduced number of sexual partners engaging in unprotected anal intercourse
Measured: 6 months
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 completionJun 2007
- Study completionJun 2007
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Vel S McKleroy, MPH, BSW, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252083
- Sponsor's protocol ID
- CDC-NCHSTP-U65/CCU623833
- Other IDs
- U65/CCU623833-01-1
- Status last verified
- Apr 2012
- First submitted
- 10 Nov 2005
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planned Parenthood Center of El Paso Adopting and Demonstrating the Adaptation of Prevention Techniques With Popular Opinion Leader (ADAPT-POL)
- ClinicalTrials.gov ID
- NCT00252083
- Acronym / sponsor ID
- CDC-NCHSTP-U65/CCU623833
- Conditions
- HIV Infections
- Keywords
- Seropositive, MSM, Hispanic, Popular Opinion Leader, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Jul 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (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.
This study will look at the following questions:
- Was there a significant difference in HIV prevention knowledge, risk reduction attitudes, norms, intentions, self efficacy, number of sexual partners, and incidence of unprotected anal intercourse among seropositive Hispanic men who have sex with men (MSM) after the implementation of ADAPT-POL?
Hypothesis: There will be a significant increase in HIV prevention knowledge, intentions, and self efficacy concerning condom use. There will be a decrease in risk attitudes, norms, number of sexual partners, and incidence of unprotected anal intercourse among seropositive Hispanic MSM after the implementation of ADAPT-POL.
- How is exposure to the intervention and intervention dosage related to the following variables: HIV prevention knowledge, attitudes, intentions, and behaviors concerning unprotected anal intercourse?
Hypothesis: Intervention exposure and dosage are positively correlated with improved HIV prevention knowledge, attitudes, intentions, and behaviors concerning unprotected anal intercourse.
Detailed description
The proposed project, Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT), has two main goals: first, to assist the Centers for Disease Control and Prevention (CDC) to better understand the processes needed for adapting evidence-based behavioral interventions to fit new conditions or target populations; second, to utilize the CDC's draft adaptation guidance to adapt Jeff Kelly's Popular Opinion Leader (POL) for use with adult, seropositive Hispanic men who have sex with other men (MSM). The target population will directly participate in all phases of the intervention adaptation process.
ADAPT, known as ADAPT-POL in El Paso, will include formative research and outcome monitoring. Throughout both periods, the ADAPT-POL staff will conduct process monitoring and evaluation to assess the delivery of the intervention, and to help the CDC understand how the draft adaptation guidance procedures work in a real world setting. Representatives of the target population will participate in focus groups, key informant interviews, and community advisor meetings during the formative phase; and potentially serve as popular opinion leaders (POLs) during the implementation phase.
The knowledge obtained during the ADAPT-POL intervention will be diffused to other interventions and programs at the Planned Parenthood Center of El Paso (PPCEP). This will allow PPCEP management and staff to make informed decisions about the adoption of interventions and what steps might be necessary to adapt existing and future PPCEP interventions that target Hispanic populations. At the conclusion of ADAPT activities, the CDC-developed draft adaptation guidance will be revised based on lessons learned.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- 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 (6 listed)
- HIV seropositive
- Men who have sex with other men
- Sexual contact to orgasm with a man within past year
- Hispanic
- At least 18 years of age
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 Leader | Behavioural | – |
Primary outcome
reduced incidence of unprotected anal intercourse
Time frame: 6 months
1 secondary outcome
reduced number of sexual partners engaging in unprotected anal intercourse
Time frame: 6 months
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 5 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.
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?
A study testing Popular Opinion Leader in people with 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 5 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 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?
reduced incidence of unprotected anal intercourse (time frame: 6 months). 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 5 Apr 2012.