HIVNCT06125509
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An observational study of HIV, run by Florida State University at 1 site in United States.
Trial summary
The overall goal of the current study is to define modifiable intervention targets that are developmentally- and culturally-relevant in pathways between cumulative stress and self-management outcomes - alcohol use and HIV - among Young People Living with HIV (YPLWH). Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- HIV
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 5 Aug 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 29 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young adults aged 18-29 who reside in Florida and are living with HIV and report having had at least 1 alcoholic drink in the last 30 days (see inclusion criteria).
Who may be able to join
- 18 years and 0 months to 29 years and 11 months
- Currently reside in Florida
- Report having had at least 1 alcoholic drink in the last 30 days
- Able to read and understand English
- Have internet access via smartphone, tablet or computer
- Be diagnosed as HIV positive and;
- Willing to provide informed consent.
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults
- Individuals who are not diagnosed as HIV+
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University, Center for Translational Behavioral Science
Tallahassee, Florida, 32310
About this study
Official title: Defining Intervention Targets Along Pathways From Cumulative Stress and Trauma to Alcohol and HIV Self-management Among Young People Living With HIV (Project DEFINE)
The overall goal of the current study is to define modifiable intervention targets that are developmentally- and culturally-relevant in pathways between cumulative stress and self-management outcomes - alcohol use and HIV - among Young People Living with HIV (YPLWH).
Read the detailed description
This is a correlational, longitudinal cohort study that will seek to evaluate the association of cumulative stress with self-management of alcohol (i.e. hazardous drinking) and HIV (viral suppression) among YPLWH. The study will enroll up to 175 participants between the ages of 18-29 who currently reside in Florida and are living with HIV.
In the Model phase, individuals will participate in two assessment timepoints, including baseline assessment with a two-week sleep diary completion and 9-month follow-up assessment with another two-week sleep diary completion. The aim of the model phase is to define key modifiable intervention targets by longitudinally evaluating multiple components of sleep health, and emotion and behavioral regulation among YPLWH to determine potential pathways between cumulative stress and alcohol and HIV outcomes, in the context of individual factors relevant to YPLWH (e.g., age, race/ethnicity, cannabis and other substance use, cognitive functioning, education), with an additional cross-project moderator aim to explore age, biological sex and gender, race/ethnicity, other substance use, and mental health as moderators.
In the Adapt phase, 42 of N=175 will participate in 60-90 minute focus groups, that will focus on adapting developmentally and culturally scalable measures of cumulative stress, sleep health, and emotion/behavior regulation for screening and intervention targeting, and creation of a community-informed toolkit of the adapted measures.
- Conditions
- HIV
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use
Hazardous Drinking: TLFB (Timeline Followback), covering the prior 2 weeks. Hazardous drinking is defined per NIAAA criteria as >7 drinks/week or >3 drinks/occasion for women, and >14 drinks/week or >4 drinks/occasion for men. Results are reported as number of hazardous drinking days (continuous) over the prior two weeks.
Measured: 2 weeks, at baseline and 9 month follow up
HIV Viral Load
The viral load outcome (assessed by lab report with results obtained within a 3-month window of the timepoint or study administered Dried Blood Spot (DBS) analysis) was analyzed as binary (undetectable vs. detectable). For the binary outcome, the analysis includes all participants with a valid viral load result at each available time point.
The limit of detection (LOD) of the m2000 test (DBS) is 832 copies/mL or Log 2.92 copies/mL. Samples with VL above the LOD (>Log 2.92) and samples with less than LOD <2.92 but the presence of HIV virus, are considered detectable. Samples that are not detected are reported as undetectable.
Measured: Baseline and 9 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Aug 2022
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Nova Southeastern University, University of Florida, University of Central Florida, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Sylvie Naar, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125509
- Sponsor's protocol ID
- STUDY00002535
- Other IDs
- 1P01AA029547-01
- Status last verified
- Aug 2026
- First submitted
- 6 Nov 2023
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Intervention Targets Along Pathways From Cumulative Stress and Trauma to Alcohol and HIV Self-management Among Young People Living With HIV (Project DEFINE)
- ClinicalTrials.gov ID
- NCT06125509
- Acronym / sponsor ID
- STUDY00002535
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- University of California, San Diego, Nova Southeastern University, University of Florida, University of Central Florida, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of the current study is to define modifiable intervention targets that are developmentally- and culturally-relevant in pathways between cumulative stress and self-management outcomes - alcohol use and HIV - among Young People Living with HIV (YPLWH).
Detailed description
This is a correlational, longitudinal cohort study that will seek to evaluate the association of cumulative stress with self-management of alcohol (i.e. hazardous drinking) and HIV (viral suppression) among YPLWH. The study will enroll up to 175 participants between the ages of 18-29 who currently reside in Florida and are living with HIV.
In the Model phase, individuals will participate in two assessment timepoints, including baseline assessment with a two-week sleep diary completion and 9-month follow-up assessment with another two-week sleep diary completion. The aim of the model phase is to define key modifiable intervention targets by longitudinally evaluating multiple components of sleep health, and emotion and behavioral regulation among YPLWH to determine potential pathways between cumulative stress and alcohol and HIV outcomes, in the context of individual factors relevant to YPLWH (e.g., age, race/ethnicity, cannabis and other substance use, cognitive functioning, education), with an additional cross-project moderator aim to explore age, biological sex and gender, race/ethnicity, other substance use, and mental health as moderators.
In the Adapt phase, 42 of N=175 will participate in 60-90 minute focus groups, that will focus on adapting developmentally and culturally scalable measures of cumulative stress, sleep health, and emotion/behavior regulation for screening and intervention targeting, and creation of a community-informed toolkit of the adapted measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adults aged 18-29 who reside in Florida and are living with HIV and report having had at least 1 alcoholic drink in the last 30 days (see inclusion criteria).
Key inclusion criteria (7 listed)
- 18 years and 0 months to 29 years and 11 months
- Currently reside in Florida
- Report having had at least 1 alcoholic drink in the last 30 days
- Able to read and understand English
- Have internet access via smartphone, tablet or computer
Key exclusion criteria (5 listed)
- Adults unable to consent
- Individuals who are not yet adults
- Individuals who are not diagnosed as HIV+
- Prisoners
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alcohol Use
Time frame: 2 weeks, at baseline and 9 month follow up
Hazardous Drinking: TLFB (Timeline Followback), covering the prior 2 weeks. Hazardous drinking is defined per NIAAA criteria as >7 drinks/week or >3 drinks/occasion for women, and >14 drinks/week or >4 drinks/occasion for men. Results are reported as number of hazardous drinking days (continuous) over the prior two weeks.
HIV Viral Load
Time frame: Baseline and 9 month follow-up
The viral load outcome (assessed by lab report with results obtained within a 3-month window of the timepoint or study administered Dried Blood Spot (DBS) analysis) was analyzed as binary (undetectable vs. detectable). For the binary outcome, the analysis includes all participants with a valid viral load result at each available time point. The limit of detection (LOD) of the m2000 test (DBS) is 832 copies/mL or Log 2.92 copies/mL. Samples with VL above the LOD (>Log 2.92) and samples with less than LOD <2.92 but the presence of HIV virus, are considered detectable. Samples that are not detected are reported as undetectable.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Florida State University 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 7 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 31 Aug 2026. 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?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alcohol Use (time frame: 2 weeks, at baseline and 9 month follow up). The study lists 2 primary outcomes in all. 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 31 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.