Telehealth for Pain and Unhealthy Drinking Among PLWH
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:
🦠 HIV 🦠 Chronic Pain 🦠 Unhealthy Alcohol Use
🗓️ Study Start (Actual) 3 March 2023
🗓️ Primary Completion (Estimated) February 2026
✅ Study Completion (Estimated) February 2026
👥 Enrollment (Estimated) 385
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Able to confirm HIV diagnosis, via visual evidence of antiretroviral (ART) medication bottle or medical record presented to study staff over Zoom.
    • * Engaged in unhealthy drinking, defined as:
    • * \>7 drinks for women / \> 14 drinks for men per week.
    • * OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month.
    • * Experiencing moderate or greater chronic pain (4 or greater on the numerical pain rating scale) for at least 3 months.
    • * Own a smart phone.
    • * Lives in the USA.
    • * Has a US mailing address.

    Exclusion Criteria:

    • * History of bipolar, schizoaffective disorder or schizophrenia per self report.
    • * Unstable dose of psychoactive medication for pain or alcohol/substance use \[i.e., if on medication, participant has not been on same dose for least 2 months\]
    • * History of withdrawal-related seizures or delirium tremens
    • * Current non-pharmacological treatment for alcohol use disorder or chronic pain
    • * Acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months.
    • * Current cancer-related pain
    • * Unable to provide one or more individuals for follow-up contact
    • * Individual who is unwilling to provide their sex at birth
    • * Limited or non-readers
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 August 2022
  • First Submitted that Met QC Criteria 13 August 2022
  • First Posted 16 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 January 2024
  • Last Update Posted 29 January 2024
  • Last Verified January 2024