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New treatment option for HIV
Official title Telehealth for Pain and Unhealthy Drinking Among PLWH
ClinicalTrials.gov ID: NCT05503173
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.