Introduction Underreporting of prior HIV diagnosis and antiretroviral therapy (ART) use based on self-report is well-documented in national surveys. Antiretroviral (ARV) testing has been used to improve survey estimates, by reclassifying respondents with ARVs detected in blood as previously-diagnosed and on ART. Viral load testing, which is more affordable and more routinely available than ARV testing, is also an indicator of ART use. We examined the impact of adjusting estimated knowledge of HIV-positive status and antiretroviral therapy (ART) use based on self-report with biomarkers for antiretroviral (ARV) drug detection and undetectable viral load (UVL).Methods We reclassified HIV-positive participants aged 15-64 years in the 2012 Kenya AIDS Indicator Survey (KAIS) that were unaware of their HIV-positive status by self-report as aware and on ART if either ARVs were detected or viral load was undetectable (<550 copies/mL) on dried blood spots. We compared self-report to adjustments for ARVs measurement, UVL, or both. We calculated measures of accuracy for UVL and UVL & ARV-adjusted versions of knowledge of status and ART use versus ARV-adjusted self-report as a reference standard.Results Among 235 of 648 HIV-positive respondents with UVL, self-reported status was: 65 unaware (28.7%), 25 aware, not on ART (9.9%) and 145 aware, on ART (61.3%). Treatment coverage among all HIV-positive respondents increased from 31.8% for self-report to 42.5% [95% confidence interval (CI) 37.4-47.8] based on ARV detection alone, to 42.8% (95% CI 37.9-47.8) when ARV-adjusted, 46.2% (95% CI 41.3-51.1) when UVL-adjusted and 48.8% (95% CI 43.9-53.8) when adjusted for ARV and UVL. Awareness of positive status increased from 46.9% for self-report to 56.2% (95% CI 50.7-61.6) when ARV-adjusted, 57.5% (95% CI 51.9-63.0) when UVL-adjusted, and 59.8% (95% CI 54.2-65.1) when adjusted for ARV and UVL. Sensitivity and specificity of UVL-adjusted known HIV-positive status were 95.8% and 91.3%, and of UVL-adjusted ART use were 93.0% and 88.8% respectively, versus ARV-adjusted self-report.Conclusions Undetectable viral load may be a useful adjunct or alternative to ARV detection for adjusting knowledge of status and ART use indicators in population-based surveys.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThe 2012 Kenya AIDS Indicator Survey has been supported by the President?s Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Centers for Disease Control and Prevention (CDC) under the terms of #PS001805, GH000069, and PS001814. The survey was also funded in part by support from the Global Fund, World Bank, and the Joint United Nations Programme on HIV/AIDS.Author DeclarationsAll relevant ethical guidelines have been followed and any necessary IRB and/or ethics committee approvals have been obtained.YesAll necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesAny clinical trials involved have been registered with an ICMJE-approved registry such as ClinicalTrials.gov and the trial ID is included in the manuscript.Not ApplicableI have followed all appropriate research reporting guidelines and uploaded the relevant Equator, ICMJE or other checklist(s) as supplementary files, if applicable.YesData for KAIS 2012 are available upon request from NASCOP by emailing head@nascop.or.ke, or from the Kenya National Bureau of Statistics by requesting at http://statistics.knbs.or.ke/nada/index.php

BACKGROUND: Nationally-representative surveys provide an opportunity to assess trends in recent HIV infection based on assays for recent HIV infection. METHODS: We assessed HIV incidence in Kenya in 2018 and trends in recent HIV infection among adolescents and adults in Kenya using nationally representative household surveys conducted in 2007, 2012 and 2018. To assess trends, we defined a recent HIV infection testing algorithm (RITA) that classified as recently infected (<12 months) those HIV-positive participants that were recent on the HIV-1 limiting antigen (LAg)-avidity assay without evidence of antiretroviral use. We assessed factors associated with recent and long-term (≥12 months) HIV infection versus no infection using a multinomial logit model while accounting for complex survey design. FINDINGS: Of 1,523 HIV-positive participants in 2018, 11 were classified as recent. Annual HIV incidence was 0.14% in 2018 (95% confidence interval [CI] 0.057-0.23), representing 35,900 (95% CI 16,300-55,600) new infections per year in Kenya among persons aged 15-64 years. The percentage of HIV infections that were determined to be recent was similar in 2007 and 2012 but fell significantly from 2012 to 2018 (adjusted odds ratio [aOR]=0.31, p<0.001). Compared to no HIV infection, being aged 25-34 versus 35-64 years (aOR=4.2, 95% CI 1.4-13), having more lifetime sex partners (aOR=5.2, 95% CI 1.6-17 for 2-3 partners and aOR=8.6, 95% CI 2.8-26 for ≥4 partners versus 0-1 partners), and never having tested for HIV (aOR=4.1, 95% CI 1.5-11) were independently associated with recent HIV infection. INTERPRETATION: Though HIV remains a public health priority in Kenya, HIV incidence estimates and trends in recent HIV infection support a significant decrease in new HIV infections from 2012 to 2018, a period of rapid expansion in HIV diagnosis, prevention, and treatment.

Tests for recent HIV infection (TRI) distinguish recent from long-term HIV infections using markers of antibody maturation. The limiting antigen avidity enzyme immunoassay (LAg EIA) is widely used with HIV viral load (VL) in a recent infection testing algorithm (RITA) to improve classification of recent infection status, estimate population-level HIV incidence, and monitor trends in HIV transmission. A novel rapid test for recent HIV infection (RTRI), Asanté™, can determine HIV serostatus and HIV recency within minutes on a lateral flow device through visual assessment of test strip or reader device. We conducted a field-based laboratory evaluation of the RTRI among pregnant adolescent girls and young women (AGYW) attending antenatal clinics (ANC) in Malawi.We enrolled pregnant AGYW aged <25 years testing HIV-positive for the first time at their first ANC visit from 121 ANCs in four high-HIV burden districts. Consenting participants provided blood for recency testing using LAg EIA and RTRI, which were tested in central laboratories. Specimens with LAg EIA normalized optical density values ≤2.0 were classified as probable recent infections. RTRI results were based on: (1) visual assessment: presence of a long-term line (LT) indicating non-recent infection and absence of the line indicating recent infection; or (2) a reader; specimens with LT line intensity units <3.0 were classified as probable recent infections. VL was measured for specimens classified as a probable recent infections by either assay; those with HIV-1 RNA ≥1,000 copies/mL were classified as confirmed recent infections. We evaluated the performance of the RTRI by calculating correlation between RTRI and LAg EIA results, and percent agreement and kappa between RTRI and LAg EIA RITA results.Between November 2017 to June 2018, 380 specimens were available for RTRI evaluation; 376 (98.9%) were confirmed HIV-positive on RTRI. Spearman's rho between RTRI and LAg EIA was 0.72 indicating strong correlation. Percent agreement and kappa between RTRI- and LAg EIA-based RITAs were >90% and >0.65 respectively indicating substantial agreement between the RITAs.This was the first field evaluation of an RTRI in sub-Saharan Africa, which demonstrated good performance of the assay and feasibility of integrating RTRI into routine HIV testing services for real-time surveillance of recent HIV infection.

Estimating incidence from cross-sectional data sources is both important to the understanding of the HIV epidemic and challenging from a methodological standpoint. We develop a new incidence estimator that measures the size of the undiagnosed population and the amount of time spent undiagnosed in order to infer incidence and transmission rates. The estimator is calculated using commonly collected information on testing history and HIV status and, thus, can be deployed in many HIV surveys without additional cost. If ART biomarker status and/or viral load information is available, the estimator can be adjusted for biases in self-reported testing history. The performance of the estimator is explored in two large surveys in Kenya, where we find our point estimates to be consistent with assay-derived estimates, with much smaller standard errors.

OBJECTIVE: To compare alternative methods of adjusting self-reported knowledge of HIV-positive status and antiretroviral (ARV) therapy use based on undetectable viral load (UVL) and ARV detection in blood. DESIGN: Post hoc analysis of nationally representative household survey to compare alternative biomarker-based adjustments to population HIV indicators. METHODS: We reclassified HIV-positive participants aged 15-64 years in the 2012 Kenya AIDS Indicator Survey (KAIS) that were unaware of their HIV-positive status by self-report as aware and on antiretroviral treatment if either ARVs were detected or viral load was undetectable (<550 copies/ml) on dried blood spots. We compared self-report to adjustments for ARV measurement, UVL, or both. RESULTS: Treatment coverage among all HIV-positive respondents increased from 31.8% for self-report to 42.5% [95% confidence interval (CI) 37.4-47.8] based on ARV detection alone, to 42.8% (95% CI 37.9-47.8) when ARV-adjusted, 46.2% (95% CI 41.3-51.1) when UVL-adjusted and 48.8% (95% CI 43.9-53.8) when adjusted for either ARV or UVL. Awareness of positive status increased from 46.9% for self-report to 56.2% (95% CI 50.7-61.6) when ARV-adjusted, 57.5% (95% CI 51.9-63.0) when UVL-adjusted, and 59.8% (95% CI 54.2-65.1) when adjusted for either ARV or UVL. CONCLUSION: Undetectable viral load, which is routinely measured in surveys, may be a useful adjunct or alternative to ARV detection for adjusting survey estimates of knowledge of HIV status and antiretroviral treatment coverage.

Human immunodeficiency virus (HIV) case-based surveillance (CBS) systematically and continuously collects available demographic and health event data (sentinel events*) about persons with HIV infection from diagnosis and, if available, throughout routine clinical care until death, to characterize HIV epidemics and guide program improvement (1,2). Surveillance signals such as high viral load, mortality, or recent HIV infection can be used for rapid public health action. To date, few standardized assessments have been conducted to describe HIV CBS systems globally (3,4). For this assessment, a survey was disseminated during May-July 2019 to all U.S. President's Emergency Plan for AIDS Relief (PEPFAR)-supported countries with CDC presence(dagger) (46) to describe CBS implementation and identify facilitators and barriers. Among the 39 (85%) countries that responded,( section sign) 20 (51%) have implemented CBS, 15 (38%) were planning implementation, and four (10%)( paragraph sign) had no plans for implementation. All countries with CBS reported capturing information at the point of diagnosis, and 85% captured sentinel event data. The most common characteristic (75% of implementation countries) that facilitated implementation was using a health information system for CBS. Barriers to CBS implementation included lack of country policies/guidance on mandated reporting of HIV and on CBS, lack of unique identifiers to match and deduplicate patient-level data, and lack of data security standards. Although most surveyed countries reported implementing or planning for implementation of CBS, these barriers need to be addressed to implement effective HIV CBS that can inform the national response to the HIV epidemic.

Through 2017, roughly 40 years since HIV/AIDS became a global health crisis, the world has experienced devastating consequences: an estimated 35 million HIV-infected persons have died, 17 million children have been orphaned, and 37 million persons are living with the virus [1,2]. With sustained commitment to address the epidemic, control and virtual elimination of HIV is within reach in some countries. In 2014, the Joint United Nations Programme on HIV/AIDS released ambitious treatment targets to reach HIV epidemic control by 2030, calling for 90% of all persons living with HIV (PLHIV) to be diagnosed, 90% of diagnosed PLHIV to be on HIV treatment, and 90% of treated PLHIV to be virally suppressed by 2020 (90-90-90) [3]. By 2017, 75% of PLHIV knew their HIV status, 79% of these were on treatment, and 81% of these achieved viral suppression [1]. Still millions of PLHIV who require diagnosis and treatment are not yet reached.

BACKGROUND: Death is an important but often unmeasured endpoint in public health HIV surveillance. We sought to describe HIV among deaths using a novel mortuary-based approach in Nairobi, Kenya. METHODS: Cadavers aged 15 years and older at death at Kenyatta National Hospital (KNH) and City Mortuaries were screened consecutively from January 29 to March 3, 2015. Cause of death was abstracted from medical files and death notification forms. Cardiac blood was drawn and tested for HIV infection using the national HIV testing algorithm followed by viral load testing of HIV-positive samples. RESULTS: Of 807 eligible cadavers, 610 (75.6%) had an HIV test result available. Cadavers from KNH had significantly higher HIV positivity at 23.2% (95% CI: 19.3 to 27.7) compared with City Mortuary at 12.6% (95% CI: 8.8 to 17.8), P < 0.001. HIV prevalence was significantly higher among women than men at both City (33.3% vs. 9.2%, P = 0.008) and KNH Mortuary (28.8% vs. 19.0%, P = 0.025). Half (53.3%) of HIV-infected cadavers had no diagnosis before death, and an additional 22.2% were only diagnosed during hospitalization leading to death. Although not statistically significant, 61.9% of males had no previous diagnosis compared with 45.8% of females (P = 0.144). Half (52.3%) of 44 cadavers at KNH with HIV diagnosis before death were on treatment, and 1 in 5 (22.7%) with a previous diagnosis had achieved viral suppression. CONCLUSIONS: HIV prevalence was high among deaths in Nairobi, especially among women, and previous diagnosis among cadavers was low. Establishing routine mortuary surveillance can contribute to monitoring HIV-associated deaths among cadavers sent to mortuaries.

PROBLEM/CONDITION: Use of human immunodeficiency virus (HIV)-mortality surveillance data can help public health officials monitor, evaluate, and improve HIV treatment programs. Many high-income countries have high-coverage civil registration and vital statistics (CRVS) systems linked to case-based HIV surveillance on which to base HIV mortality estimates. However, in the absence of comprehensive CRVS systems in low- and medium-income countries, such as Kenya, mortuary surveillance can be used to understand the occurrence of HIV infection among cadavers. In 2015, a pilot HIV-related mortuary surveillance system was implemented in the two largest mortuaries in Nairobi, Kenya. CDC conducted an evaluation to assess performance attributes and identify strengths and weaknesses of the surveillance system pilot. PERIOD COVERED: Data collection: January 29-March 3, 2015; evaluation: November 2015. DESCRIPTION OF THE SYSTEM: The surveillance system objectives were to determine HIV positivity among cadavers at two mortuary sites in Nairobi, Kenya, and to determine annual cause-specific and HIV-specific mortality rates among the cadavers. Cadavers of persons aged >/=15 years at death admitted to either mortuary during a 33-day period were included. Demographic information and place and time of death were entered into a surveillance register. Cardiac blood was collected using transthoracic aspiration, and blood specimens were tested for HIV in a central laboratory. Causes of death were abstracted from mortuary and hospital records. Of the 807 cadavers brought to the mortuaries, 610 (75.6%) had an HIV test result available. The overall unadjusted HIV-positivity rate was 19.5% (119/610), which differed significantly by sex (14.6% among men versus 29.5% among women). EVALUATION: The evaluation was conducted using CDC guidelines for evaluating public health surveillance systems. The attributes of simplicity, flexibility, data quality (completeness and validity), acceptability, sensitivity, predictive value positive, representativeness, timeliness, and stability were examined. The evaluation steps included review of the surveillance system documents, in-depth interviews with 20 key informants (surveillance system staff, including mortuary and laboratory staff, and stakeholders involved in funding or implementation), and review of the surveillance database. RESULTS AND INTERPRETATION: Implementation of the pilot mortuary surveillance system was complex because of extensive paperwork and the need to collect and process specimens outside of business hours. However, the flexibility of the system accommodated multiple changes during implementation, including changes in specimen collection techniques and data collection tools. Acceptability was initially low among the mortuary staff but increased after concerns regarding workload were resolved. Timeliness of specimen collection could not be measured because time of death was rarely documented. Completeness of data available from the system was generally high except for cause of death (46.5%). Although the two largest mortuaries in Nairobi were included, the surveillance system might not be representative of the Nairobi population. One of the mortuaries was affiliated with the national referral hospital and included cadavers of admitted patients, some deaths might have occurred outside Nairobi, and data were collected for only 1 month. PUBLIC HEALTH ACTIONS: Mortuary surveillance can provide data on HIV positivity among cadavers and HIV-related mortality, which are not available from other sources in most sub-Saharan African countries. Availability of these mortality data will help describe a country's progress toward achieving epidemic control and achieving Joint United Nations Programme on HIV/AIDS 95-95-95 targets. To understand HIV mortality in high-prevalence regions, the mortuary surveillance system is being replicated in Western Kenya. Although a low-cost system, its sustainability depends on external funding because mortuary surveillance is not yet incorporated into the national AIDS strategic framework in Kenya.

OBJECTIVE: To assess changes and equity in antiretroviral therapy (ART) use in Kenya and South Africa. METHODS: We analysed national population-based household surveys conducted in Kenya and South Africa between 2007 and 2012 for factors associated with lack of ART use among people living with HIV (PLHIV) aged 15-64 years. We considered ART use to be inequitable if significant differences in use were found between groups of PLHIV (e.g. by sex). FINDINGS: ART use among PLHIV increased from 29.3% (95% confidence interval [CI]: 22.8-35.8) to 42.5% (95%CI: 37.4-47.7) from 2007 to 2012 in Kenya and 17.4% (95%CI: 14.2-20.9) to 30.3% (95%CI: 27.2-33.6) from 2008 to 2012 in South Africa. In 2012, factors independently associated with lack of ART use among adult Kenyan PLHIV were rural residency (adjusted odds ratio [aOR] 1.98, 95%CI: 1.23-3.18), younger age (15-24 years: aOR 4.25, 95%CI: 1.7-10.63, and 25-34 years: aOR 5.16, 95%CI: 2.73-9.74 versus 50-64 years), nondisclosure of HIV status to most recent sex partner (aOR 2.41, 95%CI: 1.27-4.57) and recent recreational drug use (aOR 2.50, 95%CI: 1.09-5.77). Among South African PLHIV in 2012, lack of ART use was significantly associated with younger age (15-24 years: aOR 4.23, 95%CI: 2.56-6.70, and 25-34 years: aOR 2.84, 95%CI: 1.73-4.67, versus 50-64 years), employment status (aOR 1.61, 95%CI: 1.16-2.23 in students versus unemployed), and recent recreational drug use (aOR 4.56, 95%CI: 1.79-11.57). CONCLUSION: Although we found substantial increases in ART use in both countries over time, we identified areas needing improvement including among rural Kenyans, students in South Africa, and among young people and drug users in both countries.

BACKGROUND: A recent infection testing algorithm (RITA) that includes a test for recent HIV infection and a viral load (VL) test is the recommended strategy to estimate population-level HIV incidence, reducing false-recent misclassification to <1%. The inclusion of information on exposure to antiretroviral therapy (ART), as a supplement to VL testing, could improve RITA performance by further lowering false-recent misclassification of true long-term infection. METHODS: In 2012, Kenya and South Africa conducted national population-based surveys that collected information on HIV recency (i.e., HIV antibody seroconversion, on average, in the past 130 days) using the Limiting Antigen Avidity Enzyme Immunoassay (LAg), HIV RNA levels, and ART exposure among HIV-infected respondents aged 15-49 years. In Kenya, ART exposure was defined as testing positive for one or more antiretroviral (ARV) drugs using high performance liquid chromatography coupled with tandem mass spectrometry, and, if not ARV-positive, self-reporting ART exposure in the past. In South Africa ART exposure was defined as testing ARV-positive. Two RITA strategies were compared: RITA #1 defined recent infection as LAg-recent with unsuppressed VL (HIV RNA>/=1,000 copies/mL) and RITA #2 defined recent infection as LAg-recent with unsuppressed VL and, if unsuppressed, having ART exposure. RESULTS: RITA-derived incidence among persons aged 15-49 years in Kenya was 0.9% on RITA #1 and 0.8% on RITA #2. In South Africa, RITA-derived incidence was 2.2% on RITA #1 and 1.7% on RITA #2. Among LAg-recent specimens with unsuppressed VL in Kenya and South Africa, 16.0% and 19.7% had evidence of ART exposure, respectively. DISCUSSION: Although the performance of a VL- and ART-based RITA was encouraging, additional research is needed across HIV-1 subtypes and sub-populations to calibrate and validate this algorithm.

The prevalence of hepatitis C virus (HCV) infection in the Kenyan population has not been previously determined. We estimated the Kenyan HCV prevalence in HIV-negative persons aged 15-64 years. This is a retrospective cross-sectional study using data from the 2007 Kenya AIDS Indicator Survey-a nationally representative sample of 15,853 persons aged 15-64 years who completed a health interview and provided a blood specimen. Of the 1,091 randomly selected participants, 50 tested positive for HCV antibody using the automated chemiluminescence immunoassay, corresponding to a weighted HCV antibody positivity rate of 4.4% (95% confidence interval: 3.3-5.9%) or 848,000 (range: 634,000-1,100,000) persons. Hepatitis C virus RNA, a marker for current infection, was not detected in any of the tested antibody-positive specimens. The high HCV antibody prevalence together with no current infection suggests that some HCV antibody serologic testing in Kenya may result in false positives whereas others may be because of spontaneous viral clearance.

Understanding how HIV is acquired can inform interventions to prevent infection. We constructed a risk profile of 10-24 year olds participating in the 2012 Kenya AIDS Indicator Survey and classified them as perinatally infected if their biological mother was infected with HIV or had died, or if their father was infected with HIV or had died (for those lacking mother's data). The remaining were classified as sexually infected if they had sex, and the remaining as parenterally infected if they had a blood transfusion. Overall, 84 (1.6%) of the 5298 10-24 year olds tested HIV positive; 9 (11%) were aged 10-14 and 75 (89%) 15-24 years. Five (56%) 10-14 year olds met criteria for perinatal infection; 4 (44%) did not meet perinatal, sexual or parenteral transmission criteria and parental HIV status was not established. Of the 75 HIV-infected, 15 to 24 year olds, 5 (7%) met perinatal transmission, 63 (84%) sexual and 2 (3%) parenteral criteria; 5 (7%) were unclassified. Perinatal transmission likely accounted for 56% and sexual transmission for 84% of infections among 10-14 year olds and 15-24 year olds, respectively. Although our definitions may have introduced some uncertainty, and with the number of infected participants being small, our findings suggest that mixed modes of HIV transmission exist among adolescents and young people.

BACKGROUND: Declines in HIV prevalence and increases in antiretroviral treatment coverage have been documented in Kenya, but population-level mortality associated with HIV has not been directly measured. In urban areas where a majority of deaths pass through mortuaries, mortuary-based studies have the potential to contribute to our understanding of excess mortality among HIV-infected persons. We used results from a cross-sectional mortuary-based HIV surveillance study to estimate the association between HIV and mortality for Nairobi, the capital city of Kenya. METHODS AND FINDINGS: HIV seropositivity in cadavers measured at the two largest mortuaries in Nairobi was used to estimate HIV prevalence in adult deaths. Model-based estimates of the HIV-infected and uninfected population for Nairobi were used to calculate a standardized mortality ratio and population-attributable fraction for mortality among the infected versus uninfected population. Monte Carlo simulation was used to assess sensitivity to epidemiological assumptions. When standardized to the age and sex distribution of expected deaths, the estimated HIV positivity among adult deaths aged 15 years and above in Nairobi was 20.9% (95% CI 17.7-24.6%). The standardized mortality ratio of deaths among HIV-infected versus uninfected adults was 4.35 (95% CI 3.67-5.15), while the risk difference was 0.016 (95% CI 0.013-0.019). The HIV population attributable mortality fraction was 0.161 (95% CI 0.131-0.190). Sensitivity analyses demonstrated robustness of results. CONCLUSIONS: Although 73.6% of adult PLHIV receive antiretrovirals in Nairobi, their risk of death is four-fold greater than in the uninfected, while 16.1% of all adult deaths in the city can be attributed to HIV infection. In order to further reduce HIV-associated mortality, high-burden countries may need to reach very high levels of diagnosis, treatment coverage, retention in care, and viral suppression.

BACKGROUND: Efforts to reach UNAIDS' treatment and viral suppression targets have increased demand for viral load (VL) testing and strained existing laboratory networks, affecting turnaround time. Longer VL turnaround times delay both initiation of formal adherence counseling and switches to second-line therapy for persons failing treatment and contribute to poorer health outcomes. METHODS: We utilized descriptive statistics and logistic regression to analyze VL testing data collected in Malawi between January 2013 and March 2016. The primary outcomes assessed were greater-than-median pretest phase turnaround time (days elapsed from specimen collection to receipt at the laboratory) and greater-than-median test phase turnaround time (days from receipt to testing). RESULTS: The median number of days between specimen collection and testing increased 3-fold between 2013 (8 days, interquartile range (IQR) = 6-16) and 2015 (24, IQR = 13-39) (p<0.001). Multivariable analysis indicated that the odds of longer pretest phase turnaround time were significantly higher for specimen collection districts without laboratories capable of conducting viral load tests (adjusted odds ratio (aOR) = 5.16; 95% confidence interval (CI) = 5.04-5.27) as well as for Malawi's Northern and Southern regions. Longer test phase turnaround time was significantly associated with use of dried blood spots instead of plasma (aOR = 2.30; 95% CI = 2.23-2.37) and for certain testing months and testing laboratories. CONCLUSION: Increased turnaround time for VL testing appeared to be driven in part by categorical factors specific to the phase of turnaround time assessed. Given the implications of longer turnaround time and the global effort to scale up VL testing, addressing these factors via increasing efficiencies, improving quality management systems and generally strengthening the VL spectrum should be considered essential components of controlling the HIV epidemic.

BACKGROUND: Laboratory tests that can distinguish recent from long-term HIV infection are used to estimate HIV incidence in a population but can potentially misclassify a proportion of long-term HIV infections as recent. Correct application of an assay requires determination of the proportion false recents (PFR) as part of the assay characterization and for calculating HIV incidence in a local population using a HIV incidence assay. METHODS: From April 2009 to December 2010, blood specimens were collected from HIV-infected individuals attending 9 outpatient clinics (OPCs) in Vietnam (4 from northern and 5 from southern Vietnam). Participants were living with HIV for ≥1 year and reported no antiretroviral drug (ARV) treatment. Basic demographic data and clinical information were collected. Specimens were tested with the BED capture enzyme immunoassay (BED-CEIA) and the Limiting-antigen (LAg)-Avidity EIA. PFR was estimated by dividing the number of specimens classified as recent by the total number of specimens; 95% confidence intervals (CI) were calculated. Specimens that tested recent had viral load testing performed. RESULTS: Among 1,813 specimens (north, n= 942 and south, n = 871), the LAg-Avidity EIA PFR was 1.7% (CI 1.2-2.4) and differed by region [north 2.7% (CI 1.8, 3.9) versus south 0.7% (CI 0.3, 1.5); p=0.002]. The BED-CEIA PFR was 2.3% (CI 1.7, 3.0) and varied by region [north 3.4% (CI: 2.4, 4.7) versus south 1.0% (CI 0.5, 1.2), p<0.001]. Excluding specimens with an undetectable VL, the LAg-Avidity EIA PFR was 1.2% (CI: 0.8, 1.9) and the BED-CEIA PFR was 1.7% (CI: 1.2, 2.4). CONCLUSIONS: The LAg-Avidity EIA PFR was lower than the BED-CEIA PFR. After excluding specimens with an undetectable VL, the PFR for both assays was similar. A low PFR should facilitate the implementation of the LAg-Avidity EIA for cross-sectional incidence estimates in Vietnam.

HIV-1 transmitted drug resistance (TDR) is of increasing public health concern in sub-Saharan Africa with the rollout of antiretroviral (ARV) therapy. Such data are, however, limited in Kenya, where HIV-1 drug resistance testing is not routinely performed. From a population-based household survey conducted between September and November 2012 in rural western Kenya, we retrospectively assessed HIV-1 TDR baseline rates, its determinants, and genetic diversity among drug-naive persons aged 15-59 years with acute HIV-1 infections (AHI) and recent HIV-1 infections (RHI) as determined by nucleic acid amplification test and both Limiting Antigen and BioRad avidity immunoassays, respectively. HIV-1 pol sequences were scored for drug resistance mutations using Stanford HIVdb and WHO 2009 mutation guidelines. HIV-1 subtyping was computed in MEGA6. Eighty seven (93.5%) of the eligible samples were successfully sequenced. Of these, 8 had at least one TDR mutation, resulting in a TDR prevalence of 9.2% (95% CI 4.7-17.1). No TDR was observed among persons with AHI (n = 7). TDR prevalence was 4.6% (95% CI 1.8-11.2) for nucleoside reverse transcriptase inhibitors (NRTIs), 6.9% (95% CI 3.2-14.2) for non- nucleoside reverse transcriptase inhibitors (NNRTIs), and 1.2% (95% CI 0.2-6.2) for protease inhibitors. Three (3.4% 95% CI 0.8-10.1) persons had dual-class NRTI/NNRTI resistance. Predominant TDR mutations in the reverse transcriptase included K103N/S (4.6%) and M184V (2.3%); only M46I/L (1.1%) occurred in the protease. All the eight persons were predicted to have different grades of resistance to the ARV regimens, ranging from potential low-level to high-level resistance. HIV-1 subtype distribution was heterogeneous: A (57.5%), C (6.9%), D (21.8%), G (2.3%), and circulating recombinant forms (11.5%). Only low CD4 count was associated with TDR (p = 0.0145). Our findings warrant the need for enhanced HIV-1 TDR monitoring in order to inform on population-based therapeutic guidelines and public health interventions.

INTRODUCTION: Understanding the levels and associated factors of non-adherence to antiretroviral therapy (ART) is crucial in designing interventions to improve adherence and health outcomes of ART. We assessed non-adherence to ART among HIV-infected persons reporting ART use in a nationally representative survey in Kenya. METHODS: The Kenya AIDS Indicator Survey 2012 was a population-based, household survey of persons aged 18 months-64 years conducted in 2012-2013. Self-reported information was collected on demographics, sexual behaviour, HIV status, and ART use. Blood was collected for HIV testing, and if HIV infected, CD4 and viral load testing. HIV-positive specimens were tested for the presence of antiretroviral (ARV) drugs using a qualitative ARV assay using liquid chromatography-tandem mass spectrometry. HIV-positive persons who reported receiving ART but did not have the ARV biomarker present were defined as being non-adherent to their ARV medication. We restricted our analysis to HIV-infected persons aged 15-64 years who reported receiving ART and had laboratory-confirmed results from ARV testing. Multivariate logistic regression was used to identify variables associated with non-adherence. RESULTS: A total of 648 (5.6%; CI 4.9-6.3) tested HIV-positive of whom 559 (86.3%) had sufficient volume of blood to be tested for ARV drugs. Of those, 271 (47.7%; CI 41.8-53.6) self-reported HIV-positive status during the interview and 186 (69.1%; CI 62.2-76.0) of those reported taking ART. The ARV biomarker was absent in 18 of 186 individuals (9.4%; CI 4.9-13.8) who thus were defined as being non-adherent to ART. Non-adherence was associated with being aged 15-29 years (AOR 8.39; CI 2.26-31.22, p = 0.002) compared to aged 30-64 years, rural residence (AOR 5.87; CI 1.39-25.61, p = 0.016) compared with urban residence and taking recreational drugs in the past 30 days (AOR 5.89; CI 1.30-26.70, p = 0.022). CONCLUSION: Overall, less than 10% of Kenyans aged 15-64 years on ART were not adhering to their HIV medication, highlighting the success of the Kenyan national ART program. Our findings, however, point to the need for targeted interventions particularly for young persons, those in rural areas to improve adherence outcomes, as well as delivery of treatment programs that include psychosocial support as a preventative measure to minimize substance abuse and the risk of treatment failure.

The World Health Organization (WHO) recommends viral load testing as the preferred method for monitoring the clinical response of patients with human immunodeficiency virus (HIV) infection to antiretroviral therapy (ART). Viral load monitoring of patients on ART helps ensure early diagnosis and confirmation of ART failure and enables clinicians to take an appropriate course of action for patient management. When viral suppression is achieved and maintained, HIV transmission is substantially decreased, as is HIV-associated morbidity and mortality. CDC and other U.S. government agencies and international partners are supporting multiple countries in sub-Saharan Africa to provide viral load testing of persons with HIV who are on ART. This report examines current capacity for viral load testing based on equipment provided by manufacturers and progress with viral load monitoring of patients on ART in seven sub-Saharan countries (Cote d'Ivoire, Kenya, Malawi, Namibia, South Africa, Tanzania, and Uganda) during January 2015-June 2016. By June 2016, based on the target numbers for viral load testing set by each country, adequate equipment capacity existed in all but one country. During 2015, two countries tested >85% of patients on ART (Namibia [91%] and South Africa [87%]); four countries tested <25% of patients on ART. In 2015, viral suppression was >80% among those patients who received a viral load test in all countries except Cote d'Ivoire. Sustained country commitment and a coordinated global effort is needed to reach the goal for viral load monitoring of all persons with HIV on ART.

OBJECTIVE: There is evidence of substantial subnational variation in the HIV epidemic. However, robust spatial HIV data are often only available at high levels of geographic aggregation and not at the finer resolution needed for decision making. Therefore, spatial analysis methods that leverage available data to provide local estimates of HIV prevalence may be useful. Such methods exist but have not been formally compared when applied to HIV. DESIGN/METHODS: Six candidate methods - including those used by the Joint United Nations Programme on HIV/AIDS to generate maps and a Bayesian geostatistical approach applied to other diseases - were used to generate maps and subnational estimates of HIV prevalence across three countries using cluster level data from household surveys. Two approaches were used to assess the accuracy of predictions: internal validation, whereby a proportion of input data is held back (test dataset) to challenge predictions; and comparison with location-specific data from household surveys in earlier years. RESULTS: Each of the methods can generate usefully accurate predictions of prevalence at unsampled locations, with the magnitude of the error in predictions similar across approaches. However, the Bayesian geostatistical approach consistently gave marginally the strongest statistical performance across countries and validation procedures. CONCLUSIONS: Available methods may be able to furnish estimates of HIV prevalence at finer spatial scales than the data currently allow. The subnational variation revealed can be integrated into planning to ensure responsiveness to the spatial features of the epidemic. The Bayesian geostatistical approach is a promising strategy for integrating HIV data to generate robust local estimates.

Integrated approaches provide better understanding of HIV/AIDS epidemics. We optimised a multiassay algorithm (MAA) and assessed HIV incidence, correlates of recent infections, viral diversity, plus transmission clusters among participants screened for Kisumu Incidence Cohort Study (KICoS1) (2007-2009). We performed BED-CEIA, Limiting antigen (LAg) avidity, Biorad avidity, and viral load (VL) tests on HIV-positive samples. Genotypic analyses focused on HIV-1 pol gene. Correlates of testing recent by MAA were assessed using logistic regression model. Overall, 133 (12%, 95% CI: 10.2-14.1) participants were HIV-positive, of whom 11 tested recent by MAA (BED-CEIA OD-n < 0.8 + LAg avidity OD-n < 1.5 + VL > 1000 copies/mL), giving an incidence of 1.46% (95% CI: 0.58-2.35) per year. This MAA-based incidence was similar to longitudinal KICoS1 incidence. Correlates of testing recent included sexually transmitted infection (STI) treatment history (OR = 3.94, 95% CI: 1.03-15.07) and syphilis seropositivity (OR = 10.15, 95% CI: 1.51-68.22). Overall, HIV-1 subtype A (63%), D (15%), C (3%), G (1%) and recombinants (18%), two monophyletic dyads and intrinsic viral mutations (V81I, V81I/V, V108I/V and K101Q) were observed. Viral diversity mirrored known patterns in this region, while resistance mutations reflected likely non-exposure to antiretroviral drugs. Management of STIs may help address ongoing HIV transmission in this region.

Pediatric human immunodeficiency virus (HIV) infection remains an important public health issue in resource-limited settings. In 2015, 1.4 million children aged <15 years were estimated to be living with HIV (including 170,000 infants born in 2015), with the vast majority living in sub-Saharan Africa. In 2014, 150,000 children died from HIV-related causes worldwide. Access to timely HIV diagnosis and treatment for HIV-infected infants reduces HIV-associated mortality, which is approximately 50% by age 2 years without treatment. Since 2011, the annual number of HIV-infected children has declined by 50%. Despite this gain, in 2014, only 42% of HIV-exposed infants received a diagnostic test for HIV, and in 2015, only 51% of children living with HIV received antiretroviral therapy (1). Access to services for early infant diagnosis of HIV (which includes access to testing for HIV-exposed infants and clinical diagnosis of HIV-infected infants) is critical for reducing HIV-associated mortality in children aged <15 years. Using data collected from seven countries supported by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), progress in the provision of HIV testing services for early infant diagnosis was assessed. During 2011-2015, the total number of HIV diagnostic tests performed among HIV-exposed infants within 6 weeks after birth (tests for early infant diagnosis of HIV), as recommended by the World Health Organization (WHO) increased in all seven countries (Cote d'Ivoire, the Democratic Republic of the Congo, Haiti, Malawi, South Africa, Uganda, and Zambia); however, in 2015, the rate of testing for early infant diagnosis among HIV-exposed infants was <50% in five countries. HIV positivity among those tested declined in all seven countries, with three countries (Cote d'Ivoire, the Democratic Republic of the Congo, and Uganda) reporting >50% decline. The most common challenges for access to testing for early infant diagnosis included difficulties in specimen transport, long turnaround time between specimen collection and receipt of results, and limitations in supply chain management. Further reductions in HIV mortality in children can be achieved through continued expansion and improvement of services for early infant diagnosis in PEPFAR-supported countries, including initiatives targeted to reach HIV-exposed infants, ensure access to programs for early infant diagnosis of HIV, and facilitate prompt linkage to treatment for children diagnosed with HIV infection.

OBJECTIVES: Estimating HIV incidence is critical for identifying groups at risk for HIV infection, planning and targeting interventions, and evaluating these interventions over time. The use of reliable estimation methods for HIV incidence is thus of high importance. The aim of this study was to compare methods for estimating HIV incidence in a population-based cross-sectional survey. DESIGN/METHODS: The incidence estimation methods evaluated included assay-derived methods, a testing history-derived method, and a probability-based method applied to data from the Ndhiwa HIV Impact in Population Survey (NHIPS). Incidence rates by sex and age and cumulative incidence as a function of age were presented. RESULTS: HIV incidence ranged from 1.38 [95% confidence interval (CI) 0.67-2.09] to 3.30 [95% CI 2.78-3.82] per 100 persons-years overall; 0.59 [95% CI 0.00-1.34] to 2.89 [95% CI 0.11-5.68] in men; and 1.62 [95% CI 0.16-6.04] to 4.03 [95% CI 3.30-4.77] per 100 persons-years in women. Women had higher incidence rates than men for all methods. Incidence rates were highest among women aged 15-24 and 25-34 years and highest among men aged 25-34 years. CONCLUSION: Comparison of different methods showed variations in incidence estimates, but they were in agreement to identify most-at-risk groups. The use and comparison of several distinct approaches for estimating incidence are important to provide the best-supported estimate of HIV incidence in the population.

Scaling up access to HIV viral load testing for individuals undergoing antiretroviral therapy in low-resource settings is a global health priority, as emphasised by research showing the benefits of suppressed viral load for the individual and the whole population. Historically, large-scale diagnostic test implementation has been slow and incomplete because of service delivery and other challenges. Building on lessons from the past, in this Personal View we propose a new framework to accelerate viral load scale-up and ensure equitable access to this essential test. The framework includes the following steps: (1) ensuring adequate financial investment in scaling up this test; (2) achieving pricing agreements and consolidating procurement to lower prices of the test; (3) strengthening functional tiered laboratory networks and systems to expand access to reliable, high-quality testing across countries; (4) strengthening national leadership, with prioritisation of laboratory services; and (5) demand creation and uptake of test results by clinicians, nurses, and patients, which will be vital in ensuring viral load tests are appropriately used to improve the quality of care. The use of dried blood spots to stabilise and ship samples from clinics to laboratories, and the use of point-of-care diagnostic tests, will also be important for ensuring access, especially in settings with reduced laboratory capacity. For countries that have just started to scale up viral load testing, lessons can be learnt from countries such as Botswana, Brazil, South Africa, and Thailand, which have already established viral load programmes. This framework might be useful for guiding the implementation of viral load with the aim of achieving the new global HIV 90-90-90 goals by 2020.

In bio-behavioural surveys measuring prevalence of infection with human immunodeficiency virus (HIV), respondents should be asked the results of their last HIV test. However, many government authorities, nongovernmental organizations, researchers and other civil society stakeholders have stated that respondents involved in such surveys should not be asked to self-report their HIV status. The reasons offered for not asking respondents to report their status are that responses may be inaccurate and that asking about HIV status may violate the respondents' human rights and exacerbate stigma and discrimination. Nevertheless, we contend that, in the antiretroviral therapy era, asking respondents in bio-behavioural surveys to self-report their HIV status is essential for measuring and improving access to - and coverage of - services for the care, treatment and prevention of HIV infection. It is also important for estimating the true size of the unmet needs in addressing the HIV epidemic and for interpreting the behaviours associated with the acquisition and transmission of HIV infection correctly. The data available indicate that most participants in health-related surveys are willing to respond to a question about HIV status - as one of possibly several sensitive questions about sexual and drug use behaviours. Ultimately, normalizing the self-reporting of HIV status could help the global community move from an era of so-called exceptionalism to one of destigmatization - and so improve the epidemic response worldwide.

OBJECTIVES: To assess the impact of undisclosed HIV infection and antiretroviral (ARV) therapy (ART) on national estimates of diagnosed HIV and ART coverage in Kenya. METHODS: HIV-positive dried blood spot samples from Kenya's second AIDS Indicator Survey were tested for an ARV biomarker by liquid chromatography-tandem mass spectrometry. Estimates of diagnosed HIV and ART use based on self-report were compared with those corrected for undisclosed HIV infection and ART use based on ARV testing. Multivariate analysis determined factors associated with undisclosed HIV infection and ART use among persons on ART. RESULTS: Among 559 HIV-positive samples, the ARV biomarker was detected in 42.5% (CI 37.4-47.7). ARV drugs were present in 90.7% (CI 86.1-95.2) reporting HIV-positive status and receiving ART, 66.7% (CI 59.9-73.4) reporting HIV-positive status irrespective of ART use, 21.0% (CI 13.4-28.6) reporting HIV-negative status, and 19.3% (CI 9.0-29.5) reporting no previous HIV test. After correcting for undisclosed HIV infection and ART use, diagnosed HIV increased from 46.9% to 57.2% and ART coverage increased from 31.8% to 42.8%. Undisclosed HIV infection on ART was associated with being aged 25-39 years and not visiting a health provider in the past year, while younger age and higher wealth was associated with undisclosed ART use. CONCLUSION: Substantial levels of undisclosed HIV infection and ART use while on ART were observed, resulting in diagnosed HIV underestimated by 112,000 persons and ART coverage by 131,000 persons. Supplementing self-reported ART status with objective measures of ART use in national population-based sero-surveys can improve monitoring of treatment targets in countries.

Current estimates put the prevalence of hepatitis B virus (HBV) infection in Kenya at 5-8%. We determined the HBV infection prevalence in the human immunodeficiency virus (HIV)-negative Kenyan adult and adolescent population based on samples collected from a national survey. We analyzed data from HIV-negative participants in the 2007 Kenya AIDS Indicator Survey to estimate the HBV infection prevalence. We defined past or present HBV infection as presence of total hepatitis B core antibody (HBcAb), and chronic HBV infection (CHBI) as presence of both total HBcAb and hepatitis B surface antigen (HBsAg). We calculated crude and adjusted odds of HBV infection by demographic characteristics and risk factors using logistic regression analyses. Of 1,091 participants aged 15-64 years, approximately 31.5% (95% confidence interval [CI] = 28.0-35.3%) had exposure to HBV, corresponding to approximately 6.1 million (CI = 5.4-6.8 million) with past or present HBV infection. The estimated prevalence of CHBI was 2.1% (95% CI = 1.4-3.1%), corresponding to approximately 398,000 (CI = 261,000-602,000) with CHBI. CHBI is a major public health problem in Kenya, affecting approximately 400,000 persons. Knowing the HBV infection prevalence at baseline is important for planning and public health policy decision making and for monitoring the impact of viral hepatitis prevention programs.

INTRODUCTION: At the individual level, there is clear evidence that Human Immunodeficiency Virus (HIV) transmission can be substantially reduced by lowering viral load. However there are few data describing population-level HIV viremia especially in high-burden settings with substantial under-diagnosis of HIV infection. The 2nd Kenya AIDS Indicator Survey (KAIS 2012) provided a unique opportunity to evaluate the impact of antiretroviral therapy (ART) coverage on viremia and to examine the risks for failure to suppress viral replication. We report population-level HIV viral load suppression using data from KAIS 2012. METHODS: Between October 2012 to February 2013, KAIS 2012 surveyed household members, administered questionnaires and drew serum samples to test for HIV and, for those found to be infected with HIV, plasma viral load (PVL) was measured. Our principal outcome was unsuppressed HIV viremia, defined as a PVL ≥ 550 copies/mL. The exposure variables included current treatment with ART, prior history of an HIV diagnosis, and engagement in HIV care. All point estimates were adjusted to account for the KAIS 2012 cluster sampling design and survey non-response. RESULTS: Overall, 61.2% (95% CI: 56.4-66.1) of HIV-infected Kenyans aged 15-64 years had not achieved virological suppression. The base10 median (interquartile range [IQR]) and mean (95% CI) VL was 4,633 copies/mL (0-51,596) and 81,750 copies/mL (59,366-104,134), respectively. Among 266 persons taking ART, 26.1% (95% CI: 20.0-32.1) had detectable viremia. Non-ART use, younger age, and lack of awareness of HIV status were independently associated with significantly higher odds of detectable viral load. In multivariate analysis for the sub-sample of patients on ART, detectable viremia was independently associated with younger age and sub-optimal adherence to ART. DISCUSSION: This report adds to the limited data of nationally-representative surveys to report population- level virological suppression. We established heterogeneity across the ten administrative and HIV programmatic regions on levels of detectable viral load. Timely initiation of ART and retention in care are crucial for the elimination of transmission of HIV through sex, needle and syringe use or from mother to child. Further refinement of geospatial mapping of populations with highest risk of transmission is necessary.

INTRODUCTION: A recent infection testing algorithm (RITA) that can distinguish recent from long-standing HIV infection can be applied to nationally representative population-based surveys to characterize and identify risk factors for recent infection in a country. MATERIALS AND METHODS: We applied a RITA using the Limiting Antigen Avidity Enzyme Immunoassay (LAg) on stored HIV-positive samples from the 2007 Kenya AIDS Indicator Survey. The case definition for recent infection included testing recent on LAg and having no evidence of antiretroviral therapy use. Multivariate analysis was conducted to determine factors associated with recent and long-standing infection compared to HIV-uninfected persons. All estimates were weighted to adjust for sampling probability and nonresponse. RESULTS: Of 1,025 HIV-antibody-positive specimens, 64 (6.2%) met the case definition for recent infection and 961 (93.8%) met the case definition for long-standing infection. Compared to HIV-uninfected individuals, factors associated with higher adjusted odds of recent infection were living in Nairobi (adjusted odds ratio [AOR] 11.37; confidence interval [CI] 2.64-48.87) and Nyanza (AOR 4.55; CI 1.39-14.89) provinces compared to Western province; being widowed (AOR 8.04; CI 1.42-45.50) or currently married (AOR 6.42; CI 1.55-26.58) compared to being never married; having had ≥ 2 sexual partners in the last year (AOR 2.86; CI 1.51-5.41); not using a condom at last sex in the past year (AOR 1.61; CI 1.34-1.93); reporting a sexually transmitted infection (STI) diagnosis or symptoms of STI in the past year (AOR 1.97; CI 1.05-8.37); and being aged <30 years with: 1) HSV-2 infection (AOR 8.84; CI 2.62-29.85), 2) male genital ulcer disease (AOR 8.70; CI 2.36-32.08), or 3) lack of male circumcision (AOR 17.83; CI 2.19-144.90). Compared to HIV-uninfected persons, factors associated with higher adjusted odds of long-standing infection included living in Coast (AOR 1.55; CI 1.04-2.32) and Nyanza (AOR 2.33; CI 1.67-3.25) provinces compared to Western province; being separated/divorced (AOR 1.87; CI 1.16-3.01) or widowed (AOR 2.83; CI 1.78-4.45) compared to being never married; having ever used a condom (AOR 1.61; CI 1.34-1.93); and having a STI diagnosis or symptoms of STI in the past year (AOR 1.89; CI 1.20-2.97). Factors associated with lower adjusted odds of long-standing infection included using a condom at last sex in the past year (AOR 0.47; CI 0.36-0.61), having no HSV2-infection at aged <30 years (AOR 0.38; CI 0.20-0.75) or being an uncircumcised male aged <30 years (AOR 0.30; CI 0.15-0.61). CONCLUSION: We identified factors associated with increased risk of recent and longstanding HIV infection using a RITA applied to blood specimens collected in a nationally representative survey. Though some false-recent cases may have been present in our sample, the correlates of recent infection identified were epidemiologically and biologically plausible. These methods can be used as a model for other countries with similar epidemics to inform targeted combination prevention strategies aimed to drastically decrease new infections in the population.

BACKGROUND: Sentinel surveillance for HIV among women attending antenatal clinics using unlinked anonymous testing is a cornerstone of HIV surveillance in sub-Saharan Africa. Increased use of routine antenatal HIV testing allows consideration of using these programmatic data rather than sentinel surveillance data for HIV surveillance. METHODS: To gauge Kenya's readiness to discontinue sentinel surveillance, we evaluated whether recommended World Health Organization standards were fulfilled by conducting data and administrative reviews of antenatal clinics that offered both routine testing and sentinel surveillance in 2010. RESULTS: The proportion of tests that were HIV-positive among women aged 15-49 years was 6.2 % (95 % confidence interval [CI] 4.6-7.7 %] in sentinel surveillance and 6.5 % (95 % CI 5.1-8.0 %) in routine testing. The agreement of HIV test results between sentinel surveillance and routine testing was 98.0 %, but 24.1 % of specimens that tested positive in sentinel surveillance were recorded as negative in routine testing. Data completeness was moderate, with HIV test results recorded for 87.8 % of women who received routine testing. CONCLUSIONS: Additional preparation is required before routine antenatal HIV testing data can supplant sentinel surveillance in Kenya. As the quality of program data has markedly improved since 2010 a repeat evaluation of the use of routine antenatal HIV testing data in lieu of ANC sentinel surveillance is recommended.