Browsing by Author "Sachathep, Karampreet K."

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned From the Population-Based HIV Impact Assessment Project
    (JAIDS Journal of Acquired Immune Deficiency Syndromes, 2021) Patel, Hetal K.; Duong, Yen T.; Birhanu, Sehin; Dobbs, Trudy; Lupoli, Kathryn; Moore, Carole; Detorio, Mervi; Sleeman, Katrina; Manjengwa, Julius; Gordon, Floris Wray; Yavo, Daniel; Jackson, Keisha; Domaoal, Robert A.; Yufenyuy, Ernest L.; Vedapuri, Shanmugam; Ndongmo, Clement B.; Ogollah, Francis M.; Dzinamarira, Tafadzwa; Rubinstein, Paul; Sachathep, Karampreet K.; Longwe, Herbert; Voetsch, Andrew C.; Parekh, Bharat S.
    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.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. 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.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.
  • Thumbnail Image
    Item
    Coronavirus Disease 2019 (COVID-19) Mitigation Efforts and Testing During an In-Person Training Event—Uganda, 12–29 October 2020
    (Clinical Infectious Diseases, 2021) Laws, Rebecca L.; Biraro, Sam; Kirungi, Wilford; Gianetti, Brittany; Aibo, Dorothy; Awor, Anna C.; West, Christine; Sachathep, Karampreet K.; Kiyingi, Herbert; Ward, Jennifer; Mwangi, Christina; Nkurunziza, Peter
    Viral load monitoring (VLM) to identify individuals failing antiretroviral therapy (ART) is not widely available in resource-limited settings. We compared the genotypic resistance patterns between clients with VLM versus immunological monitoring (IM).Between 2004–2008, 559 ART naïve clients were enrolled in a prospective cohort, initiated on ART, and monitored with viral load (VL) and CD4+ cell counts every 6 months (VLM group). From February 2008 through June 2009, 998 clients on ART for 36–40 months (corresponding to the follow-up time of the VLM group) at the same clinic and monitored with CD4+ cell counts every 6 months were recruited into a cross sectional study (IM group). Samples from VLM clients at 12, 24 and 36 months and IM clients at 36–40 months with VL > 2000 copies/ml underwent genotypic drug resistance testing.Baseline characteristics were similar. Virologic failure (VL > 400 copies/ml) at 12, 24 and 36 months in the VLM group were 12%, 6% and 8% respectively, and in the IM group 10% at 36–40 months. Samples from 39 VLM and 70 IM clients were genotyped. 23/39 (59%) clients in the VLM group (at 12, 24 or 36 months) compared to 63/70 (90%) in the IM group, (P < 0.0001) had at least 1 non-nucleoside reverse transcriptase mutation. 19/39 (49%) of VLM clients had an M184V mutation compared to 61/70 (87%) in the IM group (P < 0.0001). Only 2/39 (5%) of VLM clients developed thymidine analogue mutations compared to 34/70 (49%) of IM clients (P < 0.0001).Routine VL monitoring reduced the rate of accumulated genotypic resistance to commonly used ART in Uganda.