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This study aimed to estimate health state utility values (HSUVs) for the key health states found in opioid use disorder (OUD) cost-effectiveness models in the published literature. Data were obtained from six trials representing 1,777 individuals with OUD in the NIDA Clinical Trials Network (CTN-0001, -0002, -0009. -0030, -0049, and -0051). Researchers implemented mapping algorithms to harmonize data from different measures of quality of life (the SF-12 Versions 1 and 2 and the EQ-5D-3 L). They performed a regression analysis to quantify the relationship between HSUVs and the following variables: days of extra-medical opioid use in the past 30 days, injecting behaviors, treatment with medications for OUD, HIV status, and age. A secondary analysis explored the impact of opioid withdrawal symptoms.
There were statistically significant reductions in HSUVs associated with extra-medical opioid use (-0.002 (95% CI [-0.003,-0.0001]) to -0.003 (95% CI [-0.005,-0.002]) per additional day of heroin or other opiate use, respectively), drug injecting compared to not injecting (-0.043 (95% CI [-0.079,-0.006])), HIV-positive diagnosis compared to no diagnosis (-0.074 (95% CI [-0.143,-0.005])), and age (-0.001 per year (95% CI [-0.003,-0.0002])). Parameters associated with medications for OUD treatment were not statistically significant after controlling for extra-medical opioid use (0.0131 (95% CI [-0.0479,0.0769])), in line with prior studies. The secondary analysis revealed that withdrawal symptoms are a fundamental driver of HSUVs, with predictions of 0.817 (95% CI [0.768, 0.858]), 0.705 (95% CI [0.607, 0.786]), and 0.367 (95% CI [0.180, 0.575]) for moderate, severe, and worst level of symptoms, respectively.
Conclusions: Researchers for this study observed HSUVs for OUD that were higher than those from previous studies that had been conducted without input from people living with the condition.
Related protocols: CTN-0001, CTN-0002, CTN-0009, CTN-0030, CTN-0049, CTN-0051
This secondary analysis of CTN-0049 and CTN-0064 aimed to determine whether endorsement patterns of psychosocial symptoms revealed distinct subgroups, or latent classes, of people living with HIV who use substances (PLWH-SU), and to assess whether these classes demonstrated differential health outcomes over time. It uses data from 801 PLWH-SU initially enrolled across 11 US hospitals during 2012–2014 (CTN-0049) and followed up in 2017 (CTN-0064). Latent class analysis included 28 psychosocial items. Regression analysis examined class membership as a predictor of viral suppression. Survival analysis examined class as a predictor of all-cause mortality. The selected model identified five unique classes. Individuals in classes characterized by more severe and more numerous psychosocial symptoms at baseline had lower likelihoods of viral suppression and survival.
Conclusions: The study demonstrated the importance of considering patterns of overlapping psychosocial symptoms to identify subgroups of PLWH-SU and reveal their risks for adverse outcomes. Integration of primary, mental health, and substance use care is essential to address the needs of this population.
Related protocols: CTN-0049, CTN-0064
Suicide is the tenth leading cause of death in the United States and continues to be a major public health concern. Suicide risk is highly prevalent among individuals with co-occurring substance use disorders (SUD) and mental health disorders, making them more prone to adverse substance use related outcomes including overdose. Identifying individuals with SUD who are suicidal, and therefore potentially most at risk of overdose, is an important step to address the synergistic epidemics of suicides and overdose fatalities in the United States. The current study assesses whether patterns of suicidality endorsement can indicate risk for substance use and overdose.
Latent class analysis (LCA) was used to assess patterns of item level responses to the Concise Health Risk Tracking Self-Report (CHRT-SR), which measures thoughts and feelings associated with suicidal propensity. We used data from 2,541 participants with SUD who were enrolled across 8 randomized clinical trials in the National Drug Abuse Treatment Clinical Trials Network from 2012 to 2021 (CTN-0037, -0049, -0051, -0053, -0054, -0064, -0067, -0068). Characteristics of individuals in each class were assessed, and multivariable logistic regression was performed to examine class membership as a predictor of overdose. LCA was also used to analyze predictors of substance use days.
Three classes were identified and discussed: Class (1) Minimal Suicidality, with low probabilities of endorsing each CHRT-SR construct; Class (2) Moderate Suicidality, with high probabilities of endorsing pessimism, helplessness, and lack of social support, but minimal endorsement of despair or suicidal thoughts; and Class (3) High Suicidality with high probabilities of endorsing all constructs. Individuals in the High Suicidality class comprise the highest proportions of males, Black/African American individuals, and those with a psychiatric history and baseline depression, as compared with the other two classes. Regression analysis revealed that those in the High Suicidality class are more likely to overdose as compared to those in the Minimal Suicidality class (p = 0.04).
Conclusions: Suicidality is an essential factor to consider when building strategies to screen, identify, and address individuals at risk for overdose. The integration of detailed suicide assessment and suicide risk reduction is a potential solution to help prevent suicide and overdose among people with SUD.
Related protocols: CTN-0037, CTN-0049, CTN-0051, CTN-0053, CTN-0054, CTN-0064, CTN-0067, CTN-0068
The HIV/AIDS epidemic remains a major public health concern since the 1980s; untreated HIV infection has numerous consequences on quality of life. To optimize patients’ health outcomes and to reduce HIV transmission, this study, using data from CTN-0049 and CTN-0064, focused on vulnerable populations of people living with HIV (PLWH) and compared different predictive strategies for viral suppression using longitudinal or repeated measures.
The four methods of predicting viral suppression are (1) including the repeated measures of each feature as predictors, (2) utilizing only the initial (baseline) value of the feature as predictor, (3) using the last observed value as the predictors and (4) using a growth curve estimated from the features to create individual-specific prediction of growth curves as features. These models were compared using Synthetic Random Forests (SRF).
The SRF models predicted HIV viral suppression in CTN-0064 with an accuracy rate as high as 70%. The person-specific trajectories (Model 4) had the best predictive performance of the approaches. Not surprisingly, among the other models, those with characteristics from closer time-points produced better model fit than using baseline aspects only.
Conclusions: The model with person-specific trajectories had the best predictive power as compared to other models. The findings from this study are valuable, since they provide evidence that incorporating not just levels of predictors but also their change over time improves predictive performance of our models. Using person-specific intercepts and slopes provides a novel and useful approach to creating predictive models using repeated measurements. It also suggests the possibility of incorporating these types of modeling efforts into ongoing clinical monitoring using medical records.
Related protocols: CTN-0049, CTN-0064
Engaging people living with HIV who report substance use (PLWH-SU) in care is essential to HIV medical management and prevention of new HIV infections. Factors associated with poor engagement in HIV care include a combination of syndemic psychosocial factors, mental and physical comorbidities, and structural barriers to healthcare utilization. Patient navigation (PN) is designed to reduce barriers to care, but its effectiveness among PLWH-SU remains unclear. In this study, researchers analyzed data from NIDA Clinical Trials Network protocol CTN-0049, a three-arm randomized controlled trial testing the effect of a 6-month PN with and without contingency management (CM), on engagement in HIV care and viral suppression among PLWH-SU (n=801). Latent profile analysis was used to identify subgroups of individuals’ experiences to 23 barriers to care. The effects of PN on engagement in care and viral suppression were compared across latent profiles. Three latent profiles of barriers to care were identified. The results revealed that PN interventions are likely to be most effective for PLWH-SU with fewer, less severe healthcare barriers. Special attention should be given to individuals with a history of abuse, intimate partner violence, and discrimination, as they may be less likely to benefit from PN alone and require additional interventions.
Related protocols: CTN-0049
Increasing rates of overdose and overdose deaths are a significant public health problem. Research has examined co-occurring mental health conditions, including suicidality, as a risk factor for intentional and unintentional overdose among individuals with substance use disorder (SUD). However, this research has been limited to single site studies of self-reported outcomes.
The current research evaluated suicidality as a predictor of overdose events in 2541 participants who use substances enrolled across eight multi-site clinical trials completed within the National Drug Abuse Treatment Clinical Trials Network between 2012 to 2021 (CTN-0037, -0049, -0051, -0053, -0054, -0064, -0067, and -0068). The trials assessed baseline suicidality with the Concise Health Risk Tracking Self-Report (CHRT-SR). Overdose events were determined by reports of adverse events, cause of death, or hospitalization due to substance overdose, and verified through a rigorous adjudication process. Multivariate logistic regression was performed to assess continuous CHRT-SR score as a predictor of overdose, controlling for covariates.
CHRT-SR score was associated with overdose events (p=0.03) during the trial; the likelihood of overdose increased as continuous CHRT score increased (OR 1.02). Participants with lifetime heroin use were more likely to overdose (OR 3.08).
Conclusions: Response to the marked rise in overdose deaths should integrate suicide risk reduction as part of prevention strategies.
Related protocols: CTN-0037, CTN-0049, CTN-0051, CTN-0053, CTN-0054, CTN-0064, CTN-0067, CTN-0068
People living with HIV who report substance use (PLWH-SU) face many barriers to care, resulting in an increased risk for poor health outcomes and the potential for ongoing disease transmission. This study evaluates the mechanisms by which patient navigation (PN) and contingency management (CM) interventions may work to address barriers to cae and improve HIV outcomes in this population.
Mediation analysis was conducted using data from CTN-0049 (Project HOPE), a randomized, multi-site trial testing PN interventions to improve HIV care outcomes among 801 hospitalized PLHW-SU. Direct and indirect effects of PN and PN+CM were evaluated through five potential mediators (psychosocial conditions, healthcare avoidance, financial hardship, system barriers, and self-efficacy for HIV treatment adherence) on engagement in HIV care and viral suppression.
The PN+CM intervention had an indirect effect on improving engagement in HIV care at 6 months by increasing self-efficacy for HIV treatment adherence. PN+CM also led to increases in viral suppression at 6 months via increases in self-efficacy, although the direct effects were not significant. No mediating effects were observed for PN alone.
Conclusions: PN+CM interventions for PLWH-SU can increase an individual’s self-efficacy for HIV treatment adherence, which in turn improves engagement in care at 6 months and may contribute to viral suppression over 12 months. Building self-efficacy may be a key factor in the success of such interventions and should be considered as a primary goal of PN+CM in practice.
Related protocols: CTN-0049, CTN-0049-A-1
People living with HIV (PLWH) who use drugs experience worse health outcomes than their non-using counterparts. Little is known about how often they seek dental care and the factors that influence their utilization. PLWH with substance use disorders who were inpatients at 11 urban hospitals (n = 801) participated in a NIDA Clinical Trials Network study (CTN-0049, Project HOPE) to improve engagement in HIV outcomes. Dental care utilization at each time point during the study period (baseline, 6 months and/or 12 months) was assessed (n = 657). Univariate analysis and logistic regression were used to examine factors associated with dental care utilization. Over half (59.4%) reported not having received any dental care at any timepoint. Participants with less than high school education had lower odds of reporting dental care utilization than those with more than education (aOR = 0.60 [95% CI 0.37–0.99], p = 0.0382). Participants without health insurance also had lower odds of reporting dental care utilization than those with insurance (aOR = 0.50 [95% CI 0.331–0.76], p = 0.0012). Higher food insecurity was associated with having recent dental care utilization (OR = 1.03 [95% CI 1.00, 1.05], p = 0.0359). Additionally, those from Southern states were less likely to report dental care utilization (aOR = 0.55 [95% CI 0.38, 0.79], p = 0.0013).
Conclusions: Having health insurance and education are key factors associated with use of dental care for PLWH with substance use disorders. The association between food insecurity and dental care utilization among this population suggests the need for further exploration.
Related protocols: CTN-0049
There is a growing public health concern around the potential impact of the opioid crisis on efforts to eradicate HIV. This secondary analysis seeks to determine if those who report opioids as their primary problem drug compared to those who report other drugs and/or alcohol differ in engagement in HIV primary care among a sample of hospitalized people with HIV (PWH) who use drugs and/or alcohol, a traditionally marginalized and difficult to engage population key to ending the HIV epidemic.
A total of 801 participants (67% male; 75% Black, non-Hispanic; mean age 44.2) with uncontrolled HIV and reported drug and/or alcohol use were recruited from 11 hospitals around the U.S. in cities with high HIV prevalence from 2012 to 2014 for a multisite clinical trial to improve HIV-viral suppression (CTN-0049, Project HOPE).
A generalized linear model compared those who reported opioids as their primary problem drug to those who reported other problem drugs and/or alcohol on their previous engagement in HIV primary care, controlling for age, sex, race, education, income, any previous drug and/or alcohol treatment, length of time since diagnosis and study site.
A total of 95 (11.9%) participants reported opioids as their primary problem drug. In adjusted models, those who reported opioids were significantly less likely to have ever engaged in HIV primary care than those who reported no problem drug use, stimulants, and polydrug use but no alcohol. While not statistically significant, the trend in the estimates of the remaining drug and/or alcohol categories (alcohol, cannabis, polydrug use with alcohol, and [but excluding the estimate for] other), point to a similar phenomena: those who identify opioids as their primary problem drug are engaging in HIV primary care less.
Conclusions: These findings suggest that for hospitalized PWH who use drugs and/or alcohol, tailored and expanded efforts are especially needed to link those who report problem opioid use to HIV primary care.
Related protocols: CTN-0049
While patient navigation has been shown to be an effective approach for linking persons to HIV care, and contingency management is effective at improving substance use-related outcomes, Project HOPE combined these two interventions in a novel way to engage HIV-positive patients with HIV and substance use treatment.
The aims of this paper are to examine patient navigator views regarding how contingency management interacted with and affected their navigation process. Individual, semi-structured interviews lasting approximately 60 minutes were administered to 22 patient navigators from the original 10 Project HOPE study sites. The interviews address the patient navigator’s professional background, descriptions of the participant population, substance use disorder vs. HIV treatment entry and engagement issues, and the use of contingency management within the navigation service delivery protocol.
Patient navigators believed that financial incentives helped motivate participant attendance at navigation sessions, particularly early in study involvement, which helped them to establish rapport and develop relationships with participants. Patient navigators often noted that financial incentives positively influenced targeted HIV health-related behaviors, such as attending medical appointments, which provided a rapid pay-off with an escalating sum. Contingency management was more complex when used by the patient navigators for substance use-related behaviors, particularly when incentives revolved around negative urine screening. Patient navigators noted that not all participants responded the same way to the contingency management and that the incentives were particularly helpful when participants were financially strained with limited resources or when internal motivation was lacking.
Conclusions: Overall, patient navigators found the inclusion of contingency management to be helpful and effective at influencing participant behaviors, particularly concerning navigation session attendance and HIV healthcare-related participation. However, issues and concerns surrounding the inclusion of contingency management for drug-related behaviors as delivered in Project HOPE were noted.
Related protocols: CTN-0049
This secondary analysis of data from Clinical Trials Network protocol CTN-0049, Project HOPE, compares outcomes for two groups of HIV+ substance users randomized in a 3-arm trial to receive Patient Navigation with (PN+CM) or without (PN) contingent financial incentives (CM). Mean age of participants was 45 years; the majority was male (67%), African American (78%), unemployed (35%), or disabled (50%). Behaviors incentivized for PN+CM were (1) attendance at HIV care visits and (2) verification of an active HIV medication prescription.
Incentives were associated with shorter time to treatment initiation and higher rates of behaviors during the 6-month intervention with exception of month 6 HIV care visits. Median HIV care visits were 3 (IQR 2–4) for PN+CM versus 1.5 (IQR 0–3) for PN (Wilcoxon p < 0.001); median validated medication checks were 4 (IQR 2–6) for PN+CM versus 1 (IQR 0–3) for PN (Wilcoxon p < 0.001). Viral suppression rates at end of treatment were not significantly different for the two groups but were directly related to the number of behaviors completed for both care visits and validated medication.
Conclusions: Contingent financial incentives added to a PN intervention were associated with better engagement in the navigation intervention, including earlier initiation and higher sustained rates of key health-related behaviors deemed necessary to achieve a final goal of viral load suppression. In addition to higher rates of initiation, it was notable that incentives were associated with a shorter average time both to the initial HIV care visit and to first verified pick up of HIV medication among those who ever initiated these behaviors. These robust results suggest value of incentives as a tool to enhance linkage to care, as well as speeding up or “kick starting” early steps in the care process within a navigation intervention. Adjustments to the incentive program may be needed to achieve greater rates of sustained health behavior change that result in improved viral load outcomes.
Related protocols: CTN-0049, CTN-0049-A-1
People living with HIV (PLWH) who use substances continue to have shorter life expectancies and worse health outcomes than PLWH who do not use substances. Another important contributor to factors that can affect the health of PLWH who use substances is these individuals’ frequent interactions with the criminal justice system.
This analysis of baseline data from the NIDA Clinical Trials Network CTN-0049 study (Project HOPE) aimed to expand the current literature examining the complex relationships between PLWH who use substances’ substance use behaviors and criminal justice involvement to better inform future studies and program implementation.
Researchers performed latent class analyses (LCA) to identify discrete classes, or clusters, of PLWH based on their past year substance use behaviors and lifetime arrest history. Multinomial logistic regressions were also performed to identify key characteristics associated with class membership. Five classes of substance users were identified (minimal drug users, cocaine users, substantial cocaine/hazardous alcohol users, problem polysubstance users, substantial cocaine/heroin users) as well as 3 classes of arrest history (minimal arrests, non-drug arrests, drug-related arrests).
While several demographic variables such as age and being Black or Hispanic were associated with class membership for some of the latent classes, participation in substance use treatment was the only covariate that was significantly associated with membership in all classes in both substance use and arrest history LCA models.
Conclusions: This analysis supports the utility of latent class analysis in revealing complex patterns of behaviors. The findings are a first step toward better understanding the complex dynamics of substance use and of criminal justice system involvement among PLWH that may be useful in informing the future direction of research studies aiming to examine the complex interactions among substance use, criminal justice involvement, and HIV care. HIV intervention strategies may need to take into consideration such nuanced differences to better inform patient care.
Related protocols: CTN-0049
Cigarette smoking is prevalent in people living with HIV/AIDS (PLHIV) who abuse alcohol and/or illicit substances. This study evaluated whether smoking is predictive of virologic non-suppression (>200 copies/mL) and low CD4 count (<200 cells/mm3) during 1-year follow-up in medically hospitalized, substance-using PLHIV recruited for a multi-site trial (CTN-0049, Project HOPE: Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users). Smoking status was assessed with the Heaviness of Smoking Index (HSI).
Analyses revealed that, controlling for baseline differences and adherence to antiretroviral therapy, non-smokers (n=237), compared to smokers scoring in the medium-to-high range on the HSI (n=386), were significantly more likely to achieve viral suppression. There was a significant smoking-by-time interaction for CD4 cell count, with smokers less likely to have low CD4 count at baseline and 6-month follow-up, but more likely to have low CD4 count at 12-month follow-up.
Conclusion: The results of this exploratory analysis suggest that smoking may play a role in immunologic response in HIV-infected substance users. Future research to replicate this finding and to delineate the potential mechanisms by which smoking may affect HIV progression seems warranted.
Related protocols: CTN-0049
Interventions are needed to improve viral suppression rates among persons with HIV and substance use. A 3-arm randomized multi-site study (CTN-0049, Project HOPE) was conducted to evaluate the effect on HIV outcomes of usual care referral to HIV and substance use services (N=253) versus patient navigation delivered alone (PN: N=266) or together with contingency management (PN+CM: N=271) that provided financial incentives targeting potential behavioral mediators of viral load suppression. This secondary analysis evaluates the effects of financial incentives on attendance at PN sessions and the relationship between session attendance and viral load suppression at the end of the intervention.
Frequency of sessions attended was analyzed over time and by distribution of individual session attendance frequency (PN vs PN+CM). Percent virally suppressed (<200 copies/mL) at 6 months was compared for low, medium, and high rate attenders. In PN+CM a total of $220 could be earned for attendance at 11 PN sessions over the 6-month intervention with payments ranging from $10 to $30 under an escalating schedule.
The majority (74%) of PN-only participants attended 6 or more sessions but only 28% attended 10 or more and 16% attended all eleven sessions. In contrast, 90% of PN+CM attended 6 or more visits, 69% attended 10 or more, and 57% attended all eleven. Overall (PN and PN+CM participants combined) percent with viral load suppression at 6-months was 15, 38, and 54% among those who attended 0-5, 6-9, and 10-11 visits, respectively.
Conclusion: In this secondary post hoc analysis, contact with patient negotiators was increased by attendance incentives. Higher rates of attendance at patient navigation sessions was associated with viral suppression at the 6-month follow-up assessment. Study results support use of attendance incentives to improve rates of contact between service providers and patients, particularly patients who are difficult to engage in care.
Related protocols: CTN-0049
Contingency management (CM) interventions generally target a single behavior such as attendance or drug use. However, disease outcomes are mediated by complex chains of both healthy and interfering behaviors enacted over extended periods of time. This paper describes a novel multi-target contingency management (CM) program developed for use with HIV positive substance users enrolled in a CTN multi-site study (CTN-0049, Project HOPE). Participants were randomly assigned to usual care (referral to health care and SUD treatment) or 6-months strength-based patient navigation interventions with (PN+CM) or without (PN only) the CM program. Primary outcome of the trial was viral load suppression at 12-months post-randomization. Up to $1160 could be earned over 6 months under escalating schedules of reinforcement. Earnings were divided among eight CM targets: two PN-related (PN visits, paperwork completion; 26% of possible earnings), four health-related (HIV care visits, lab blood draw visits, medication check, viral load suppression; 47% of possible earnings), and two drug-use abatement (treatment entry, submission of drug negative UAs; 27% of earnings).
This paper describes the rationale for selection of targets, pay amounts, and pay schedules. The CM program was compatible with and fully integrated into the PN intervention. The Project HOPE CM program offers one example of how a multi-target CM intervention might be structured and deployed to impact a critical outcome in a difficult to treat population (in this case, HIV positive substance users). Subsequent data analysis examining the impact of the CM intervention on behavior frequencies will inform the structure and content of future multi-target CM interventions, while considerations of sustainability and cost-effectiveness will be needed to inform implementation policy.
Related protocols: CTN-0049