Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial

E Jennifer Edelman, Stephen A Maisto, Nathan B Hansen, Christopher J Cutter, James Dziura, Yanhong Deng, Lynn E Fiellin, Patrick G O'Connor, Roger Bedimo, Cynthia L Gibert, Vincent C Marconi, David Rimland, Maria C Rodriguez-Barradas, Michael S Simberkoff, Janet P Tate, Amy C Justice, Kendall J Bryant, David A Fiellin, E Jennifer Edelman, Stephen A Maisto, Nathan B Hansen, Christopher J Cutter, James Dziura, Yanhong Deng, Lynn E Fiellin, Patrick G O'Connor, Roger Bedimo, Cynthia L Gibert, Vincent C Marconi, David Rimland, Maria C Rodriguez-Barradas, Michael S Simberkoff, Janet P Tate, Amy C Justice, Kendall J Bryant, David A Fiellin

Abstract

Background: At-risk levels of alcohol use threaten the health of patients with HIV (PWH), yet evidence-based strategies to decrease alcohol use and improve HIV-related outcomes in this population are lacking. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among PWH and at-risk alcohol use.

Methods: In this multi-site, randomized trial conducted between January 28, 2013 through July 14, 2017, we enrolled PWH and at-risk alcohol use [defined as alcohol consumption of ≥ 14 drinks per week or ≥ 4 drinks per occasion in men ≤ 65 years old or ≥ 7 drinks per week or ≥ 3 drinks per occasion in women or men > 65 years old]. ISAT (n = 46) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 47) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat principles.

Results: Despite a multi-pronged approach, we only recruited 37% of the target population (n = 93/254). Among ISAT participants, 50% advanced to Step 2, among whom 57% advanced to Step 3. Participants randomized to ISAT and TAU had no observed difference in drinks per week over the past 30 days at week 24 (primary outcome) [least square means (Ls mean) (95% CI) = 8.8 vs. 10.6; adjusted mean difference (AMD) (95% CI) = - 0.4 (- 3.9, 3.0)].

Conclusion: An insufficient number of patients were interested in participating in the trial. Efforts to enhance motivation of PWH with at-risk alcohol use to engage in alcohol-related research and build upon ISAT are needed. Trial registration Clinicaltrials.gov: NCT01410123, First posted August 4, 2011.

Keywords: Alcohol-related disorders; Delivery of health care; HIV; Integrated.

Conflict of interest statement

The authors have no competing interests.

Figures

Fig. 1
Fig. 1
Participant flow
Fig. 2
Fig. 2
Visit attendance among those randomized to integrated stepped alcohol treatment. Denominator is among those eligible for the intervention: Step 1: n = 46; Step 2: n = 23; Step 3: n = 13 for APM1-4, n = 12 for APM 5. BNI  Brief Negotiated Interview, MET Motivational Enhancement Therapy, APM Addiction Physician Management
Fig. 3
Fig. 3
Drinking outcomes. a Drinks per week over the past 30 days; b Proportion of participants with no heavy drinking days over the past 30 days. Data points are least square means or proportions with whiskers denoting 95% CIs

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