Interventions
HARP
The ongoing HIV and Alcohol Research center focused on Polypharmacy (HARP) Pilots 1 and 2 from Project 1 are pharmacist-led intervention studies that combine self-reported alcohol use and biomarkers (phosphatidylethanol concentration) to communicate risk to individuals with HIV who are on 5 or more medications (polypharmacy). Additional risks such as falls and neurocognitively active meds will be factored into Pilot 2 using the learned framework of Pilot 1.
HARP Project 1 Pilot Training Manual
HARP Project 2 includes a series of three open-label pilot studies that consist of a 12-week intervention including off-label use of medication with medical management and a clinical pharmacist-delivered behavioral intervention to treat alcohol use disorder among individuals with HIV. Participants will receive counseling that incorporates brief feedback and advice with motivational enhancement techniques to assist the participant in changing their behaviors with respect to alcohol consumption and/or polypharmacy. In addition, participants will be offered varenicline in the first pilot study.
FIRST
The Financial Incentives, Randomization with Stepped Treatment (FIRST) Trial is a 7-site randomized clinical trial designed to determine the efficacy of Contingency Management (CM) plus Stepped Care for unhealthy alcohol use among patients with HIV.
FIRST Intervention and Protocol Manuals
FIRST Patient Materials
FIRST Tracking and Visit Forms
FIRST Trial Publications
2023
- Perspectives on contingency management for alcohol use and alcohol-associated conditions among people in care with HIV.Cohen SM, DePhilippis D, Deng Y, Dziura J, Ferguson T, Fucito LM, Justice AC, Maisto S, Marconi VC, Molina P, Paris M, Rodriguez-Barradas MC, Simberkoff M, Petry NM, Fiellin DA, Edelman EJ. Alcohol Clin Exp Res (Hoboken). 2023 Sep; 2023 Aug 29. PMID: 37524371.
- Contingency management with stepped care for unhealthy alcohol use among individuals with HIV: Protocol for a randomized controlled trial.Edelman EJ, Dziura J, Deng Y, DePhilippis D, Fucito LM, Ferguson T, Bedimo R, Brown S, Marconi VC, Goetz MB, Rodriguez-Barradas MC, Simberkoff MS, Molina PE, Weintrob AC, Maisto SA, Paris M, Justice AC, Bryant KJ, Fiellin DA. Contemp Clin Trials. 2023 Aug; 2023 May 23. PMID: 37230168.
STEP
The Starting Treatment for Ethanol in Primary HIV Care (STEP) Trials were three linked randomized clinical trials designed to evaluate the impact of integrated stepped alcohol treatment to address unhealthy alcohol use among individuals with HIV.
STEP Trial Documents
STEP Trial Publications
2022
- Change in Alcohol Use Based on Self-Report and a Quantitative Biomarker, Phosphatidylethanol, in People With HIV.McGinnis KA, Tate JP, Bryant KJ, Justice AC, O'Connor PG, Rodriguez-Barradas MC, Crystal S, Cutter CJ, Hansen NB, Maisto SA, Marconi VC, Williams EC, Cook RL, Gordon AJ, Gordon KS, Eyawo O, Edelman EJ, Fiellin DA. AIDS Behav. 2022 Mar; 2021 Sep 20. PMID: 34542779.
2020
- Validating Self-Reported Unhealthy Alcohol Use With Phosphatidylethanol (PEth) Among Patients With HIV.Eyawo O, Deng Y, Dziura J, Justice AC, McGinnis K, Tate JP, Rodriguez-Barradas MC, Hansen NB, Maisto SA, Marconi VC, O'Connor PG, Bryant K, Fiellin DA, Edelman EJ. Alcohol Clin Exp Res. 2020 Oct; 2020 Sep 19. PMID: 33460225.
- Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial.Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O'Connor PG, Bedimo R, Gibert CL, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Tate JP, Justice AC, Bryant KJ, Fiellin DA. Addict Sci Clin Pract. 2020 Jul 29; 2020 Jul 29. PMID: 32727618.
2019
- Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial.Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O'Connor PG, Bedimo R, Gibert CL, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Tate JP, Justice AC, Bryant KJ, Fiellin DA. J Subst Abuse Treat. 2019 Nov; 2019 Aug 17. PMID: 31540617.
- Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial.Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O'Connor PG, Bedimo R, Gibert CL, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Tate JP, Justice AC, Bryant KJ, Fiellin DA. Lancet HIV. 2019 Aug; 2019 May 17. PMID: 31109915.
2017
- 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.Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Fiellin LE, O'Connor PG, Bedimo R, Gibert C, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Justice AC, Bryant KJ, Fiellin DA. Contemp Clin Trials. 2017 Jan; 2016 Nov 20. PMID: 27876616.
2016
- Implementation of integrated stepped care for unhealthy alcohol use in HIV clinics.Edelman EJ, Hansen NB, Cutter CJ, Danton C, Fiellin LE, O'Connor PG, Williams EC, Maisto SA, Bryant KJ, Fiellin DA. Addict Sci Clin Pract. 2016 Jan 13; 2016 Jan 13. PMID: 26763048.
Project Dawn
This randomized clinical trial designed to evaluate the efficacy of counseling + injectable naltrexone vs. counseling + placebo among individuals with HIV with heavy drinking and antiretroviral non-adherence. Among n=51 enrolled participants, we did not detect an effect of the intervention on ART adherence or other HIV-related outcomes; however, it was associated with fewer heavy drinking days and reached a population of individuals who had limited prior alcohol treatment.
Project Dawn Publication
2019
- Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial.Edelman EJ, Moore BA, Holt SR, Hansen N, Kyriakides TC, Virata M, Brown ST, Justice AC, Bryant KJ, Fiellin DA, Fiellin LE. AIDS Behav. 2019 Jan. PMID: 30073637.