Telehealth for Pain and Unhealthy Drinking Among PLWH (NCT05503173) | Clinical Trial Compass
RecruitingNot Applicable
Telehealth for Pain and Unhealthy Drinking Among PLWH
United States385 participantsStarted 2023-03-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of alcoholic drinks consumed per week at 6 months
Timeframe: 6 months
2
Number of heavy episodic drinking days the past month at 6 months
Timeframe: 6 months
3
Rating of pain severity and interference at 6 months