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.

Coronavirus Disease 2019 (COVID-19) Mitigation Efforts and Testing During an In-Person Training Event-Uganda, 12-29 October 2020.

Large public-health training events may result in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission. Universal SARS-CoV-2 testing during trainings for the Uganda Population-based HIV Impact Assessment identified 28 of 475 (5.9%) individuals with coronavirus disease 2019 (COVID-19) among attendees; most (89.3%) were asymptomatic. Until COVID-19 vaccine is readily available for staff and participants, effective COVID-19 mitigation measures, along with SARS-CoV-2 testing, are recommended for in-person trainings, particularly when trainees will have subsequent contact with survey participants.

Population Viral Load, Viremia, and Recent HIV-1 Infections: Findings From Population-Based HIV Impact Assessments (PHIAs) in Zimbabwe, Malawi, and Zambia.

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 <1000 copies/mL), and antiretrovirals in the blood to identify recent HIV-1 cases. RESULTS: Among 1510 enumeration areas (EAs) across the 3 surveys, 52,036 adults aged 15-59 years resided in 1363 (90.3%) EAs with at least one HIV-positive adult consenting to interview and blood draw and whose VL was tested. Mean HIV prevalence across these EAs was 13.1% [95% confidence intervals (CI) 12.7 to 13.5]. Mean VLS prevalence across these EAs was 58.7% (95% CI: 57.3 to 60.0). In multivariable analysis, PVL was associated with a recent HIV-1 case in that EA (adjusted odds ratio: 1.4, 95% CI: 1.2 to 1.6, P = 0.001). VLS prevalence was inversely correlated with recent infections (adjusted odds ratio: 0.3, 95% CI: 0.1 to 0.6, P = 0.004). The 90-90-90 indicators, namely, the prevalence of HIV diagnosis, antiretroviral therapy coverage, and VLS at the EA level, were inversely correlated with HIV recency at the EA level. CONCLUSIONS: We found a strong association between PVL and VLS prevalence and recent HIV-1 infection at the EA level across 3 southern African countries with generalized HIV epidemics. These results suggest that population-based measures of VLS in communities may serve as a proxy for epidemic control.