In March 2016, the Centers for Disease Control issued a guideline (CDCG) for prescribing opioids for chronic pain in general primary care settings, which was intended to reduce prescription opioid-related harms while maintaining pain control and function. However, due to a paucity of data on the effectiveness of prescription opioid risk mitigation strategies, ambiguity in some of the CDCG recommendations, and the challenging nature of the patient-provider opioid conversation, the success of the CDCG may hinge on the manner in which it is implemented in individual care settings. In this proposal, we have chosen to focus on the HIV primary care setting for which we will develop a tailored, algorithmic ?testable? version of the CDCG (?CDCG intervention?), and then pilot it in a randomized-controlled feasibility study. The development process will involve collaboration with stakeholders. First we will elicit recommendations from 50 HIV-infected individuals using a process of Public Deliberation. Next we will collaborate with an advisory board of HIV healthcare providers to use these recommendations to develop and iteratively refine the CDCG intervention. For the feasibility study, we will randomize and train 10 HIV primary care providers (PCPs) to provide the CDCG intervention or usual care to consenting patients (~5 per PCP) to whom they already prescribe opioids for chronic pain. The intervention will be provided for 6 months during which time patient-participants will be monitored for signs of opioid misuse, and changes in pain control, antiretroviral adherence, and their relationship with their provider. Multiple aspects of feasibility will be examined, including but not limited to: recruitment and randomization of PCPs, maintenance of intervention fidelity for the duration of the study, appropriateness of the control arm, and appropriateness of the outcome measures. The results of the study will be the basis for a future large, randomized controlled trial which will provide evidence for the effectiveness of the CDCG intervention in improving prescription opioid safety in the HIV primary care setting, and will also provide insights into how the CDCG might best be implemented in other settings.

Public Health Relevance

Chronic pain is common in HIV and often treated with prescription opioids, but these medications can be abused. This project will engage patients and their healthcare providers in a collaborative process to develop a method of prescribing opioids more safely, based on recommendations recently made by the Centers for Disease Control (CDC). This method will then undergo preliminary testing, the results of which will be used to plan future larger-scale studies to prove whether the method improves patient safety.

National Institute of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Research Demonstration and Dissemination Projects (R18)
Project #
Application #
Study Section
Healthcare Patient Safety and Quality Improvement Research (HSQR)
Program Officer
Perfetto, Deborah
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Icahn School of Medicine at Mount Sinai
Schools of Medicine
New York
United States
Zip Code