HIV
Conditions
Brief 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).
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.
Interventions
None listed
Sponsors
Florida State University
University of California, San Diego
Nova Southeastern University
University of Florida
University of Central Florida
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Adults unable to consent * Individuals who are not yet adults * Individuals who are not diagnosed as HIV+ * Prisoners * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
When participants consented to enroll in the Define study, they were consenting to participate in both the Model Phase and Adapt Phase (qualitative focus groups). Participants were selected for the Adapt Phase based on completion of all Model Phase activities. However, there was a lack of participant interest in the Adapt Phase activities resulting in a small number of participants. Additionally, there were recording errors and the audio recordings were not able to be transcribed for analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 105 Participants |
| Age, Continuous | 26.3 Years STANDARD_DEVIATION 2.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 105 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 105 |
| other Total, other adverse events | 0 / 105 |
| serious Total, serious adverse events | 0 / 105 |
Outcome results
None listed