Perceptions Towards HCV Treatment with Direct Acting Antivirals (DAAs): A Qualitative Analysis with Persons with HIV/HCV Co-infection Who Delay or Refuse Treatment.

In the United States, approximately 25% of people with HIV (PWH) are co-infected with hepatitis C (HCV). Since 2014, highly effective and well-tolerated direct-acting antivirals (DAAs) have revolutionized HCV treatment. Uptake of DAAs by people with HIV/HCV co-infection has improved but remains suboptimal due to system, provider, and patient-level barriers. To explore patient-level issues by better understanding their attitudes towards DAA treatment, we conducted qualitative interviews with 21 persons with HIV/HCV co-infection who did not consent to DAA treatment or delayed treatment for at least 1 year after diagnosis. We found PWH perceived DAA treatment barriers and facilitators on multiple levels of the social-ecological environment: the individual (HCV disease and treatment literacy), interpersonal (peer influence), institutional (media and healthcare provider relationship), and structural levels (treatment cost and adherence support). Recommendations to improve DAA treatment uptake include HCV-treatment adherence support, HCV disease and treatment literacy training (particularly for substance use and DAA treatment interactions), and encouraging PWH who have successfully completed DAA treatment to speak with their peers.

Challenges to Achieving HCV Micro-Elimination in People With HIV in the United States: Provider Perspectives and the Role of Implicit Bias.

The prevalence of HIV/HCV (hepatitis C virus) co-infection is high particularly in persons who inject drugs (PWID) and is increasing because of the evolving opioid epidemic in the United States. The introduction of effective antiviral medications for HCV has raised the strategic goal of HCV micro-elimination, and efforts to understand the barriers to treatment are critical. In this study, we explored the provider perspective of factors that inhibit HCV micro-elimination efforts in people with HIV (PWH), including the role of implicit bias and related stigma in providers' health care decision making. We used the mixed-methods approach of nominal group technique (NGT) with 14 participants from 11 different clinics engaged in two virtual focus group sessions (n = 5 and n = 9). Responses from the NGTs were rank ordered during the sessions to identify providers' perspectives of major barriers and facilitators, then identified possible implicit bias after the NGTs concluded. There were 12 responses given for micro-elimination barriers with the three most prioritized being housing instability, medication nonadherence concerns, and inability to motivate patients. Of these, eight were categorized as potential implicit biases. Among the 14 responses given for facilitators of treatment, the three major solutions included distributive models of care, improved provider knowledge, and increased patient engagement. Although the solutions offered were insightful, there was consensus that the individual lives of patients were the root cause of most barriers to care. We recommend further research on behavioral design interventions that promote patients' involvement in decision making and focus on patients' eligibility criteria for HCV treatment as opposed to providers' perceived barriers to treatment.

Mobile Health Technology Use and the Acceptability of an mHealth Platform for HIV Prevention Among Men Who Have Sex With Men in Malaysia: Cross-sectional Respondent-Driven Sampling Survey.

BACKGROUND: The growth in mobile technology access, utilization, and services holds great promise in facilitating HIV prevention efforts through mobile health (mHealth) interventions in Malaysia. Despite these promising trends, there is a dearth of evidence on the use of mHealth platforms that addresses HIV prevention among Malaysian men who have sex with men. OBJECTIVE: The goal of this study was to gain insight into (1) access and utilization of communication technology (eg, landline phone, internet, mobile phone), (2) acceptability of mHealth-based interventions for HIV prevention services, and (3) preferences regarding the format and frequency of mHealth interventions among Malaysian men who have sex with men. METHODS: We conducted a cross-sectional survey with Malaysian men who have sex with men between July 2018 and March 2020. Participants were recruited using respondent-driven sampling in the Greater Kuala Lumpur region of Malaysia. We collected information on demographic characteristics, HIV risk-related behaviors, access to and the frequency of use of communication technology, and acceptability of using mHealth for HIV prevention using a self-administered questionnaire with a 5-point scale (1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time). RESULTS: A total of 376 men participated in the survey. Almost all respondents owned or had access to a smartphone with internet access (368/376, 97.9%) and accessed the internet daily (373/376, 99.2%), mainly on a smartphone (334/376, 88.8%). Participants on average used smartphones primarily for social networking (mean 4.5, SD 0.8), followed by sending or receiving emails (mean 4.0, SD 1.0), and searching for health-related information (mean 3.5, SD 0.9). There was high acceptance of the use of mHealth for HIV prevention (mean 4.1, SD 1.5), including for receiving HIV prevention information (345/376, 91.8%), receiving medication reminders (336/376, 89.4%), screening and monitoring sexual activity (306/376, 81.4%) or illicit drug use (281/376, 74.7%), and monitoring drug cravings (280/376, 74.5%). Participants overwhelmingly preferred a smartphone app over other modalities (eg, text, phone call, email) for engaging in mHealth HIV prevention tools. Preference for app notifications ranged from 186/336 (53.9%), for receiving HIV prevention information, to 212/336 (69.3%), for screening and monitoring sexual activity. Acceptance of mHealth was higher for those who were university graduates (P=.003), living in a relationship with a partner (P=.04), engaged in sexualized drug use (P=.01), and engaged in receptive anal sex (P=.006). CONCLUSIONS: Findings from this study provide support for developing and deploying mHealth strategies for HIV prevention using a smartphone app in men who have sex with men-a key population with suboptimal engagement in HIV prevention and treatment.

Pregnant Women and Opioid Use Disorder: Examining the Legal Landscape for Controlling Women's Reproductive Health.

Women with opioid use disorder ("OUD") are more likely than other women to experience sexual assault, unintentional pregnancy, transactional sex and coercion regarding reproductive health care choices than women without OUD. Laws described as family friendly may be punitive rather than helpful to women and rarely apply to men. Laws regarding reproductive health and OUD are unevenly enforced and therefore biased against poor, minority women. As part of a larger study oriented toward strengthening systems of care related to the intersection of HIV and OUD, we conducted an analysis of state laws related to pregnant and postpartum women with OUD. Data on disparities in child removals and pregnant women's use of evidence-based treatment for OUD by income and race were captured for the five states with the most restrictive laws in both categories. Laws that were purportedly designed to improve reproductive health outcomes for women with OUD and/or their children often have the opposite of the expressed intended outcome. There is a relationship between restrictive reproductive choice and coercive OUD treatment policy for women. Restrictive state regulations for pregnant women with OUD persist despite negative outcomes for maternal and child health. Altering coercive and/or criminalizing regulation and redefining 'family friendly' may improve outcomes for individuals and families.

Use of Pre-exposure Prophylaxis Among People Who Inject Drugs: Exploratory Findings of the Interaction Between Race, Homelessness, and Trust.

Scale-up of pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) remains suboptimal. Patient-level factors are often complex and may contribute to scale-up. Using cross-sectional data from 234 opioid-dependent patients on methadone who met eligibility criteria for PrEP, we conducted logistic regression analyses to assess potential moderators associated with being on PrEP (n = 60). Mean provider trust was significantly higher among Blacks vs Whites (39.4 vs 34.9; p = 0.002) and non-homeless vs homeless participants (37.5 vs 34.8; p = 0.008). Though race/ethnicity was not a significant moderator on provider trust and PrEP use, increased provider trust was marginally associated with increased PrEP use among Blacks (p = 0.058). Additionally, homelessness significantly moderated provider trust and PrEP use (p = 0.024). Provider trust among non-homeless participants was positively correlated with PrEP use (p = 0.013) but not among homeless participants. Strategies that promote provider trust in Blacks and non-homeless PWID on methadone may improve PrEP scale-up.

Purposeful Fentanyl Use and Associated Factors among Opioid-Dependent People Who Inject Drugs.

Introduction: In recent years, opioid-related mortality has increased steadily in the United States. Fentanyl, a synthetic opioid, has been a primary driver of the current wave of overdose-related deaths. Little is known, however, about fentanyl use among opioid-dependent people who inject drugs (PWID). We, therefore, sought to characterize purposeful fentanyl use among PWID. Methods: A cross-sectional survey was administrated to 104 opioid-dependent PWID on methadone who self-reported drug- or sex-related risk behaviors. Participants were recruited between July 2018 and October 2019 from a methadone clinic in New Haven, Connecticut. Multivariable logistic regressions were used to identify independent correlates of purposeful fentanyl use. Results: Overall, 43.2% and 22.1% of the participants reported any (lifetime) or recent (past 30 days) purposeful fentanyl use, respectively. Independent correlates of any purposeful fentanyl use were younger age (aOR= 0.94; p = 0.021), recent daily injection (aOR= 3.52; p = 0.047), recent cocaine use (aOR= 3.54; p = 0.041), and moderate/severe depression (aOR= 3.82; p = 0.028). Independent correlates of recent purposeful fentanyl use were moderate/severe depression (aOR= 10.94; p = 0.031), recently sharing injection equipment (aOR= 2.96; p = 0.044), and recently engaging in transactional sex (aOR= 3.60; p = 0.026). Conclusions: These findings indicate that opioid-dependent PWID on methadone remain at increased risk for overdose given the high prevalence of ongoing purposeful fentanyl exposure. Interventions to reduce the harms associated with fentanyl use should target young PWID and active fentanyl users, with an emphasis on achieving adequate methadone dosage and screening and treating depression in methadone-maintained patients who preferentially seek fentanyl.

The cascade of care for commercially-insured persons with opioid use disorder and comorbid HIV and HCV infections.

BACKGROUND: Opioid use disorder (OUD) significantly impacts individual and public health and exacerbated further by concurrent infectious diseases. A syndemic approach is needed to address the intertwined OUD, HIV, and HCV epidemics, including the expanded use of medications for opioid use disorder (MOUD). METHODS: To identify MOUD scale-up opportunities, we conducted a retrospective cohort study, representing commercially insured persons, and created the OUD care continuum, including HIV and HCV influences in adults (18-64 years) newly diagnosed with OUD in 2019 using Merative MarketSan data. RESULTS: Among 124,467,633 individuals, the prevalence of OUD was 0.4 % (95 % CI: 0.36 %-0.46 %; N = 497,871), with 327,277 (65.7 %, 95 % CI: 65.60 %-65.87 %) newly diagnosed in 2019. Among these newly diagnosed individuals (54 % men, mean age 44±0.01), 53,568 (27.0 %, 95 % CI: 26.4 %-27.5 %) were prescribed MOUD, with retention rates at 1, 3, and 6 months being 89.0 % (95 % CI: 88.2 %-89.8 %), 66.0 % (95 % CI: 64.8 %-67.2 %), and 50.3 % (95 % CI: 48.3 %-51.6 %), respectively. Buprenorphine was the most prescribed MOUD (79.6 %, 95 % CI: 78.6 %-80.7 %), followed by XR-NTX (14.9 %, 95 % CI:14.0 %-15.8 %) and methadone (5.5 %, 95 % CI: 4.9 %-6.1 %). Six-month retention was highest for methadone (73.4 %, 95 % CI: 73.0 %-73.8 %), however, followed by buprenorphine (55.7 %, 95 % CI: 55.3 %-57.1 %) and substantially lower for XR-NTX (12.6 %, 95 % CI: 10.6 %-14.6 %). Screening for HIV and HCV was low among OUD enrollees (11.1 %, 14.4 %), slightly higher for MOUD initiators (18.0 %, 21.6 %). Being prescribed MOUD was correlated with HCV infection (AOR: 2.54; 95 % CI: 2.41-2.68), HCV/HIV coinfection (AOR: 1.89; 95 % CI: 1.41-2.53), and hospitalization for OUD-related services (AOR: 1.14; 95 % CI: 1.11-1.17), yet hospitalization for OUD-related services was positively correlated with XR-NTX (AOR: 2.72; 95 % CI: 2.56-2.85) prescription and negatively with methadone (AOR: 0.19; 95 % CI: 0.16-0.23) prescription. Having HIV was negatively correlated with being prescribed methadone (AOR: 0.33; 95 % CI: 0.13-0.86). CONCLUSIONS: Substantial gaps in the OUD cascade persist, underscoring better implementation opportunities for MOUD prescription in hospital-based settings and expanding access to methadone beyond highly regulated sites given its low coverage yet high treatment retention.

Treatment of Hepatitis C virus among people who inject drugs at a syringe service program during the COVID-19 response: The potential role of telehealth, medications for opioid use disorder and minimal demands on patients.

BACKGROUND: Healthcare delivery was disrupted during the COVID-19 pandemic, requiring minimized in-person contact between patients and clinicians. During the pandemic, people with opioid use disorder (OUD) were not only at elevated risk for COVID-19, but had markedly reduced access to treatment for OUD, Hepatitis C virus (HCV) and HIV due to recommended decreased in-person visits. METHODS: From March 15-June 15, 2020 at the syringe services program (SSP) in New Haven, Connecticut, USA, a differentiated care model evolved with reduced clinical demands on people who inject drugs (PWID) to ensure screening and treatment for HCV, HIV and OUD, with a focus on HCV treatment. This model involved a single, bundled screening, evaluation, testing (SET) and monitoring strategy for all three conditions, minimal in-person visits, followed by tele-health communication between patients, outreach workers and clinicians. In-person visits occurred only during induction onto methadone and phlebotomy at baseline and phlebotomy 12 weeks post-treatment for HCV to measure sustained virological response (SVR). Patients received supportive texts/calls from outreach workers and clinicians. RESULTS: Overall, 66 actively injecting PWID, all with OUD, underwent bundled laboratory screening; 35 had chronic HCV infection. Participants were 40 years (mean), mostly white (N = 18) men (N = 28) and 12 were unstably housed. Two were lost to-follow-up and 2 were incarcerated, leaving 31 who started pan-genotypic direct-acting antivirals (DAAs). The mean time from referral to initial phlebotomy and initiation of DAAs was 6.9 and 9.9 days, respectively. Fourteen additional patients were newly started on buprenorphine and 6 started on methadone; three and four, respectively, were on treatment at baseline. Overall, 29 (93.5%) PWID who initiated DAAs achieved SVR; among unstably housed persons the SVR was 83.3%. CONCLUSIONS: In response to COVID-19, an innovative differentiated care model for PWID at an SSP evolved that included successful co-treatment for HCV, HIV and OUD using a client-centered approach that reduces treatment demands on patients yet supports ongoing access to evidence-based treatments.

Structural barriers to implementing recommended tuberculosis preventive treatment in primary care clinics in rural South Africa.

The World Health Organization (WHO) recommends tuberculosis preventive treatment (TPT) in people with HIV (PWH), yet implementation remains poor, especially in rural communities. We examined factors influencing TPT initiation in PWH on antiretroviral therapy (ART) in rural South Africa using the Promoting Action on Research Implementation in Health Services (PARiHS) framework to identify contextual factors and facilitation strategies to successfully implement TPT. Patient and clinical factors were extracted from medical records at two primary healthcare clinics (PHCs). Among 455 TPT eligible indivdiuals, only 263 (57.8%) initiated TPT. Patient-level characteristics (older age and symptoms of fever or weight loss) were significantly associated with TPT initiation in bivariate analysis, but PHC was the only independent correlate of TPT initiation (aOR: 2.24; 95% CI: 1.49-3.38). Clinic-level factors are crucial targets for implementing TPT to reduce the burden of HIV-associated TB. Gaps in knowledge of HCW, staff shortages, and non-integrated HIV/TB services were identified barriers to TPT implementation. Evidence-based strategies for facilitating TPT implementation that might be under-prioritized include ongoing reprioritization, expanding training for primary care providers, and quality improvement strategies (organisational changes, multidisciplinary teams, and monitoring and feedback). Addressing contextual barriers through these facilitation strategies may improve future TPT implementation in this setting.

Strengthening systems of care for people with or at risk for HIV, HCV and opioid use disorder: a call for enhanced data collection.

BACKGROUND: The syndemic between opioid use disorder (OUD), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) results in excessive burdens on the healthcare system. Integrating these siloed systems of care is critical to address all three conditions adequately. In this implementation project, we assessed the data capacity of the health system to measure a cascade of care (COC) across HIV, HCV and OUD services in five states to help guide public health planning. MATERIALS AND METHODS: Data for this study were gathered from publicly available datasets and reports from government (SAMSHA, CMS, HRSA and CDC) sites. We created, where possible, COCs for HIV, HCV, and OUD spanning population estimate, diagnosis, treatment initiation, treatment retention, and patient outcomes for each of five states in the study. RESULTS: The process of data collection showed that baseline COCs examining the intersections of OUD, HIV, and HCV cannot be produced and that there are missing data in all states examined. Collection of specific data points is not consistent across all states. States are better at reporting HIV cascades due to federal requirements. Only gross estimates could be made for OUD cascades in all states because data are separated by payer source, leaving no central point of data collection from all sources. Data for HCV were not publicly available. CONCLUSION: It is difficult to assess the strategies needed or the progress made towards increasing treatment access and decreasing the burden of disease without the ability to construct an accurate baseline. Using integrated COCs with relevant benchmarks can not only guide public health planning, but also provide meaningful targets for intervention.KEY MESSAGESWhile HIV COCs are available for most states at least annually, they are not disaggregated for populations with co-occurring OUD or HCV.Data to calculate HCV COC are not available and data to calculate OUD COC are partially available, but only for specific payers.States do not have systems in place to measure the scope of the syndemic or to identify targets for quality improvement activities.

Willingness to initiate pre-exposure prophylaxis (PrEP) and its use among opioid-dependent individuals in drug treatment.

BACKGROUND: People who use drugs (PWUD) continue to experience a disproportionate HIV burden due to drug- and sex-related risk behaviors. Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection, but very little is known about PrEP use among PWUD and their willingness to initiate PrEP. METHODS: We conducted a cross-sectional survey among 234 HIV-negative, opioid-dependent individuals recruited from an urban methadone clinic. Participants were assessed using an audio-computer assisted self-interview technique. Bivariate and multiple logistic regressions were used to explore independent correlates of actual PrEP use and willingness to initiate PrEP. RESULTS: One-fourth (25.6 %) of participants had previously used PrEP. Over two-thirds (67.1 %) of participants had previously heard of PrEP, and 65.0 % were willing to take it. In multivariable logistic regression analyses, the number of times participants engaged in HIV testing (aOR = 1.66, p < 0.01) and whether they visited a healthcare provider (aOR=20.81, p = 0.02) were associated with a higher likelihood of PrEP use, while perceived HIV risk (aOR=2.71, p < 0.01) and previous use of PrEP (aOR=3.57, p < 0.01) were significantly associated with willingness to initiate PrEP. CONCLUSION: PrEP use was low among PWUD, but their willingness to initiate PrEP was moderate, which indicated a significant discrepancy between actual PrEP use and willingness to use it. Our findings highlight the importance of healthcare providers engaging opioid-dependent individuals in discussions about PrEP and the need for innovative strategies to increase their awareness of PrEP and modify their perceptions of HIV risk.

Awareness about and willingness to use long-acting injectable pre-exposure prophylaxis (LAI-PrEP) among people who use drugs.

In the Bangkok Tenofovir Study of oral pre-exposure prophylaxis (PrEP; TDF/FTC), adherence was poor. Long-acting injectable pre-exposure prophylaxis (LAI-PrEP) for HIV prevention may help overcome adherence challenges and is currently being tested in clinical trials, but not in people who use drugs (PWUD), an important key population that remains highly vulnerable to HIV. Since PWUD are not currently included in trials of LAI-PrEP, we sought to examine awareness about LAI-PrEP and factors associated with willingness to use LAI-PrEP in this understudied population. Participants included 234 HIV-negative people with opioid use disorder and self-reported HIV-risk behaviors recruited from Connecticut's largest addiction treatment program. We analyzed data from a standardized assessment using audio computer-assisted self-interview (ACASI) to assess the independent factors associated with willingness to use LAI-PrEP. While only 25.6% of participants were aware of LAI-PrEP (67.1% had heard of oral PrEP), after being given a description of it, 73.5% were willing to use it, if it were available. Participants were most commonly concerned about long-term side effects (76.9%) of LAI-PrEP. Independent correlates of willingness to use LAI-PrEP were female sex (aOR = 2.181, p = 0.018), recent visit to healthcare provider (aOR = 2.9, p = 0.023), high perceived risk of acquiring HIV (aOR = 3.3, p = 0.007), and having previously taken oral PrEP (aOR = 3.284, p = 0.017). Findings suggest that PWUD are highly interested in PrEP, especially in LAI-PrEP formulations. Our results indicate the potential for LAI-PrEP, as an alternative to oral daily PrEP, to be implemented into existing evidence-based HIV-based HIV prevention efforts that target high-risk PWUD.

Feasibility and Acceptability of an mHealth-Based Approach as an HIV Prevention Strategy Among People Who Use Drugs on Pre-Exposure Prophylaxis.

INTRODUCTION: There has been increasing interest in the use of mHealth technology in health care. To our knowledge, however, there is a lack of empirical evidence on the utilization of text messaging services (short message service; SMS) for HIV prevention among opioid-dependent people who use drugs (PWUD). As part of our formative work, we conducted an in-depth feasibility and acceptability study on the use of SMS reminders for HIV prevention in this risk group. METHODS: Forty HIV-negative, opioid-dependent PWUD who are currently taking pre-exposure prophylaxis (PrEP) were enrolled in the study. Participants received daily PrEP text reminders and weekly HIV risk reduction-related messages, which were developed using a user-centered approach. Participants were assessed at baseline and immediately post-intervention. Following the post-intervention assessment, participants completed an in-depth qualitative interview. RESULTS: Feasibility of text messaging service was high, as assessed by participants' willingness to receive text messages (100%), retention (95%), and successful delivery of text messages (97%). Results further showed that participants were satisfied and perceived the use of daily PrEP reminder text messages as valuable and acceptable [mean: 75.0 (range 0-100)]. Whereas, acceptability for the weekly text messages on HIV risk reduction was 60.3 (±15.6), with 58.3% recommending them for future use. Thematic data exploration revealed important information for understanding and refining SMS content as well as logistical preferences. CONCLUSION: Our findings provide preliminary evidence of the feasibility and acceptability of a text messaging-based approach as a potential tool for primary HIV prevention to improve PrEP adherence and HIV risk reduction among this underserved population. HIV risk reduction text messages need further modifications to become more appealing, with participant feedback taken into consideration.