Telehealth intervention for managing pain and unhealthy drinking in people living with HIV
Integrated Telehealth Intervention To Reduce Chronic Pain And Unhealthy Drinking Among People Living With HIV (PLWH)
This study is testing a new online program to help people with HIV manage their pain and drinking habits better compared to just receiving basic advice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 385 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05503173 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares 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 with HIV and moderate to severe chronic pain will be recruited through digital media and will complete remote assessments. The study includes a two-week ecological momentary assessment phase to evaluate alcohol use, chronic pain, and behavior change mechanisms before participants are randomly assigned to either the intervention or control group. The remote nature of the study aims to reduce barriers related to transportation and time commitments for participants.
Who should consider this trial
Good fit: Ideal candidates are individuals living with HIV who experience moderate or greater chronic pain and engage in unhealthy drinking behaviors.
Not a fit: Patients with a history of severe mental health disorders or those currently receiving non-pharmacological treatment for alcohol use disorder or chronic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve pain management and reduce unhealthy alcohol use among individuals living with HIV.
How similar studies have performed: Other studies have shown promise in using telehealth interventions for similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Charles River Campus, Boston University, Psychology Department- remote study — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Tibor P Palfai, PhD — Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences
- Study coordinator: Tibor P Palfai, PhD
- Email: palfai@bu.edu
- Phone: (617) 353-9345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.