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Introduction: HIV self‐testing (HIVST) is a discreet and convenient way to reach people with HIV who do not know their status, including many who may not otherwise test. To inform World Health Organization (WHO) guidance, we assessed the effect of HIVST on uptake and frequency of testing, as well as identification of HIV‐positive persons, linkage to care, social harm, and risk behaviour. Methods: We systematically searched for studies comparing HIVST to standard HIV testing until 1 June 2016. Meta‐analyses of studies reporting comparable outcomes were conducted using a random‐effects model for relative risks (RR) and 95% confidence intervals. The quality of evidence was evaluated using GRADE. Results: After screening 638 citations, we identified five randomized controlled trials (RCTs) comparing HIVST to standard HIV testing services among 4,145 total participants from four countries. All offered free oral‐fluid rapid tests for HIVST and were among men. Meta‐analysis of three RCTs showed HIVST doubled uptake of testing among men (RR = 2.12; 95% CI: 1.51, 2.98). Meta‐analysis of two RCTs among men who have sex with men showed frequency of testing nearly doubled (Rate ratio = 1.88; 95% CI: 1.17; 3.01), resulting in two more tests in a 12–15‐month period (Mean difference = 2.13; 95% CI: 1.59, 2.66). Meta‐analysis of two RCTs showed HIVST also doubled the likelihood of an HIV‐positive diagnosis (RR = 2.02; 95% CI: 0.37, 10.76, 5.32). Across all RCTs, there was no indication of harm attributable to HIVST and potential increases in risk‐taking behaviour appeared to be minimal. Conclusions: HIVST is associated with increased uptake and frequency of testing in RCTs. Such increases, particularly among those at risk who may not otherwise test, will likely identify more HIV‐positive individuals as compared to standard testing services alone. However, further research on how to support linkage to confirmatory testing, prevention, treatment and care services is needed. WHO now recommends HIVST as an additional HIV testing approach.

Introduction Knowledge of HIV status relies on accurate HIV testing, and is the first step towards access to HIV treatment and prevention programmes. Globally, HIV‐status unawareness represents a significant challenge for achieving zero new HIV infections and deaths. In order to enhance knowledge of HIV status, the World Health Organisation (WHO) recommends a testing strategy that includes the use of HIV‐specific antibody point‐of‐care tests (POCT). These POCTs do not detect acute HIV infection, the stage of disease when viral load is highest but HIV antibodies are undetectable. Complicating things further, in the presence of antiretroviral therapy (ART) for pre‐exposure prophylaxis (PrEP) or post‐exposure prophylaxis (PEP), other currently available testing technologies, such as viral load detection for diagnosis of acute HIV infection, may yield false‐negative results. In this scoping review, we evaluate the evidence and discuss alternative HIV testing algorithms that may mitigate diagnostic dilemmas in the setting of increased utilization of ART for immediate treatment and prevention of HIV infection. Discussion Missed acute HIV infection prevents people living with HIV (PLHIV) from accessing early treatment, increases likelihood of onward transmission, and allows for inappropriate initiation or continuation of PrEP, which may result in HIV drug resistance. While immediate ART is recommended for all PLHIV, studies have shown that starting ART in the setting of acute HIV infection may result in a delayed or complete absence of development of HIV‐specific antibodies, posing a diagnostic challenge that is particularly pertinent to resource‐limited, high HIV burden settings where HIV‐antibody POCTs are standard of care. Similarly, ART used as PrEP or PEP may supress HIV RNA viral load, complicating current HIV testing algorithms in resource‐wealthy settings where viral detection is included. As rollout of PrEP continues, HIV testing algorithms may need to be modified. Conclusions With increasing use of PrEP and ART in acute infection we anticipate diagnostic challenges using currently available HIV testing strategies. Research and surveillance are needed to determine the most appropriate assays and optimal testing algorithms that are accurate, affordable and sustainable.

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.

Introduction: In the era of ambitious HIV targets, novel HIV testing models are required for hard‐to‐reach groups such as men, who remain underserved by existing services. Pregnancy presents a unique opportunity for partners to test for HIV, as many pregnant women will attend antenatal care (ANC). We describe the views of pregnant women and their male partners on HIV self‐test kits that are woman‐delivered, alone or with an additional intervention. Methods: A formative qualitative study to inform the design of a multi‐arm multi‐stage cluster‐randomized trial, comprised of six focus group discussions and 20 in‐depth interviews, was conducted. ANC attendees were purposively sampled on the day of initial clinic visit, while men were recruited after obtaining their contact information from their female partners. Data were analysed using content analysis, and our interpretation is hypothetical as participants were not offered self‐test kits. Results: Providing HIV self‐test kits to pregnant women to deliver to their male partners was highly acceptable to both women and men. Men preferred this approach compared with standard facility‐based testing, as self‐testing fits into their lifestyles which were characterized by extreme day‐to‐day economic pressures, including the need to raise money for food for their household daily. Men and women emphasized the need for careful communication before and after collection of the self‐test kits in order to minimize the potential for intimate partner violence although physical violence was perceived as less likely to occur. Most men stated a preference to first self‐test alone, followed by testing as a couple. Regarding interventions for optimizing linkage following self‐testing, both men and women felt that a fixed financial incentive of approximately USD$2 would increase linkage. However, there were concerns that financial incentives of greater value may lead to multiple pregnancies and lack of child spacing. In this low‐income setting, a lottery incentive was considered overly disappointing for those who receive nothing. Phone call reminders were preferred to short messaging service. Conclusions: Woman‐delivered HIV self‐testing through ANC was acceptable to pregnant women and their male partners. Feedback on additional linkage enablers will be used to alter pre‐planned trial arms.

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.

Alere™ HIV Combo is the only rapid and sensitive point-of-care 4th generation (antigen/antibody) HIV test newly available in Thailand which is advantageous of differentiating between positivity of antigen or antibody or both, especially in acute HIV infection (AHI). AHI in this study was defined by positive machine-based 4th generation test with measurable HIV-RNA but negative 3rd generation (IgM/IgG antibody only) tests. To evaluate the performance characteristics of Alere™ HIV Combo. Fifty stored plasma samples of subjects diagnosed with AHI were used to evaluate Alere™ HIV Combo. Of the 50 AHI samples, Alere™ HIV Combo was positive in 37 (74%): 5 with antibody positive only (R1), 26 with p24 antigen positive only (R2), and 6 with both p24 antigen and antibody positive (R3). Mean sample/cut-off (S/ CO) ratios from machine-based 4th generation test of R1, R2 and R3 were 21.55, 148.38 and 72.97 respectively as compared to 7.57 for the 13 non-reactive (NR) samples. The corresponding median log10 HIV-RNA of NR, R1, R2 and R3 were 5.59, 5.86, 7.00 and 6.61 copies/mL respectively. R2 and R3 had significantly higher S/CO and HIV-RNA than NR and R1. Alere™ HIV Combo detected mainly p24 antigen in AHI as seen in 32/50 (64%) subjects and could detect 11/50 (22%) antibody in AHI samples which were missed by the two 3rd generation HIV tests used in our testing algorithm. Alere™ HIV Combo is the ideal screening test in a setting with high AHI where machine-based 4th generation test is not available.

Background Many southern African countries are nearing the global goal of diagnosing 90% of people with HIV by 2020. In 2016, 84 and 86% of people with HIV knew their status in Malawi and Zimbabwe, respectively. However, gaps remain, particularly among men. We investigated awareness and use of, and willingness to self-test for HIV and explored sociodemographic associations before large-scale implementation. Methods We pooled responses from two of the first cross-sectional Demographic and Health Surveys to include HIV self-testing (HIVST) questions in Malawi and Zimbabwe in 2015–16. We investigated sociodemographic factors and sexual risk behaviours associated with previously testing for HIV, and past use, awareness of, and future willingness to self-test using univariable and multivariable logistic regression, adjusting for the sample design and limiting analysis to participants with a completed questionnaire and valid HIV test result. We restricted analysis of willingness to self-test to Zimbabwean men, as women and Malawians were not systematically asked this question. Results Of 31,385 individuals, 31.2% of men had never tested compared with 16.5% of women ( p  < 0.001). For men, the likelihood of having ever tested increased with age. Past use and awareness of HIVST was very low, 1.2 and 12.6%, respectively. Awareness was lower among women than men (9.1% vs 15.3%, adjusted odds ratio [aOR] = 1.55; 95% confidence interval [CI]: 1.37–1.75), and at younger ages, and lower education and literacy levels. Willingness to self-test among Zimbabwean men was high (84.5%), with greater willingness associated with having previously tested for HIV, being at high sexual risk (highest willingness [aOR = 3.74; 95%CI: 1.39–10.03, p  < 0.009]), and being ≥25 years old. Wealthier men had greater awareness of HIVST than poorer men ( p  < 0.001). The highest willingness to self-test (aOR = 3.74; 95%CI: 1.39–10.03, p  < 0.009) was among men at high HIV-related sexual risk. Conclusions In 2015–16, many Malawian and Zimbabwean men had never tested for HIV. Despite low awareness and minimal HIVST experience, willingness to self-test was high among Zimbabwean men, especially older men with moderate-to-high HIV-related sexual risk. These data provide a valuable baseline against which to investigate population-level uptake of HIVST as programmes scale up. Programmes introducing, or planning to introduce, HIVST should consider including relevant questions in population-based surveys.

Background Improving the coverage of antenatal care is regarded as an important strategy to reduce the risks of maternal and child mortality in low income settings like Gambia. Nonetheless, a large number of countries in Africa, including Gambia, are struggling to attain an optimum level of healthcare utilization among pregnant women. The role of socioeconomic inequalities in maternal healthcare uptake has received little attention in Gambia. To address this evidence gap, the present study analyses nationally representative data to explore the socioeconomic inequalities in the use of maternal healthcare. Methods Data on women aged 15–49 years ( n  = 5351) were extracted from the latest round of Gambia Demographic and Health Survey in 2013 for this study. The outcome measures were early and adequate antenatal visit and HIV tests during the last pregnancy. Data were analyzed using descriptive and multivariate regression methods. Socioeconomic status was assessed through the women’s education, type of employment, and household wealth quintile. Results From the total of 5351 participants included in the study, 38.7 and 78.8% of the women had early and adequate ANC visits respectively with a 65.4% HIV test coverage during ANC visits. The odds of early [OR = 1.30, 95% confidence interval (CI) =1.06, 1.59] and adequate [OR = 1.45, 95%CI = 1.15, 1.82] ANC visits were higher in the rural areas compared with urban. Women with secondary [OR = 1.24, 95%CI = 1.04, 1.48] and higher education [OR = 1.80, 95%CI = 1.20, 2.70] had higher odds of making early ANC visits. Women from richest wealth quintile households had significantly higher odds of having early [OR = 1.49, 95%CI = 1.14, 1.95] and adequate ANC visits [OR = 2.06, 95%CI = 1.48, 2.87], but not of having HIV tests. Having access to electronic media showed a positive association with adequate ANC visits [OR = 1.32, 95%CI = 1.08, 1.62] and with taking HIV test during ANC [OR = 1.48, 95%CI = 1.21, 1.80]. A fewer odds of having unintended child was associated with early ANC visit [OR = 0.70, 95%CI = 0.59, 0.84], but positively associated with taking HIV test [OR = 1.75, 95%CI = 1.42, 2.15]. Conclusion A large proportion of women in Gambia were not using antenatal care and HIV tests during pregnancy. There are important sociodemographic differences in using maternal healthcare services such as HIV testing during pregnancy. This calls for strategic direction to promote the utilization of these services.

Background In low-income countries with poor coverage of healthcare services such as Mozambique, antenatal care serves as a vital tool for providing life-saving and cost-effective services for pregnant mothers. Nonetheless, many countries in Africa, including Mozambique, are struggling to attain an optimum level of antenatal care (at least 4 visits) utilisation among pregnant women. In the present study, we aimed to assess the sociodemographic and economic factors associated with antenatal care use in Mozambique. Methods Cross-sectional data from the latest round of Mozambique Demographic and Health Survey (2011) on women aged 15–49 years ( n  = 7080) were analysed. The outcome measures were early and adequate antenatal visit and HIV tests during the last pregnancy. Data were analysed using descriptive and multivariate regression methods. The predictor variables included various demographic (e.g. age, parity), empowerment (e.g. type of employment, household wealth status) and sociocultural factors (e.g. ethnicity, religion). Results Of the 7080 women whose data was analyzed, 15.3 and 60.1% had early and adequate ANC visits respectively while 75.4% received HIV test during ANC visits. The odds of early ANC visits were higher [OR = 1.300, 95%CI = 1.062,1.592] among women in the rural areas compared with those in the urban areas. However, participants in rural areas had lower odds [OR = 0.788, 0.687,0.902] of receiving HIV tests during ANC visits. Women in the urban areas with secondary [OR = 1.296, 95%CI = 1.007,1.666] and higher [OR = 1.663, 95%CI = 1.052,2.628] education had higher odds of having early ANC visit. Those in the higher wealth quintiles also had significantly increased odds of using all three types of ANC indicators, particularly for rural women in the highest wealth quintile [OR = 4.776, 95%CI = 1.250,18.24]. Being within the higher wealth quintiles was found to significantly increase the odds of using all three types of ANC indicators, particularly women from rural areas with highest wealth quintile [OR = 4.776, 95%CI = 1.250,18.24]. Conclusion About two-fifth of the women in Mozambique are not using adequate antenatal care and about and a quarter do not take HIV tests during pregnancy. The sources of low and unequal use of these vital health services might be rooted in women’s socioeconomic status and cultural issues that require special policy and research attention.

Background An individual is considered HIV positive when a confirmatory HIV-1/HIV-2 differentiation test returns positive following an initial reactive antigen/antibody combination screen. Falsely reactive HIV screens have been reported in patients with various concomitant infectious and autoimmune conditions. Falsely positive confirmatory HIV differentiation assays are seen less frequently, but have been observed in cases of pregnancy, pulmonary embolism, and malaria. Case presentation A healthy 27 year-old man was referred after a reactive ADVIA Centaur® HIV Ag/Ab screen and positive Bio-Rad Geenius™ HIV 1/2 Confirmatory assay, suggesting HIV-1 infection. The patient’s HIV viral load was undetectable prior to initiation of antiretroviral therapy, and remained undetectable on subsequent testing after initiation of antiretroviral therapy. Both Centaur® and Geenius™ tests were repeated and returned reactive. As this patient was believed to be at low risk of acquiring HIV infection, samples were additionally run on Genscreen™ HIV-1 Ag assay and Fujirebio Inno-LIA™ HIV-1/2 score, with both returning non-reactive. For confirmation, the patient’s proviral HIV DNA testing was negative, confirming the initial results as being falsely positive. The patient disclosed that he had been using a variety of anabolic steroids before and during the time of HIV testing. Discussion and conclusions The erroneous diagnosis of HIV can result in decreased quality of life and adverse effects of antiretroviral therapy if initiated, hence the importance of interpreting the results of HIV testing in the context of an individual patient. This reports suggests a potential association between the use of anabolic steroids and falsely-reactive HIV testing.