Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05503173

Telehealth for Pain and Unhealthy Drinking Among PLWH

Led by Boston University · Updated on 2025-06-17

385

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

B

Boston University

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This randomized controlled trial is a between-groups design to compare the Motivational and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief Advice and Information Control condition. Two-hundred and fifty participants who have HIV with moderate or greater chronic pain will be randomized for the trial. Recruitment will take place through digital media. A unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. Consent and baseline assessment will be completed remotely. Following baseline assessment, participants will complete two weeks of ecological momentary assessment (EMA) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. Following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. Participants will complete outcome assessment measures at 3- and 6-months post-baseline. Following the 3-month outcome assessment, participants will complete another two weeks of EMA.

CONDITIONS

Official Title

Telehealth for Pain and Unhealthy Drinking Among PLWH

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to confirm HIV diagnosis via visual evidence of antiretroviral medication bottle or medical record shown over Zoom
  • Engaged in unhealthy drinking defined as more than 7 drinks per week for women or more than 14 drinks per week for men, or 3 or more drinks for women or 4 or more drinks for men on one occasion in the past month
  • Experiencing moderate or greater chronic pain (score of 4 or higher on numerical pain rating scale) for at least 3 months
  • Own a smartphone
  • Lives in the USA
  • Has a US mailing address
Not Eligible

You will not qualify if you...

  • History of bipolar disorder, schizoaffective disorder, or schizophrenia by self-report
  • Unstable dose of psychoactive medication for pain or alcohol/substance use (not on same dose for at least 2 months)
  • History of withdrawal-related seizures or delirium tremens
  • Currently receiving non-pharmacological treatment for alcohol use disorder or chronic pain
  • Acute life-threatening illness requiring treatment or planned surgery for pain-related condition in next 6 months
  • Current cancer-related pain
  • Unable to provide one or more individuals for follow-up contact
  • Unwilling to provide sex at birth
  • Limited or non-reader abilities

AI-Screening

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Trial Site Locations

Total: 1 location

1

Charles River Campus, Boston University, Psychology Department- remote study

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

T

Tibor P Palfai, PhD

CONTACT

K

Kara Magane, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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