The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients

Abstract

Unhealthy alcohol use is common among HIV-positive patients, yet effective evidence-based treatments are rarely provided in clinical settings providing HIV care. Further, given patient variability in response to initial treatments, stepped care approaches may be beneficial. We describe the rationale, aims and study design for the current Starting Treatment for Ethanol in Primary care Trials (STEP Trials); three parallel randomized controlled effectiveness trials being conducted in five Infectious Disease Clinics. Participants meeting criteria for: 1) at-risk drinking, 2) moderate alcohol use with liver disease (MALD), or 3) alcohol use disorder (AUD) are randomized to integrated stepped care versus treatment as usual. For those with at-risk drinking or MALD, integrated stepped care starts with a one session brief intervention and follow-up 2-week telephone booster. Based on pre-specified nonresponse criteria, participants may be “stepped up” at week 4 to receive four sessions of motivational enhancement therapy (MET) and “stepped up” again at week 12 for addiction physician management (APM) and consideration of alcohol pharmacotherapy. For those with AUD, integrated stepped care begins with APM. Non-responders may be “stepped up” at week 4 to receive MET and again at week 12 for a higher level of care (e.g. intensive outpatient program). The primary outcome is alcohol consumption assessed at 24 weeks, and secondary outcome is the VACS Index, a validated measure of HIV morbidity and mortality risk. Results from the STEP Trials should inform future research and the implementation of interventions to address unhealthy alcohol use among HIV-positive individuals.

Validating Self‐Reported Unhealthy Alcohol Use With Phosphatidylethanol (PEth) Among Patients With HIV

“…This study uses baseline data collected as part of the STEP trials, described in detail elsewhere (Edelman et al, 2019a(Edelman et al, , 2019bEdelman et al, 2017). Briefly, the STEP Trials consist of 3 multi-site, parallel, randomized controlled trials designed to evaluate the effectiveness of integrated stepped alcohol treatment compared to treatment as usual to address unhealthy alcohol use (see criteria below) among individuals with HIV.…”

Fresh Perspectives on the Alcohol and HIV Nexus: A Call for Action in an Era of Increased Opportunities and Challenges

“…Patients with an alcohol use disorder begin with APM. Non-responders may be “stepped up” to receive MET at week 4 and be “stepped up” again to receive higher level of care such as an intensive outpatient treatment program at week 12 [24]. This study uses self-reported measures of alcohol consumption, breathalyzer testing to measure current alcohol levels and PEth testing to determine chronic alcohol exposure.…”

Perceptions of alcohol use in the context of HIV treatment: a qualitative study

“… 35 Although HIV infected patients are already on many treatments, some with alcohol dependency may require pharmacological interventions to improve both HIV and AUD outcomes. 36 A number of trials to integrate AUDs in HIV care settings are on-going. 37 Some of the findings in this study can inform the design of future trials, for example taking gender into account as single-gender groups in this setting may help to optimize participation in behavioral interventions.…”