Evidence map›Paper›PMID 34166309›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2021

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

Hetal K Patel, Yen T Duong, Sehin Birhanu, Trudy Dobbs, Kathryn Lupoli, Carole Moore, Mervi Detorio, Katrina Sleeman, Julius Manjengwa, Floris Wray-Gordon and 16 more

Registry-linked trialAbstract read
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04117984 (Swaziland HIV Incidence Measurement Survey), which is not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04117984 completednot on this map

Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016): a Population-based HIV Impact Assessment (PHIA)

TypeobservationalSponsorColumbia UniversityRan2016 to 2019Enrolled15,429ConditionsHIV/AIDS
3 · Its place in the literature

Who cites it

26 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Hetal K PatelDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Yen T DuongICAP at Columbia University, New York, NY.
Sehin BirhanuDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Trudy DobbsDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Kathryn LupoliDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Carole MooreDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Mervi DetorioDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Katrina SleemanDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Julius ManjengwaICAP at Columbia University, New York, NY.
Floris Wray-GordonDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Daniel YavoDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Keisha JacksonDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Robert A DomaoalDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Ernest L YufenyuyDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Shanmugam VedapuriDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Clement B NdongmoDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Francis M OgollahICAP at Columbia University, New York, NY.
Tafadzwa DzinamariraICAP at Columbia University, New York, NY.
Paul RubinsteinICAP at Columbia University, New York, NY.
Karampreet K SachathepICAP at Columbia University, New York, NY.
Melissa MetzICAP at Columbia University, New York, NY.
Herbert LongweICAP at Columbia University, New York, NY.
Suzue SaitoICAP at Columbia University, New York, NY.
Kristin BrownDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Andrew C VoetschDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
Bharat S ParekhDivision of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.

Funding

CGH CDC HHS U2G GH001226CGH CDC HHS U2G GH001271PEPFAR
6 · The paper itself

Abstract

backgroundConducting 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.

methodsLaboratory 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.

resultsOverall, 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.

conclusionsOngoing 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.

Indexed as

HIV-1Developing CountriesEpidemiological MonitoringHealth SurveysHIV InfectionsHumansLaboratory PersonnelLaboratory Proficiency TestingQuality Control

Identifiers

PMID34166309
PMCPMC10966620

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.