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Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain

Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02272829
Acronym
CHOACOT
Enrollment
8
Registered
2014-10-23
Start date
2015-05-31
Completion date
2017-08-31
Last updated
2017-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Older Adults, Opioid Misuse

Brief summary

This project will develop a novel collaborative treatment, based on the primary care behavioral consultation model and behavior therapy techniques including motivational interviewing and functional assessment, in which a patient, a Behavioral Health Consultant (BHC) and a HIV primary care provider share a unified plan targeting misuse of prescribed opioid analgesics in older HIV+ adults. The intervention will involve meetings between the BHC and the PCP, the BHC and the participant, and the BHC, PCP and the participant. Opioid misuse will be the primary outcome variable. Quality of the patient-provider relationship, pain, problematic use of other substances, antiretroviral adherence, and psychosocial functioning will be secondary outcomes.

Detailed description

Up to 20% of HIV patients receive prescriptions for chronic opioid therapy (COT) to treat chronic pain. This project will develop a novel collaborative treatment, based on the primary care behavioral consultation model and behavior therapy techniques including motivational interviewing and functional assessment, in which a patient, a Behavioral Health Consultant and a HIV primary care provider share a unified plan targeting misuse of prescribed opioid analgesics in older HIV+ adults. This would be the first theoretically-driven, empirically-tested intervention that specifically attends to the difficult issues around chronic pain and opioid prescription in HIV clinical practice. This project will develop a collaborative, brief, behavioral consultation intervention targeting misuse of prescribed opioids in older HIV+ adults. The intervention, CHOACOT (Consultation for HIV+ Older Adults on Chronic Opioid Therapy), will consist of: 1. three meetings between the Behavioral Health Specialist (BHS) and the patient 2. two brief consultations between the BHC and the HIV-PCP 3. a joint meeting of the patient, BHC, and HIV-PCP. To achieve our aims, we will develop CHOACOT beginning with an iterative open trial (n=10). Next, we will conduct a pilot randomized clinical trial (n=30) of CHOACOT versus enhanced Treatment-As-Usual. Opioid misuse will be the primary outcome variable. Quality of the patient-provider relationship, pain, problematic use of other substances, antiretroviral adherence, and psychosocial functioning will be secondary outcomes. The specific aims are: Aim 1. Develop and refine CHOACOT so that it meets standards of feasibility and acceptability for HIV PCPs, BHCs, and participants; 1a. To develop and field test a CHOACOT BHC manual; 1b. To develop a reliable measure of BHC manual adherence; 1c. To develop and field-test BHC training and supervision procedures. Aim 2. Refine research procedures (e.g., consent and randomization processes, assessment procedures), and establish their feasibility and acceptability to participants while confirming recruitment goal targets. Misuse of prescribed opioids is the primary outcome. Secondary outcomes are problematic use of substances with a high potential for lethality when used with COT (benzodiazepines, cocaine, alcohol, heroin), ARV adherence, viral load, pain, psychosocial functioning, patient-provider alliance, and treatment satisfaction and acceptability. This line of work could lead to the incorporation into HIV care of a theoretically-driven and empirically-tested brief intervention for older HIV patients who are prescribed opioids for chronic pain and for whom there is concern about opioid misuse.

Interventions

BEHAVIORALChoacot: Behavioral Intervention for Chronic Opioid Use

This is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP.

OTHERHealth Education

Sponsors

Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HIV patients with a physician at the enrollment site; * Age 50 or older; * Chronic pain (pain duration for at least six months); * Daily use of an opioid analgesic, prescribed by an HIV-PCP at the study site, for at least the past 90 days; * Patients endorse feeling at risk of losing their pain medication prescription, or that they are unhappy with how they and their doctors are working together to manage their pain; * Patient-rated Addictions Behavior Checklist score \> 3, as a recommended cut-point indicating opioid misuse.

Exclusion criteria

* Current, severe psychiatric symptoms requiring immediate clinical attention; * Inability to understand English; * Cognitive impairment severe enough to interfere with ability to actively participate in CHOACOT.

Design outcomes

Primary

MeasureTime frameDescription
opioid use4 monthsopioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period

Secondary

MeasureTime frameDescription
quality of the patient-provider relationship4 monthsquality of the patient-provider relationship will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
pain4 monthspain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
problematic use of other substances4 monthsproblematic use of other substances will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
antiretroviral adherence4 monthsantiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
psychosocial functioning4 monthspsychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026