Staff-Facilitated Telemedicine Care Delivery for Treatment of Hepatitis C Infection among People Who Inject Drugs.

BACKGROUND: Telemedicine offers the opportunity to provide clinical services remotely, thereby bridging geographic distances for people engaged in the medical system. Following the COVID-19 pandemic, the widespread adoption of telemedicine in clinical practices has persisted, highlighting its continued relevance for post-pandemic healthcare. Little is known about telemedicine use among people from socially marginalized groups. METHODS: The No One Waits (NOW) Study is a single-arm clinical trial measuring the acceptability, feasibility, and safety of an urban point-of-diagnosis hepatitis C (HCV) treatment initiation model delivered in a non-clinical community setting. Participants enrolled in the NOW Study are recruited via street outreach targeting people experiencing homelessness and injecting drugs. Throughout the NOW Study, clinical care is delivered through a novel staff-facilitated telemedicine model that not only addresses geographic and transportation barriers, but also technology and medical mistrust, barriers often unique to this population. While clinicians provide high-quality specialty practice-based care via telemedicine, on-site staff provide technical support, aid in communication and rapport, and review the clinicians' instructions and next steps with participants following the visits. Research questionnaires collect information on participants' experience with and perceptions of telemedicine (a) prior to treatment initiation and (b) at treatment completion. DISCUSSION: For people from socially marginalized groups with HCV infection, creative person-centered care approaches are necessary to diagnose, treat, and cure HCV. Although non-clinical, community-based staff-facilitated telemedicine requires additional resources compared to standard-of-care telemedicine, it could expand the reach and offer a valuable entrance into technology-delivered care for socially marginalized groups. TRIAL REGISTRATION: NCT03987503.

High prevalence of hepatitis B virus susceptibility among persons undergoing community-based hepatitis C virus treatment.

BACKGROUND: Due to shared modes of transmission, coinfection with hepatitis B virus (HBV) and hepatitis C virus (HCV) is common, and HBV vaccination is recommended for all persons with HCV who remain susceptible to HBV. To identify potential gaps in HBV vaccination among this high-risk population, we aimed to determine the patterns of HBV susceptibility in persons undergoing community-based HCV treatment. METHODS: We performed a cross-sectional study within two community-based HCV treatment programs in an urban US setting. Participants were identified for HCV screening and confirmatory testing via street-outreach recruitment directed at persons experiencing homelessness and currently using drugs. Participants were excluded if HBsAg was reactive. Cohort characteristics were obtained via intake surveys and descriptive analysis was performed by exposure status. RESULTS: Among 150 participants without chronic HBV receiving community-based HCV treatment, 43% had evidence of prior HBV infection, 26% were immune from vaccination, and 31% were non-immune. Among the subset of the cohort reporting current injection drug use (IDU) (N = 100), 31% (n = 10) of those aged 24-40 and 47% (n = 23) of those aged 41-57 remained susceptible to HBV infection. By contrast only two participants aged 58-74 were HBV non-immune (11%), with 84% immune due to prior exposure. CONCLUSIONS: Our data reflect a high prevalence of HBV susceptibility among persons undergoing community-based HCV treatment. Although younger patients were more likely to be immune due to vaccination, a high proportion remained non-immune to HBV, particularly among those reporting current IDU. Our data reflect a gap in HBV vaccination among younger persons with HCV and suggest a potential role for co-localizing HBV vaccination with community-based HCV screening and treatment.

Low-income San Franciscans' Access to Basic Needs during COVID Shelter-in-Place: A Focus on People Who Use Drugs.

We conducted a cross-sectional study of low-income San Franciscans to assess the impact of COVID-19 on their life and well-being during the period of the COVID-19 pandemic when the focus was on higher socioeconomic populations. Stratified analyses compared people who used drugs with those who did not and open-ended response data were sorted into themes. Of the 145 participants, most (70%) changed their behavior by practicing social distancing and reducing the number of their contacts. Of people who used drugs (98, 68%), 40% reported increased difficulty accessing/using drugs, 33% reduced access to drug treatment, and 41% increased concern about drug overdose for themselves or others. Compared with those who did not, people who used drugs experienced improvements in access to food, feeling supported by friends and family, and access to medical care. Our findings indicate the shift in services during COVID-19 had mixed impacts on people who use drugs.

Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations: A Nonrandomized Controlled Trial.

Importance: Disparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors. Objective: To determine the feasibility, acceptability, and safety of HCV treatment at the point of HCV infection diagnosis disclosure in a nonclinical community setting. Design, Setting, and Participants: In this single-arm nonrandomized controlled trial conducted between July 1, 2020, and October 31, 2021, street-outreach recruitment targeted people experiencing homelessness and injecting drugs in an urban US community who were eligible for simplified HCV treatment. Interventions: Study procedures were designed to reflect the community environment and services needed to provide HCV testing, disclosure, and treatment in a nonclinical site. The test-and-treat No One Waits (NOW) model of care provided a 2-week starter pack of 400 mg of sofosbuvir and 100 mg of velpatasvir at time of HCV RNA results disclosure. Participants were transitioned to insurance-provided sofosbuvir-velpatasvir when feasible to complete a 12-week treatment course. Main Outcomes and Measures: The primary end point was sustained virologic response at posttreatment week 12 or later (SVR12). Acceptability end points were treatment initiation and completion. Safety end points were treatment discontinuation because of a late exclusion criterion and adverse events. Results: Of the 492 people (median [IQR] age, 48 [37-58] years; 62 [71%] male) who underwent anti-HCV testing, 246 (50%) tested anti-HCV positive, and 111 (23%) tested HCV RNA positive and were eligible for simplified HCV treatment. Eighty-nine of the 111 eligible participants (80%) returned for confirmatory RNA results, and 87 (98%) accepted and initiated HCV treatment. Seventy (80%) were currently injecting drugs, 83 (97%) had an income below the poverty line, and 53 (61%) were currently unsheltered. Most had HCV genotype 1a (45 [52%]) or 3 (20 [23%]). Sixty-nine (79%) completed 12 weeks of sofosbuvir-velpatasvir treatment, 2 stopped treatment because of low adherence, and 16 were lost to follow-up. Of the 66 participants who completed treatment and had a successful blood draw, 61 (92%) had undetectable HCV RNA at treatment completion. Of the 87 treated patients, 58 achieved SVR12, leading to a treatment response of 67% (95% CI, 56%-76%) among the intention-to-treat group and 84% (95% CI, 73%-92%) among the per-protocol group. There were no adverse events, late exclusions, or deaths. Conclusions and Relevance: In this nonrandomized controlled trial of HCV treatment at the point of diagnosis, the NOW model of care reduced steps between HCV testing and treatment initiation and resulted in high levels of treatment initiation, completion, and cure. The NOW model of care can expand the current HCV test-and-treat toolkit by reaching a broader population of marginalized communities and expediting curative therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT03987503.

A pilot study to understand and respond to loss, theft, and misplacement of hepatitis C treatment medication for people who inject drugs.

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A mixed-methods evaluation of the impact of a person-centered family planning intervention for community health workers on family planning outcomes in India.

BACKGROUND: Person-centered quality for family planning has been gaining increased attention, yet few interventions have focused on this, or measured associations between person-centered quality for family planning and family planning outcomes (uptake, continuation, etc.). In India, the first point of contact for family planning is often the community health care worker, in this case, Accredited Social Health Activists (ASHAs). METHODS: In this study, we evaluate a training on person-centered family planning as an add-on to a training on family planning provision for urban ASHAs in Varanasi, India in 2019 using mixed methods. We first validate a scale to measure person-centered family planning in a community health worker population and find it to be valid. Higher person-centered family planning scores are associated with family planning uptake. RESULTS: Comparing women who saw intervention compared to control ASHAs, we find that the intervention had no impact on overall person-centered family planning scores. Women in the intervention arm were more likely to report that their ASHA had a strong preference about what method they choose, suggesting that the training increased provider pressure. However, qualitative interviews with ASHAs suggest that they value person-centered care for their interactions and absorbed the messages from the intervention. CONCLUSIONS: More research is needed on how to intervene to change behaviors related to person-centered family planning. TRIAL REGISTRATION: This study received IRB approval from the University of California, San Francisco (IRB # 15-25,950) and was retrospectively registered at clinicaltrials.gov ( NCT04206527 ).