Rapid Scale-up of an Antiretroviral Therapy Program Before and During the COVID-19 Pandemic - Nine States, Nigeria, March 31, 2019-September 30, 2020.

In 2018, an estimated 1.8 million persons living in Nigeria had HIV infection (1.3% of the total population), including 1.1 million (64%) who were receiving antiretroviral therapy (ART) (1). Effective ART reduces morbidity and mortality rates among persons with HIV infection and prevents HIV transmission once viral load is suppressed to undetectable levels (2,3). In April 2019, through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR),* CDC launched an 18-month ART Surge program in nine Nigerian states to rapidly increase the number of persons with HIV infection receiving ART. CDC analyzed programmatic data gathered during March 31, 2019-September 30, 2020, to describe the ART Surge program's progress on case finding, ART initiation, patient retention, and ART Surge program growth. Overall, the weekly number of newly identified persons with HIV infection who initiated ART increased approximately eightfold, from 587 (week ending May 4, 2019) to 5,329 (week ending September 26, 2020). The ART Surge program resulted in 208,202 more HIV-infected persons receiving PEPFAR-supported ART despite the COVID-19 pandemic (97,387 more persons during March 31, 2019-March 31, 2020 and an additional 110,815 persons during April 2020-September 2020). Comprehensive, data-guided, locally adapted interventions and the use of incident command structures can help increase the number of persons with HIV infection who receive ART, reducing HIV-related morbidity and mortality as well as decreasing HIV transmission.

Expanding access to HIV services during the COVID-19 pandemic-Nigeria, 2020.

BACKGROUND: To accelerate progress toward the UNAIDS 90-90-90 targets, US Centers for Disease Control and Prevention Nigeria country office (CDC Nigeria) initiated an Antiretroviral Treatment (ART) Surge in 2019 to identify and link 340,000 people living with HIV/AIDS (PLHIV) to ART. Coronavirus disease 2019 (COVID-19) threatened to interrupt ART Surge progress following the detection of the first case in Nigeria in February 2020. To overcome this disruption, CDC Nigeria designed and implemented adapted ART Surge strategies during February-September 2020. METHODS: Adapted ART Surge strategies focused on continuing expansion of HIV services while mitigating COVID-19 transmission. Key strategies included an intensified focus on community-based, rather than facility-based, HIV case-finding; immediate initiation of newly-diagnosed PLHIV on 3-month ART starter packs (first ART dispense of 3 months of ART); expansion of ART distribution through community refill sites; and broadened access to multi-month dispensing (MMD) (3-6 months ART) among PLHIV established in care. State-level weekly data reporting through an Excel-based dashboard and individual PLHIV-level data from the Nigeria National Data Repository facilitated program monitoring. RESULTS: During February-September 2020, the reported number of PLHIV initiating ART per month increased from 11,407 to 25,560, with the proportion found in the community increasing from 59 to 75%. The percentage of newly-identified PLHIV initiating ART with a 3-month ART starter pack increased from 60 to 98%. The percentage of on-time ART refill pick-ups increased from 89 to 100%. The percentage of PLHIV established in care receiving at least 3-month MMD increased from 77 to 93%. Among PLHIV initiating ART, 6-month retention increased from 74 to 92%. CONCLUSIONS: A rapid and flexible HIV program response, focused on reducing facility-based interactions while ensuring delivery of lifesaving ART, was critical in overcoming COVID-19-related service disruptions to expand access to HIV services in Nigeria during the first eight months of the pandemic. High retention on ART among PLHIV initiating treatment indicates immediate MMD in this population may be a sustainable practice. HIV program infrastructure can be leveraged and adapted to respond to the COVID-19 pandemic.

Longitudinal viral load outcomes of adults with HIV after detectable viremia on tenofovir, lamivudine, and dolutegravir.

BACKGROUND: :To inform optimal management of HIV viremia on TLD, we examined viral load (VL) outcomes of a large cohort of adult PLHIV on TLD in Nigeria. METHODS: :We conducted a retrospective study of adult PLHIV who had ≥1 VL after initiating TLD during January 2017-February 2023. VLs were categorized as undetectable (≤50 copies/mL), low low-level viremia (LLV, 51-199 copies/mL), high LLV (200-999 copies/mL), virologic nonsuppression (VLNS, ≥1000 copies/mL), and virologic failure (VF, ≥2 consecutive VLNS results). Among patients with ≥2 VLs on TLD, we described how viremia changed over time and examined virologic outcomes after VF. We identified predictors of subsequent VLNS using mixed-effects logistic regression and conducted planned contrasts between levels of VL result and regimen types. RESULTS: :Analysis of 82,984 VL pairs from 47,531 patients demonstrated viral resuppression to ≤50 copies/mL at follow-up VL in 66.7% of those with initial low LLV, 59.1% of those with initial high LLV, and 48.9% of those with initial VLNS. Of 662 patients with a follow-up VL after VF, 94.6% stayed on TLD; of which 57.8% (359/621) were undetectable at next VL without regimen change. Previous low LLV (aOR 1.74, 1.56-1.93), high LLV (aOR 2.35, 2.08-2.65), and VLNS (aOR 6.45, 5.81-7.16) were associated with increasingly higher odds of subsequent VLNS, whereas a previously undetectable VL (aOR 1.08, 0.99-1.71) on TLD was not. CONCLUSIONS: :Despite increased odds of subsequent VLNS, most PLHIV with detectable viremia on TLD, including those with VF, will resuppress to an undetectable VL without a regimen change.

Effect of Test and Treat on clinical outcomes in Nigeria: A national retrospective study.

BACKGROUND: In Nigeria, results from the pilot of the Test and Treat strategy showed higher loss to follow up (LTFU) among people living with HIV compared to before its implementation. The aim of this evaluation was to assess the effects of antiretroviral therapy (ART) initiation within 14 days on LTFU at 12 months and viral suppression. METHODS: We conducted a retrospective cohort study using routinely collected de-identified patient-level data hosted on the Nigeria National Data Repository from 1,007 facilities. The study population included people living with HIV age ≥15. We used multivariable Cox proportional frailty hazard models to assess time to LTFU comparing ART initiation strategy and multivariable log-binomial regression for viral suppression. RESULTS: Overall, 26,937 (38.13%) were LTFU at 12 months. Among individuals initiated within 14 days, 38.4% were LTFU by 12 months compared to 35.4% for individuals initiated >14 days (p<0.001). In the adjusted analysis, individuals who were initiated ≤14 days after HIV diagnosis had a higher hazard of being LTFU (aHR 1.15, 95% CI 1.10-1.20) than individuals initiated after 14 days of HIV diagnosis. Among individuals with viral load results, 86.2% were virally suppressed. The adjusted risk ratio for viral suppression among individuals who were initiated ≤14 days compared to >14 days was not statistically significant. CONCLUSION: LTFU was higher among individuals who were initiated within 14 days compared to greater than 14 days after HIV diagnosis. There was no difference for viral suppression. The provision of early tailored interventions to support newly diagnosed people living may contribute to reducing LTFU.

From Paper Files to Web-Based Application for Data-Driven Monitoring of HIV Programs: Nigeria's Journey to a National Data Repository for Decision-Making and Patient Care.

BACKGROUND: Timely and reliable data are crucial for clinical, epidemiologic, and program management decision making. Electronic health information systems provide platforms for managing large longitudinal patient records. Nigeria implemented the National Data Repository (NDR) to create a central data warehouse of all people living with human immunodeficiency virus (PLHIV) while providing useful functionalities to aid decision making at different levels of program implementation. OBJECTIVE: We describe the Nigeria NDR and its development process, including its use for surveillance, research, and national HIV program monitoring toward achieving HIV epidemic control. METHODS: Stakeholder engagement meetings were held in 2013 to gather information on data elements and vocabulary standards for reporting patient-level information, technical infrastructure, human capacity requirements, and information flow. Findings from these meetings guided the development of the NDR. An implementation guide provided common terminologies and data reporting structures for data exchange between the NDR and the electronic medical record (EMR) systems. Data from the EMR were encoded in extensible markup language and sent to the NDR over secure hypertext transfer protocol after going through a series of validation processes. RESULTS: By June 30, 2021, the NDR had up-to-date records of 1,477,064 (94.4%) patients receiving HIV treatment across 1,985 health facilities, of which 1,266,512 (85.7%) patient records had fingerprint template data to support unique patient identification and record linkage to prevent registration of the same patient under different identities. Data from the NDR was used to support HIV program monitoring, case-based surveillance and production of products like the monthly lists of patients who have treatment interruptions and dashboards for monitoring HIV test and start. CONCLUSION: The NDR enabled the availability of reliable and timely data for surveillance, research, and HIV program monitoring to guide program improvements to accelerate progress toward epidemic control.

Low-level viraemia among people living with HIV in Nigeria: a retrospective longitudinal cohort study.

BACKGROUND: HIV transmission can occur with a viral load of at least 200 copies per mL of blood and low-level viraemia can lead to virological failure; the threshold level at which risk for virological failure is conferred is uncertain. To better understand low-level viraemia prevalence and outcomes, we analysed retrospective longitudinal data from a large cohort of people living with HIV on antiretroviral therapy (ART) in Nigeria. METHODS: In this retrospective cohort study using previously collected longitudinal patient data, we estimated rates of virological suppression (≤50 copies per mL), low-level viraemia (51-999 copies per mL), virological non-suppression (≥1000 copies per mL), and virological failure (≥2 consecutive virological non-suppression results) among people living with HIV aged 18 years and older who initiated and received at least 24 weeks of ART at 1005 facilities in 18 Nigerian states. We analysed risk for low-level viraemia, virological non-suppression, and virological failure using log-binomial regression and mixed-effects logistic regression. FINDINGS: At first viral load for 402 668 patients during 2016-21, low-level viraemia was present in 64 480 (16·0%) individuals and virological non-suppression occurred in 46 051 (11·4%) individuals. Patients with low-level viraemia had increased risk of virological failure (adjusted relative risk 2·20, 95% CI 1·98-2·43; p<0·0001). Compared with patients with virological suppression, patients with low-level viraemia, even at 51-199 copies per mL, had increased odds of low-level viraemia and virological non-suppression at next viral load; patients on optimised ART (ie, integrase strand transfer inhibitors) had lower odds than those on non-integrase strand transfer inhibitors for the same low-level viraemia range (eg, viral load ≥1000 copies per mL following viral load 400-999 copies per mL, integrase strand transfer inhibitor: odds ratio 1·96, 95% CI 1·79-2·13; p<0·0001; non-integrase strand transfer inhibitor: 3·21, 2·90-3·55; p<0·0001). INTERPRETATION: Patients with low-level viraemia had increased risk of virological non-suppression and failure. Programmes should revise monitoring benchmarks and targets from less than 1000 copies per mL to less than 50 copies per mL to strengthen clinical outcomes and track progress to epidemic control. FUNDING: None.

Optimizing community linkage to care and antiretroviral therapy Initiation: Lessons from the Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS) and their adaptation in Nigeria ART Surge.

BACKGROUND: Ineffective linkage to care (LTC) is a known challenge for community HIV testing. To overcome this challenge, a robust linkage to care strategy was adopted by the 2018 Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS). The NAIIS linkage to care strategy was further adapted to improve Nigeria's programmatic efforts to achieve the 1st 90 as part of the Nigeria Antiretroviral Therapy (ART) Surge initiative, which also included targeted community testing. In this paper we provide an overview of the NAIIS LTC strategy and describe the impact of this strategy on both the NAIIS and the Surge initiatives. METHODS: The NAIIS collaborated with community-based organizations (CBOs) and deployed mobile health (mHealth) technology with real-time dashboards to manage and optimize community LTC for people living with HIV (PLHIV) diagnosed during the survey. In NAIIS, CBOs' role was to facilitate linkage of identified PLHIV in community to facility of their choice. For the ART Surge, we modified the NAIIS LTC strategy by empowering both CBOs and mobile community teams as responsible for not only active LTC but also for community testing, ART initiation, and retention in care. RESULTS: Of the 2,739 PLHIV 15 years and above identified in NAIIS, 1,975 (72.1%) were either unaware of their HIV-positive status (N = 1890) or were aware of their HIV-positive status but not receiving treatment (N = 85). Of these, 1,342 (67.9%) were linked to care, of which 952 (70.9%) were initiated on ART. Among 1,890 newly diagnosed PLHIV, 1,278 (67.6%) were linked to care, 33.7% self-linked and 66.3% were linked by CBOs. Among 85 known PLHIV not on treatment, 64 (75.3%) were linked; 32.8% self-linked and 67.2% were linked by a CBO. In the ART Surge, LTC and treatment initiation rates were 98% and 100%, respectively. Three-month retention for monthly treatment initiation cohorts improved from 76% to 90% over 6 months. CONCLUSIONS: Active LTC strategies by local CBOs and mobile community teams improved LTC and ART initiation in the ART Surge initiative. The use of mHealth technology resulted in timely and accurate documentation of results in NAIIS. By deploying mHealth in addition to active LTC, CBOs and mobile community teams could effectively scale up ART with real-time documentation of client-level outcomes.

Evaluation of the clinical outcomes of the Test and Treat strategy to implement Treat All in Nigeria: Results from the Nigeria Multi-Center ART Study.

In December 2016, the Nigerian Federal Ministry of Health updated its HIV guidelines to a Treat All approach, expanding antiretroviral therapy (ART) eligibility to all individuals with HIV infection, regardless of CD4+ cell count, and recommending ART be initiated within two weeks of HIV diagnosis (i.e., the Test and Treat strategy). The Test and Treat policy was first piloted in 32 local government areas (LGAs). The primary objective of this study was to evaluate the clinical outcomes of adult patients initiated on ART within two weeks of HIV diagnosis during this pilot. We conducted a retrospective cohort analysis of patients who initiated ART within two weeks of new HIV diagnosis between October 2015 and September 2016 in eight randomly selected LGAs participating in the Test and Treat pilot study. 2,652 adults were newly diagnosed and initiated on ART within two weeks of HIV diagnosis. Of these patients, 8% had documentation of a 12-month viral load measurement, and 13% had documentation of a six-month viral load measurement. Among Test and Treat patients with a documented viral load, 79% were suppressed (≤400 copies/ml) at six months and 78% were suppressed at 12 months. By 12 months post-ART initiation, 34% of the patients who initiated ART under the Test and Treat strategy were lost to follow-up. The median CD4 cell count among patients initiating ART within two weeks of HIV diagnosis was 323 cells/mm3 (interquartile range, 161-518). While randomized controlled trials have demonstrated that Test and Treat strategies can improve patient retention and increase viral suppression compared to standard of care, these findings indicate that the effectiveness of Test and Treat in some settings may be far lower than the efficacy demonstrated in randomized controlled trials. Significant attention to the way Test and Treat strategies are implemented, monitored, and improved particularly related to early retention, can help expand access to ART for all patients.