Integrated Stepped Care for Unhealthy Alcohol Use in HIV

HIV Clinical Trial

Official title:

Integrated Stepped Care for Unhealthy Alcohol Use in HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410123
• Other study ID #: 1105008544
• Secondary ID: U01AA020795
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: August 31, 2018

Study information

• Verified date: December 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a series of 3 linked randomized clinical trials of 6 month duration, with a total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with unhealthy alcohol use.

Description:

Unhealthy alcohol use threatens the health benefits seen with antiretroviral therapy (ART) for HIV-infected (HIV+) patients. Although research has demonstrated the efficacy of brief interventions, motivational counseling, and medications to treat unhealthy alcohol use in HIV uninfected patients, there is limited research or use of these treatments in HIV+ patients. We have demonstrated that integrated treatment of addiction in HIV clinics is feasible. Stepped care algorithms can facilitate the evaluation of varying intensities of treatments for unhealthy alcohol use. The proposed study will compare onsite Integrated Stepped Care treatment (ISC) to treatment as usual (TAU) in three, linked, 6-month randomized clinical trials in 642 HIV+ patients with unhealthy alcohol use. Screened patients are randomized to ISC or TAU after determining that they meet criteria for either 1) at-risk drinking, 2) alcohol abuse or dependence or 3) moderate alcohol consumption in the presence of liver disease. ISC and TAU are tailored to the drinking category. ISC for at-risk drinkers and those with Moderate Alcohol use and Liver Disease begins with a brief intervention and is stepped up to Motivational Enhancement Therapy (MET) in those who meet predefined failure criteria. ISC for abuse or dependence begins with addiction physician management (APM) including alcohol pharmacotherapy if not contraindicated. APM is stepped up to include MET if predefined failure criteria are met. The study will test the hypothesis that ISC leads to decreased alcohol consumption and improved HIV biomarkers. Data analyses will be conducted on the intention to treat sample.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: August 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Be HIV-infected and receiving HIV care at one of the participating medical centers.

2. Meet one of the following criteria for unhealthy alcohol use:

• At-risk Drinking Study- greater than 14 drinks per week or greater than 4 drinks per occasion in men and greater than 7 drinks per week or greater than 3 drinks per occasion in women and those over 65.

• Alcohol Abuse or Dependence Study - Meet DSM-IV TR criteria for alcohol abuse or dependence, not in remission.

• Moderate Alcohol + Liver Disease Study - Report alcohol consumption in the past month, are HCV co-infected, confirmed by HCV viral load or have liver fibrosis - Fib-4 (>1.45). Do not meet criteria for at-risk drinking, alcohol abuse or dependence.

3. Be able to understand English and provide informed consent.

Exclusion Criteria:

1. Be acutely suicidal, or with a psychiatric condition that affects the ability to provide informed consent or participate in counseling interventions (e.g. psychotic, dementia, delusional).

2. Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)

3. Have medical conditions that would preclude completing or be of harm during the course of the study.

4. Pregnant or nursing women or women who do not agree to use a reliable form of birth control.

Related Conditions & MeSH terms

• Alcoholism
• Hepatitis C
• HIV
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Other:
• Integrated Stepped Care (ISC)
At risk drinking: Step 1: Brief negotiated interview (BNI) + booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction Physician Management + Alcohol pharmacotherapy Alcohol abuse/dependence: Step 1: Addiction Physician Management + Alcohol Pharmacotherapy; Step 2: Motivational Enhancement Therapy; Step 3: Detoxification and aftercare Moderate Alcohol + Liver Disease: Step 1: Brief Negotiated Interview (BNI)+ booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction physician management + alcohol pharmacotherapy.
• Treatment as Usual
The TAU arm will receive a handout with alcohol information embedded within general health-related information (exercise, smoking cessation, and flu vaccination) and standard care as provided by their treating physician. All patients will have access to a NIAAA informational website.

Locations

Country	Name	City	State
United States	VAMC Atlanta	Atlanta	Georgia
United States	Dallas VA Medical Center	Dallas	Texas
United States	VAMC Houston	Houston	Texas
United States	New York VAMC - New York Harbor Healthcare System	New York	New York
United States	Washington DC VAMC	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

References & Publications (7)

Edelman EJ, Hansen NB, Cutter CJ, Danton C, Fiellin LE, O'Connor PG, Williams EC, Maisto SA, Bryant KJ, Fiellin DA. Implementation of integrated stepped care for unhealthy alcohol use in HIV clinics. Addict Sci Clin Pract. 2016 Jan 13;11(1):1. doi: 10.1186/s13722-015-0048-z. — View Citation

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. Integrated stepped alcohol treatment for — View Citation

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. Integrated stepped alcohol treatment for — View Citation

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. Integrated stepped alcohol treatment for — View Citation

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. 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. Contemp Clin Trials. 2017 Jan;52:80-90. doi: 10.1016/j.cct.2016.11.008. Epub 2016 Nov 20. Erratum In: Contemp Clin Trials. 2017 Sep;60:125. — View Citation

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. Validating Self-Reported Unhealthy Alcohol Use With Phosphatidylethanol (PEth) Among Patien — View Citation

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. Change in Alcohol Use Based on Self-Repor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At risk drinking: Drinks per week		6 months
Primary	Alcohol abuse or dependence: Drinks per week		6 months
Primary	Moderate Alcohol + Liver Disease group: Abstinence.		6 months
Secondary	Alcohol consumption by phosphatidylethanol (PEth), an alcohol biomarker		6 months
Secondary	Change in biological markers as measured by the VACS index.		6 months