Strategies of Managing Repeated Measures: Using Synthetic Random Forest to Predict HIV Viral Suppression Status Among Hospitalized Persons with HIV.

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 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. This study suggested the individual-specific prediction of the growth curve performed the best in terms of lowest error rate on an independent set of test data.

Initiation of Antiretroviral Therapy in the Hospital Is Associated With Linkage to Human Immunodeficiency Virus (HIV) Care for Persons Living With HIV and Substance Use Disorder.

BACKGROUND: Studies have demonstrated benefits of antiretroviral therapy (ART) initiation on the day of human immunodeficiency virus (HIV) testing or at first clinical visit. The hospital setting is understudied for immediate ART initiation. METHODS: CTN0049, a linkage-to-care randomized clinical trial, enrolled 801 persons living with HIV (PLWH) and substance use disorder (SUD) from 11 hospitals across the United States. This secondary analysis examined factors related to initiating (including reinitiating) ART in the hospital and its association with linkage to HIV care, frequency of outpatient care visits, retention, and viral suppression. RESULTS: Of 801 participants, 124 (15%) initiated ART in the hospital, with more than two-thirds of these participants (80/124) initiating ART for the first time. Time to first HIV care visit among those who initiated ART in the hospital and those who did not was 29 and 54 days, respectively (P = .0145). Hospital initiation of ART was associated with increased frequency of HIV outpatient care visits at 6 and 12 months. There was no association with ART initiation in the hospital and retention and viral suppression over a 12-month period. Participants recruited in Southern hospitals were less likely to initiate ART in the hospital (P < .001). CONCLUSIONS: Previous research demonstrated benefits of immediate ART initiation, yet this approach is not widely implemented. Research findings suggest that starting ART in the hospital is beneficial for increasing linkage to HIV care and frequency of visits for PLWH and SUD. Implementation research should address barriers to early ART initiation in the hospital.

The Disaggregated Repeated Measures Design: A Novel Approach to Assess Sexual Risk Behaviors.

Although numerous studies have examined sexual and substance use behaviors that put people at risk for sexually transmitted infections including HIV, most focus on an overall measure of aggregate risk or a few simple and particular subtypes of sexual acts assessed in separate analyses. In this article, we introduce a more sensitive approach to assess how the relative characteristics of sex acts may determine the level of risk in which an individual chooses to engage. Project AWARE, a randomized clinical trial conducted among 5012 patients in nine STD clinics across the U.S., is used to illustrate the approach. Our study was guided by two aims: (1) describe a new approach to examine the count of sexual acts using a disaggregated repeated measures design and (2) show how this new approach can be used to evaluate interactions among different categories of sexual risk behaviors and other predictors of interest (such as gender/sexual orientation). Profiles of different subtypes of sexual acts in the past 6 months were assessed. Potential interactions of the characteristics associated with each subtype which resulted in up to 48 distinct subtypes of sexual risk behaviors-sex with a primary/non-primary partner; partner's HIV status; vaginal/anal sex; condom use; and substance use before or during sex act-can be examined. Specifically, we chose condom use and primary and non-primary status of partner as an application in this paper to illustrate our method. There were significantly more condomless sex acts (M = 23, SE = 0.9) and sex acts with primary partners (M = 27.1, SE = 0.9) compared to sex acts with condoms (M = 10.9, SE = 0.4, IRR = 2.10, 95% CI 1.91-2.32, p < .001) and sex acts with non-primary partner (M = 10.9, SE = 0.5, IRR = 2.5, 95% CI 2.33-2.78, p < .001). In addition, there were significant differences for the count of sexual risk behaviors among women who have sex with men (WSM), men who have sex with women (MSW) and men who have sex with men (MSM) for sex acts with and without condom use, primary and non-primary partner, and their interaction (ps = .03, < .0001, and .001, respectively). This approach extends our understanding of how people make choices among sexual behaviors and may be useful in future research on disaggregated characteristics of sex acts.

The Relationship Between Housing Status and Substance Use and Sexual Risk Behaviors Among People Currently Seeking or Receiving Services in Substance Use Disorder Treatment Programs.

Although HIV risk behaviors such as substance use and condomless sex are prevalent among people currently seeking or receiving services at substance use disorder (SUD) treatment programs, associations with housing status in this population have not been well studied. We examined the associations between housing status, substance use and HIV-related sexual risk behaviors among 1281 participants from 12 US community-based SUD programs. In addition, substance use was examined as a potential mediator of the relationship between housing status and sexual risk behaviors. We conducted Chi-square, univariate and multivariate logistic regression models on data from the National Drug Abuse Treatment Clinical Trials Network HIV Rapid Testing and Counseling study. Path analysis was used to test the mediation and indirect effects. Unstable housing was significantly associated with having multiple concurrent condomless sex partners, condomless sex with non-primary partners, and partners of unknown HIV serostatus. Homelessness was significantly associated with condomless vaginal sex and condomless sex with any substance use. The path between unstable housing and sexual risk behaviors was mediated by problematic drug use, particularly by cocaine, opioids, and marijuana use. Because housing status impacts HIV risk behaviors for individuals in SUD treatment programs, both housing status and substance use behaviors should be assessed upon program entry in order to identify and mitigate risk behaviors.

The North-South Divide: Substance Use Risk, Care Engagement, and Viral Suppression Among Hospitalized Human Immunodeficiency Virus-Infected Patients in 11 US Cities.

Regional variability in human immunodeficiency virus (HIV) care engagement remains underexplored. Multiple logistic models compared HIV outcomes for participants from 5 Southern (n = 557) and 6 non-Southern (n = 670) sites. Southern participants were less likely to experience viral suppression (adjusted odds ratio [aOR], 0.52; 95% confidence interval [CI], .37-.72) and had a higher likelihood of a CD4+ count <200 cells/µL (aOR, 1.53; 95% CI, 1.17-2.00). HIV intervention and social safety net programs should be expanded. Clinical Trials Registration: NCT01612169.

Gender Differences in HIV Sexual Risk Behaviors Among Clients of Substance Use Disorder Treatment Programs in the U.S.

This study examined differences in sexual risk behaviors by gender and over time among 1281 patients (777 males and 504 females) from 12 community-based substance use disorder treatment programs throughout the United States participating in CTN-0032, a randomized control trial conducted within the National Drug Abuse Treatment Clinical Trials Network. Zero-inflated negative binomial and negative binomial models were used in the statistical analysis. Results indicated significant reductions in most types of sexual risk behaviors among substance users regardless of the intervention arms. There were also significant gender differences in sexual risk behaviors. Men (compared with women) reported more condomless sex acts with their non-primary partners (IRR = 1.80, 95 % CI 1.21-2.69) and condomless anal sex acts (IRR = 1.74, 95 % CI 1.11-2.72), but fewer condomless sex partners (IRR = 0.87, 95 % CI 0.77-0.99), condomless vaginal sex acts (IRR = 0.83, 95 % CI 0.69-1.00), and condomless sex acts within 2 h of using drugs or alcohol (IRR = 0.70, 95 % CI 0.53-0.90). Gender-specific intervention approaches are called for in substance use disorder treatment.

Examining the Efficacy of HIV Risk-Reduction Counseling on the Sexual Risk Behaviors of a National Sample of Drug Abuse Treatment Clients: Analysis of Subgroups.

HIV counseling with testing has been part of HIV prevention in the U.S. since the 1980s. Despite the long-standing history of HIV testing with prevention counseling, the CDC released HIV testing recommendations for health care settings contesting benefits of prevention counseling with testing in reducing sexual risk behaviors among HIV-negatives in 2006. Efficacy of brief HIV risk-reduction counseling (RRC) in decreasing sexual risk among subgroups of substance use treatment clients was examined using multi-site RCT data. Interaction tests between RRC and subgroups were performed; multivariable regression evaluated the relationship between RRC (with rapid testing) and sex risk. Subgroups were defined by demographics, risk type and level, attitudes/perceptions, and behavioral history. There was an effect (p < .0028) of counseling on number of sex partners among some subgroups. Certain subgroups may benefit from HIV RRC; this should be examined in studies with larger sample sizes, designed to assess the specific subgroup(s).

Self-Reported HIV and HCV Screening Rates and Serostatus Among Substance Abuse Treatment Patients.

Substance users are at increased risk for HIV and HCV infection. Still, many substance use treatment programs (SUTP) fail to offer HIV/HCV testing. The present secondary analysis of screening data from a multi-site randomized trial of rapid HIV testing examines self-reported HIV/HCV testing patterns and serostatus of 2473 SUTP patients in 12 community-based sites that had not previously offered on-site testing. Results indicate that most respondents screened for the randomized trial tested more than a year prior to intake for HIV (52 %) and HCV (38 %). Prevalence rates were 3.6 and 30 % for HIV and HCV, respectively. The majority of participants that were HIV (52.2 %) and HCV-positive (40.5 %) reported having been diagnosed within the last 1-5 years. Multivariable logistic regression showed that members of high-risk groups were more likely to have tested. Bundled HIV/HCV testing and linkage to care issues are recommended for expanding testing in community-based SUTP settings.

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial.

IMPORTANCE: Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates. OBJECTIVE: To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients. DESIGN, SETTING, AND PARTICIPANTS: From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months. INTERVENTIONS: Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment. MAIN OUTCOMES AND MEASURES: The primary outcome was HIV viral suppression (≤200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up. RESULTS: Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68). CONCLUSIONS AND RELEVANCE: Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01612169.

The cost of implementing rapid HIV testing in sexually transmitted disease clinics in the United States.

INTRODUCTION: Rapid HIV testing in high-risk populations can increase the number of persons who learn their HIV status and avoid spending clinic resources to locate persons identified as HIV infected. METHODS: We determined the cost to sexually transmitted disease (STD) clinics of point-of-care rapid HIV testing using data from 7 public clinics that participated in a randomized trial of rapid testing with and without brief patient-centered risk reduction counseling in 2010. Costs included counselor and trainer time, supplies, and clinic overhead. We applied national labor rates and test costs. We calculated median clinic start-up costs and mean cost per patient tested, and projected incremental annual costs of implementing universal rapid HIV testing compared with current testing practices. RESULTS: Criteria for offering rapid HIV testing and methods for delivering nonrapid test results varied among clinics before the trial. Rapid HIV testing cost an average of US $22/patient without brief risk reduction counseling and US $46/patient with counseling in these 7 clinics. Median start-up costs per clinic were US $1100 and US $16,100 without and with counseling, respectively. Estimated incremental annual costs per clinic of implementing universal rapid HIV testing varied by whether or not brief counseling is conducted and by current clinic testing practices, ranging from a savings of US $19,500 to a cost of US $40,700 without counseling and a cost of US $98,000 to US $153,900 with counseling. CONCLUSIONS: Universal rapid HIV testing in STD clinics with same-day results can be implemented at relatively low cost to STD clinics, if brief risk reduction counseling is not offered.

Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: the AWARE randomized clinical trial.

IMPORTANCE: To increase human immunodeficiency virus (HIV) testing rates, many institutions and jurisdictions have revised policies to make the testing process rapid, simple, and routine. A major issue for testing scale-up efforts is the effectiveness of HIV risk-reduction counseling, which has historically been an integral part of the HIV testing process. OBJECTIVE: To assess the effect of brief patient-centered risk-reduction counseling at the time of a rapid HIV test on the subsequent acquisition of sexually transmitted infections (STIs). DESIGN, SETTING, AND PARTICIPANTS: From April to December 2010, Project AWARE randomized 5012 patients from 9 sexually transmitted disease (STD) clinics in the United States to receive either brief patient-centered HIV risk-reduction counseling with a rapid HIV test or the rapid HIV test with information only. Participants were assessed for multiple STIs at both baseline and 6-month follow-up. INTERVENTIONS: Participants randomized to counseling received individual patient-centered risk-reduction counseling based on an evidence-based model. The core elements included a focus on the patient's specific HIV/STI risk behavior and negotiation of realistic and achievable risk-reduction steps. All participants received a rapid HIV test. MAIN OUTCOMES AND MEASURES: The prespecified outcome was a composite end point of cumulative incidence of any of the measured STIs over 6 months. All participants were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum (syphilis), herpes simplex virus 2, and HIV. Women were also tested for Trichomonas vaginalis. RESULTS: There was no significant difference in 6-month composite STI incidence by study group (adjusted risk ratio, 1.12; 95% CI, 0.94-1.33). There were 250 of 2039 incident cases (12.3%) in the counseling group and 226 of 2032 (11.1%) in the information-only group. CONCLUSION AND RELEVANCE: Risk-reduction counseling in conjunction with a rapid HIV test did not significantly affect STI acquisition among STD clinic patients, suggesting no added benefit from brief patient-centered risk-reduction counseling. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01154296.

Health Care Provider Stigma Toward Patients With Substance Use Disorders: Protocol for a Nationally Representative Survey.

BACKGROUND: The US overdose epidemic is an escalating public health emergency, accounting for over 100,000 deaths annually. Despite the availability of medications for opioid use disorders, provider-level barriers, such as negative attitudes, exacerbate the treatment gap in clinical care settings. Assessing the prevalence and intensity of provider stigma, defined as the negative perceptions and behaviors that providers embody and enact toward patients with substance use disorders, across providers with different specialties, is critical to expanding the delivery of substance use treatment. OBJECTIVE: To thoroughly understand provider stigma toward patients with substance use disorders, we conducted a nationwide survey of emergency medicine and primary care physicians and dentists using a questionnaire designed to reveal how widely and intensely provider attitudes and stigma can impact these providers' clinical practices in caring for their patients. The survey also queried providers' stigma and clinical practices toward other chronic conditions, which can then be compared with their stigma and practices related to substance use disorders. METHODS: Our cross-sectional survey was mailed to a nationally representative sample of primary care physicians, emergency medicine physicians, and dentists (N=3011), obtained by American Medical Association and American Dental Association licensees based on specified selection criteria. We oversampled nonmetropolitan practice areas, given the potential differences in provider stigma and available resources in these regions compared with metropolitan areas. Data collection followed a recommended series of contacts with participants per the Dillman Total Design Method, with mixed-modality options offered (email, mail, fax, and phone). A gradually increasing compensation scale (maximum US$250) was implemented to recruit chronic nonresponders and assess the association between requiring higher incentives to participate and providers stigma. The primary outcome, provider stigma, was measured using the Medical Condition Regard Scale, which inquired about participants' views on substance use and other chronic conditions. Additional survey measures included familiarity and social engagement with people with substance use disorders; clinical practices (screening, treating, and referring for a range of chronic conditions); subjective norms and social desirability; knowledge and prior education; and descriptions of their patient populations. RESULTS: Data collection was facilitated through collaboration with the National Opinion Research Center between October 2020 and October 2022. The overall Council of American Survey Research Organizations completion rate was 53.62% (1240/2312.7; physicians overall: 855/1681.9, 50.83% [primary care physicians: 506/1081.3, 46.79%; emergency medicine physicians: 349/599.8, 58.2%]; dentists: 385/627.1, 61.4%). The ineligibility rate among those screened is applied to those not screened, causing denominators to include fractional numbers. CONCLUSIONS: Using systematically quantified data on the prevalence and intensity of provider stigma toward substance use disorders in health care, we can provide evidence-based improvement strategies and policies to inform the development and implementation of stigma-reduction interventions for providers to address their perceptions and treatment of substance use. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47548.

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs.

BACKGROUND: People with substance use disorders are vulnerable to acquiring HIV. Testing is fundamental to diagnosis, treatment, and prevention; however, in the past decade, there has been a decline in the number of substance use disorder (SUD) treatment programs offering on-site HIV testing. Fewer than half of SUDs in the USA offer on-site HIV testing. In addition, nearly a quarter of newly diagnosed cases have AIDS at the time of diagnosis. Lack of testing is one of the main reasons that annual HIV incidences have remained constant over time. Integration of HIV testing with testing for HCV, an infection prevalent among persons vulnerable to HIV infection, and in settings where they receive health services, including opioid treatment programs (OTPs), is of great public health importance. METHODS/DESIGN: In this 3-arm cluster-RCT of opioid use disorders treatment programs, we test the effect of two evidence-based "practice coaching" (PC) interventions on the provision and sustained implementation of on-site HIV testing, on-site HIV/HCV testing, and linkage to care. Using the National Survey of Substance Abuse Treatment Services data available from SAMHSA, 51 sites are randomly assigned to one of the three conditions: practice coach facilitated structured conversations around implementing change, with provision of resources and documents to support the implementation of (1) HIV testing only, or (2) HIV/HCV testing, and (3) a control condition that provides a package with information only. We collect quantitative (e.g., HIV and HCV testing at 6-month-long intervals) and qualitative site data near the time of randomization, and again approximately 7-12 months after randomization. DISCUSSION: Innovative and comprehensive approaches that facilitate and promote the adoption and sustainability of HIV and HCV testing in opioid treatment programs are important for addressing and reducing HIV and HCV infection rates. This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals receiving treatment for opioid use disorder. The study may provide valuable insight and knowledge on the multiple levels of intervention that, if integrated, may better position OTPs to improve and sustain testing practices and improve population health. TRIAL REGISTRATION: ClinicalTrials.gov NCT03135886. Registered on 2 May 2017.

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs.

Background People with substance use disorders are vulnerable to acquiring HIV. Testing is fundamental to diagnosis, treatment, and prevention; however, in the past decade, there has been a decline in the number of substance use disorder (SUD) treatment programs offering on-site HIV testing. Fewer than half of SUDs in the United States offer on-site HIV testing. In addition, nearly a quarter of newly diagnosed cases have AIDS at the time of diagnosis. Lack of testing is one of the main reasons that annual HIV incidences have remained constant over time. Integration of HIV testing with testing for HCV, an infection prevalent among persons vulnerable to HIV infection, and in settings where they receive health services, including opioid treatment programs (OTPs), is of great public health importance. Methods/Design In this 3-arm cluster-RCT of opioid use disorders treatment programs, we test the effect of two evidence-based "practice coaching" (PC) interventions on: the provision and sustained implementation of on-site HIV testing, on-site HIV/HCV testing, and linkage to care. Using the National Survey of Substance Abuse Treatment Services data available from SAMHSA, 51 sites are randomly assigned to one of the three conditions: practice coach facilitated structured conversations around implementing change, with provision of resources and documents to support the implementation of (1) HIV testing only, or (2) HIV/HCV testing, and (3) a control condition that provides a package with information only. We collect quantitative (e,g., HIV and HCV testing at six-month-long intervals) and qualitative site data near the time of randomization, and again approximately 7-12 months after randomization. Discussion Innovative and comprehensive approaches that facilitate and promote the adoption and sustainability of HIV and HCV testing in opioid treatment programs are important for addressing and reducing HIV and HCV infection rates. This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals receiving treatment for opioid use disorder. The study may provide valuable insight and knowledge on the multiple levels of intervention that, if integrated, may better position OTPs to improve and sustain testing practices and improve population health. Trial registration ClinicalTrials.gov: NCT03135886. (02 05 2017).

Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: results of a randomized trial.

OBJECTIVES: We examined the effectiveness of risk reduction counseling and the role of on-site HIV testing in drug treatment. METHODS: Between January and May 2009, we randomized 1281 HIV-negative (or status unknown) adults who reported no past-year HIV testing to (1) referral for off-site HIV testing, (2) HIV risk-reduction counseling with on-site rapid HIV testing, or (3) verbal information about testing only with on-site rapid HIV testing. RESULTS: We defined 2 primary self-reported outcomes a priori: receipt of HIV test results and unprotected anal or vaginal intercourse episodes at 6-month follow-up. The combined on-site rapid testing participants received more HIV test results than off-site testing referral participants (P<.001; Mantel-Haenszel risk ratio=4.52; 97.5% confidence interval [CI]=3.57, 5.72). At 6 months, there were no significant differences in unprotected intercourse episodes between the combined on-site testing arms and the referral arm (P=.39; incidence rate ratio [IRR]=1.04; 97.5% CI=0.95, 1.14) or the 2 on-site testing arms (P=.81; IRR=1.03; 97.5% CI=0.84, 1.26). CONCLUSIONS: This study demonstrated on-site rapid HIV testing's value in drug treatment centers and found no additional benefit from HIV sexual risk-reduction counseling.

Differential Effects of Patient Navigation across Latent Profiles of Barriers to Care among People Living with HIV and Comorbid Conditions.

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. We analyzed data from NIDA Clinical Trials Network's 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.

Cost of Hepatitis C care facilitation for HIV/Hepatitis C Co-infected people who use drugs.

BACKGROUND: Using data from a randomized trial, we evaluated the cost of HCV care facilitation that supports moving along the continuum of care for HIV/HCV co-infected individuals with substance use disorder. METHODS: Participants were HIV patients residing in the community, initially recruited from eight US hospital sites. They received HCV care facilitation (n = 51) or treatment as usual (n = 62) for up to six months. We used micro-costing methods to evaluate costs from the healthcare sector and patient perspectives in 2017 USD. We conducted sensitivity analyses varying care facilitator caseloads and examined offsetting savings using participant self-reported healthcare utilization. RESULTS: The average site start-up cost was $6320 (site range: $4320-$7000), primarily consisting of training. The mean weekly cost per participant was $20 (site range: $4-$30) for care facilitation visits and contacts, $360 (site range: $130- $700) for supervision and client outreach, and $70 (site range: $20-$180) for overhead. In sensitivity analyses applying a weekly caseload of 10 participants per care facilitator (versus 1-6 observed in the trial), the total mean weekly care facilitation cost from the healthcare sector perspective decreased to $110. Weekly participant time and travel costs averaged $7. There were no significant differences in other healthcare service costs between participants in the intervention and control arms. CONCLUSION: Weekly HCV care facilitation costs were approximately $450 per participant, but approximately $110 at a real-world setting maximum caseload of 10 participants per week. No healthcare cost offsets were identified during the trial period, although future savings might result from successful HCV treatment.

M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID.

BACKGROUND: Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. METHODS: The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial (M2HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. DISCUSSION: The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. TRIAL REGISTRATION: Clinicaltrials.gov NCT03981445 . Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201.

Self-efficacy as a mediator of patient navigation interventions to engage persons living with HIV and substance use.

BACKGROUND: 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 care and improve HIV outcomes in this population. METHODS: Mediation analysis was conducted using data from 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. RESULTS: 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 (ß = 0.042, 95% CI = 0.008, 0.086). PN + CM also led to increases in viral suppression at 6 months (ß = 0.090, 95% CI = 0.023, 0.168) and 12 months (ß = 0.069, 95% CI = 0.009, 0.129) via increases in self-efficacy, although the direct effects were not significant. No mediating effects were observed for PN alone. CONCLUSION: 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.

Care Facilitation Advances Movement Along the Hepatitis C Care Continuum for Persons With Human Immunodeficiency Virus, Hepatitis C, and Substance Use: A Randomized Clinical Trial (CTN-0064).

BACKGROUND: Direct-acting antivirals can cure hepatitis C virus (HCV). Persons with HCV/HIV and living with substance use are disadvantaged in benefiting from advances in HCV treatment. METHODS: In this randomized controlled trial, participants with HCV/HIV were randomized between February 2016 and January 2017 to either care facilitation or control. Twelve-month follow-up assessments were completed in January 2018.Care facilitation group participants received motivation and strengths-based case management addressing retrieval of HCV viral load results, engagement in HCV/HIV care, and medication adherence. Control group participants received referral to HCV evaluation and an offer of assistance in making care appointments. Primary outcome was number of steps achieved along a series of 8 clinical steps (eg, receiving HCV results, initiating treatment, sustained virologic response [SVR]) of the HCV/HIV care continuum over 12 months postrandomization. RESULTS: Three hundred eighty-one individuals were screened and 113 randomized. Median age was 51 years; 58.4% of participants were male and 72.6% were Black/African American. Median HIV-1 viral load was 27 209 copies/mL, with 69% having a detectable viral load. Mean number of steps completed was statistically significantly higher in the intervention group vs controls (2.44 vs 1.68 steps; χ 2 [1] = 7.36, P = .0067). Men in the intervention group completed a statistically significantly higher number of steps than controls. Eleven participants achieved SVR with no difference by treatment group. CONCLUSIONS: The care facilitation intervention increased progress along the HCV/HIV care continuum, as observed for men and not women. Study findings also highlight continued challenges to achieve individual-patient SVR and population-level HCV elimination. CLINICAL TRIALS REGISTRATION: NCT02641158.