Publications by authors named "Sonjelle Shilton"

12 Publications

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Feasibility, effectiveness and cost of a decentralized HCV care model among the general population in Delhi, India.

Liver Int 2021 Nov 24. Epub 2021 Nov 24.

FIND, Geneva, Switzerland.

Background And Aims: India has a significant burden of hepatitis C virus (HCV) infection and has committed to achieving national elimination by 2030. This will require a substantial scale-up in testing and treatment. The "HEAD-Start Project Delhi" aimed to enhance HCV diagnosis and treatment pathways among the general population.

Methods: A prospective study was conducted at 5 district hospitals (Arm 1: one-stop shop), 15 polyclinics (Arm 2: referral for viral load (VL) testing and treatment) and 62 screening camps (Arm 3: referral for treatment). HCV prevalence, retention in the HCV care cascade, and turn-around time were measured.

Results: Between January and September 2019, 37 425 participants were screened for HCV. The median (IQR) age of participants was 35 (26-48) years, with 50.4% male and 49.6% female. A significantly higher proportion of participants in Arm 1 (93.7%) and Arm 3 (90.3%) received a VL test compared with Arm 2 (52.5%, P < .001). Of those confirmed positive, treatment was initiated at significantly higher rates for participants in both Arms 1 (85.6%) and 2 (73.7%) compared to Arm 3 (41.8%, P < .001). Arm 1 was found to be a cost-saving strategy compared to Arm 2, Arm 3, and no action.

Conclusions: Delivery of all services at a single site (district hospitals) resulted in a higher yield of HCV seropositive cases and retention compared with sites where participants were referred elsewhere for VL testing and/or treatment. The highest level of retention in the care cascade was also associated with the shortest turn-around times.
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November 2021

Assessing Values and Preferences Toward SARS-CoV-2 Self-testing Among the General Population and Their Representatives, Health Care Personnel, and Decision-Makers: Protocol for a Multicountry Mixed Methods Study.

JMIR Res Protoc 2021 Nov 26;10(11):e33088. Epub 2021 Nov 26.

FIND, the global alliance for diagnostics, Geneva, Switzerland.

Background: Accessible, safe, and client-centered SARS-CoV-2 testing services are an effective way to halt its transmission. Testing enables infected individuals to isolate or quarantine to prevent further transmission. In countries with limited health systems and laboratory capacity, it can be challenging to provide accessible and safe screening for COVID-19. Self-testing provides a convenient, private, and safe testing option; however, it also raises important concerns about lack of counseling and ensuring timely reporting of self-test results to national surveillance systems. Investigating community members' views and perceptions regarding SARS-CoV-2 self-testing is crucial to inform the most effective and safe strategies for implementing said testing.

Objective: We aimed to determine whether SARS-CoV-2 self-testing was useful to diagnose and prevent the spread of SARS-CoV-2 for populations in low-resource settings and under which circumstances it would be acceptable.

Methods: This multisite, mixed methods, observational study will be conducted in 9 countries-Brazil, India, Indonesia, Kenya, Malawi, Nigeria, Peru, the Philippines, and South Africa-and will consists of 2 components: cross-sectional surveys and interviews (semistructured and group) among 4 respondent groupings: the general population, general population representatives, health care workers, and decision-makers. General population and health care worker survey responses will be analyzed separately from each other, using bivariate and multivariate inferential analysis and descriptive statistics. Semistructured interviews and group interviews will be audiorecorded, transcribed, and coded for thematic comparative analysis.

Results: As of November 19, 2021, participant enrollment is ongoing; 4364 participants have been enrolled in the general population survey, and 2233 participants have been enrolled in the health care workers survey. In the qualitative inquiry, 298 participants have been enrolled. We plan to complete data collection by December 31, 2021 and publish results in 2022 via publications, presentations at conferences, and dissemination events specifically targeted at local decision-makers, civil society, and patient groups.

Conclusions: The views and perceptions of local populations are crucial in the discussion of the safest strategies for implementing SARS-CoV-2 self-testing. We intend to identify sociocultural specificities that may hinder or accelerate the widespread utilization of SARS-CoV-2 self-testing.

International Registered Report Identifier (irrid): DERR1-10.2196/33088.
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November 2021

Assessing cost-effectiveness of hepatitis C testing pathways in Georgia using the Hep C Testing Calculator.

Sci Rep 2021 Nov 1;11(1):21382. Epub 2021 Nov 1.

Massachusetts General Hospital, Boston, MA, USA.

The cost of testing can be a substantial contributor to hepatitis C virus (HCV) elimination program costs in many low- and middle-income countries such as Georgia, resulting in the need for innovative and cost-effective strategies for testing. Our objective was to investigate the most cost-effective testing pathways for scaling-up HCV testing in Georgia. We developed a Markov-based model with a lifetime horizon that simulates the natural history of HCV, and the cost of detection and treatment of HCV. We then created an interactive online tool that uses results from the Markov-based model to evaluate the cost-effectiveness of different HCV testing pathways. We compared the current standard-of-care (SoC) testing pathway and four innovative testing pathways for Georgia. The SoC testing was cost-saving compared to no testing, but all four new HCV testing pathways further increased QALYs and decreased costs. The pathway with the highest patient follow-up, due to on-site testing, resulted in the highest discounted QALYs (123 QALY more than the SoC) and lowest costs ($127,052 less than the SoC) per 10,000 persons screened. The current testing algorithm in Georgia can be replaced with a new pathway that is more effective while being cost-saving.
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November 2021

Values and preferences for hepatitis C self-testing among the general population and healthcare workers in Rwanda.

BMC Infect Dis 2021 Oct 14;21(1):1064. Epub 2021 Oct 14.

Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.

Background: In 2018, Rwanda launched a 5-year hepatitis C virus (HCV) elimination plan as per the World Health Organization global targets to eliminate HCV by 2030. To improve awareness of HCV status, strategies are needed to ensure easy access to HCV testing by as-yet unreached populations. HCV-self-testing, an innovative strategy, could further increase HCV testing uptake. This assessment explores perceptions around HCV self-testing among members of the public and healthcare workers in Rwanda.

Methods: A qualitative study was undertaken in Masaka District Hospital, comprising individual interviews, group interviews and participatory action research (PAR) activities. Purposive and snowball sampling methods guided the selection of informants. Informed consent was obtained from all participants. A thematic analysis approach was used to analyse the findings.

Results: The participants comprised 36 members of the public and 36 healthcare workers. Informants appreciated HCV self-testing as an innovative means of increasing access to HCV testing, as well as an opportunity to test privately and subsequently autonomously decide whether to seek further HCV care. Informants further highlighted the need to make HCV self-testing services free of charge at the nearest health facility. Disadvantages identified included the lack of pre/post-test counselling, as well as the potential psychosocial harm which may result from the use of HCV self-testing.

Conclusion: HCV self-testing is perceived to be an acceptable method to increase HCV testing in Rwanda. Further research is needed to assess the impact of HCV self-testing on HCV cascade of care outcomes.
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October 2021

Hepatitis C core antigen test as an alternative for diagnosing HCV infection: mathematical model and cost-effectiveness analysis.

PeerJ 2021 10;9:e11895. Epub 2021 Sep 10.

Institute of Global Health, University of Geneva, Geneva, Switzerland.

Background: The cost and complexity of the polymerase chain reaction (PCR) test are barriers to diagnosis and treatment of hepatitis C virus (HCV) infection. We investigated the cost-effectiveness of testing strategies using antigen instead of PCR testing.

Methods: We developed a mathematical model for HCV to estimate the number of diagnoses and cases of liver disease. We compared the following testing strategies: antibody test followed by PCR in case of positive antibody (baseline strategy); antibody test followed by HCV-antigen test (antibody-antigen); antigen test alone; PCR test alone. We conducted cost-effectiveness analyses considering either the costs of HCV testing of infected and uninfected individuals alone (A1), HCV testing and liver-related complications (A2), or all costs including HCV treatment (A3). The model was parameterized for the country of Georgia. We conducted several sensitivity analyses.

Results: The baseline scenario could detect 89% of infected individuals. Antibody-antigen detected 86% and antigen alone 88% of infected individuals. PCR testing alone detected 91% of the infected individuals: the remaining 9% either died or spontaneously recovered before testing. In analysis A1, the baseline strategy was not essentially more expensive than antibody-antigen. In analysis A2, strategies using PCR became cheaper than antigen-based strategies. In analysis A3, antibody-antigen was again the cheapest strategy, followed by the baseline strategy, and PCR testing alone.

Conclusions: Antigen testing, either following a positive antibody test or alone, performed almost as well as the current practice of HCV testing. The cost-effectiveness of these strategies depends on the inclusion of treatment costs.
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September 2021

Hepatitis C elimination in Myanmar: Modelling the impact, cost, cost-effectiveness and economic benefits.

Lancet Reg Health West Pac 2021 May 23;10:100129. Epub 2021 Mar 23.

Burnet Institute Melbourne, 85 Commercial Rd, Melbourne 3004, Victoria, Australia.

Background: Myanmar has set national hepatitis C (HCV) targets to achieve 50% of people diagnosed and 50% treated by 2030. The WHO has additional targets of reducing incidence by 80% and mortality by 65% by 2030. We aimed to estimate the impact, cost, cost-effectiveness and net economic benefit of achieving these targets.

Methods: Mathematical models of HCV transmission, disease progression and the care cascade were calibrated to 15 administrative regions of Myanmar. Cost data were collected from a community testing and treatment program in Yangon. Three scenarios were projected for 2020-2030: (1) baseline (current levels of testing/treatment); and testing/treatment scaled up sufficiently to reach (2) the national strategy targets; and (3) the WHO targets.

Findings: Without treatment scale-up, 333,000 new HCV infections and 97,000 HCV-related deaths were estimated to occur in Myanmar 2020-2030, with HCV costing a total $100 million in direct costs (testing, treatment, disease management) and $10.4 billion in lost productivity. In the model, treating 55,000 people each year was sufficient to reach the national strategy targets and prevented a cumulative 40,000 new infections (12%) and 25,000 HCV-related deaths (25%) 2020-2030. This was estimated to cost a total $189 million in direct costs ($243 per DALY averted compared to no treatment scale-up), but only $9.8 billion in lost productivity, making it cost-saving from a societal perspective by 2024 with an estimated net economic benefit of $553 million by 2030. Reaching the WHO targets required further treatment scale-up and additional direct costs but resulted in greater longer-term benefits.

Interpretation: Current levels of HCV testing and treatment in Myanmar are insufficient to reach the national strategy targets. Scaling up HCV testing and treatment in Myanmar to reach the national strategy targets is estimated to generate significant health and economic benefits.

Funding: Gilead Sciences.
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May 2021

Values and preferences for hepatitis C self-testing among people who inject drugs in Kyrgyzstan.

BMC Infect Dis 2021 Jun 26;21(1):609. Epub 2021 Jun 26.

Foundation for Innovative New Diagnostics, Chemin des Mines 9, 1202, Geneva, Switzerland.

Background: The prevalence of hepatitis C virus (HCV) among people who inject drugs (PWID) continues to be a major public-health burden in this highly stigmatised population. To halt transmission of HCV, rapid HCV self-testing kits represent an innovative approach that could enable PWID to know their HCV status and seek treatment. As no HCV test has yet been licenced for self-administration, it is crucial to obtain knowledge around the factors that may deter or foster delivery of HCV self-testing among PWID in resource-constrained countries.

Methods: A qualitative study to assess values and preferences relating to HCV self-testing was conducted in mid-2020 among PWID in the Bishkek and Chui regions of Kyrgyzstan. Forty-seven PWID participated in 15 individual interviews, two group interviews (n = 12) and one participatory action-research session (n = 20). Responses were analysed using a thematic analysis approach with 4 predefined themes: awareness of HCV and current HCV testing experiences, and acceptability and service delivery preferences for HCV self-testing. Informants' insights were analysed using a thematic analysis approach. This research received local ethics approval.

Results: Awareness of HCV is low and currently PWID prefer community-based HCV testing due to stigma encountered in other healthcare settings. HCV self-testing would be accepted and appreciated by PWID. Acceptability may increase if HCV self-testing: was delivered in pharmacies or by harm reduction associations; was free of charge; was oral rather than blood-based; included instructions with images and clear information on the test's accuracy; and was distributed alongside pre- and post-testing counselling with linkage to confirmatory testing support.

Conclusions: HCV self-testing could increase awareness of and more frequent testing for HCV infection among PWID in Kyrgyzstan. It is recommended that peer-driven associations are involved in the delivery of any HCV self-testing. Furthermore, efforts should be maximised to end discrimination against PWID at the healthcare institutions responsible for confirmatory HCV testing and treatment provision.
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June 2021

Outcomes of the CT2 study: A 'one-stop-shop' for community-based hepatitis C testing and treatment in Yangon, Myanmar.

Liver Int 2021 11 10;41(11):2578-2589. Epub 2021 Jul 10.

Disease Elimination Program, Burnet Institute, Melbourne, Australia.

Background: With the advent of low-cost generic direct-acting antivirals (DAA), hepatitis C (HCV) elimination is now achievable even in low-/middle-income settings. We assessed the feasibility and effectiveness of a simplified clinical pathway using point-of-care diagnostic testing and non-specialist-led care in a decentralized, community-based setting.

Methods: This feasibility study was conducted at two sites in Yangon, Myanmar: one for people who inject drugs (PWID), and the other for people with liver disease. Participants underwent on-site rapid anti-HCV testing and HCV RNA testing using GeneXpert . General practitioners determined whether participants started DAA therapy immediately or required specialist evaluation. Primary outcome measures were progression through the HCV care cascade, including uptake of RNA testing and treatment, and treatment outcomes.

Findings: All 633 participants underwent anti-HCV testing; 606 (96%) were anti-HCV positive and had HCV RNA testing. Of 606 tested, 535 (88%) were RNA positive and had pre-treatment assessments; 30 (6%) completed specialist evaluation. Of 535 RNA positive participants, 489 (91%) were eligible to initiate DAAs, 477 (98%) completed DAA therapy and 421 achieved SVR12 (92%; 421/456). Outcomes were similar by site: PWID site: 91% [146/161], and liver disease site: 93% [275/295]). Compensated cirrhotic patients were treated in the community; they achieved an SVR12 of 83% (19/23). Median time from RNA test to DAA initiation was 3 days (IQR 2-5).

Conclusions: Delivering a simplified, non-specialist-led HCV treatment pathway in a decentralized community setting was feasible in Yangon, Myanmar; retention in care and treatment success rates were very high. This care model could be integral in scaling up HCV services in Myanmar and other low- and middle-income settings.
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November 2021

HCV Viral Load Greater Than 1000 IU/ml at Time of Virologic Failure in Direct-Acting Antiviral-Treated Patients.

Adv Ther 2021 03 15;38(3):1690-1700. Epub 2021 Feb 15.

Boston Medical Center, Section of Infectious Diseases, Boston University School of Public Health, Boston, MA, USA.

Introduction: One of the remaining barriers to reaching WHO elimination targets of achieving global hepatitis C (HCV) cure is a lack of an established lower limit of detection (LLOD) to confirm cure post-treatment in near-patient technologies. Determining a LLOD at virologic failure aids in increasing testing feasibility through point-of-care assays in resource-limited settings.

Methods: We described the level of viremia in 69 patients experiencing virologic failure across 20 clinical trials (ENDURANCE-1, ENDURANCE-2, ENDURANCE-3, ENDURANCE-4, ENDURANCE 5-6, MAGELLAN-1, MAGELLAN-2, EXPEDITION-1, EXPEDITION-2, EXPEDITION-3, EXPEDITION-4, EXPEDITION-5, EXPEDITION-8, SURVEYOR-1, SURVEYOR-2, VOYAGE-1, VOYAGE-2, CERTAIN-1, CERTAIN-2 and APRI). These findings were categorized as on-treatment, post-treatment week (PTW) 4 or PTW12 failures.

Results: The mean HCV RNA level at baseline in the overall population of 5033 patients was 4,193,712 IU/ml ± 5,955,028 (6.2 log IU/ml ± 0.8) compared to 9,585,957 IU/ml ± 8,247,669 (6.8 log IU/ml ± 0.5) in 69 patients experiencing virologic failure by PTW12. The mean HCV RNA level at the time of virologic failure for all patients was 6,004,980 IU/ml ± 7,077,728 (6.4 log IU/ml ± 0.7). Twenty patients had on-treatment virologic failure with a mean HCV RNA level at the time of failure of 9,136,360 IU/ml ± 8,572,113 (6.7 log IU/ml ± 0.7), 36 patients had relapsed by PTW4 with a mean HCV RNA level at the time of relapse of 4,131,344 IU/ml ± 5,246,954 (6.3 log IU/ml ± 0.6), and 13 patients, who experienced relapse between PTW4 and PTW12, had a mean HCV RNA at relapse of 6,376,003 IU/ml ± 7,758,968 (6.3 log IU/ml ± 1.0).

Conclusions: At PTW12, 100% of virologic failures had an HCV RNA > 3.0 log IU/ml. The data are encouraging that with a LLOD of 3.0 log IU/ml, a point-of-care test could identify all treatment failures accurately; larger studies, including real-world data, are needed to confirm these findings.
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March 2021

Integration of hepatitis C treatment at harm reduction centers in Georgia-Findings from a patient satisfaction survey.

Int J Drug Policy 2020 10 31;84:102893. Epub 2020 Jul 31.

Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address:

Background: Georgia launched national HCV elimination program in 2015. PWID may experience barriers to accessing HCV care. To improve linkage to care among PWID, pilot program to integrate HCV treatment with HR services at opiate substitution therapy (OST) centers and needle syringe program (NSP) sites was initiated. Our study aimed to assess satisfaction of patients with integrated HCV treatment services at HR centers.

Methods: Survey was conducted among convenience sample of patients receiving HCV treatment at 5 integrated care sites and 4 specialized clinics not providing HR services. Simplified pre-treatment diagnostic algorithm and treatment monitoring procedure was introduced for HCV treatment programs at OST/NSP centers which includes fewer pre-treatment and monitoring tests compared to standard algorithm.

Results: In total, 358 patients participated in the survey - 48.6% receiving HCV treatment at the specialized clinics while 51.4% at HR site with integrated treatment. Similar proportions of surveyed patients at HR sites (88.0%) and clinics (84.5%) stated that they did not face any barriers to enrollment in the elimination program. Most patients from HR pilot sites and specialized clinics stated that they received comprehensive information about the treatment (98.4% vs 94.3%; p<0.010). 95% of respondents at both sites were confident that confidentiality was completely protected during treatment. Higher proportion of patients at pilot sites thought that HCV treatment services provided at facility were good compared to those from the specialized clinics (85.3% vs 81.0%). We found significant difference in the time to treatment, measured as average time from viremia testing to administration of first dose of HCV medication: 42.9% of patients at pilot sites vs 4.6% at specialized clinics received the first dose of medication within two weeks.

Conclusion: Quality of services and perceived satisfaction of patients receiving treatment, suggests that integration of HCV treatment with HR services is feasible.
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October 2020

Decentralized, Community-Based Hepatitis C Point-of-Care Testing and Direct-Acting Antiviral Treatment for People Who Inject Drugs and the General Population in Myanmar: Protocol for a Feasibility Study.

JMIR Res Protoc 2020 Jul 14;9(7):e16863. Epub 2020 Jul 14.

Disease Elimination, Burnet Institute, Melbourne, Australia.

Background: The advent of direct-acting antivirals (DAAs) and point-of-care (POC) testing platforms for hepatitis C allow for the decentralization of care to primary care settings. In many countries, access to DAAs is generally limited to tertiary hospitals, with limited published research documenting decentralized models of care in low-and middle-income settings.

Objective: This study aims to assess the feasibility, acceptability, effectiveness, and cost-effectiveness of decentralized community-based POC testing and DAA therapy for hepatitis C among people who inject drugs and the general population in Yangon, Myanmar.

Methods: Rapid diagnostic tests for anti-hepatitis C antibodies were carried out on-site and, if reactive, were followed by POC GeneXpert hepatitis C RNA polymerase chain reaction tests. External laboratory blood tests to exclude other major health issues were undertaken. Results were given to participants at their next appointment, with the participants commencing DAA therapy that day if a specialist review was not required. Standard clinical data were collected, and the participants completed behavioral questionnaires. The primary outcome measures are the proportion of participants receiving GeneXpert hepatitis C RNA test, the proportion of participants commencing DAA therapy, the proportion of participants completing DAA therapy, and the proportion of participants achieving sustained virological response 12 weeks after completing DAA therapy.

Results: Recruitment was completed on September 30, 2019. Monitoring visits and treatment outcome visits are scheduled to continue until June 2020.

Conclusions: This feasibility study in Myanmar contributes to the evidence gap for community-based hepatitis C care in low- and middle-income settings. Evidence from this study will inform the scale-up of hepatitis C treatment programs in Myanmar and globally.
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July 2020

Facilitators and barriers in the utilization of World Health Organization's Preventing Early Pregnancy Guidelines in formulating laws, policies and strategies: what do stakeholders in Ethiopia say?

Int J Adolesc Med Health 2019 Jul 4;33(5). Epub 2019 Jul 4.

Departments of Pediatrics and Global Health, University of Washington, 6200 Northeast 74th Street, Suite 110, Box 354920, Seattle, WA 98115, USA.

Background: Each year, approximately 16 million 15-19 year-old girls give birth. In 2011 the World Health Organization (WHO) published the evidence-based "Preventing Early Pregnancy and Poor Reproductive Outcomes among Adolescents in Low and Middle Income Countries" guidelines to inform policies and programs. However, little is known about their country-level use to influence supportive environments to reduce early childbearing. We sought to identify alignment of Ethiopian laws, polices and strategies with these guidelines, whether these guidelines contributed to them, and identify facilitators and barriers to their utilization.

Methods: First, we analyzed Ethiopian legal, policy, and strategy documents relating to adolescent pregnancy to determine their alignment with the WHO early pregnancy guidelines. We then conducted and thematically analyzed 11 interviews with key informants (KIs) working in adolescent and/or reproductive health at the national level.

Results: Laws, policies, and strategies to address early childbearing are in place in Ethiopia and address the six domains of the WHO adolescent pregnancy guidelines. KIs reported that they were aware of the WHO adolescent pregnancy guidelines, but none mentioned it without prompting. Six barrier/facilitator themes emerged: knowledge, national agenda, laws, resources, culture, and cooperation.

Conclusions: Ethiopia has a policy framework consistent with WHO's adolescent pregnancy guidelines which may have contributed to their development. The lack of spontaneous identification of the guidelines by the KIs we interviewed, raises questions of their knowledge and use of the guidelines. Targeted dissemination of guidelines by WHO to relevant stakeholders may facilitate their use.
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July 2019