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OBJECTIVE We present findings from the nationally representative Zimbabwe Population-based HIV Impact Assessment that characterize Zimbabwe's progress toward the Joint United Nations Programme on HIV/AIDS 90-90-90 targets. DESIGN We conducted a cross-sectional household survey. METHODS Consenting adults and children in the household were eligible to participate in Zimbabwe Population-based HIV Impact Assessment (October 2015-August 2016). Participants completed face-to-face interviews and provided blood for HIV, CD4, viral load, and syphilis testing. Viral load suppression (VLS) was defined as HIV RNA

BACKGROUND HIV population viral load (PVL) can reflect antiretroviral therapy program effectiveness and transmission potential in a community. Using nationally representative data from household surveys conducted in Zimbabwe, Malawi, and Zambia in 2015-16, we examined the association between various VL measures and the probability of at least one recent HIV-1 infection in the community. METHODS We used limiting-antigen avidity enzyme immunoassay, viral load suppression (VLS) (HIV RNA

Background HIV-1 incidence calculation currently includes recency classification by HIV-1 incidence assay and unsuppressed viral load (VL ≥ 1000 copies/mL) in a recent infection testing algorithm (RITA). However, persons with recent classification not virally suppressed and taking antiretroviral (ARV) medication may be misclassified. Setting We used data from 13 African household surveys to describe the impact of an ARV-adjusted RITA on HIV-1 incidence estimates. Methods HIV-seropositive samples were tested for recency using the HIV-1 Limiting Antigen (LAg)-Avidity enzyme immunoassay, HIV-1 viral load, ARVs used in each country, and ARV drug resistance. LAg-recent result was defined as normalized optical density values ≤1.5. We compared HIV-1 incidence estimates using 2 RITA: RITA1: LAg-recent + VL ≥ 1000 copies/mL and RITA2: RITA1 + undetectable ARV. We explored RITA2 with self-reported ARV use and with clinical history. Results Overall, 357 adult HIV-positive participants were classified as having recent infection with RITA1. RITA2 reclassified 55 (15.4%) persons with detectable ARV as having long-term infection. Those with detectable ARV were significantly more likely to be aware of their HIV-positive status (84% vs. 10%) and had higher levels of drug resistance (74% vs. 26%) than those without detectable ARV. RITA2 incidence was lower than RITA1 incidence (range, 0%-30% decrease), resulting in decreased estimated new infections from 390,000 to 341,000 across the 13 countries. Incidence estimates were similar using detectable or self-reported ARV (R2 > 0.995). Conclusions Including ARV in RITA2 improved the accuracy of HIV-1 incidence estimates by removing participants with likely long-term HIV infection.

Background The population-based HIV impact assessment (population-based HIV impact assessments) surveys are among the first to estimate national adult HIV incidence, subnational prevalence of viral load suppression, and pediatric HIV prevalence. We summarize the survey methods implemented in Zimbabwe, Malawi, and Zambia, as well as response rates and quality metrics. Methods Each cross-sectional, household-based survey used a 2-stage cluster design. Survey preparations included sample design, questionnaire development, tablet programming for informed consent and data collection, community mobilization, establishing a network of satellite laboratories, and fieldworker training. Interviewers collected demographic, behavioral, and clinical information using tablets. Blood was collected for home-based HIV testing and counseling (HBTC) and point-of-care CD4+ T-cell enumeration with results immediately returned. HIV-positive blood samples underwent laboratory-based confirmatory testing, HIV incidence testing, RNA polymerase chain reaction (viral load), DNA polymerase chain reaction (early infant diagnosis), and serum antiretroviral drug detection. Data were weighted for survey design, and chi square automatic interaction detection-based methods were used to adjust for nonresponse. Results Each survey recruited a nationally representative, household-based sample of children and adults over a 6-10-month period in 2015 and 2016. Most (84%-90%) of the 12,000-14,000 eligible households in each country participated in the survey, with 77%-81% of eligible adults completing an interview and providing blood for HIV testing. Among eligible children, 59%-73% completed HIV testing. Across the 3 surveys, 97.8% of interview data were complete and had no errors. Conclusion Conducting a national population-based HIV impact assessment with immediate return of HIV and other point-of-care test results was feasible, and data quality was high.

BACKGROUND The need for accurate HIV annual program planning data motivated the compressed timeline for the 2018 Nigerian HIV/AIDS Indicator and Impact Survey (NAIIS). The survey team used stakeholder cooperation and responsive design, using survey process and paradata to refine survey implementation, to quickly collect high-quality data. We describe processes that led to generation of data for program and funding decisions, ensuring HIV services were funded in 2019. SETTING Nigeria is the most populous country in Africa, with approximately 195 million people in 36 states and the Federal Capital Territory. Challenges include multiple security threats, poor infrastructure, seasonal rains, and varied health system capacity. METHODS Stakeholders worked together to plan and implement NAIIS. Methods from other population-based HIV impact assessments were modified to meet challenges and the compressed timeline. Data collection was conducted in 6 webs. Responsive design included reviewing survey monitoring paradata and laboratory performance. Costs required to correct data errors, for example, staff time and transportation, were tracked. RESULTS NAIIS data collection was completed in 23 weeks, ahead of the originally scheduled 24 weeks. Responsive design identified and resolved approximately 68,000 interview errors, affecting approximately 62,000 households, saving about US$4.4 million in costs. Biweekly field laboratory test quality control improved from 50% to 100% throughout NAIIS. CONCLUSIONS Cooperation across stakeholders and responsive design ensured timely release of NAIIS results and informed planning for HIV epidemic control in Nigeria. Based on NAIIS results, funds were provided to place an additional 500,000 HIV-positive Nigerians on antiretroviral therapy by the end of 2020, pushing Nigeria toward epidemic control.

The World Health Organization and national guidelines recommend HIV testing and counseling at tuberculosis (TB) clinics for all patients, regardless of TB diagnosis (1). Population-based HIV Impact Assessment (PHIA) survey data for 2015-2016 in Malawi, Zambia, and Zimbabwe were analyzed to assess HIV screening at TB clinics among persons who had positive HIV test results in the survey. The analysis was stratified by history of TB diagnosis* (presumptive versus confirmed†), awareness§ of HIV-positive status, antiretroviral therapy (ART)¶ status, and viral load suppression among HIV-positive adults, by history of TB clinic visit. The percentage of adults who reported having ever visited a TB clinic ranged from 4.7% to 9.7%. Among all TB clinic attendees, the percentage who reported that they had received HIV testing during a TB clinic visit ranged from 48.0% to 62.1% across the three countries. Among adults who received a positive HIV test result during PHIA and who did not receive a test for HIV at a previous TB clinic visit, 29.4% (Malawi), 21.9% (Zambia), and 16.2% (Zimbabwe) reported that they did not know their HIV status at the time of the TB clinic visit. These findings represent missed opportunities for HIV screening and linkage to HIV care. In all three countries, viral load suppression rates were significantly higher among those who reported ever visiting a TB clinic than among those who had not (p

Between October 2015 and August 2016, Zimbabwe conducted the Zimbabwe Population-Based HIV Impact Assessment (ZIMPHIA) cross-sectional survey to determine progress toward epidemic control. Of 25,131 eligible adults aged 15-64 years, 20,577 (81.8%) consented to face-to-face questionnaire and biomarker testing in this nationally representative household survey. Home-based rapid HIV testing was performed using Determine, First Response, and STAT-PAK as the tiebreaker. HIV-positive tests were confirmed in a laboratory using Geenius HIV-1/2; viral load (VL) was measured using Roche TaqMan and BioMerieux NucliSENS. Recency of infection was tested using Sedia HIV-1 Limiting Antigen (LAg)-Avidity. Presence of antiretroviral (ARV) drugs was detected using high performance liquid chromatography/mass spectrometry (HPLC/MS). The recent infection testing algorithm included LAg-avidity enzyme immunoassay [normalized optical density (ODn ≤1.5), VL ≥1,000 copies/mL, and absence of ARV drugs]. Weighted annual HIV incidence was compared with United Nations Joint Programme on HIV/AIDS (UNAIDS) Spectrum models estimates. Overall, 26 of 2,901 HIV-seropositive individuals had a recent infection (men, 8; women, 18). Overall weighted annual incidence among persons aged 15-64 years was 0.42% [95% confidence interval (CI): 0.25-0.59] and was 0.44% (95% CI: 0.25-0.62) for those aged 15-49 years, similar to 2016 Spectrum model estimate (0.54%, 95% CI: 0.49-0.66) for this age group. Among persons aged 15-49 years, HIV prevalence was 13.35% (95% CI: 12.71-14.02), estimated HIV-positive individuals were 968,951 (95% CI: 911,473-1,026,430), of these, 41,911 (95% CI: 37,412-44,787) were annual-new infections, and this was similar to 2016 Spectrum estimates. The observed HIV incidence in ZIMPHIA 2015-2016 validated the 2016 Spectrum estimates and Zimbabwe's progress toward epidemic control.

Background Data on awareness of HIV status among people living with HIV (PLHIV) are critical to estimating progress toward epidemic control. To ascertain the accuracy of self-reported HIV status and antiretroviral drug (ARV) use in the Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS), we compared self-reported HIV status with HIV rapid diagnostic test (RDT) results and self-reported ARV use with detectable blood ARV levels. Methods On the basis of responses and test results, participants were categorized by HIV status and ARV use. Self-reported HIV status and ARV use performance characteristics were determined by estimating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Proportions and other analyses were weighted to account for complex survey design. Results During NAIIS, 186,405 participants consented for interview out of which 58,646 reported knowing their HIV status. Of the 959 (weighted, 1.5%) who self-reported being HIV-positive, 849 (92.1%) tested HIV positive and 64 (7.9%) tested HIV negative via RDT and polymerase chain reaction test for discordant positive results. Of the 849 who tested HIV positive, 743 (89.8%) reported using ARV and 72 (10.2%) reported not using ARV. Of 57,687 who self-reported being HIV negative, 686 (1.2%) tested HIV positive via RDT, with ARV biomarkers detected among 195 (25.1%). ARV was detected among 94.5% of those who self-reported using ARV and among 42.0% of those who self-reported not using ARV. Overall, self-reported HIV status had sensitivity of 52.7% (95% confidence interval [CI]: 49.4%–56.0%) with specificity of 99.9% (95% CI: 99.8%–99.9%). Self-reported ARV use had sensitivity of 95.2% (95% CI: 93.6%–96.7%) and specificity of 54.5% (95% CI: 48.8%–70.7%). Conclusions Self-reported HIV status and ARV use screening tests were found to be low-validity measures during NAIIS. Laboratory tests to confirm self-reported information may be necessary to determine accurate HIV and clinical status for HIV studies in Nigeria.

BACKGROUND In the population-based HIV impact assessment surveys, early infant diagnosis (EID) was provided to infants

BACKGROUND Conducting HIV surveys in resource-limited settings is challenging because of logistics, limited availability of trained personnel, and complexity of testing. We described the procedures and systems deemed critical to ensure high-quality laboratory data in the population-based HIV impact assessments and large-scale household surveys. METHODS Laboratory professionals were engaged in every stage of the surveys, including protocol development, site assessments, procurement, training, quality assurance, monitoring, analysis, and reporting writing. A tiered network of household, satellite laboratories, and central laboratories, accompanied with trainings, optimized process for blood specimen collection, storage, transport, and real-time monitoring of specimen quality, and test results at each level proved critical in maintaining specimen integrity and high-quality testing. A plausibility review of aggregate merged data was conducted to confirm associations between key variables as a final quality check for quality of laboratory results. RESULTS Overall, we conducted a hands-on training for 3355 survey staff across 13 surveys, with 160-387 personnel trained per survey on biomarker processes. Extensive training and monitoring demonstrated that overall, 99% of specimens had adequate volume and 99.8% had no hemolysis, indicating high quality. We implemented quality control and proficiency testing for testing, resolved discrepancies, verified >300 Pima CD4 instruments, and monitored user errors. Aggregate data review for plausibility further confirmed the high quality of testing. CONCLUSIONS Ongoing engagement of laboratory personnel to oversee processes at all levels of the surveys is critical for successful national surveys. High-quality population-based HIV impact assessments laboratory data ensured reliable results and demonstrated the impact of HIV programs in 13 countries.

Biomarkers for detecting early HIV infection and estimating HIV incidence should minimize false-recent rates (FRRs) while maximizing mean duration of recent infection (MDRI). We compared HIV subtypes B, E and D (BED) capture enzyme immunoassay (BED), Sedia limiting antigen (LAg) avidity enzyme immunoassay, and Bio-Rad avidity incidence (BRAI) assays using samples from Zimbabwean postpartum women infected with clade C HIV. We calculated MDRIs using 590 samples from 351 seroconverting postpartum women, and FRRs using samples from 2,825 women known to be HIV positive for >12 months. Antibody kinetics were more predictable with LAg and had higher precision compared with BED or BRAI. BRAI also exhibited more variability, and avidity reversal in some cases. For BED, LAg, and BRAI, used alone or with viral load, MDRI values in days were: BED-188 and 170 at normalized optical density (ODn) 0.8; LAg-104 and 100 at ODn cutoff 1.5; BRAI-135 and 134 at avidity index cutoff 30%. Corresponding FRRs were: BRAI 1.1% and 1.0% and LAg 0.57% and 0.35%: these were 3.8-10.9 times lower than BED values of 4.8% and 3.8%. BRAI and LAg have significantly lower FRRs and MDRIs than in published studies, and much lower than BED and could be used to estimate incidence in perinatal women and to measure population-level HIV incidence in HIV control operations in Africa.

In 2017, rapid human immunodeficiency virus (HIV) testing services enabled the HIV diagnosis and treatment of approximately 15.3 million persons with HIV infection in sub-Saharan Africa with life-saving antiretroviral therapy (ART) (1). Although suboptimal testing practices and misdiagnoses have been reported in sub-Saharan Africa and elsewhere, trends in population burden and rate of false positive HIV diagnosis (false diagnosis) have not been reported (2,3). Understanding the population prevalence and trends of false diagnosis is fundamental for guiding rapid HIV testing policies and practices. To help address this need, CDC analyzed data from 57,655 residents aged 15–59 years in the Chókwè Health and Demographic Surveillance System (CHDSS) in Mozambique to evaluate trends in the rate (the percentage of false diagnoses among retested persons reporting a prior HIV diagnosis) and population prevalence of false diagnosis. From 2014 to 2017, the observed rate of false diagnosis in CHDSS decreased from 0.66% to 0.00% (p

Laboratory assays that can accurately distinguish recent (occurring within the past year) from long-standing (1 year) HIV infection are crucial for understanding HIV transmission dynamics in a population. However, often these efforts are confounded by inaccurate HIV diagnosis and the presence of HIV-2 in the population being surveyed. This study describes development of a multiplex assay that can simultaneously perform HIV diagnosis, HIV serotyping, and detection of recent HIV-1 infection in a single well. HIV diagnosis and HIV-2 serotyping were accomplished by coupling beads with an HIV-1 p24-gp41 fusion protein and HIV-2 peptide from gp36 immunodominant region, respectively. HIV-1 recent infection detection was accomplished by coupling beads with limiting amounts of multi-subtype gp41 immunodominant protein, recombinant immunodominant region, group M (rIDR-M). Assay conditions, including concentration of coupled antigens, were systematically optimized using well-characterized specimens with known HIV-status (positive or negative), HIV-2 specimens, and recent or long-term HIV-1 classification based on LAg-Avidity enzyme immunoassay (EIA) in a stepwise manner. Beads were then combined in a multiplex assay to evaluate its performance using large panel of specimens (n = 1,500) that included HIV-1 positive (n = 570, recent = 78, long-term = 492), HIV-2 positive (n = 31), and seronegative individuals (n = 899). The diagnostic component of the assay performed with high sensitivity (99.8%) and specificity (99.7%), while the HIV-2 serotyping sensitivity and specificity were 96.7% and 100%, respectively. There was a high correlation (R = 0.84) between the LAg-Avidity EIA and the multiplex assay for recent infection detection. The assay showed high inter- and intra-assay reproducibility with %coefficient of variation of10% in the dynamic range. The multiplex assay has the ability to diagnose HIV infection, perform serotyping, and detect and distinguish recent from long-term HIV infections, all in a single well. This novel assay has the potential to simplify HIV surveillance by reducing the multiple steps that are otherwise required.

The Malawi Ministry of Health implemented a new surveillance activity in April 2019 to detect recent HIV infections using a rapid test for recent infection (RTRI) to identify areas of ongoing transmission and guide response activities.At 23 health facilities in Blantyre District, healthcare workers (HCWs) were trained to conduct recent infection testing. In September 2019, we conducted a cross-sectional survey at these sites to explore the acceptability and feasibility of integrating this activity into routine HIV testing services (HTS).Research assistants interviewed HCWs using a semi-structured survey. Descriptive statistics were used to summarize quantitative responses and thematic analysis was used to group open-ended text.We interviewed 119 HCWs. Eighty-two percent of participants reported the RTRI was easy-to-use. HCWs perceived high client acceptability; 100% reported clients as 'somewhat' or 'very accepting'. Challenges included 68% of HCWs estimating they spend ≥20 min beyond routine HTS per client for this activity and 51% performing at least two additional finger pricks to complete the testing algorithm. HCWs differed in their perceptions of whether results should be returned to clients.This study assessed HCW experiences using point-of-care RTRIs for HIV recent infection surveillance. Overall, HCWs perceived RTRIs to be acceptable, easy-to-use, and valuable. Though only clients with new HIV diagnoses are tested for recent infection, additional time may be substantial at high-volume health service delivery points. Providing response plans or aggregated recent infection results to HCWs and/or clients may support motivation and sustainability of this novel surveillance activity.

Introduction New HIV infection during pre-conception and pregnancy is a significant contributor of mother–to–child transmission of HIV in South Africa. This study estimated HIV incidence (defined as new infection within the last one year from the time of the survey which included both new infections occurred during pregnancy or just before pregnancy) among pregnant women and described the characteristics of recently infected pregnant women at national level. Methods Between 1 October and 15 November 2017, we conducted a national cross–sectional survey among pregnant women aged 15–49 years old attending antenatal care at 1,595 public facilities. Blood specimens were collected from pregnant women and tested for HIV in a centralised laboratory. Plasma viral load and Limiting Antigen Avidity Enzyme Immunosorbent Assay (LAg) tests were further performed on HIV positive specimens to differentiate between recent and long–term infections. Recent infection was defined as infection that occurred within one year from the date of collection of blood specimen for the survey. Data on age, age of partner, and marital status were collected through interviews. Women whose specimens were classified as recent by LAg assay and with viral loads >1,000 copies/mL were considered as recently infected. The calculated proportion of HIV positive women with recent infection was adjusted for assay–specific parameters to estimate annual incidence. Survey multinomial logistic regression was used to examine factors associated with being recently infected using HIV negative women as a reference group. Age–disparate relationship was defined as having a partner 5 or more years older. Results Of 10,049 HIV positive participants with LAg and viral load data, 1.4% (136) were identified as recently infected. The annual HIV incidence was 1.5% (95% confidence interval (CI): 1.2–1.7). In multivariable analyses, being single (adjusted odds ratio, aOR: 3.4, 95% CI: 1.8–6.2) or cohabiting (aOR: 3.8, 95% CI: 1.8–7.7), compared to being married as well as being in an age–disparate relationship among young women (aOR: 3.1, 95% CI: 2.0–4.7; reference group: young women (15–24years) whose partners were not 5 years or more older) were associated with higher odds of recent infection. Conclusions Compared to previous studies among pregnant women, the incidence estimated in this study was substantially lower. However, the UNAIDS target to reduce incidence by 75% by 2020 (which is equivalent to reducing incidence to

With the highest HIV incidence and prevalence globally, the government of Eswatini started a substantial scale-up of HIV treatment and prevention services in 2011. Two sequential large population-based surveys were conducted before and after service expansion to assess the impact of the national response. Cross-sectional, household-based, nationally representative samples of adults, ages 18 to 49 years, were sampled in 2011 and 2016. We measured HIV prevalence, incidence (recent infection based on limiting antigen ≤1.5 optical density units and HIV RNA ≥1000 copies/mL), viral load suppression (HIV RNA

BACKGROUND Male circumcision (MC) offers men lifelong partial protection from heterosexually acquired HIV infection. The impact of MC on HIV incidence has not been quantified in nationally representative samples. Data from the population-based HIV impact assessments were used to compare HIV incidence by MC status in countries implementing voluntary medical MC (VMMC) programs. METHODS Data were pooled from population-based HIV impact assessments conducted in Eswatini, Lesotho, Malawi, Namibia, Tanzania, Uganda, Zambia, and Zimbabwe from 2015 to 2017. Incidence was measured using a recent infection testing algorithm and analyzed by self-reported MC status distinguishing between medical and nonmedical MC. Country, marital status, urban setting, sexual risk behaviors, and mean population HIV viral load among women as an indicator of treatment scale-up were included in a random-effects logistic regression model using pooled survey weights. Analyses were age stratified (15-34 and 35-59 years). Annualized incidence rates and 95% confidence intervals (CIs) and incidence differences were calculated between medically circumcised and uncircumcised men. RESULTS Men 15-34 years reporting medical MC had lower HIV incidence than uncircumcised men [0.04% (95% CI: 0.00% to 0.10%) versus 0.34% (95% CI: 0.10% to 0.57%), respectively; P value = 0.01]; whereas among men 35-59 years, there was no significant incidence difference [1.36% (95% CI: 0.32% to 2.39%) versus 0.55% (95% CI: 0.14% to 0.67%), respectively; P value = 0.14]. DISCUSSION Medical MC was associated with lower HIV incidence in men aged 15-34 years in nationally representative surveys in Africa. These findings are consistent with the expected ongoing VMMC program impact and highlight the importance of VMMC for the HIV response in Africa.

IntroductionThe Joint United Nations Programme on HIV/AIDS (UNAIDS) has set a target of ≥90% of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) to have viral load suppression (VLS). We examined factors associated with nonsuppressed viral Load (NVL).MethodsWe included PLHIV receiving ART aged 15–59 years from Eswatini, Lesotho, Malawi, Zambia, and Zimbabwe. Blood samples from PLHIV were analyzed for HIV RNA and recent exposure to antiretroviral drugs (ARVs). Outcomes were NVL (viral load ≥1000 copies/mL), virologic failure (VF; ARVs present and viral load ≥1000 copies/mL), interrupted ART (ARVs absent and viral load ≥1000 copies/mL), and receiving second-line ART. We calculated odds ratios and incidence rate ratios for factors associated with NVL, VF, interrupted ART, and switching to second-line ART.ResultsThe prevalence of NVL was 11.2%: 8.2% experienced VF, and 3.0% interrupted ART. Younger age, male gender, less education, suboptimal adherence, receiving nevirapine, HIV non-disclosure, never having married, and residing in Zimbabwe, Lesotho, or Zambia were associated with higher odds of NVL. Among people with NVL, marriage, female gender, shorter ART duration, higher CD4 count, and alcohol use were associated with higher odds for interrupted ART and lower odds for VF. Many people with VF (44.8%) had CD4 counts ConclusionsCountries are approaching UNAIDS VLS targets for adults. Treatment support for people initiating ART with asymptomatic HIV infection, scale-up of viral load monitoring, and optimized ART regimens may further reduce NVL prevalence.

BackgroundAs Zimbabwe approaches epidemic control of HIV, programs now prioritize viral load over CD4 monitoring, making it difficult to identify persons living with HIV (PLHIV) suffering from advanced disease (AD). We present an analysis of cross-sectional ZIMPHIA data, highlighting PLHIV with AD and concurrent viral load suppression (VLS).MethodsZIMPHIA collected blood specimens for HIV testing from 22,501 consenting adults (ages 15 years and older); 3,466 PLHIV had CD4 and VL results. Household HIV testing used the national serial algorithm, and those testing positive then received point-of-care CD4 enumeration with subsequent VL testing. We used logistic regression analysis to explore factors associated with concurrent AD and VLS (ResultsOf the 3,466 PLHIV in the survey with CD4 and VL results, 17% were found to have AD (CD4ConclusionsThe percentage of PLHIV with AD and VLS illustrates the conundrum of decreased support for CD4 monitoring, as these patients may not receive appropriate clinical services for advanced HIV disease. In high-prevalence settings such as Zimbabwe, CD4 monitoring support warrants further consideration to differentiate care appropriately for the most vulnerable PLHIV. Males may need to be prioritized, given their over-representation in this sub-population.

OBJECTIVE: The Lesotho Population-based HIV Impact Assessment survey was conducted nationally and designed to measure HIV prevalence, incidence, and viral load suppression (VLS). DESIGN: A nationally representative sample of 9403 eligible households was surveyed between November 2016 and May 2017; analyses account for study design. Consenting participants provided blood samples, socio-demographic, and behavioral information. METHODS: Blood samples were tested using the national rapid HIV testing algorithm. HIV-seropositive results were confirmed with Geenius supplemental assay. Screening for detectable concentrations of antiretroviral analytes was conducted on dried blood specimens from all HIV-positive adults using high-resolution liquid chromatography coupled with tandem mass spectrometry. Self-reported and/or antiretroviral biomarker data were used to classify individuals as HIV-positive and on treatment. Viral load testing was performed on all HIV-positive samples at central labs. VLS was defined as HIV RNA below 1000 copies/ml. RESULTS: Overall, 25.6% of adults aged 15–59 years were HIV-positive. Among seropositive adults, 81.0% (male 76.6%, female 84.0%) reported knowing their HIV status, 91.8% of people living with HIV (male 91.6%, female 92.0%) who reported knowing their status reporting taking antiretrovirals, and 87.7% (male and female 87.7%) of these had VLS. Younger age was significantly associated with being less likely to be aware of HIV status for both sexes. CONCLUSIONS: Findings from this population-based survey provide encouraging data in terms of HIV testing and treatment uptake and coverage. Specific attention to reaching youth to engage them in HIV-related interventions are critical to achieving epidemic control.

ObjectiveThis is the first large-scale assessment of the implementation of HIV Rapid Test Quality Improvement Initiative in South Africa.MethodsWe used a quasi-experimental one group post-test only design. The intervention implemented starting April 2014 comprised health-care worker training on quality assurance (QA) of HIV rapid testing and enrolment of the facilities in proficiency testing (PT), targeting 2,077 healthcare facilities in 32 high HIV burden districts. Following the intervention, two consecutive rounds of site assessments were undertaken. The first, conducted after a median of 7.5 months following the training, included 1,915 facilities that participated in the QA training, while the second, conducted after a median of one-year following the first-round assessment included 517 (27.0%) of the 1,915 facilities. In both assessments, the Stepwise-Process-for-Improving-the-quality-of-HIV-Rapid-Testing (SPI-RT) checklist was used to score facilities' performance in 7 domains: training, physical facility, safety, pre-testing, testing, post-testing and external quality assessment. Facilities' level of readiness for national certification was assessed.ResultBetween 2016 and 2017, there were four PT cycles. PT participation increased from 32.4% (620/1,915) in 2016 to 91.5% (1,753/1,915) in 2017. In each PT cycle, PT results were returned by 76%-87% of facilities and a satisfactory result (>80%) was achieved by ≥95% of facilities. In the SPI-RT assessment, in round-one, 22.3% of facilities were close to or eligible for national certification-this significantly increased to 38.8% in round-two (P-valueConclusionFacilities performance on the domains that are critical for accuracy of diagnosis (i.e. pre-testing, testing and post-testing) remained largely unchanged. This study provided several recommendations to improve QA implementation in South Africa, including the need to improve routine use of internal quality control for corrective actions.

Reliable and accurate laboratory assays to detect recent HIV-1 infection have potential as simple and practical methods of estimating HIV-1 incidence in cross-sectional surveys. This study describes validation of the limiting-antigen (LAg) avidity enzyme immunoassay (EIA) in a cross-sectional national survey, conducted in Swaziland, comparing it to prospective follow-up incidence. As part of the Swaziland HIV-1 Incidence Measurement Survey (SHIMS), 18,172 individuals underwent counseling and HIV rapid testing in a household-based, population survey conducted from December 2010 to June 2011. Plasma samples from HIV-positive persons were classified as recent infections using an incidence testing algorithm with LAg-Avidity EIA (normalized optical density ≤1.5) followed by viral load (VL ≥1,000 copies/mL). All HIV-seronegative samples were tested for acute HIV-1 infection by nucleic acid amplification test (NAAT) pooling. HIV-seronegative individuals who consented to follow-up were retested ∼6 months later to detect observed HIV-1 seroconversion. HIV-1 incidence estimates based on LAg+VL and NAAT were calculated using assay-specific parameters and were compared with prospective incidence estimate. A total of 5,803 (31.9%) of 18,172 survey participants tested HIV seropositive; of these 5,683 (97.9%) were further tested with LAg+VL algorithm. The weighted annualized incidence from the longitudinal cohort study was 2.4% (95% confidence interval 2.0-2.7). Based on cross-sectional testing of HIV positives with LAg+VL algorithm, overall weighted annualized HIV-1 incidence was 2.5% (2.0-3.0), whereas NAAT-based incidence was of 2.6%. In addition, LAg-based incidence in men (1.8%; 1.2-2.5) and women (3.2%; 2.4-3.9) were similar to estimates based on observed incidence (men = 1.7%, women = 3.1%). Changes in HIV-1 incidence with age in men and women further validate plausibility of the algorithm. These results demonstrate that the LAg EIA, in a serial algorithm with VL, is a cost-effective tool to estimate HIV-1 incidence in cross-sectional surveys.

Background A previous analysis of the impact of drought in Africa on HIV demonstrated an 11% greater prevalence in HIV-endemic rural areas attributable to local rainfall shocks. The Lesotho Population-Based HIV Impact Assessment (LePHIA) was conducted after the severe drought of 2014–2016, allowing for reevaluation of this relationship in a setting of expanded antiretroviral coverage. Methods and findings LePHIA selected a nationally representative sample between November 2016 and May 2017. All adults aged 15–59 years in randomly selected households were invited to complete an interview and HIV testing, with one woman per household eligible to answer questions on their experience of sexual violence. Deviations in rainfall for May 2014–June 2016 were estimated using precipitation data from Climate Hazards Group InfraRed Precipitation with Station Data (CHIRPS), with drought defined as, Andrea Low and colleagues present findings from their study in which a link between drought and increased HIV incidence in young girls in Lesotho is observed., Author summary Why was this study done? Periods of climate extremes have been shown to lead to increases in high-risk behaviors, particularly in agricultural communities dependent on rainfall for their livelihoods. Prior studies have linked these increases in riskier sexual behaviors, such as extramarital partnerships and transactional sex, to increases in HIV acquisition. The Lesotho Population-Based HIV Impact Assessment, a national HIV survey conducted from November 2016 to May 2017 following a 2-year severe drought in southern Africa, allowed us to reevaluate this relationship in the setting of expanded antiretroviral use. What did the researchers do and find? We paired geospatial data on accumulated rainfall from 2014 to 2016 with data from the survey to determine if there were any associations between drought and HIV outcomes. A total of 12,887 adults ages 15–59 years completed a detailed questionnaire, and 11,682 underwent an HIV test. Adolescent girls and young women ages 15–24 years in rural areas of drought had higher rates of high-risk behaviors, such as early sexual debut and transactional sex, and had lower educational attainment. Living in a drought area appeared to be associated with greater HIV prevalence in young females and was associated with a lower HIV prevalence in young males. However, external migration, commonly seen during these periods, was associated with a greater prevalence of HIV in men and women. What do these findings mean? Future policy on mitigation of climate change in southern Africa may consider including HIV prevention interventions in populations at high risk. This could include preexposure prophylaxis (PrEP) for migrants and young women in areas of severe food insecurity. Likewise, HIV programs that provide social and economic support to young women as part of an HIV prevention strategy should consider targeting areas affected by drought. Further studies should be done in other settings to investigate the external validity of these findings, particularly in terms of the impact on HIV in young women.

Introduction HIV misdiagnosis leads to severe individual and public health consequences. Retesting for verification of all HIV-positive cases prior to antiretroviral therapy initiation can reduce HIV misdiagnosis, yet this practice has not been not widely implemented. Methods We evaluated and compared the cost of retesting for verification of HIV seropositivity (retesting) to the cost of antiretroviral treatment (ART) for misdiagnosed cases in the absence of retesting (no retesting), from the perspective of the health care system. We estimated the number of misdiagnosed cases based on a review of misdiagnosis rates, and the number of positives persons needing ART initiation by 2020. We presented the total and per person costs of retesting as compared to no retesting, over a ten-year horizon, across 50 countries in Africa grouped by income level. We conducted univariate sensitivity analysis on all model input parameters, and threshold analysis to evaluate the parameter values where the total costs of retesting and the costs no retesting are equivalent. Cost data were adjusted to 2017 United States Dollars. Results and discussion The estimated number of misdiagnoses, in the absence of retesting was 156,117, 52,720 and 29,884 for lower-income countries (LICs), lower-middle income countries (LMICs), and upper middle-income countries (UMICs), respectively, totaling 240,463 for Africa. Under the retesting scenario, costs per person initially diagnosed were: $40, $21, and $42, for LICs, LMICs, and UMICs, respectively. When retesting for verification is implemented, the savings in unnecessary ART were $125, $43, and $75 per person initially diagnosed, for LICs, LMICs, and UMICs, respectively. Over the ten-year horizon, the total costs under the retesting scenario, over all country income levels, was $475 million, and was $1.192 billion under the no retesting scenario, representing total estimated savings of $717 million in HIV treatment costs averted. Conclusions Results show that to reduce HIV misdiagnosis, countries in Africa should implement the WHO’s recommendation of retesting for verification prior to ART initiation, as part of a comprehensive quality assurance program for HIV testing services.

HIV diagnostics have played a central role in the remarkable progress in identifying, staging, initiating, and monitoring infected individuals on life-saving antiretroviral therapy. They are also useful in surveillance and outbreak responses, allowing for assessment of disease burden and identification of vulnerable populations and transmission "hot spots," thus enabling planning, appropriate interventions, and allocation of appropriate funding. HIV diagnostics are critical in achieving epidemic control and require a hybrid of conventional laboratory-based diagnostic tests and new technologies, including point-of-care (POC) testing, to expand coverage, increase access, and positively impact patient management. In this review, we provide (i) a historical perspective on the evolution of HIV diagnostics (serologic and molecular) and their interplay with WHO normative guidelines, (ii) a description of the role of conventional and POC testing within the tiered laboratory diagnostic network, (iii) information on the evaluations and selection of appropriate diagnostics, (iv) a description of the quality management systems needed to ensure reliability of testing, and (v) strategies to increase access while reducing the time to return results to patients. Maintaining the central role of HIV diagnostics in programs requires periodic monitoring and optimization with quality assurance in order to inform adjustments or alignment to achieve epidemic control.

Laboratory assays that identify recent HIV infections are important for assessing impacts of interventions aimed at reducing HIV incidence. Kinetics of HIV humoral responses can vary with inherent assay properties, and between HIV subtypes, populations, and physiological states. They are important in determining mean duration of recent infection (MDRI) for antibody-based assays for detecting recent HIV infections. We determined MDRIs for multi-subtype peptide representing subtypes B, E and D (BED)-capture enzyme immunoassay, limiting antigen (LAg), and Bio-Rad Avidity Incidence (BRAI) assays for 101 seroconverting postpartum women, recruited in Harare from 1997 to 2000 during the Zimbabwe Vitamin A for Mothers and Babies trial, comparing them against published MDRIs estimated from seroconverting cases in the general population. We also compared MDRIs for women who seroconverted either during the first 9 months, or at later stages, postpartum. At cutoffs (C) of 0.8 for BED, 1.5 for LAg, and 40% for BRAI, estimated MDRIs for postpartum mothers were 192, 104, and 144 days, 33%, 32%, and 52% lower than published estimates of 287, 152 and 298 days, respectively, for clade C samples from general populations. Point estimates of MDRI values were 7%–19% shorter for women who seroconverted in the first 9 months postpartum than for those seroconverting later. MDRI values for three HIV incidence biomarkers are longer in the general population than among postpartum women, particularly those who recently gave birth, consistent with heightened immunological activation soon after birth. Our results provide a caution that MDRI may vary significantly between subjects in different physiological states.

The Mozambique Indicators of Immunization, Malaria and HIV/AIDS (IMASIDA) survey was conducted in 2015 and used a two Enzyme Immunoassay (EIA) (Vironostika HIV-1/2 and Murex HIV-1/2) based algorithm to determine the HIV status of the consented participants. The Mozambique Ministry of Health, with support from the US Centers for Disease Control and Prevention (US CDC), added Bio-Rad Geenius™ HIV-1/2 Supplemental Assay to the IMASIDA HIV testing algorithm to confirm all specimens that were found to be reactive on one or both EIAs. In total 11690 specimens were collected to estimate the proportion of HIV positive samples. Results indicate that the proportion of HIV positive samples based on the concordant positive results of two EIA assays was 21.5% (2518/11690). The addition of the Geenius assay to the IMASIDA HIV testing algorithm demonstrated that 792 (31.5%) of 2518 specimens were false-positive and reduced the proportion of HIV positive samples to 14.7% (1722/11690), demonstrating the importance of including a highly specific HIV test to confirm HIV diagnosis. HIV surveys exclusively based on EIA testing algorithm may result in misleading high prevalence results. Our results demonstrate that more specific confirmatory testing should be added to the EIA-based algorithms to ensure accurate HIV diagnosis and correct HIV prevalence estimate in cross-sectional surveys.

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.

Summary Background HIV acquisition remains high among adolescent girls and young women (AGYW, aged 15–24 years) in sub-Saharan Africa. We aimed to estimate prevalence and incidence of HIV in AGYW and to identify correlates of HIV infection by using data from the Lesotho Population-based HIV Impact Assessment (LePHIA). Methods LePHIA was a nationally representative survey of adults and children based on a multistage cluster sampling method with random selection of enumeration areas and households. All adults aged 15 years and older who had slept in the household the night before were eligible for participation; participants completed an interview and HIV testing. We estimated incidence with the HIV-1 limiting antigen avidity enzyme immunoassay combined with viral load and examined the association between demographic and behavioural variables (including characteristics of cohabitating mothers and sexual partners, when available) and prevalence and incidence among AGYW using logistic regression, incorporating survey weights. Findings We interviewed 8824 households, including 2358 AGYW who were tested for HIV infection. Weighted HIV prevalence was 11·1% (95% CI 9·7–12·5) in the overall population (273 of 2358 AGYW), 5·7% (4·1–7·2) in adolescent girls aged 15–19 years (64 of 1156), and 16·7% (14·4–19·0) in women aged 20–24 years (209 of 1212). Annualised HIV incidence was 1·8% (0·8–2·8). Correlates of prevalent infection include reporting a history of anal sex (adjusted odds ratio [aOR] 3·08, 1·11–8·57), having lived outside Lesotho in the past year (1·86, 1·01–3·42), having a partner suspected or known to be HIV positive (11·7, 6·0–22·5), and having two or more lifetime sexual partners (1·84, 1·21–2·78, for 2–3 lifetime sexual partners; 2·44, 1·45–4·08, for ≥4 lifetime sexual partners). For the 570 AGYW living with their mothers, maternal education was negatively associated with HIV prevalence in their daughters (aOR 0·36, 0·15–0·82, per increase in level attended). For AGYW with a cohabitating partner, the factors associated with AGYW infection were partner age (OR 4·54, 1·30–15·80, for partners aged 35–49 years, although the OR was no longer significant when adjusted for HIV status of partner), HIV status (aOR 11·22, 4·05–31·05), lack of viral load suppression (OR 0·16, 0·04–0·66), and partner employment in the past year (aOR 3·41, 1·12–10·42). Interpretation The findings confirm the importance of improving the treatment cascade in male partners and targeting preventive interventions to AGYW who are at increased risk. A regional approach to prevention could mitigate the effect of migration on transnational spread of HIV. Funding President's Emergency Plan for AIDS Relief through the Centers for Disease Control and Prevention.

In 2016, an estimated 1.5 million females aged 15-24 years were living with human immunodeficiency virus (HIV) infection in Eastern and Southern Africa, where the prevalence of HIV infection among adolescent girls and young women (3.4%) is more than double that for males in the same age range (1.6%) (1). Progress was assessed toward the Joint United Nations Programme on HIV/AIDS (UNAIDS) 2020 targets for adolescent girls and young women in sub-Saharan Africa (90% of those with HIV infection aware of their status, 90% of HIV-infected persons aware of their status on antiretroviral treatment [ART], and 90% of those on treatment virally suppressed [HIV viral load

The CCAS EXPERT SUMMIT convened an array of international experts in Barbados on August 27–31, 2017 under the theme “From Care to Cure–Shifting the HIV Paradigm.” The Caribbean Cytometry & Analytical Society (CCAS) partnered with the Joint United Nations Programme on HIV/AIDS (UNAIDS) to deliver a program that reviewed the advances in antiretroviral therapy and the public health benefits accruing from treatment as prevention. Particular emphasis was placed on reexamining stigma and discrimination through a critical appraisal of whether public health messaging and advocacy had kept pace with the advances in medicine. Persistent fear of HIV driving discriminatory behavior was widely reported in different regions and sectors, including the healthcare profession itself; continued fear of the disease was starkly misaligned with the successes of new medical treatments and progress toward the UNAIDS 90-90-90 targets. The summit therefore adopted the mantra “Test-Treat-Defeat” to help engage with the public in a spirit of optimism aimed at creating a more conducive environment for persons to be tested and treated and, thereby, help reduce HIV disease and stigma at the individual and community levels.

A 2014 report revealed sensitivities of 92%, 87% and 90% to anti-HIV, HBsAg and anti-HCV, respectively, at African blood center laboratories but substantial international investments in national blood transfusion services (NBTS) have since been made. During 2017, we performed a proficiency testing study at 84 blood center laboratories in seven African countries, including 55 NBTS and 29 non-NBTS laboratories. A blinded panel of 25 plasma samples (including negatives and pedigreed positives for anti-HIV, HBsAg and anti-HCV) was shipped to each participating laboratory for routine testing. Assay types in use were “Rapid” and enzyme immunoassay generations 3 [EIA-3] and 4 [EIA-4]. Sensitivity and specificity to each assay target were estimated using two general estimating equation models that assumed binomial distributions and clustered assay targets by laboratory. Analogous multivariable models added laboratory type, assay type, and all two-way interactions. Mean (95% CI) sensitivity to anti-HIV was 97% (95%–98%), compared with 76% (71%–81%) for HBsAg and 80% (75%–86%) for anti-HCV. Mean (95% CI) specificity was 95% (93%–97%) for anti-HIV, 96% (93%–98%) for HBsAg, and 95% (90%–98%) for anti-HCV. Sensitivity to all targets was high at NBTS laboratories (> 92%) and when EIA-3 assays were used (> 97%). Lower sensitivities to HBsAg and anti-HCV were associated with non-NBTS laboratories and/or assay types other than EIA-3. We conclude that proficiency for HIV testing has improved but remains suboptimal for HBsAg and anti-HCV testing. Remediation measures and reassessment are planned for poorly performing laboratories.

Introduction: Although individual HIV rapid diagnostic tests (RDTs) show good performance in evaluations conducted by WHO, reports from several African countries highlight potentially significant performance issues. Despite widespread use of RDTs for HIV diagnosis in resource-constrained settings, there has been no systematic, head-to-head evaluation of their accuracy with specimens from diverse settings across sub-Saharan Africa. We conducted a standardized, centralized evaluation of eight HIV RDTs and two simple confirmatory assays at a WHO collaborating centre for evaluation of HIV diagnostics using specimens from six sites in five sub-Saharan African countries. Methods: Specimens were transported to the Institute of Tropical Medicine (ITM), Antwerp, Belgium for testing. The tests were evaluated by comparing their results to a state-of-the-art reference algorithm to estimate sensitivity, specificity and predictive values. Results: 2785 samples collected from August 2011 to January 2015 were tested at ITM. All RDTs showed very high sensitivity, from 98.8% for First Response HIV Card Test 1–2.0 to 100% for Determine HIV 1/2, Genie Fast, SD Bioline HIV 1/2 3.0 and INSTI HIV-1/HIV-2 Antibody Test kit. Specificity ranged from 90.4% for First Response to 99.7% for HIV 1/2 STAT-PAK with wide variation based on the geographical origin of specimens. Multivariate analysis showed several factors were associated with false-positive results, including gender, provider-initiated testing and the geographical origin of specimens. For simple confirmatory assays, the total sensitivity and specificity was 100% and 98.8% for ImmunoComb II HIV 12 CombFirm (ImmunoComb) and 99.7% and 98.4% for Geenius HIV 1/2 with indeterminate rates of 8.9% and 9.4%. Conclusions: In this first systematic head-to-head evaluation of the most widely used RDTs, individual RDTs performed more poorly than in the WHO evaluations: only one test met the recommended thresholds for RDTs of ≥99% sensitivity and ≥98% specificity. By performing all tests in a centralized setting, we show that these differences in performance cannot be attributed to study procedure, end-user variation, storage conditions, or other methodological factors. These results highlight the existence of geographical and population differences in individual HIV RDT performance and underscore the challenges of designing locally validated algorithms that meet the latest WHO-recommended thresholds.

Introduction Dual HIV/syphilis rapid diagnostic tests (RDTs) may prevent congenital syphilis by facilitating syphilis diagnosis in pregnant women receiving HIV testing. The dual HIV-1/2 treponemal syphilis RDT ( Chembio DPP HIV-Syphilis Assay ) performs well in the lab, but its field performance is unknown. We investigated test performance under field conditions for this dual RDT and Malawi’s single RDTs for HIV and syphilis to assess whether the dual RDT might be a suitable substitute for the first-line single RDT in Malawi’s HIV algorithm. Methods During Jul 2014−Nov 2015, 1798 pregnant women attending a first antenatal visit were recruited if their HIV status was negative or unknown. Women received the single HIV (Determine HIV-1/2) and syphilis (Determine Syphilis TP) RDTs and the dual RDT. By Dec 2016, CDC had performed Rapid Plasma Reagin (RPR), Treponema pallidum particle agglutination (TPPA), and 3 rd -generation HIV EIA testing with Western Blot confirmation. In Jan 2017, the validity of all RDTs relative to the CDC HIV algorithm, TPPA, and TPPA/RPR results were calculated. Results Of 1791 women (99.6%) with complete results, 258 (14.4%) were HIV-positive by CDC’s algorithm; 81 (4.5%) were TPPA+; and 46 (2.6%) were TPPA+/RPR+. The dual RDT was 95.0% sensitive and 96.0% specific for HIV; the single HIV RDT was 93.0% sensitive and 99.3% specific. HIV test specificities were significantly different (p Conclusion The dual RDT syphilis component performed comparably to the single syphilis RDT and performed very well among women likely to vertically transmit syphilis. The dual RDT HIV component had comparable sensitivity but lower specificity than the single HIV RDT.