- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00252083
ADAPT-POL: Planned Parenthood Center of El Paso Adopting and Demonstrating the Adaptation of Prevention Techniques
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?
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
El Paso, Texas, United States, 79902
- Planned Parenthood Center of El Paso
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reduced incidence of unprotected anal intercourse
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reduced number of sexual partners engaging in unprotected anal intercourse
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vel S McKleroy, MPH, BSW, Centers for Disease Control and Prevention
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCHSTP-U65/CCU623833
- U65/CCU623833-01-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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