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Introduction: As people with HIV age, prevention and management of other communicable and non-communicable diseases (NCDs) will become increasingly important. Integration of screening and treatment for HIV and NCDs is a promising approach for addressing the dual burden of these diseases. The aim of this study was to assess the epidemiological impact and cost-effectiveness of a community-wide integrated programme for screening and treatment of HIV, hypertension and diabetes in Kenya. Methods: Coupling a microsimulation of cardiovascular diseases (CVDs) with a population-based model of HIV dynamics (the Spectrum), we created a hybrid HIV/CVD model. Interventions were modelled from year 2019 (baseline) to 2023, and population was followed to 2033. Analyses were carried at a national level and for three selected regions (Nairobi, Coast and Central). Results: At a national level, the model projected 7.62 million individuals living with untreated hypertension, 692,000 with untreated diabetes and 592,000 individuals in need of ART in year 2018. Improving ART coverage from 68% at baseline to 88% in 2033 reduced HIV incidence by an estimated 64%. Providing NCD treatment to 50% of diagnosed cases from 2019 to 2023 and maintaining them on treatment afterwards could avert 116,000 CVD events and 43,600 CVD deaths in Kenya over the next 15 years. At a regional level, the estimated impact of expanded HIV services was highest in Nairobi region (averting 42,100 HIV infections compared to baseline) while Central region experienced the highest impact of expanded NCD treatment (with a reduction of 22,200 CVD events). The integrated HIV/NCD intervention could avert 7.76 million disability-adjusted-life-years (DALYs) over 15 years at an estimated cost of $6.68 billion ($445.27 million per year), or $860.30 per DALY averted. At a cost-effectiveness threshold of $2,010 per DALY averted, the probability of cost-effectiveness was 0.92, ranging from 0.71 in Central to 0.92 in Nairobi region. Conclusions: Integrated screening and treatment of HIV and NCDs can be a cost-effective and impactful approach to save ives of people with HIV in Kenya, although important variation exists at the regional level. Containing the substantial costs required for scale-up will be critical for management of HIV and NCDs on a national scale. Keywords: HIV; diabetes mellitus; hypertension; Kenya; cost-benefit analysis; computer simulation, 1 | INTRODUCTION The HIV epidemic in Kenya is one of the largest globally, with an estimated 1.6 million people living with HIV (PLHIV) in 2018 [1]. According to the [...]

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. Keywords: HIV testing, community-based HIV self-testing; cost-effectiveness; mathematical modelling; HIV; benefits and cost, 1 | INTRODUCTION The ambitious UNAIDS targets, set in 2014, of diagnosing 90% of people living with HIV, having 90% of those diagnosed on antiretroviral treatment (ART) and having virological [...]

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. Keywords: HIV/AIDS; HIV self-test; HIV testing; social harms; Malawi, 1 | INTRODUCTION Despite concerted efforts to scale-up HIV testing services, in 2017, approximately 25% of people with HIV remain undiagnosed [1]. Globally, men, young people and key populations are [...]

Introduction: Social, structural and systems barriers inhibit uptake of HIV testing. HIV self-testing (HIVST) has shown promising uptake by otherwise underserved priority groups including men, young people and first-time testers. Here, we use characteristics of HIVST kit recipients to investigate delivery to these priority groups during HIVST scale-up in three African countries. Methods: Kit distributors collected individual-level age, sex and testing history from all clients. These data were aggregated and analysed by country (Malawi, Zambia and Zimbabwe) for five distribution models: local community-based distributor (CBD: door-to-door, street and local venues), workplace distribution (WD), integration into HIV testing services (IHTS), or pubic health facilities (IPHF) and during demand creation for voluntary male medical circumcision (VMMC). Used kits were collected and re-read from CBD and IHTS recipients. Results: Between May 2015 and July 2017, 628,705 HIVST kits were distributed in Malawi (172,830), Zambia (190,787) and Zimbabwe (265,091). Community-based models, the first to be established, accounted for 519,658 (82.7%) of kits distributed, with 275,419 (53.0%) used kits returned. Subsequent model diversification delivered 54,453 (8.7%) test-kits through IHTS, 23,561 (3.7%) through VMMC, 21,183 (3.4%) through IPHF and 9850 (1.7%) through WD. Men took 294,508 (48.2%) kits, and 263,073 (43.1%) went to young people (16 to 24 years). A higher proportion of male self-testers (65,577; 22.3%) were first-time testers than women (54,096; 17.1%) with this apparent in Zimbabwe (16.2% vs. 11.4%), Zambia (25.4% vs. 17.7%) and Malawi (27.9% vs. 25.9%). The highest proportions of first-time testers were in young (16 to 24 years) and older (>50 years) men (country-ranges: 18.7% to 35.9% and 13.8% to 26.8% respectively). Most IHTS clients opted for HIVST in preference to standard HTS in each of 12 delivery sites, with those selecting HIVST having lower HIV prevalence, potentially due to self-selection. Conclusions: HIVST delivered at scale using several different models reached a high proportion of men, young people and first-time testers in Malawi, Zambia and Zimbabwe, some of whom may not have tested otherwise. As men and young people have limited uptake under standard facility-and community-based HIV testing, innovative male- and youth-sensitive approaches like HIVST may be essential to reaching UNAIDS fast-track targets for 2020. Keywords: HIV self-testing; HIV testing; men; adolescents; stigma; Malawi; Zambia; Zimbabwe, 1 | INTRODUCTION In 2016, 36.7 million people were living with HIV (PLHIV), with 1.8 million new HIV infections and one million HIV/AIDS-related deaths [1]. Despite substantial progress toward the [...]

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[R] 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 reread 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[R] HIV-1/2 rapid antibody tests is not currently a valid methodologica 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. Keywords: HIV self-testing; Quality assurance; Delayed re-reading; Visual stability; False reactive; Misdiagnosis; HIV testing, 1 | INTRODUCTION HIV self-testing (HIVST) is being scaled-up using a variety of distribution models throughout Africa, the Americas, Asia and Europe [1-4]. No clear monitoring and evaluation or external [...]

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 surveilance 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. Keywords: quality assurance; policy; in vitro diagnostics; post market; implementation; harmonization, 1 | INTRODUCTION The World Health Organization (WHO) defines HIV self-testing (HIVST) as 'a process in which a person collects his or her own specimen (oral fluid or blood) and [...]

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. Keywords: HIV self-test; performance; in vitro diagnosis; instructions for use; Zambia; Malawi, 1 | INTRODUCTION HIV self-testing (HIVST) is increasingly being introduced as a testing approach recommended by the World Health Organization (WHO) to reach those who may not otherwise test [1,2]. [...]

As part of the global response to the HIV/AIDS epidemic, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is committed to the provision of high-quality services and ensuring testing accuracy. Two recently published papers focusing on HIV testing and misdiagnosis in sub-Saharan Africa by Kosack et al. report on evaluations of HIV rapid diagnostic tests (RDTs) and found lower than expected specificity and sensitivity on some tests when used in certain geographic locations. The magnitude of PEPFAR's global HIV response has been possible due to the extensive use of RDTs, which have made HIV diagnosis accessible all over the world. We take the opportunity to address concerns raised about the potential implications that these findings could have on real-world HIV testing accuracy. PEPFAR supported countries adhere to the normative guidance by World Health Organization (WHO) supporting algorithms which require sequential positive tests for diagnostic accuracy. An analysis of Medecins Sans Frontieres (MSF) RDT site-specific data applied to PEPFAR in-country protocols demonstrate a variation in the diagnostic accuracy of the testing algorithms, but with a very small population-level effect. The data demonstrate, with the use of these algorithms, that the RDT outcomes found in the study by Kosack et al. would be largely mitigated and would not be expected to have a significant impact on diagnostic accuracy and overall programming in most countries. Avoiding any misdiagnosis is a priority for PEPFAR, and it remains vital to gain a deeper understanding of the causes and the extent of diagnostic errors and any misclassification. Extensive quality control mechanisms and continued research are essential. With a focus on epidemic control and ensuring diagnostic accuracy, PEPFAR recommends that all countries use WHO pre-qualified RDTs within the recommended strategies and algorithms for HIV testing. We also support validation of HIV testing algorithms using in-country specimens to determine optimal performance, and the reverification testing of all people diagnosed with HIV prior to starting treatment as an essential quality assurance measure., 1 | INTRODUCTION The recently published papers, Towards more accurate HIV testing in sub-Saharan Africa: a multi-site evaluation of HIV RDTs and risk factors for false positives and HIV misdiagnosis [...]

Introduction: HIV testing has rapidly expanded into diverse, decentralized settings. While increasing accessibility to HIV testing is beneficial, it may lead to unintended consequences such as being pressured to test. We examined the frequency correlates and contexts of pressured HIV testing among Chinese men who have sex with men (MSM) using mixed methods. Methods: We conducted an online survey of MSM (N = 1044) in May 2017. Pressured HIV testing was defined as being forced to test for HIV. We conducted logistic regression analysis to determine the associations between pressured HIV testing and socio-demographic and sexual behavioural factors. Follow-up interviews (n = 17) were conducted with men who reported pressured testing and we analysed qualitative data using a thematic analysis approach. Results: Ninety-six men (9.2%) reported experiencing pressure to test for HIV. Regular male sex partners were the most common source of pressure (61%, 59/96), and the most common form of pressure was a threat to end a relationship with the one who was being pressured (39%, 37/96). We found a higher risk of pressured testing in men who had only used HIV self-testing compared to men who had never self-tested (AOR 2.39 (95%Cl: 1.38 to 4.14)). However, this relationship was only significant among men with low education (AOR 5.88 (95% Cl: 1.92 to 17.99)) and not among men with high education (AOR 1.62 (95% Cl: 0.85 to 3.10)). After pressured testing, about half of men subsequently tested for HIV (55%, 53/96) without pressure--none reported being diagnosed with HIV. Consistent with this finding, qualitative data suggest that perceptions of pressure existed on a continuum and depended on the relationship status of the one who pressured them. Although being pressured to test was accompanied by negative feelings, men who were pressured into testing often changed their attitude towards HIV testing, testing behaviours, sexual behaviours and relationship with the one who pressured them to test. Conclusion: Pressured HIV testing was reported among Chinese MSM, especially from men with low education levels and men who received HIV self-testing. However, in some circumstances, pressure to test helped MSM in several ways, challenging our understanding of the role of agency in the setting of HIV testing. Keywords: HIV; coercion; testing; men who have sex with men; China; mixed methods, 1 | INTRODUCTION Men who have sex with men (MSM) in China are estimated to account for a third of new HIV infections each year [1]. Increasing the coverage and [...]

Byline: Vijay. Sardana, Parag. Moon Sir, Since the onset of the acquired immunodeficiency syndrome (AIDS) pandemic in 1981, the human immunodeficiency virus (HIV) has spread exponentially throughout the world. HIV [...]

To prevent the virus from rebounding after drug therapy, researchers must first map where it lurks in the body.To prevent the virus from rebounding after drug therapy, researchers must first map where it lurks in the body., Author(s): Sara ReardonAuthor Affiliations:Virus detectives test whole-body scans in search of HIV's hiding places HIV invades immune cells called T cells and uses them to replicate itself. [see PDF for [...]

Background Home-based HIV testing and counselling (HTC) achieves high uptake, but is difficult and expensive to implement and sustain. We investigated a novel alternative based on HIV self-testing (HIVST). The aim was to evaluate the uptake of testing, accuracy, linkage into care, and health outcomes when highly convenient and flexible but supported access to HIVST kits was provided to a well-defined and closely monitored population. Methods and Findings Following enumeration of 14 neighbourhoods in urban Blantyre, Malawi, trained resident volunteer-counsellors offered oral HIVST kits (OraQuick ADVANCE Rapid HIV-1/2 Antibody Test) to adult ([greater than or equal to] 16y old) residents (n = 16,660) and reported community events, with all deaths investigated by verbal autopsy. Written and demonstrated instructions, pre- and post-test counselling, and facilitated HIV care assessment were provided, with a request to return kits and a self-completed questionnaire. Accuracy, residency, and a study-imposed requirement to limit HIVST to one test per year were monitored by home visits in a systematic quality assurance (QA) sample. Overall, 14,004 (crude uptake 83.8%, revised to 76.5% to account for population turnover) residents self-tested during months 1-12, with adolescents (16-19 y) most likely to test. 10,614/14,004 (75.8%) participants shared results with volunteer-counsellors. Of 1,257 (11.8%) HIV-positive participants, 26.0% were already on antiretroviral therapy, and 524 (linkage 56.3%) newly accessed care with a median CD4 count of 250 cells/[micro]l (interquartile range 159-426). HIVST uptake in months 13-24 was more rapid (70.9% uptake by 6 mo), with fewer (7.3%, 95% CI 6.8%-7.8%) positive participants. Being 'forced to test', usually by a main partner, was reported by 2.9% (95% CI 2.6%-3.2%) of 10,017 questionnaire respondents in months 1-12, but satisfaction with HIVST (94.4%) remained high. No HIVST-related partner violence or suicides were reported. HIVST and repeat HTC results agreed in 1,639/1,649 systematically selected (1 in 20) QA participants (99.4%), giving a sensitivity of 93.6% (95% CI 88.2%-97.0%) and a specificity of 99.9% (95% CI 99.6%-100%). Key limitations included use of aggregate data to report uptake of HIVST and being unable to adjust for population turnover. Conclusions Community-based HIVST achieved high coverage in two successive years and was safe, accurate, and acceptable. Proactive HIVST strategies, supported and monitored by communities, could substantially complement existing approaches to providing early HIV diagnosis and periodic repeat testing to adolescents and adults in high-HIV settings., Introduction Sub-Saharan Africa is still disproportionately affected by the HIV epidemic, accounting for 71% (24.7 million) of people living with HIV globally; in 2013, 71% of the 2.1 million global [...]

Introduction: West Africa is characterized by the circulation of HIV-1 and HIV- 2. The laboratory diagnosis of these two infections as well as the choice of a first-line antiretroviral therapy (ART) is challenging, considering the limited access to second-line regimens. This study aimed at confirming the classification of HIV-2 and HIV-1&2 dually reactive patients followed up in the HIV-2 cohort of the West African Database to evaluate AIDS collaboration. Method: A cross-sectional survey was conducted from March to December 2012 in Burkina Faso, Cote d'Ivoire and Mali among patients classified as HIV-2 or HIV-1&2 dually reactive according to the national HIV testing algorithms. A 5-ml blood sample was collected from each patient and tested in a single reference laboratory in Cote d'Ivoire (CeDReS, Abidjan) with two immunoenzymatic tests: ImmunoCombII[R] (HIV-1&2 ImmunoComb BiSpot-Alere) and an in-house ELISA test, approved by the French National AIDS and hepatitis Research Agency (ANRS). Results: A total of 547 patients were included; 57% of them were initially classified as HIV-2 and 43% as HIV-1&2 dually reactive. Half of the patients had CD4 [greater than or equal to] 500 cells/[mm.sup.3] and 68.6% were on ART. Of the 312 patients initially classified as HIV-2, 267 (85.7%) were confirmed as HIV-2 with ImmunoCombII[R] and in-house ELISA while 16 (5.1%) and 9 (2.9%) were reclassified as HIV-1 and HIV-1&2, respectively (Kappa = 0.69; p Conclusions: Patients with HIV-2 mono-infection are correctly discriminated by the national algorithms used in West African countries. HIV-1&2 dually reactive patients should be systematically investigated, with a standardized algorithm using more accurate tests, before initiating ART as at least 4 out of 10 of them could initiate an effective first-line ART for HIV-1 and optimize their second-line treatment options. Keywords: HIV-2; HIV-1&2 dually reactive; testing; classification; West Africa., Introduction West Africa is characterized by the circulation of both HIV-1 and HIV-2, which leads to co-infections with HIV-1 and HIV-2 (HIV-1&2) [1-4]. The biological diagnosis of these co-infections [5-7] [...]