Home-based hepatitis C self-testing in people who inject drugs and men who have sex with men in Georgia: a protocol for a randomised controlled trial

Introduction Globally, it is estimated that more than three-quarters of people with chronic hepatitis C virus (HCV) are unaware of their HCV status. HCV self-testing (HCVST) may improve access and uptake of HCV testing particularly among key populations such as people who inject drugs (PWID) and men who have sex with men (MSM) where HCV prevalence and incidence are high and barriers to accessing health services due to stigma and discrimination are common. Methods and analysis This randomised controlled trial compares an online programme offering oral fluid-based HCVST delivered to the home with referral to standard-of-care HCV testing at HCV testing sites. Eligible participants are adults self-identifying as either MSM or PWID who live in Tbilisi or Batumi, Georgia, and whose current HCV status is unknown. Participants will be recruited through an online platform and randomised to one of three arms for MSM (courier delivery, peer delivery and standard-of-care HCV testing (control)) and two for PWID (peer delivery and standard-of-care HCV testing (control)). Participants in the postal delivery group will receive an HCVST kit delivered by an anonymised courier. Participants in the peer delivery groups will schedule delivery of the HCVST by a peer. Control groups will receive information on how to access standard-of-care testing at a testing site. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who (a) receive a positive result and are made aware of their status, (b) are referred to and complete HCV RNA confirmatory testing, and (c) start treatment. Acceptability, feasibility, and attitudes around HCV testing and cost will also be evaluated. The target sample size is 1250 participants (250 per arm)

A quasi-randomised controlled trial of online distribution of home-based hepatitis C self-testing for key populations in Malaysia: a study protocol.

BACKGROUND: Malaysia has an estimated hepatitis C virus (HCV) prevalence of 1.9% among its adult population and a history of providing HCV treatment in the public sector. In 2019, Malaysia launched a 5-year national strategic plan for viral hepatitis control and has been expanding HCV testing and treatment to the primary care and community levels, while actively engaging key populations in services for hepatitis care. The Ministry of Health (MoH) is seeking to specifically understand how to better target HCV services at men who have sex with men (MSM); HCV self-testing could increase the uptake of HCV testing among this group. METHODS: We aim to integrate HCV antibody self-testing into an existing online platform used for HIV self-testing, to evaluate the acceptability and impact of an online HCV self-testing programme in Malaysia. This is a non-blinded parallel group quasi-randomised superiority study comparing HCV self-testing via an online distribution model with the standard care, which involves attending a clinic for facility-based HCV antibody testing (control, 2:1). Participants will be randomised to either the HCV self-testing via online distribution arm, in which either an oral fluid- or blood-based HCV self-test kit will be mailed to them, or the control arm, where they will be provided with information about the nearest centre with HCV testing. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who (a) receive a positive result and are made aware of their status, (b) are referred to and complete HCV RNA confirmatory testing, and (c) start treatment. Acceptability, feasibility, attitudes around HCV testing, and cost will also be evaluated. The target sample size is 750 participants. DISCUSSION: This study is one of the first in the world to explore the real-world impact of HCV self-testing on key populations using online platforms and compare this with standard HCV testing services. The outcomes of this study will provide critical evidence about testing uptake, linkage to care, acceptability, and any social harms that may emerge due to HCV self-testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT04982718

Systematic review of the accuracy of plasma preparation tubes for HIV viral load testing.

Expanding access to HIV viral load testing is essential to improving the care and treatment of people living with HIV/AIDS and ending the AIDS epidemic. Though significant investments have been made in the past five years, many high burden, low resource countries continue to have viral load access rates below 50%. Plasma preparation tubes (PPTs) can simplify storage, transport, and preparation of plasma used for viral load testing. A systematic review was conducted to evaluate the accuracy of plasma preparation tubes for HIV viral load testing. Study results regarding the accuracy of PPT viral load measurements across various storage and transportation conditions were examined. The quality of evidence was evaluated using GRADE and QUADAS-2 criteria. The review identified 16 studies using PPTs with data from 6,141 individuals from 1995 to 2014. Overall the quality of evidence was rated as moderate, with unclear applicability for studies evaluating viral load assays that are no longer commercially available. Significantly elevated viral load results (>0.3 log copies/ml difference) have been observed with PPTs; however, when manufacturer handling instructions are followed, when plasma is aliquoted into a secondary tube, or when PPTs are centrifuged prior to testing, PPT results only differed from standard EDTA plasma testing using commercially available viral load assays by a range on average of -0.03 to +0.08 log copies/ml across studies. Although spuriously elevated viral load results have been observed with PPTs, following proper sample handing techniques have been shown to provide accurate results. PPTs, therefore, provide a high quality alternative specimen type for countries seeking solutions to infrastructure and specimen transportation challenges in an effort to scale-up viral load testing and achieve 90-90-90 targets

Performance of non-laboratory staff for diagnostic testing and specimen collection in HIV programs: A systematic review and meta-analysis.

BackgroundIn most high HIV burden countries, many HIV patients do not have reliable access to required diagnostic laboratory tests. Task shifting of clinical tasks to lower cadres of health care workers and lay counselors has been successful in scaling up treatment for HIV and may also be an effective strategy in expanding access to essential diagnostic testing.MethodsWe screened major electronic databases between 1 January 2005 to 26 August 2018 to identify studies assessing ease of use and accuracy of task shifting of HIV-related diagnostic testing and/or specimen collection to non-laboratory health staff. Two independent reviewers screened all titles and abstracts for studies that analyzed diagnostic accuracy, patient impact, ease-of-use, or cost-effectiveness. Studies were assessed for quality, bias, and applicability following the QUADAS-2 framework. We generated summary estimates using random-effects meta-analyses.ResultsWe identified 42 relevant studies. Overall, point-of-care CD4 testing performed by non-laboratory staff had a mean bias of -54.44 (95% CI: -72.40 --36.48) compared to conventional laboratory-based. Though studies were limited, the diagnostic accuracy of point-of-care alanine transaminase enzyme (ALT) and hemoglobin testing performed by non-laboratory staff was comparable to conventional laboratory-based testing by laboratory professionals. Point-of-care testing and/or specimen collection were generally found to be acceptable and easy to use for non-laboratory staff.ConclusionsTask shifting of testing using point-of-care technologies to non-laboratory staff was comparable to laboratory professionals operating the same technology in the laboratory. Some variability was observed comparing the performance of point-of-care CD4 testing by non-laboratory staff to conventional laboratory-based technologies by laboratory professionals indicating potential lower performance was likely technological rather than operator caused. The benefits of task shifting of testing may outweigh any possible harms as task shifting allows for increased decentralization, access of specific diagnostics, and faster result delivery

POC CD4 Testing Improves Linkage to HIV Care and Timeliness of ART Initiation in a Public Health Approach: A Systematic Review and Meta-Analysis

<div><p>Background</p><p>CD4 cell count is an important test in HIV programs for baseline risk assessment, monitoring of ART where viral load is not available, and, in many settings, antiretroviral therapy (ART) initiation decisions. However, access to CD4 testing is limited, in part due to the centralized conventional laboratory network. Point of care (POC) CD4 testing has the potential to address some of the challenges of centralized CD4 testing and delays in delivery of timely testing and ART initiation. We conducted a systematic review and meta-analysis to identify the extent to which POC improves linkages to HIV care and timeliness of ART initiation.</p><p>Methods</p><p>We searched two databases and four conference sites between January 2005 and April 2015 for studies reporting test turnaround times, proportion of results returned, and retention associated with the use of point-of-care CD4. Random effects models were used to estimate pooled risk ratios, pooled proportions, and 95% confidence intervals.</p><p>Results</p><p>We identified 30 eligible studies, most of which were completed in Africa. Test turnaround times were reduced with the use of POC CD4. The time from HIV diagnosis to CD4 test was reduced from 10.5 days with conventional laboratory-based testing to 0.1 days with POC CD4 testing. Retention along several steps of the treatment initiation cascade was significantly higher with POC CD4 testing, notably from HIV testing to CD4 testing, receipt of results, and pre-CD4 test retention (all p<0.001). Furthermore, retention between CD4 testing and ART initiation increased with POC CD4 testing compared to conventional laboratory-based testing (p = 0.01). We also carried out a non-systematic review of the literature observing that POC CD4 increased the projected life expectancy, was cost-effective, and acceptable.</p><p>Conclusions</p><p>POC CD4 technologies reduce the time and increase patient retention along the testing and treatment cascade compared to conventional laboratory-based testing. POC CD4 is, therefore, a useful tool to perform CD4 testing and expedite result delivery.</p></div

Proportions and risk ratios of patients reaching the next stage in the testing and treatment cascade.

<p>(a) Proportions of patients reaching the next stage in the testing and treatment cascade. Orange dashes and bars represent the estimated proportion of retention and 95% confidence intervals of patients receiving conventional laboratory-based testing, while blue dashes and bars represent the estimated proportion of retention and 95% confidence intervals of patients receiving POC CD4 testing. (b) Risk ratios for the likelihood of retention until the next stage in the testing and treatment cascade.</p

PRISMA diagram of search outcome and included studies.

<p>PRISMA diagram of search outcome and included studies.</p