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HIVNCT05503173

Telehealth for Pain and Unhealthy Drinking Among PLWH

A study testing MCBMAP and Brief Advice and Information in people with HIV and Chronic Pain, run by Boston University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, Chronic Pain, Unhealthy Alcohol Use
What is being tested?
MCBMAP and Brief Advice and Information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
1 siteUnited States
Study dates
3 Mar 2023to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Integrated Telehealth Intervention To Reduce Chronic Pain And Unhealthy Drinking Among People Living With HIV (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.

Being tested
MCBMAP, Brief Advice and Information
Keywords
Pain management, Telehealth, Unhealthy drinking, Ecological momentary assessment
Medical subject headings
Chronic Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MCBMAPBehavioural

    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 InformationOther

    Also called Treatment as usual

    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.

Study groups in NCT05503173
Study groupRoleWhat they receive
Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP)ExperimentalParticipants randomized to this arm will receive MCBMAP which utilizes a self-regulation framework to integrate evidence-based approaches for chronic pain and unhealthy drinking.
Receives: Behavioral: MCBMAP
Brief Advice and InformationActive comparatorParticipants randomized to this arm will be provided treatment as usual for their conditions.
Receives: Other: Brief Advice and Information

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of alcoholic drinks consumed per week at 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.

    Measured: 6 months

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

    Measured: 6 months

  3. Rating of pain severity and interference at 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.

    Measured: 6 months

Secondary outcomes (2)

  1. Rating of pain severity at 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.

    Measured: 6 months

  2. Rating of pain interference at 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start3 Mar 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05503173
Sponsor's protocol ID
H-42405
Other IDs
1P01AA029546-01
Status last verified
Jul 2026
First submitted
13 Aug 2022
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Palfai TP, Bernier LB, Kratzer MP, Magane KM, Fielman S, Otis JD, Heeren TC, Winter MR, Stein MD. Integrated telehealth intervention to reduce chronic pain and unhealthy drinking among people living with HIV: protocol for a randomized controlled trial. Addict Sci Clin Pract. 2024 Sep 5;19(1):64. doi: 10.1186/s13722-024-00493-3.

    PubMed 39238059

Questions about this trial

What is this clinical trial studying?

A study testing MCBMAP and Brief Advice and Information in people with HIV and Chronic Pain, run by Boston University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of alcoholic drinks consumed per week at 6 months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05503173, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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