NCT05503173 Telehealth for Pain and Unhealthy Drinking Among PLWH
| NCT ID | NCT05503173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 385 participants |
| Start Date | 2023-03-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 385 participants in total. It began in 2023-03-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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
Contact & Investigator
Tibor P Palfai, PhD
PRINCIPAL INVESTIGATOR
Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences
Frequently Asked Questions
Who can join the NCT05503173 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05503173 currently recruiting?
Yes, NCT05503173 is actively recruiting participants. Contact the research team at palfai@bu.edu for enrollment information.
Where is the NCT05503173 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05503173 clinical trial?
NCT05503173 is sponsored by Boston University. The principal investigator is Tibor P Palfai, PhD at Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences. The trial plans to enroll 385 participants.
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