NCT06131931 · University of Central Florida
HIV Prevention Intervention for Latino Male Couples
What this study is about
The primary objective of this proposal is to test the effectiveness of Connecting Latinxs en Pareja (CLP). CLP is a four-session intervention grounded in social cognitive theory and a relationship oriented ecological framework.
View original scientific description
The primary objective of this proposal is to test the efficacy of Connecting Latinxs en Pareja (CLP). CLP is a four-session intervention grounded in social cognitive theory and a relationship oriented ecological framework. 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.
Interventions
OTHER
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.
OTHER
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.
Primary outcome measures
HIV Prevention sessions and assessments
Time frame: 4 years
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 by conducting weekly sessions and assessments.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- at least 18 years
- 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
- Either partner:
- 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
- individuals who are not yet adults
Where
- Orlando, Florida
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), University of San Francisco
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 6, 2024 · Source of record for eligibility and locations