HIVNCT06131931
HIV Prevention Intervention for Latino Male Couples
A study testing CLP Intervention and WP Intervention in people with HIV, run by University of Central Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- CLP Intervention and WP Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- prisoners
- individuals who are not yet adults
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida
Orlando, Florida, 32816
Amoy Fraser, PhD, CCRP, PMP, 4072668742, amoy.fraser@ucf.edu
Erica Martin, BS, 4072668742, erica.martin@ucf.edu
About this study
Official title: Connecting Latinos En Pareja: a Couples-based HIV Prevention Intervention for Latino Male Couples
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.
Read the detailed description
The investigators will recruit 200 Latinx male couples (N=400 individuals) from 50 Ending the HIV Epidemic (EHE) jurisdictions and an additional 17 areas with high HIV burden among Latinxs. Building from our previous success in engaging sexual minority Latinx men, the investigators will implement a multipronged recruitment strategy, including social media and social networking apps and venue-based recruitment. Couples will be randomly assigned to CLP or a piloted Wellness Promotion (WP) time and attention matched control condition. Follow- up will occur every 3 months over 9 months, and biological (hair biomarkers for Pre-Exposure Prophylaxis (PrEP) and Antiretroviral Therapy (ART) adherence) and behavioral and psychosocial data collected. The primary outcome, HIV protection, is operationalized with a validated composite algorithm as protected acts of anal intercourse (i.e., anal sex acts in which condoms, PrEP, or Treatment as Prevention (TasP) are used to reduce risk of HIV transmission) within the couple and with outside partners. Guided by the Designing for Dissemination and Sustainability (D4DS) framework, the investigators will derive practical recommendations and considerations for sustainability and scaling up of the intervention (or other next steps). All intervention sessions will be conducted via Zoom by a facilitator. The facilitator will conduct all remote sessions from a private office at the University of Central Florida College of Medicine. Study participants will collect their own hair samples and mail it back to the University of California San Francisco. Participants will receive the collection toolkit and paid stamped mail package to ship samples. Hair sample collection is noninvasive and does not require specific skills, sterile equipment, or specialized storage. Samples can be stored at room temperature for long periods prior to analysis and shipped without taking the precautions associated with biohazardous materials.
- Conditions
- HIV
- Being tested
- CLP Intervention, WP Intervention
- Keywords
- HIV, Latino, male, couples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLP InterventionOther
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 InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Connecting Latinxs en Pareja (CLP) | Experimental | CLP is a four-session intervention grounded in social cognitive theory and a relationship oriented ecological framework. Receives: Other: CLP Intervention |
| Wellness Promotion (WP) | Active comparator | WP focuses on nutrition, fitness, healthcare, and stress management and emphasizes adherence to medical regimens and medication management. Receives: Other: WP Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Prevention sessions and assessments
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start21 Jun 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131931
- Sponsor's protocol ID
- STUDY00005650
- Other IDs
- 1R01MD018963-01A1
- Status last verified
- Dec 2024
- First submitted
- 4 Nov 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Latinos En Pareja: a Couples-based HIV Prevention Intervention for Latino Male Couples
- ClinicalTrials.gov ID
- NCT06131931
- Acronym / sponsor ID
- STUDY00005650
- Conditions
- HIV
- Keywords
- HIV, Latino, male, couples
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of San Francisco
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Nov 2023 (actual)
- 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.
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.
Detailed description
The investigators will recruit 200 Latinx male couples (N=400 individuals) from 50 Ending the HIV Epidemic (EHE) jurisdictions and an additional 17 areas with high HIV burden among Latinxs. Building from our previous success in engaging sexual minority Latinx men, the investigators will implement a multipronged recruitment strategy, including social media and social networking apps and venue-based recruitment. Couples will be randomly assigned to CLP or a piloted Wellness Promotion (WP) time and attention matched control condition. Follow- up will occur every 3 months over 9 months, and biological (hair biomarkers for Pre-Exposure Prophylaxis (PrEP) and Antiretroviral Therapy (ART) adherence) and behavioral and psychosocial data collected. The primary outcome, HIV protection, is operationalized with a validated composite algorithm as protected acts of anal intercourse (i.e., anal sex acts in which condoms, PrEP, or Treatment as Prevention (TasP) are used to reduce risk of HIV transmission) within the couple and with outside partners. Guided by the Designing for Dissemination and Sustainability (D4DS) framework, the investigators will derive practical recommendations and considerations for sustainability and scaling up of the intervention (or other next steps). All intervention sessions will be conducted via Zoom by a facilitator. The facilitator will conduct all remote sessions from a private office at the University of Central Florida College of Medicine. Study participants will collect their own hair samples and mail it back to the University of California San Francisco. Participants will receive the collection toolkit and paid stamped mail package to ship samples. Hair sample collection is noninvasive and does not require specific skills, sterile equipment, or specialized storage. Samples can be stored at room temperature for long periods prior to analysis and shipped without taking the precautions associated with biohazardous materials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connecting Latinxs en Pareja (CLP) | Experimental | Other: CLP InterventionCLP is a four-session intervention grounded in social cognitive theory and a relationship oriented ecological framework. |
| Wellness Promotion (WP) | Active comparator | Other: WP InterventionWP focuses on nutrition, fitness, healthcare, and stress management and emphasizes adherence to medical regimens and medication management. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| CLP Intervention4 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 | Connecting Latinxs en Pareja (CLP) |
| WP Intervention4 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. | Other | Wellness Promotion (WP) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLP Intervention and WP Intervention in people with HIV, run by University of Central Florida 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 7 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: looking for participants now, as of the sponsor's last update on 6 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Martinez, JD, MPH, MS (4072668742, omar.martinez@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Prevention sessions and assessments (time frame: 4 years). 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 6 Dec 2024.