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Background: The prevalence of diseases other than tuberculosis (TB) detected during chest X‐ray screening is poorly described in sub‐Saharan Africa. Computer‐assisted digital chest X‐ray technology is available for TB screening and has the potential to be a screening tool for non‐communicable diseases as well. Low‐ and middle‐income countries are in a transition period where the burden of non‐communicable diseases is increasing, but health systems are mainly focused on addressing infectious diseases. Methods: Participants were adults undergoing computer‐assisted chest X‐ray screening for tuberculosis in a community‐wide tuberculosis prevalence survey in Blantyre, Malawi. Adults with abnormal radiographs by field radiographer interpretation were evaluated by a physician in a community‐based clinic. X‐ray classifications were compared to classifications of a random sample of normal chest X‐rays by radiographer interpretation. Radiographic features were classified using WHO Integrated Management for Adult Illnesses (IMAI) guidelines. All radiographs taken at the screening tent were analysed by the Qure.ai qXR v2.0 software. Results: 5% (648/13,490) of adults who underwent chest radiography were identified to have an abnormal chest X‐ray by the radiographer. 387 (59.7%) of the participants attended the X‐ray clinic, and another 387 randomly sampled normal X‐rays were available for comparison. Participants who were referred to the community clinic had a significantly higher HIV prevalence than those who had been identified to have a normal CXR by the field radiographer (90 [23.3%] vs. 43 [11.1%] p‐value < 0.001). The commonest radiographic finding was cardiomegaly (20.7%, 95% CI 18.0–23.7). One in five (81/387) chest X‐rays were misclassified by the radiographer. The overall mean Qure.ai qXR v2.0 score for all reviewed X‐rays was 0.23 (SD 0.20). There was a high concordance of cardiomegaly classification between the physician and the computer‐assisted software (109/118, 92.4%). Conclusion: There is a high burden of cardiomegaly on a chest X‐ray at a community level, much of which is in patients with diabetes, heart disease and high blood pressure. Cardiomegaly on chest X‐ray may be a potential tool for screening for cardiovascular NCDs at the primary care level as well as in the community. [ABSTRACT FROM AUTHOR]

Background: HIV and tuberculosis are frequently diagnosed concurrently. In March 2021, World Health Organization recommended that antiretroviral therapy (ART) should be started within two weeks of tuberculosis treatment start, at any CD4 count. We assessed whether earlier ART improved outcomes in people with newly diagnosed HIV and tuberculosis. Methods: We did a systematic review by searching nine databases for trials that compared earlier ART to later ART initiation in people with HIV and tuberculosis. We included studies published from database inception to 12 March 2021. We compared ART within four weeks versus ART more than four weeks after TB treatment, and ART within two weeks versus ART between two and eight weeks, and stratified analysis by CD4 count. The main outcome was death; secondary outcomes included IRIS and AIDS‐defining events. We pooled effect estimates using random effects meta‐analysis. Results and discussion: We screened 2468 abstracts, and identified nine trials. Among people with all CD4 counts, there was no difference in mortality by earlier ART (≤4 week) versus later ART (>4 week) (risk difference [RD] 0%, 95% confidence interval [CI] −2% to +1%). Among people with CD4 count ≤50 cells/mm3, earlier ART (≤4 weeks) reduced risk of death (RD −6%, −10% to −1%). Among people with all CD4 counts earlier ART (≤4 weeks) increased the risk of IRIS (RD +6%, 95% CI +2% to +10%) and reduced the incidence of AIDS‐defining events (RD −2%, 95% CI −4% to 0%). Results were similar when trials were restricted to the four trials which permitted comparison of ART within two weeks to ART between two and eight weeks. Trials were conducted between 2004 and 2014, before recommendations to treat HIV at any CD4 count or to rapidly start ART in people without TB. No trials included children or pregnant women. No trials included integrase inhibitors in ART regimens. Discussion: Earlier ART did not alter risk of death overall among people living with HIV who had TB disease. For logistical and patient preference reasons, earlier ART initiation for everyone with TB and HIV may be preferred to later ART. [ABSTRACT FROM AUTHOR]

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Copyright of Tropical Medicine & International Health is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract: Introduction: HIV and tuberculosis (TB) remain leading causes of preventable death in low‐ and middle‐income countries (LMICs). The World Health Organization (WHO) recommends HIV testing for all individuals with TB symptoms, but implementation has been suboptimal. We conducted a systematic literature review and meta‐analyses to estimate HIV and TB prevalence, and short‐term (two to six months) mortality, among adults with TB symptoms at community‐ and facility level. Methods: We searched Embase, Global Health and MEDLINE databases, and reviewed conference abstracts for studies reporting simultaneous HIV and TB screening of adults in LMICs published between January 2003 and December 2017. Meta‐analyses were performed to estimate prevalence of HIV, undiagnosed TB and mortality risk at different health system levels. Results: Sixty‐two studies including 260,792 symptomatic adults were identified, mostly from Africa and Asia. Median HIV prevalence was 19.2% (IQR: 8.3% to 40.4%) at community level, 55.7% (IQR: 20.9% to 71.2%) at primary care level and 80.7% (IQR: 73.8% to 84.6%) at hospital level. Median TB prevalence was 6.9% (IQR: 3.3% to 8.4%) at community, 20.5% (IQR: 11.7% to 46.4%) at primary care and 36.4% (IQR: 22.9% to 40.9%) at hospital level. Median short‐term mortality was 22.6% (IQR: 15.6% to 27.7%) among inpatients, 3.1% (IQR: 1.2% to 4.2%) at primary care and 1.6% (95% CI: 0.45 to 4.13, n = 1 study) at community level. Conclusions: Adults with TB symptoms have extremely high prevalence of HIV infection, even when identified through community surveys. TB prevalence and mortality increased substantially at primary care and inpatient level respectively. Strategies to expand symptom‐based TB screening combined with HIV and TB testing for all symptomatic individuals should be of the highest priority for both disease programmes in LMICs with generalized HIV epidemics. Interventions to reduce short‐term mortality are urgently needed. [ABSTRACT FROM AUTHOR]

Copyright of Tropical Medicine & International Health is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: The World Health Organization (WHO) recommends that HIV-positive adults with CD4 count ≤500 cells/mm3 initiate antiretroviral therapy (ART). In many countries of sub-Saharan Africa, CD4 count is not widely available or consistently used and instead the WHO clinical staging system is used to determine ART eligibility. However, concerns have been raised regarding its discriminatory ability to identify patients eligible to start ART. We therefore reviewed the accuracy of WHO stage 3 or 4 assessment in identifying ART eligibility according to CD4 count thresholds for ART initiation. Methods: We systematically searched PubMed and Global Health databases and conference abstracts using a comprehensive strategy for studies that compared the results of WHO clinical staging with CD4 count thresholds. Studies performed in sub-Saharan Africa and published in English between 1998 and 2013 were eligible for inclusion according to our predefined study protocol. Two authors independently extracted data and assessed methodological quality and risk of bias using the Quality Assessment Tool for Diagnostic Accuracy Studies (QUADAS-2) tool. Summary estimates of sensitivity and specificity were derived for each CD4 count threshold and hierarchical summary receiver operator characteristic curves were plotted. Results: Fifteen studies met the inclusion criteria, including 25,032 participants from 14 countries. Most studies assessed individuals attending ART clinics prior to treatment initiation. WHO clinical stage 3 or 4 disease had a sensitivity of 60% (95% CI: 45–73%, Q=914.26, p<0.001) and specificity of 73% (95% CI: 60–83%, Q=1439.43, p<0.001) for a CD4 threshold of ≤200 cells/mm3 (11 studies); sensitivity and specificity for a threshold of CD4 count ≤350 cells/mm3 were 45% (95% CI: 26–66%, Q=1607.31, p<0.001) and 85% (95% CI: 69–93%, Q=896.70, p<0.001), respectively (six studies). For the threshold of CD4 count ≤500 cells/mm3 sensitivity was 14% (95% CI: 13–15%) and specificity was 95% (95% CI: 94–96%) (one study). Conclusions: When used for individual treatment decisions, WHO clinical staging misses a high proportion of individuals who are ART eligible by CD4 count, with sensitivity falling as CD4 count criteria rises. Access to accurate, accessible, robust and affordable CD4 count testing methods will be a pressing need for as long as ART initiation decisions are based on criteria other than seropositivity. [ABSTRACT FROM AUTHOR]

Introduction Linkage from HIV testing and counselling (HTC) to initiation of antiretroviral therapy (ART) is suboptimal in many national programmes in sub-Saharan Africa, leading to delayed initiation of ART and increased risk of death. Reasons for failure of linkage are poorly understood. Methods Semi-structured qualitative interviews were undertaken with health providers and HIV-positive primary care patients as part of a prospective cohort study at primary health centres in Blantyre, Malawi. Patients successful and unsuccessful in linking to ART were included. Results Progression through the HIV care pathway was strongly influenced by socio-cultural norms, particularly around the perceived need to regain respect lost during a period of visibly declining health. Capacity to call upon the support of networks of families, friends and employers was a key determinant of successful progression. Over-busy clinics, non-functioning laboratories and unsuitable tools used for ART eligibility assessment (WHO clinical staging system and centralized CD4 count measurement) were important health systems determinants of drop-out. Conclusions Key interventions that could rapidly improve linkage include guarantee of same-day, same-clinic ART eligibility assessments; utilization of the support offered by peer-groups and community health workers; and integration of HTC and ART programmes. [ABSTRACT FROM AUTHOR]

Copyright of Tropical Medicine & International Health is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

To present an algorithm for primary-care health workers for identifying HIV-infected adolescents in populations at high risk through mother-to-child transmission. Five hundred and six adolescent (10-18 years) attendees to two primary care clinics in Harare, Zimbabwe, were recruited. A randomly extracted 'training' data set ( n = 251) was used to generate an algorithm using variables identified as associated with HIV through multivariable logistic regression. Performance characteristics of the algorithm were evaluated in the remaining ('test') records ( n = 255) at different HIV prevalence rates. HIV prevalence was 17%, and infection was independently associated with client-reported orphanhood, past hospitalization, skin problems, presenting with sexually transmitted infection and poor functional ability. Classifying adolescents as requiring HIV testing if they reported >1 of these five criteria had 74% sensitivity and 80% specificity for HIV, with the algorithm correctly predicting the HIV status of 79% of participants. In low-HIV-prevalence settings (<2%), the algorithm would have a high negative predictive value (≥99.5%) and result in an estimated 60% decrease in the number of people needing to test to identify one HIV-infected individual, compared with universal testing. Our simple algorithm can identify which individuals are likely to be HIV infected with sufficient accuracy to provide a screening tool for use in settings not already implementing universal testing policies among this age-group, for example immigrants to low-HIV-prevalence countries. [ABSTRACT FROM AUTHOR]

Objective: To qualitatively investigate reasons why individuals who reported chronic cough of 2 weeks or more in a cross-sectional prevalence survey had not accessed community-based outreach or other diagnostic services.Methods: This study was nested into a cluster randomised trial comparing two methods of providing community-level diagnosis for tuberculosis (TB). Twenty individuals (12 males) with previously unreported chronic cough, because of undiagnosed pulmonary TB in five cases, were interviewed. An additional 20 individuals who had attended clinical services participated in two focus group discussions. Data were coded and analysed using grounded theory principles.Results: Participants described cough, and specifically their own symptoms, as having many possible causes other than TB. People avoided care-seeking for cough to avoid a possible diagnosis of 'TB2' (HIV-related TB). Waiting in the hope of spontaneous resolution was common. Delaying treatment-seeking was also a strategy for deferring costs. Another common theme was negative perceptions of health facilities, as places where people anticipated discourteous treatment and being put at risk of contracting TB and HIV. Expectations that they should be in control of their own health further contributed to delayed health-seeking in men.Conclusions: Some individuals remain reluctant to be investigated for chronic cough even when provided with community-level services, with fear of the connotations of being diagnosed with TB and an aversion to contact with health providers among the dominant themes. In men, deferred acceptance that a chronic cough should be investigated may be related to concepts of masculinity, especially when symptoms are mild. [ABSTRACT FROM AUTHOR]

Introduction: HIV self‐testing (HIVST) provides couples and individuals with a discreet, convenient and empowering testing option. As with all HIV testing, potential harms must be anticipated and mitigated to optimize individual and public health benefits. Here, we describe social harms (SHs) reported during HIVST implementation in Malawi, and propose a framework for grading and responding to harms, according to their severity. Methods: We report findings from six HIVST implementation studies in Malawi (2011 to 2017) that included substudies investigating SH reports. Qualitative methods included focus group discussions, in‐depth interviews and critical incident interviews. Earlier studies used intensive quantitative methods (post‐test questionnaires for intimate partner violence, household surveys, investigation of all deaths in HIVST communities). Later studies used post‐marketing reporting with/without community engagement. Pharmacovigilance methodology (whereby potentially life‐threatening/changing events are defined as "serious") was used to grade SH severity, assuming more complete passive reporting for serious events. Results: During distribution of 175,683 HIVST kits, predominantly under passive SH reporting, 25 serious SHs were reported from 19 (0.011%) self‐testers, including 15 partners in eight couples with newly identified HIV discordancy, and one perinatally infected adolescent. There were no deaths or suicides. Marriage break‐up was the most commonly reported serious SH (sixteen individuals; eight couples), particularly among serodiscordant couples. Among new concordant HIV‐positive couples, blame and frustration was common but rarely (one episode) led to serious SHs. Among concordant HIV‐negative couples, increased trust and stronger relationships were reported. Coercion to test or disclose was generally considered "well‐intentioned" within established couples. Women felt empowered and were assertive when offering HIVST test kits to their partners. Some women who persuaded their partner to test, however, did report SHs, including verbal or physical abuse and economic hardship. Conclusions: After more than six years of large‐scale HIVST implementation and in‐depth investigation of SHs in Malawi, we identified approximately one serious reported SH per 10,000 HIVST kits distributed, predominantly break‐up of married serodiscordant couples. Both "active" and "passive" reporting systems identified serious SH events, although with more complete capture by "active" systems. As HIVST is scaled‐up, efforts to support and further optimize community‐led SH monitoring should be prioritized alongside HIVST distribution. [ABSTRACT FROM AUTHOR]

Introduction: The ability to achieve an accurate test result and interpret it correctly is critical to the impact and effectiveness of HIV self‐testing (HIVST). Simple and easy‐to‐use devices, instructions for use (IFU) and other support tools have been shown to be key to good performance in sub‐Saharan Africa and may be highly contextual. The objective of this study was to explore the utility of cognitive interviewing in optimizing the local understanding of manufacturers' IFUs to achieve an accurate HIVST result. Methods: Functionally literate and antiretroviral therapy‐naive participants were purposefully selected between May 2016 and June 2017 to represent intended users of HIV self‐tests from urban and rural areas in Malawi and Zambia. Participants were asked to follow IFUs for HIVST. We then conducted cognitive interviews and observed participants while they attempted to complete the HIVST steps using a structured guide, which mirrored the steps in the IFU. Qualitative data were analysed using a thematic approach. Results: Of a total of 61 participants, many successfully performed most steps in the IFU. Some had difficulties in understanding these and made errors, which could have led to incorrect test results, such as incorrect use of buffer and reading the results prematurely. Participants with lower levels of literacy and inexperience with standard pictorial images were more likely to struggle with IFUs. Difficulties tended to be more pronounced among those in rural settings. Ambiguous terms and translations in the IFU, unfamiliar images and symbols, and unclear order of the steps to be followed were most commonly linked to errors and lower comprehension among participants. Feedback was provided to the manufacturer on the findings, which resulted in further optimization of IFUs. Conclusions: Cognitive interviewing identifies local difficulties in conducting HIVST from manufacturer‐translated IFUs. It is a useful and practical methodology to optimize IFUs and make them more understandable. [ABSTRACT FROM AUTHOR]

Introduction: HIV self‐testing (HIVST) was first proposed as an additional option to standard HIV testing services in the 1980s. By 2015, two years after the first HIVST kit was approved for the American market and the year in which Unitaid invested in the "HIV Self‐Testing AfRica (STAR) Initiative," HIVST remained unexplored with negligible access in low‐ and middle‐income countries (LMIC). However, rapid progress had been made. This commentary outlines the interlinked market, regulatory and policy barriers that had inhibited product development and kept HIVST out of LMIC policy. We detail the components of STAR that enabled rapid HIVST scale‐up, including critical investments in implementation, research, market forecasting, and engagement with manufacturers and regulators. Discussion: The STAR Initiative has generated crucial information about how to distribute HIVST products effectively, ethically and efficiently. Service delivery models range from clinic‐based distribution to workplace and partner‐delivered approaches to reach first‐time male testers, to community outreach to sex workers and general population "hotspots." These data directly informed supportive policy, notably the 2016 WHO guidelines strongly recommending HIVST as an additional testing approach, and regulatory change through support for WHO prequalification of the first HIVST kit in 2017. In July 2015, only two countries had national HIVST policies and were implementing HIVST. Three years later, 59 countries have policies, actively implemented in 28, with an additional 53 countries reporting policies under development. By end‐November 2018 several quality‐assured HIVST products had been registered, including two WHO prequalified tests. STAR Initiative countries have drafted regulations governing in vitro diagnostics, including HIVST products. With enabling policies, pre‐qualification and regulations in place, donor procurement of kits has increased rapidly, to a forecasted estimate of 16 million HIVST kits procured by 2020. Conclusions: The STAR Initiative provided a strong foundation to introduce HIVST in LMICs and allow for rapid scale‐up based on the wealth of multi‐country evidence gathered. Together with sustained coordination and acceleration of market development work, HIVST can help address the testing gap and provide a focused and cost‐effective means to expand access to treatment and prevention services. [ABSTRACT FROM AUTHOR]

Introduction: New HIV testing strategies are needed to reach the United Nations' 90‐90‐90 target. HIV self‐testing (HIVST) can increase uptake, but users' perspectives on optimal models of distribution and post‐test services are uncertain. We used discrete choice experiments (DCEs) to explore the impact of service characteristics on uptake along the testing cascade. Methods: DCEs are a quantitative survey method that present respondents with repeated choices between packages of service characteristics, and estimate relative strengths of preferences for service characteristics. From June to October 2016, we embedded DCEs within a population‐based survey following door‐to‐door HIVST distribution by community volunteers in two rural Zimbabwean districts: one DCE addressed HIVST distribution preferences; and the other preferences for linkage to confirmatory testing (LCT) following self‐testing. Using preference coefficients/utilities, we identified key drivers of uptake for each service and simulated the effect of changes of outreach and static/public clinics' characteristics on LCT. Results: Distribution and LCT DCEs surveyed 296/329 (90.0%) and 496/594 (83.5%) participants; 81.8% and 84.9% had ever‐tested, respectively. The strongest distribution preferences were for: (1) free kits – a $1 increase in the kit price was associated with a disutility (U) of −2.017; (2) door‐to‐door kit delivery (U = +1.029) relative to collection from public/outreach clinic; (3) telephone helpline for pretest support relative to in‐person or no support (U = +0.415); (4) distributors from own/local village (U = +0.145) versus those from external communities. Participants who had never HIV tested valued phone helplines more than those previously tested. The strongest LCT preferences were: (1) immediate antiretroviral therapy (ART) availability: U = +0.614 and U = +1.052 for public and outreach clinics, respectively; (2) free services: a $1 user fee increase decreased utility at public (U = −0.381) and outreach clinics (U = −0.761); (3) proximity of clinic (U = −0.38 per hour walking). Participants reported willingness to link to either location; but never‐testers were more averse to LCT. Simulations showed the importance of availability of ART: ART unavailability at public clinics would reduce LCT by 24%. Conclusions: Free HIVST distribution by local volunteers and immediately available ART were the strongest relative preferences identified. Accommodating LCT preferences, notably ensuring efficient provision of ART, could facilitate "resistant testers" to test while maximizing uptake of post‐test services. [ABSTRACT FROM AUTHOR]

Introduction: The prevalence of undiagnosed HIV is declining in Africa, and various HIV testing approaches are finding lower positivity rates. In this context, the epidemiological impact and cost‐effectiveness of community‐based HIV self‐testing (CB‐HIVST) is unclear. We aimed to assess this in different sub‐populations and across scenarios characterized by different adult HIV prevalence and antiretroviral treatment programmes in sub‐Saharan Africa. Methods: The synthesis model was used to address this aim. Three sub‐populations were considered for CB‐HIVST: (i) women having transactional sex (WTS); (ii) young people (15 to 24 years); and (iii) adult men (25 to 49 years). We assumed uptake of CB‐HIVST similar to that reported in epidemiological studies (base case), or assumed people use CB‐HIVST only if exposed to risk (condomless sex) since last HIV test. We also considered a five‐year time‐limited CB‐HIVST programme. Cost‐effectiveness was defined by an incremental cost‐effectiveness ratio (ICER; cost‐per‐disability‐adjusted life‐year (DALY) averted) below US$500 over a time horizon of 50 years. The efficiency of targeted CB‐HIVST was evaluated using the number of additional tests per infection or death averted. Results: In the base case, targeting adult men with CB‐HIVST offered the greatest impact, averting 1500 HIV infections and 520 deaths per year in the context of a simulated country with nine million adults, and impact could be enhanced by linkage to voluntary medical male circumcision (VMMC). However, the approach was only cost‐effective if the programme was limited to five years or the undiagnosed prevalence was above 3%. CB‐HIVST to WTS was the most cost‐effective. The main drivers of cost‐effectiveness were the cost of CB‐HIVST and the prevalence of undiagnosed HIV. All other CB‐HIVST scenarios had an ICER above US$500 per DALY averted. Conclusions: CB‐HIVST showed an important epidemiological impact. To maximize population health within a fixed budget, CB‐HIVST needs to be targeted on the basis of the prevalence of undiagnosed HIV, sub‐population and the overall costs of delivering this testing modality. Linkage to VMMC enhances its cost‐effectiveness. [ABSTRACT FROM AUTHOR]

Introduction: Strategies employing a single rapid diagnostic test (RDT) such as HIV self‐testing (HIVST) or "test for triage" (T4T) are proposed to increase HIV testing programme impact. Current guidelines recommend serial testing with two or three RDTs for HIV diagnosis, followed by retesting with the same algorithm to verify HIV‐positive status before anti‐retroviral therapy (ART) initiation. We investigated whether clients presenting to HIV testing services (HTS) following a single reactive RDT must undergo the diagnostic algorithm twice to diagnose and verify HIV‐positive status, or whether a diagnosis with the setting‐specific algorithm is adequate for ART initiation. Methods: We calculated (1) expected number of false‐positive (FP) misclassifications per 10,000 HIV negative persons tested, (2) positive predictive value (PPV) of the overall HIV testing strategy compared to the WHO recommended PPV ≥99%, and (3) expected cost per FP misclassified person identified by additional verification testing in a typical low‐/middle‐income setting, compared to the expected lifetime ART cost of $3000. Scenarios considered were as follows: 10% prevalence using two serial RDTs for diagnosis, 1% prevalence using three serial RDTs, and calibration using programmatic data from Malawi in 2017 where the proportion of people testing HIV positive in facilities was 4%. Results: In the 10% HIV prevalence setting with a triage test, the expected number of FP misclassifications was 0.86 per 10,000 tested without verification testing and the PPV was 99.9%. In the 1% prevalence setting, expected FP misclassifications were 0.19 with 99.8% PPV, and in the Malawi 2017 calibrated setting the expected misclassifications were 0.08 with 99.98% PPV. The cost per FP identified by verification testing was $5879, $3770, and $24,259 respectively. Results were sensitive to assumptions about accuracy of self‐reported reactive results and whether reactive triage test results influenced biased interpretation of subsequent RDT results by the HTS provider. Conclusions: Diagnosis with the full algorithm following presentation with a reactive triage test is expected to achieve PPV above the 99% threshold. Continuing verification testing prior to ART initiation remains recommended, but HIV testing strategies involving HIVST and T4T may provide opportunities to maintain quality while increasing efficiency as part of broader restructuring of HIV testing service delivery. [ABSTRACT FROM AUTHOR]

Introduction: Scale‐up of HIV self‐testing (HIVST) will play a key role in meeting the United Nation's 90‐90‐90 targets. Delayed re‐reading of used HIVST devices has been used by early implementation studies to validate the performance of self‐test kits and to estimate HIV positivity among self‐testers. We investigated the stability of results on used devices under controlled conditions to assess its potential as a quality assurance approach for HIVST scale‐up. Methods: 444 OraQuick®HIV‐1/2 rapid antibody tests were conducted using commercial plasma from two HIV‐positive donors and HIV‐negative plasma (high‐reactive n = 148, weak‐reactive n = 148 and non‐reactive n = 148) and incubated them for six months under four conditions (combinations of high and low temperatures and humidity). Devices were re‐read daily for one week, weekly for one subsequent month and then once a month by independent readers unaware of the previous results. We used multistage transition models to investigate rates of change in device results, and between storage conditions. Results and discussion: There was a high incidence of device instability. Forty‐three (29%) of 148 initially non‐reactive results became false weak‐reactive results. These changes were observed across all incubation conditions, the earliest on Day 4 (n = 9 kits). No initially HIV‐reactive results changed to a non‐reactive result. There were no significant associations between storage conditions and hazard of results transition. We observed substantial statistical agreement between independent re‐readers over time (agreement range: 0.74 to 0.96). Conclusions: Delayed re‐reading of used OraQuick®HIV‐1/2 rapid antibody tests is not currently a valid methodological approach to quality assurance and monitoring as we observed a high incidence (29%) of true non‐reactive tests changing to false weak‐reactive and therefore its use may overestimate true HIV positivity. [ABSTRACT FROM AUTHOR]

Introduction: HIV self‐testing (HIVST) is being introduced as a new way for more undiagnosed people to know their HIV status. As countries start to implement HIVST, assuring the quality and regulating in vitro diagnostics, including HIVST, are essential. We aimed to document the emerging regulatory landscape and perceptions of key stakeholders involved in HIVST policy and regulation prior to implementation in three low‐ and middle‐income countries. Methods: Between April and August 2016, we conducted semi‐structured interviews in Malawi, Zambia and Zimbabwe to understand the relationships between different stakeholders on their perceptions of current and future HIVST regulation and the potential impact on implementation. We purposively sampled and interviewed 66 national‐level key stakeholders from the Ministry of Health and the regulatory, laboratory, logistical, donor and non‐governmental sectors. We used a thematic approach to analysis with an inductively developed common coding framework to allow inter‐country comparison of emerging themes. Results: In all countries, the national reference laboratory was monitoring the quality of HIVST kits entering the public sector. In Malawi, there was no legal mandate to regulate medical devices, in Zambia one regulatory body with a clear mandate had started developing regulations and in Zimbabwe the mandate to regulate was overlapping between two bodies. Stakeholders indicated that they had a poor understanding of the process and requirements for HIVST regulation, as well as lack of clarity and coordination between organizational roles. The need for good collaboration between sectors, a strong post‐market surveillance model for HIVST and technical assistance to develop regulators capacity was noted as priorities. Key informants identified technical working groups as a potential way collaboration could be improved upon to accelerate the regulation of HIVST. Conclusion: Regulation of in vitro diagnostic devices, including HIVST, is now being recognized as important by regulators after a regional focus on pharmaceuticals. HIVST is providing an opportunity for each country to develop similar regulations to others in the region leading to a more coherent regulatory environment for the introduction of new devices. [ABSTRACT FROM AUTHOR]