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NCT Number: NCT05503173

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.

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Key information

Conditions

HIV Agnosia Chronic Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Unhealthy Alcohol Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCBMAP

Behavioral

MCBMAP integrates motivational interviewing (MI) and cognitive-behavioral skill training interventions for unhealthy drinking with cognitive-behavioral and self- management approaches for chronic pain. The intervention is delivered through internet-based videoconferencing and supplemented with web-based content to support the intervention. The initial treatment session provides a rationale for addressing alcohol and pain together in the context of HIV management, and initiates MI related to alcohol use. Participants receive 6 additional treatment sessions over the subsequent weeks.

Brief Advice and Information

Other

Through videoconferencing an interventionist will provide participants psychoeducation about the effects of alcohol and pain on HIV symptoms, advice/recommendations to reduce alcohol use, and a list of local treatment resources for alcohol and chronic pain.

Other names: Treatment as usual

Primary outcomes

  1. Number of alcoholic drinks consumed per week at 6 months

    Time frame: 6 months

    Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.

  2. Number of heavy episodic drinking days the past month at 6 months

    Time frame: 6 months

    Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.

  3. Rating of pain severity and interference at 6 months

    Time frame: 6 months

    Assessed by the PEG Scale Assessing Pain Intensity and Interference (PEG) which is a 3-item scale measuring pain intensity, emotional function, and physical function over the past week.

Secondary outcomes

  1. Rating of pain severity at 6 months

    Time frame: 6 months

    Assessed by the Brief Pain Inventory (BPI) which a 9-item self-report questionnaire in which participants rate the severity of pain and the degree of pain interference with various dimensions of feeling and function. Related pain is rated on a 0-10 scale and scored as Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.

  2. Rating of pain interference at 6 months

    Time frame: 6 months

    Assessed by the Brief Pain Inventory (BPI) which a 9-item self-report questionnaire in which participants rate the severity of pain and the degree of pain interference with various dimensions of feeling and function. Related pain is rated on a 0-10 scale and scored as Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Integrated Telehealth Intervention To Reduce Chronic Pain And Unhealthy Drinking Among People Living With HIV (PLWH)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2022
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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