INTRODUCTION: As part of a laboratory strengthening program in Malawi to achieve and maintain International Organization for Standardization (ISO) 15189 accreditation, we intended to mentor selected HIV molecular laboratories to achieve this accreditation. Due to the COVID-19 pandemic, mentorship pivoted to a hybrid model using an Internet-based approach and on-site mentorships. We describe the implementation of this strategy, successes, and challenges. METHODS: We conducted weekly, 1-hour virtual mentorship sessions for the 5 initial laboratories (cohort 1) selected based on their Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) performance score of 3 or more stars. Laboratories presented updates and supporting documents electronically, and trainings were conducted virtually. In September 2020, when travel restrictions were relaxed, we initiated hybrid mentorships and audits for cohort 1 laboratories. The same hybrid approach was used to mentor 4 additional laboratories in cohort 2. We performed descriptive analysis, and the Wilcoxon signed-rank test was used to compare the training pre-and post-test scores. RESULTS: Between March 2020 and May 2023, the team completed a total of 54 virtual mentorship sessions and 20 on-site visits across 9 laboratories. Overall, the team conducted 8 training sessions for 35 laboratory quality officers. Median score improvement (pre-test vs. post-test scores) was observed across individual trainings and across cohorts (P<.01). At the end of cohort 1, 4 of 5 (80%) laboratories were accredited. One laboratory that did not reach accreditation joined cohort 2. At the end of the mentoring period, all 5 cohort 2 laboratories were accredited. CONCLUSIONS: We demonstrated that using a hybrid mentorship model for accreditation was a successful strategy during the COVID-19 pandemic. For the first time in Malawi, this strategy resulted in accrediting 9 of the 10 HIV molecular laboratories in 3 years at a reduced cost. Continuous mentorship is key in the maintenance of accreditation.

Many SARS-CoV-2 infections are asymptomatic, thus reported cases underestimate actual cases. To improve estimates, we conducted surveillance for SARS-CoV-2 seroprevalence among pregnant women attending their first antenatal care visit (ANC1) from June 2021 through May 2022. We administered a questionnaire to collect demographic, risk factors, and COVID-19 vaccine status information and tested dried blood spots for SARS-CoV-2 antibodies. Although <1% of ANC1 participants reported having had COVID-19, monthly SARS-CoV-2 seroprevalence increased from 15.4% (95% CI: 10.5-21.5) in June 2021 to 65.5% (95% CI: 55.5-73.7) in May 2022. Although COVID-19 vaccination was available in March 2021, uptake remained low, reaching a maximum of 9.5% (95% CI: 5.7-14.8) in May 2022. Results of ANC1 serosurveillance provided prevalence estimates helpful in understanding this population case burden that was available through self-report and national case reports. To improve vaccine uptake, efforts to address fears and misconceptions regarding COVID-19 vaccines are needed.

The US President's Emergency Plan for AIDS Relief (PEPFAR) supports molecular HIV and tuberculosis diagnostic networks and information management systems in low- and middle-income countries. We describe how national programs leveraged these PEPFAR-supported laboratory resources for SARS-CoV-2 testing during the COVID-19 pandemic. We sent a spreadsheet template consisting of 46 indicators for assessing the use of PEPFAR-supported diagnostic networks for COVID-19 pandemic response activities during April 1, 2020, to March 31, 2021, to 27 PEPFAR-supported countries or regions. A total of 109 PEPFAR-supported centralized HIV viral load and early infant diagnosis laboratories and 138 decentralized HIV and TB sites reported performing SARS-CoV-2 testing in 16 countries. Together, these sites contributed to >3.4 million SARS-CoV-2 tests during the 1-year period. Our findings illustrate that PEPFAR-supported diagnostic networks provided a wide range of resources to respond to emergency COVID-19 diagnostic testing in 16 low- and middle-income countries.

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.