Point of Care CD4 Testing in National Household Surveys - Results and Quality Indicators from Eleven Population-Based HIV Impact Assessment (PHIA) Surveys.

Population-based HIV Impact Assessments (PHIAs) are national household (HH) surveys that provide HIV diagnosis and CD4 testing with an immediate return of results. Accurate CD4 results improve HIV-positive participants' clinical care and inform the effectiveness of HIV programs. Here, we present CD4 results from the PHIA surveys that were conducted in 11 countries in sub-Saharan Africa between 2015 and 2018. All of the HIV-positive participants and 2 to 5% of the HIV-negative participants were offered Pima CD4 (Abbott, IL, USA) point-of-care (POC) tests. The quality of the CD4 test was ensured by conducting instrument verification, comprehensive training, quality control, a review of testing errors and an analysis of unweighted CD4 data by HIV status, age, gender, and antiretroviral (ARV) treatment status. Overall, CD4 testing was completed for 23,085 (99.5%) of the 23,209 HIV-positive and 7,329 (2.7%) of the 270,741 negative participants in 11 surveys. The instrument error rate was 11.3% (range, 4.4% to 15.7%). The median CD4 values among HIV-positive and HIV-negative participants (aged 15+) were 468 cells/mm3 (interquartile range [IQR], 307 to 654) and 811 cells/mm3 (IQR, 647 to 1,013), respectively. Among the HIV-positive participants (aged 15+), those with detectable ARVs had higher CD4 values (508 cells/mm3) than those with undetectable ARVs (385.5 cells/mm3). Among the HIV-positive participants (aged 15+), 11.4% (2,528/22,253) had a CD4 value of less than 200 cells/mm3, and approximately half of them (1,225/2,528 = 48.5%) had detectable ARVs, whereas 51.5% (1,303/2,528) had no detectable ARVs (P < 0.0001). We successfully implemented high quality POC CD4 testing using Pima instruments. Our data come from nationally representative surveys in 11 countries and provide unique insights regarding the CD4 distribution among HIV-positive individuals as well as the baseline CD4 values among HIV-negative individuals. IMPORTANCE The manuscript describes CD4 levels among HIV-positive individuals and baseline CD4 levels among HIV-negative individuals from 11 sub-Saharan countries, thereby highlighting the importance of CD4 markers in the context of the HIV epidemic. Despite increased ARV access in each country, advanced HIV disease (CD4 < 200 cells/mm3) persists among approximately 11% of HIV-positive individuals. Therefore, it is important that our findings are shared with the scientific community to assist with similar implementations of point-of-care testing and to conduct a review of HIV programmatic gaps.

Progress towards controlling the HIV epidemic in urban Ethiopia: Findings from the 2017-2018 Ethiopia population-based HIV impact assessment survey.

INTRODUCTION: In 2014, the Joint United Nations Programme on HIV/AIDS set an 'ambitious' 90-90-90 target for 2020. By 2016, there were disparities observed among countries in their progress towards the targets and some believed the targets were not achievable. In this report, we present the results of data from the Ethiopia Population-based HIV Impact Assessment survey analyzed to assess progress with the targets and associated factors. METHODS: We conducted a nationally representative survey in urban areas of Ethiopia. Socio-demographic and behavioural data were collected from consenting participants using a structured interview. HIV testing was done following the national HIV rapid testing algorithm and seropositivity confirmed using a supplemental laboratory assay. HIV viral suppression was considered if the viral load was <1,000 RNA copies/ml. Screening antiretroviral drugs was done for efavirenz, lopinavir, and tenofovir, which were in use during the survey period. In this analysis, we generated weighted descriptive statistics and used bivariate and logistic regression analysis to examine for associations. The 95% confidence interval was used to measure the precision of estimates and the significance level set at p<0.05. RESULTS: Of 19,136 eligible participants aged 15-64 years, 614 (3% [95% CI: 0.8-3.3]) were HIV-positive, of which 79.0% (95% CI: 4.7-82.7) were aware of their HIV status, and 97.1% (95% CI: 95.0-98.3 were on antiretroviral therapy, of which 87.6% (95% CI: 83.9-90.5) achieved viral load suppression. Awareness about HIV-positive status was significantly higher among females (aOR = 2.8 [95% CI: 1.38-5.51]), significantly increased with age, the odds being highest for those aged 55-64 years (aOR = 11.4 [95% CI: 2.52-51.79]) compared to those 15-24 years, and was significantly higher among those who used condom at last sex in the past 12 months (aOR = 5.1 [95% CI: 1.68-15.25]). Individuals with secondary education and above were more likely to have achieved viral suppression (aOR = 8.2 [95% CI: 1.82-37.07]) compared with those with no education. CONCLUSION: Ethiopia made encouraging progress towards the UNAIDS 90-90-90 targets. The country needs to intensify its efforts to achieve the targets. A particular focus is required to fill the gaps in knowledge of HIV-positive status to increase case identification among population groups such as males, the youth, and those with low education.

Factors associated with unawareness of HIV-positive status in urban Ethiopia: Evidence from the Ethiopia population-based HIV impact assessment 2017-2018.

BACKGROUND: The HIV epidemic in Ethiopia is concentrated in urban areas. Ethiopia conducted a Population-based HIV Impact Assessment (EPHIA) in urban areas between October 2017 and April 2018 to measure the status of the country's response to the epidemic. METHODS: We conducted field data collection and HIV testing in randomly selected households using the national, rapid testing algorithm with laboratory confirmation of seropositive samples using a supplemental assay. In addition to self-report on HIV diagnosis and treatment, all HIV-positive participants were screened for a set of HIV antiretroviral (ARV) drugs indicative of the first- and second-line regimens. We calculated weighted frequencies and 95% confidence intervals to assess regional variation in participants' level of unawareness of their HIV-positive status (adjusted for ARV status). RESULTS: We interviewed 20,170 survey participants 15-64 years of age, of which 19,136 (95%) were tested for HIV, 614 (3.2%) tested positive, and 119 (21%) of HIV-positive persons were unaware of their HIV status. Progress towards the UNAIDS first 90 target (90% of people living with HIV would be aware of their HIV status by 2020) substantially differed by administrative region of the country. In the bivariate analysis using log binomial regression, three regions (Oromia, Addis Ababa, and Harari), male gender, and young age (15-24 years) were significantly associated with awareness of HIV positive status. In multivariate analysis, the same variables were associated with awareness of HIV-positive status. CONCLUSION: One-fifth of the HIV-positive urban population were unaware of their HIV-positive status. The number of unaware HIV-positive individuals has a different distribution than the HIV prevalence. National and regional planning and monitoring activities could address this potentially substantial source of undetected HIV infection by increasing HIV testing among young people, men and individuals who do not use condoms.

A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned From the Population-Based HIV Impact Assessment Project.

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.