Yoga and Physical Therapy for Chronic Pain and Opioid Use Disorder Onsite in an Opioid Treatment Program: A Randomized Controlled Trial.

BACKGROUND: There is a lack of integrated treatment for chronic pain and opioid use disorder (OUD). Yoga and physical therapy (PT) may improve pain and physical function of people living with (PLW) chronic low back pain (CLBP) and may also reduce opioid craving and use, but PLW with OUD face barriers to accessing these interventions. We hypothesize that compared to treatment as usual (TAU), providing yoga and PT onsite at opioid treatment programs (OTPs) will be effective at improving pain, opioid use, and quality of life among people with CLBP and OUD, and will be cost-effective. METHODS: In this hybrid type-1 effectiveness-implementation study, we will randomly assign 345 PLW CLBP and OUD from OTPs in the Bronx, NY, to 12 weeks of onsite yoga, onsite PT, or TAU. Primary outcomes are pain intensity, opioid use, and cost-effectiveness. Secondary outcomes include physical function and overall well-being. DISCUSSION: This trial tests an innovative, patient-centered approach to combined management for pain and OUD in real-world settings. We rigorously examine the efficacy of yoga and PT onsite at OTPs as nonpharmacologic, cost-effective treatments among people with CLBP and OUD who face barriers to integrated care.

Preference heterogeneity for HIV pre-exposure prophylaxis care among gay, bisexual, and other men who have sex with men in the United States: a large discrete choice experiment.

Background: PrEP uptake among Black and Latino gay, bisexual, and other men who have sex with men (GBM) remains low in the United States. The design and implementation of PrEP delivery programs that incorporate the preferences of Black and Latino GBM may overcome barriers to uptake. We aimed to identify preferences for PrEP care among high-priority GBM in the U.S. with a large discrete choice experiment. Methods: We conducted two discreet choice experiments (DCE) to elicit care preferences for (1) Starting PrEP and (2) Continuing PrEP care among GBM clinically indicated for PrEP. The DCE web-based survey was nested in a longitudinal cohort study of GBM in the U.S., implemented with video and audio directions among 16-49 year-old participants, not using PrEP, and verified to be HIV-negative. All participants were presented with 16 choice sets, with choices determined by BLGBM and PrEP implementation stakeholders. We calculated overall utility scores and relative importance and used latent class analyses (LCA) to identify classes within the Starting and Continuing PrEP DCE. Multivariable analysis was performed to identify factors associated with class membership. Findings: Among 1514 participants, mean age was 32 years; 46·5% identified as Latino, 21·4% Black, and 25·2 White; 37·5% had an income less than USD $20,000. Two latent classes were identified for Starting PrEP: Class 1 (n=431 [28·5%]) was driven by preference for more traditional in-person care, and Class 2 (n=1083 [71·5%]) preferred flexible care options and on-demand PrEP. In a multivariable model, having a sexual health doctor (adjusted OR 0·7, CI 0·5, 0·9), having a primary care provider (OR 0·7,CI 0·5, 0·9, p= 0·023), and concerns over PrEP side effects (OR 1·1, CI 1·0,1·2, p= 0·003) were all associated with class membership. Interpretation: The different preferences identified for PrEP care indicate the need for diverse care and formulation choices to improve PrEP uptake and persistence. Addressing these preferences and understanding the factors that shape them can inform the implementation of programs that increase PrEP uptake.

Incarceration history and opioid use among adults living with HIV and chronic pain: a secondary analysis of a prospective cohort study.

BACKGROUND: Adults living with HIV have disproportionately high chronic pain, prescription opioid use, history of substance use, and incarceration. While incarceration can have long-lasting health impacts, prior studies have not examined whether distant (>1 year prior) incarceration is associated with opioid use for chronic pain, or with opioid misuse or opioid use disorder among people living with HIV and chronic pain. METHODS: We conducted a secondary analysis of a prospective cohort study of adults living with HIV and chronic pain. The independent variables were any distant incarceration and drug-related distant incarceration (both dichotomous). Dependent variables were current long-term opioid therapy, current opioid misuse, and current opioid use disorder. A series of multivariate logistic regression models were conducted, adjusting for covariates. RESULTS: In a cohort of 148 participants, neither distant incarceration nor drug-related incarceration history were associated with current long-term opioid therapy. Distant incarceration was associated with current opioid misuse (AOR 3.28; 95% CI: 1.41-7.61) and current opioid use disorder (AOR 4.40; 95% CI: 1.54-12.56). Drug-related incarceration history was also associated with current opioid misuse (AOR 4.31; 95% CI: 1.53-12.17) and current opioid use disorder (AOR 7.28; 95% CI: 2.06-25.71). CONCLUSIONS: The positive associations of distant incarceration with current opioid misuse and current opioid use disorder could indicate a persistent relationship between incarceration and substance use in people living with HIV and chronic pain. Additional research on opioid use among formerly incarcerated individuals in chronic pain treatment is needed.

Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial.

BACKGROUND: Differentiated service delivery (DSD) programs for people living with HIV (PWH) limit eligibility to patients established on antiretroviral therapy (ART), yet uncertainty exists regarding the duration on ART necessary for newly-diagnosed PWH to be considered established. We aimed to determine the feasibility, acceptability, and preliminary impact of entry into DSD at six months after ART initiation for newly-diagnosed PWH. METHODS: We conducted a pilot randomized controlled trial in three health facilities in Rwanda. Participants were randomized to: (1) entry into DSD at six months after ART initiation after one suppressed viral load (DSD-1VL); (2) entry into DSD at six months after ART initiation after two consecutive suppressed viral loads (DSD-2VL); (3) treatment as usual (TAU). We examined feasibility by examining the proportion of participants assigned to intervention arms who entered DSD, assessed acceptability through patient surveys and by examining instances when clinical staff overrode the study assignment, and evaluated preliminary effectiveness by comparing study arms with respect to 12-month viral suppression. RESULTS: Among 90 participants, 31 were randomized to DSD-1VL, 31 to DSD-2VL, and 28 to TAU. Among 62 participants randomized to DSD-1VL or DSD-2VL, 37 (60%) entered DSD at 6 months while 21 (34%) did not enter DSD because they were not virally suppressed. Patient-level acceptability was high for both clinical (mean score: 3.8 out of 5) and non-clinical (mean score: 4.1) elements of care and did not differ significantly across study arms. Viral suppression at 12 months was 81%, 81% and 68% in DSD-1VL, DSD-2VL, and TAU, respectively (p = 0.41). CONCLUSIONS: The majority of participants randomized to intervention arms entered DSD and had similar rates of viral suppression compared to TAU. Results suggest that early DSD at six months after ART initiation is feasible for newly-diagnosed PWH, and support current WHO guidelines on DSD. TRIAL REGISTRATION: Clinicaltrials.gov NCT04567693; first registered on September 28, 2020.

Trajectories of Opioid Misuse and Opioid Use Disorder Among Adults With Chronic Pain and HIV: An Observational Study.

OBJECTIVES: In a longitudinal cohort of patients with HIV and chronic pain, we sought to (1) identify trajectories of opioid misuse and opioid use disorder (OUD) symptoms, and to (2) determine whether prescription opioid dose was associated with symptom trajectories. METHODS: We leveraged an existing 12-month longitudinal observational study, Project PIMENTO, of persons living with HIV and chronic pain who received care at a hospital system in the Bronx, New York. A quota sampling strategy was used to ensure variability of prescribed opioid use in the recruited sample. Research interviews occurred quarterly and assessed opioid behaviors and criteria for OUD. To describe symptom trajectories, we conducted 2 separate longitudinal latent class analyses to group participants into (1) opioid misuse and (2) OUD trajectories. Finally, we used multinomial logistic regression models to examine the relationship between baseline prescription opioid dose and symptom trajectories. RESULTS: Of 148 total participants, at baseline 63 (42.6%) had an active opioid prescription, 69 (46.6%) met the criteria for current opioid misuse, and 44 (29.7%) met the criteria for current OUD. We found 3 opioid misuse and 3 OUD symptom trajectories, none of which showed worsened symptoms over time. In addition, we found that higher prescription opioid dose at baseline was associated with a greater OUD symptom trajectory. CONCLUSIONS: Opioid misuse and OUD were common but stable or decreasing over time. Although these results are reassuring, our findings also support prior studies that high-dose opioid therapy is associated with greater OUD symptoms.

Association Between Clinical Encounter Frequency and HIV-Related Stigma Among Newly-Diagnosed People Living with HIV in Rwanda.

HIV-related stigma in healthcare settings remains a key barrier to engaging people living with HIV (PLHIV) in care. This study investigated the association between clinical encounter frequency and HIV-related anticipated, enacted, and internalized stigma among newly-diagnosed PLHIV in Rwanda. From October 2020 to May 2022, we collected data from adult PLHIV on antiretroviral therapy (ART) in Kigali, Rwanda who were participating in a randomized, controlled trial testing early entry into differentiated care at 6 months after ART initiation. We measured anticipated HIV stigma with five-point Likert HIV Stigma Framework measures, enacted stigma with the four-point Likert HIV/AIDS Stigma Instrument, and internalized stigma with the four-point Likert HIV/AIDS Stigma Instrument. We used multivariable linear regression to test the associations between clinical encounter frequency (average inter-visit interval ≥ 50 days vs. < 50 days) and change in mean anticipated, enacted and internalized HIV stigma over the first 12 months in care. Among 93 individuals enrolled, 76 had complete data on encounter frequency and stigma measurements and were included in the present analysis. Mean internalized stigma scores of all participants decreased over the first 12 months in care. Anticipated and enacted stigma scores were low and did not change significantly over time. There was no association between encounter frequency and change in internalized stigma. In this pilot study of newly-diagnosed Rwandan PLHIV with relatively low levels of HIV-related stigma, clinical encounter frequency was not associated with change in stigma. Additional research in diverse settings and with larger samples is necessary to further explore this relationship.

Mitigation through on-site testing & education among formerly incarcerated individuals against Covid-19 - The MOSAIC study: Design and rationale.

BACKGROUND: Many of the largest COVID-19 outbreaks in the United States have occurred at carceral facilities. Criminal legal system (CLS)-involved individuals typically face structural barriers accessing medical care post-release. Improving COVID-19 testing and education for CLS-involved individuals could improve health outcomes for this vulnerable population and the communities to which they return. Community-based organizations (CBO) and community health workers (CHWs) fill care gaps by connecting CLS-involved individuals with essential re-entry services. The MOSAIC study will: 1) test an onsite CHW-led SARS-CoV-2 testing and education intervention in a reentry CBO and 2) model the cost-effectiveness of this intervention compared to standard care. METHODS: We will recruit 250 CLS-involved individuals who have left incarceration in the prior 90 days. Participants will be randomized to receive onsite Point-of-Care testing and education (O-PoC) or Standard of Care (SoC). Over one year, participants will complete quarterly questionnaires and biweekly short surveys through a mobile application, and be tested for SARS-CoV-2 quarterly, either at the CBO (O-PoC) or an offsite community testing site (SoC). O-PoC will also receive COVID-19 mitigation counseling and education from the CHW. Our primary outcome is the proportion of SARS-CoV-2 tests performed with results received by participants. Secondary outcomes include adherence to mitigation behaviors and cost-effectiveness of the intervention. DISCUSSION: The MOSAIC study will offer insight into cost effective strategies for SARS-CoV-2 testing and education for CLS-involved individuals. The study will also contribute to the growing literature on CHW's role in health education, supportive counseling, and building trust between patients and healthcare organizations.