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Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS
NA trial testing Project TRAC: Tracking and Reducing Alcohol Consumption in Acquired Immunodeficiency Syndrome in 50 participants. Completed in 7 June 2023.
| Lead sponsor | Carolyn Lauckner |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 23 May 2020 |
| Primary completion | 7 June 2023 |
| Estimated completion | 7 June 2023 |
| Sites | 1 location across United States |
Carolyn Lauckner
18 and older, any sex, with Acquired Immunodeficiency Syndrome or HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Alcohol Use Disorders Identification Test-C (AUDIT-C): A validated, self-report instrument assessing problematic alcohol use. For this 3-item scale, scores range from 0-12. Higher values represent greater problematic alcohol use. Change= Week 8 score - Baseline score
| Group | Value | 95% CI |
|---|---|---|
| Immediate Intervention Group | -0.95 | ± 1.50 |
| Waitlist Control Group | -1.00 | ± 3.32 |
Single item asking how many days in the past month participants consumed alcohol. Responses range from 0-31. Change= Days reported at 8 weeks - Days reported at baseline
| Group | Value | 95% CI |
|---|---|---|
| Immediate Intervention Group | -2.95 | ± 7.78 |
| Waitlist Control Group | -2.10 | ± 12.48 |
Participants completed up to 14 breathalyzer readings/week obtained by BACTrack mobile breathalyzer. This outcome compares average % of positive breathalyzer readings (breathalyzer values \> 0.00) per participant at Week 1 to Week 8. Numbers should be converted to percentages to aid in interpretation (e.g., -0.10 corresponds to a 10% decrease).
| Group | Value | 95% CI |
|---|---|---|
| Immediate Intervention Group | -0.10 | ± 0.25 |
| Waitlist Control Group | -0.07 | ± 0.30 |
Single item: Participants self-report on a scale of 0-100% how much of their HIV/AIDS medication they have taken in the previous month. Scores range from 0-100. Change = Week 8 score - Baseline score.
| Group | Value | 95% CI |
|---|---|---|
| Immediate Intervention Group | 0 | ± 27.71 |
| Waitlist Control Group | 1.95 | ± 6.44 |
% change in self-reported HIV/AIDS medication as measured via daily surveys, comparing percent of days HIV/AIDS medication was taken in Week 1 to Week 8. Numbers should be converted to percentages (i.e., a decrease of -0.01 is equivalent to a 1% decrease).
| Group | Value | 95% CI |
|---|---|---|
| Immediate Intervention Group | 0.01 | ± 0.03 |
| Waitlist Control Group | -0.02 | ± 0.06 |
While advances in medication have led to greatly improved outcomes for people living with HIV/AIDS, less than one-third of all people living with the disease are adherent enough to their medication to achieve viral suppression. Alcohol consumption has been shown to have a significant effect on HIV medication adherence, so the proposed research will aim to reduce alcohol use among people living with HIV/AIDS through a technology-driven intervention. This eight-session intervention will be delivered using a combination of videoconferencing, smart phones, and Bluetooth-enabled breathalyzers for monitoring of alcohol consumption, with an overall goal of reducing alcohol use, mitigating adherence issues, and achieving optimal prevention and treatment responses for people living with HIV/AIDS.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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