Trial Outcomes & Findings for SHARE Project Define (NCT NCT06125509)

Last Updated: 2026-07-28

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

105 participants

Primary outcome timeframe

2 weeks, at baseline and 9 month follow up

Results posted on

2026-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Young People With HIV (YPWH) Cohort Young people with HIV (YPWH), ages 18-29, residing in Florida enrolled in a single-group prospective longitudinal cohort study examining associations between cumulative stress and self-management outcomes (hazardous alcohol use and viral suppression). All participants completed baseline assessments and a two-week sleep diary, with repeat assessments and sleep diary at 9-month follow-up. A subset of participants additionally participated in qualitative focus groups to inform adaptation of developmentally and culturally relevant measures of cumulative stress, sleep health, and emotion/behavior regulation.
Overall Study STARTED	105
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	67

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SHARE Project Define

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Young People With HIV (YPWH) Cohort n=105 Participants Young people with HIV (YPWH), ages 18-29, residing in Florida enrolled in a single-group prospective longitudinal cohort study examining associations between cumulative stress and self-management outcomes (hazardous alcohol use and viral suppression). All participants completed baseline assessments and a two-week sleep diary, with repeat assessments and sleep diary at 9-month follow-up. A subset of participants additionally participated in qualitative focus groups to inform adaptation of developmentally and culturally relevant measures of cumulative stress, sleep health, and emotion/behavior regulation.
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	105 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants
Age, Continuous	26.3 Years STANDARD_DEVIATION 2.7 • n=20 Participants
Sex: Female, Male Female	13 Participants n=20 Participants
Sex: Female, Male Male	92 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	35 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=20 Participants
Race (NIH/OMB) Asian	2 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	47 Participants n=20 Participants
Race (NIH/OMB) White	35 Participants n=20 Participants
Race (NIH/OMB) More than one race	9 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=20 Participants
Region of Enrollment United States	105 participants n=20 Participants

PRIMARY outcome

Timeframe: 2 weeks, at baseline and 9 month follow up

Population: Only 41 participants at the 9-month follow-up completed the TLFB measure.

Outcome measures

Outcome measures
Measure	Young People With HIV (YPWH) Cohort n=105 Participants Young people with HIV (YPWH), ages 18-29, residing in Florida enrolled in a single-group prospective longitudinal cohort study examining associations between cumulative stress and self-management outcomes (hazardous alcohol use and viral suppression). All participants completed baseline assessments and a two-week sleep diary, with repeat assessments and sleep diary at 9-month follow-up. A subset of participants additionally participated in qualitative focus groups to inform adaptation of developmentally and culturally relevant measures of cumulative stress, sleep health, and emotion/behavior regulation.
Alcohol Use Baseline	1.2 number of days Standard Deviation 2.0
Alcohol Use 9-month follow-up	1.2 number of days Standard Deviation 2.6

PRIMARY outcome

Timeframe: Baseline and 9 month follow-up

Population: Only 51 of the 105 enrolled participants provided viral load at baseline. Only 29 participants provided viral load at the 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.

Outcome measures

Outcome measures
Measure	Young People With HIV (YPWH) Cohort n=51 Participants Young people with HIV (YPWH), ages 18-29, residing in Florida enrolled in a single-group prospective longitudinal cohort study examining associations between cumulative stress and self-management outcomes (hazardous alcohol use and viral suppression). All participants completed baseline assessments and a two-week sleep diary, with repeat assessments and sleep diary at 9-month follow-up. A subset of participants additionally participated in qualitative focus groups to inform adaptation of developmentally and culturally relevant measures of cumulative stress, sleep health, and emotion/behavior regulation.
HIV Viral Load 9 month follow-up · Detectable Viral Load	1 Participants
HIV Viral Load Baseline · Detectable Viral Load	8 Participants
HIV Viral Load Baseline · Undetectable Viral Load	43 Participants
HIV Viral Load 9 month follow-up · Undetectable Viral Load	28 Participants

Adverse Events

Young People With HIV (YPWH) Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sylvie Naar, PhD; Contact MPI

Florida State University

Phone: 850-644-2334

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place