Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-06-21
2028-06-30
Brief Summary
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The investigators will examine whether participants assigned to CLP report an increase in the proportion of HIV protected anal sex acts to those assigned to a Wellness Promotion (WP) time and attention matched control condition. The primary outcome, relates to use of HIV protection.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Connecting Latinxs en Pareja (CLP)
CLP is a four-session intervention grounded in social cognitive theory and a relationship oriented ecological framework.
CLP Intervention
4 weekly sessions lasting approximately 60 minutes that will be audio recorded for quality assurance. Each couple will be assigned one RA who will serve as their facilitator and guide them through the Connecting Latinxs en Pareja (CLP) sessions. The RA will deliver the appropriate intervention in either Spanish or English at the couple's preference. Sessions will be delivered via zoom (or comparable secure platform), using established procedures from the team's prior studies. Each participant will complete Qualtrics assessments at baseline, 3-, 6- and 9-months post randomization and biological (hair biomarkers for PrEP and ART adherence) and behavioral and psychosocial data collected.
Wellness Promotion (WP)
WP focuses on nutrition, fitness, healthcare, and stress management and emphasizes adherence to medical regimens and medication management.
WP Intervention
4 weekly sessions lasting approximately 60 minutes that will be audio recorded for quality assurance. Each couple will be assigned one RA who will serve as their facilitator and guide them through the Wellness Promotion (WP) sessions. The RA will deliver the appropriate intervention in either Spanish or English at the couple's preference. Sessions will be delivered via zoom (or comparable secure platform), using established procedures from the team's prior studies. Each participant will complete Qualtrics assessments at baseline, 3-, 6- and 9-months post randomization and biological (hair biomarkers for PrEP and ART adherence) and behavioral and psychosocial data collected.
Interventions
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CLP Intervention
4 weekly sessions lasting approximately 60 minutes that will be audio recorded for quality assurance. Each couple will be assigned one RA who will serve as their facilitator and guide them through the Connecting Latinxs en Pareja (CLP) sessions. The RA will deliver the appropriate intervention in either Spanish or English at the couple's preference. Sessions will be delivered via zoom (or comparable secure platform), using established procedures from the team's prior studies. Each participant will complete Qualtrics assessments at baseline, 3-, 6- and 9-months post randomization and biological (hair biomarkers for PrEP and ART adherence) and behavioral and psychosocial data collected.
WP Intervention
4 weekly sessions lasting approximately 60 minutes that will be audio recorded for quality assurance. Each couple will be assigned one RA who will serve as their facilitator and guide them through the Wellness Promotion (WP) sessions. The RA will deliver the appropriate intervention in either Spanish or English at the couple's preference. Sessions will be delivered via zoom (or comparable secure platform), using established procedures from the team's prior studies. Each participant will complete Qualtrics assessments at baseline, 3-, 6- and 9-months post randomization and biological (hair biomarkers for PrEP and ART adherence) and behavioral and psychosocial data collected.
Eligibility Criteria
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Inclusion Criteria
* reside in the 50 local jurisdictions identified by the EHE initiative or 17 jurisdictions with most HIV diagnoses among Latinxs
* identify as Latinx/Hispanic/Afro-Latinx or reports having a main partner who identifies as Latinx/Hispanic/Afro-Latin
* report having a main/primary male partner operationalized as a man with whom he has a primary ongoing sexual relationship, for at least 3 months
* at least one member of the dyad report three acts of unprotected of anal sex (with main or other partners)
* able to speak English and/or Spanish
Exclusion Criteria
* reports severe intimate partner violence (IPV) within the dyad during the past year on the Revised Conflict Tactic Scale\[1-4\]
* has a language or cognitive impairment that would prevent informed consent. Inclusion of dyads reporting severe IPV could pose dangers and ethical concerns and will be referred to domestic abuse organizations for screening and services.
* adults unable to consent
* pregnant women
* prisoners
* individuals who are not yet adults
18 Years
100 Years
MALE
Yes
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of San Francisco
OTHER
University of Central Florida
OTHER
Responsible Party
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Locations
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University of Central Florida
Orlando, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Amoy Fraser, PhD, CCRP, PMP
Role: primary
Erica Martin, BS
Role: backup
Omar Martinez, JD, MPH, MS
Role: backup
Other Identifiers
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STUDY00005650
Identifier Type: -
Identifier Source: org_study_id