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Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV
NA trial testing Intervention: (Clinician's Guide + HealthCall for HIV/HCV) in Alcohol Use Disorder in 31 participants. Completed in 8 June 2020.
| Lead sponsor | New York State Psychiatric Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 1 November 2018 |
| Primary completion | 8 June 2020 |
| Estimated completion | 8 June 2020 |
| Sites | 1 location across United States |
New York State Psychiatric Institute
Adults 18 to 99, any sex, with Alcohol Use Disorder 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.
Mean drinks per drinking day in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. Abstention is coded as zero.
| Group | Value | 95% CI |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | 2.61 | ± 3.35 |
| Educational Control Condition | 5.49 | ± 4.24 |
Number of days drank in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.
| Group | Value | 95% CI |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | -6.08 | ± 10.75 |
| Educational Control Condition | -3.09 | ± 10.4 |
Self-efficacy to change drinking in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. Participants rate eight situations regarding their confidence in their ability to resist drinking (0% - Not at all confident to 100% - Totally confident). The final score is an average that can range from 0 (lowest) to 100 (highest) self-efficacy.
| Group | Value | 95% CI |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | 74.86 | ± 17.99 |
| Educational Control Condition | 66.3 | ± 17.52 |
Readiness to change drinking in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. Higher scores indicate more readiness to change. Range from -2 to +14. The scale is scored when points are averaged for all four (precontemplation, contemplation, action, maintenance) scales. Add Contemplation + Action + Maintenance averages, then subtract Precontemplation average.
| Group | Value | 95% CI |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | 9.82 | ± 2.16 |
| Educational Control Condition | 8.98 | ± 1.67 |
Readiness to change drinking in the last 30 days,assessed at baseline and repeatedly during follow-up so that change can be analyzed. Higher scores indicate more recognition, ambivalence, and taking steps toward change, respectively. For full range and interpretation, see individual outcomes below. Recognition scale - Range 7 (very low recognition) to 35 (high recognition) Ambivalence scale - Range 4 (very low ambivalence) to 20 (very high ambivalence) Taking Steps scale - Range 8 (very low on taking steps to change drinking) to 40 (very high score)
| Group | Value | 95% CI |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | 26.08 | ± 6.4 |
| Educational Control Condition | 26.55 | ± 3.93 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | 12.25 | ± 2.99 |
| Educational Control Condition | 13.36 | ± 2.98 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | 34.33 | ± 4.79 |
| Educational Control Condition | 28.73 | ± 6.42 |
The largest number of drinks consumed within one day in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.
| Group | Value | 95% CI |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | -4 | ± 5.15 |
| Educational Control Condition | -5.36 | ± 9.51 |
Number of days engaging in binge drinking (4+ drinks) in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.
| Group | Value | 95% CI |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | -7.92 | ± 8.24 |
| Educational Control Condition | -6.27 | ± 11.66 |
Number of days intoxicated in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.
| Group | Value | 95% CI |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | -1.83 | ± 4.13 |
| Educational Control Condition | -0.64 | ± 6.67 |
Among patients with HIV, especially those also infected with HCV, heavy drinking is associated with significant risks to health. However, little is known about how to best intervene with co-infected heavy drinkers, a particularly high risk group for whom targeted intervention has not been developed. Therefore, this study proposes to test a newly developed drinking-reduction intervention for patients with both HIV and HCV, which combines components of successful interventions developed for HIV and for liver disease patients. 60 HIV/HCV co-infected drinkers from HIV primary care will be recruited in order to ensure an adequate final sample size of 45 participants completing the study. A clinic recruiter will identify and refer potential participants based on their medical record, who will then be screened for eligibility by the research coordinator. Potential participants from outside of this clinic will also be recruited through self-referrals via flyers and through RecruitMe, an online based recruitment tool. Participants will be randomly assigned to an intervention or control condition, while ensuring that equal numbers of individuals with alcohol use disorder are assigned to each condition. The intervention condition will receive brief in-person sessions with a counselor and will be asked to use a smartphone app daily to keep track of drinking and other health behaviors for two months. The intervention sessions will include information about HIV, HCV and alcohol, and the counselor will give the participant information about their liver function and alcohol use to try to motivate them to drink less. The control condition will simply be asked to drink less and will be given pamphlets with general information on HIV, Hepatitis C, and drinking from educational websites on HIV/HCV co-infection. The intervention condition will then be evaluated to see if it was more effective at reducing drinking than the control condition.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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