HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2024-01-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot intervention will consist of a brief intervention for patients with HIV who take 5 or more medications and currently (within the past month) consume alcohol. The focus of this pilot will be on bothersome symptoms and the impact of alcohol use and medications on these symptoms. The rationale is that any alcohol use may interact with medications in serious ways leading to adverse outcomes, including bothersome symptoms.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

NCT01227044

Reduction in Heavy Drinking in Patients With HIV

COMPLETED PHASE2/PHASE3

Interaction of Alcohol and Highly Active Antiretroviral Therapy (HAART) in HIV/AIDS and HIV/AIDS With Hepatitis C Virus (HCV) Co-Infection

NCT00879047

HIV Infections Hepatitis C

COMPLETED PHASE1

Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV

NCT05314088

Resilience HIV-1-infection Stress, Psychological

COMPLETED NA

Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV Supplement

NCT04984681

HIV Infections Mild Cognitive Impairment

COMPLETED NA

ARCH II Study (Alcohol Research Center on HIV Study II)

NCT02563574

Alcohol Consumption HIV Motivation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Additional outcomes were added at results entry.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Alcohol Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HIV Medications and Alcohol Use

Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol

Group Type EXPERIMENTAL

IMB-motivational interviewing (MI) techniques (IMB-MI)

Intervention Type BEHAVIORAL

The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IMB-motivational interviewing (MI) techniques (IMB-MI)

The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* participants in both Veterans Aging Cohort Study (VACS) and Medications, Alcohol, and Substance use in HIV (MASH) studies
* prescribed 5 or more medications AND who either have a positive PEth value (8+) or a self-reported AUDIT-C value consistent with current alcohol use (score \>0)

Exclusion Criteria

* Alcohol use disorder (AUD) diagnosis in the past 12 months or who test positive for AUD on the Alcohol Symptom Checklist for moderate or severe AUD (score of 4 or more)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No