Objective Regular HIV RNA testing for all HIV positive patients on antiretroviral therapy (ART) is expensive and has low yield since most tests are undetectable. Selective testing of those at higher risk of failure may improve efficiency. We investigated whether a novel analysis of adherence data could correctly classify virological failure and potentially inform a selective testing strategy. Design Multisite prospective cohort consortium. Methods We evaluated longitudinal data on 1478 adult patients treated with ART and monitored using the Medication Event Monitoring System (MEMS) in 16 United States cohorts contributing to the MACH14 consortium. Since the relationship between adherence and virological failure is complex and heterogeneous, we applied a machine-learning algorithm (Super Learner) to build a model for classifying failure and evaluated its performance using cross-validation. Results Application of the Super Learner algorithm to MEMS data, combined with data on CD4+ T cell counts and ART regimen, significantly improved classification of virological failure over a single MEMS adherence measure. Area under the ROC curve, evaluated on data not used in model fitting, was 0.78 (95% CI: 0.75, 0.80) and 0.79 (95% CI: 0.76, 0.81) for failure defined as single HIV RNA level >1000 copies/ml or >400 copies/ml, respectively. Our results suggest 25–31% of viral load tests could be avoided while maintaining sensitivity for failure detection at or above 95%, for a cost savings of $16–$29 per person-month. Conclusions Our findings provide initial proof-of-concept for the potential use of electronic medication adherence data to reduce costs through behavior-driven HIV RNA testing.
IntroductionAs antiretroviral therapy (ART) is scaled up, more patients become eligible for routine viral load (VL) monitoring, the most important tool for monitoring ART efficacy. For HIV programmes to become effective, leakages along the VL cascade need to be minimized and treatment switching needs to be optimized. However, many HIV programmes in resource‐constrained settings report significant shortfalls.MethodsFrom a public sector HIV programme in rural Swaziland, we evaluated the VL cascade of adults (≥18 years) on ART from the time of the first elevated VL (>1000 copies/mL) between January 2013 and June 2014 to treatment switching by December 2015. We additionally described HIV drug resistance for patients with virological failure. We used descriptive statistics and Kaplan–Meier estimates to describe the different steps along the cascade and regression models to determine factors associated with outcomes.Results and DiscussionOf 828 patients with a first elevated VL, 252 (30.4%) did not receive any enhanced adherence counselling (EAC). Six hundred and ninety‐six (84.1%) patients had a follow‐up VL measurement, and the predictors of receiving a follow‐up VL were being a second‐line patient (adjusted hazard ratio (aHR): 0.72; p = 0.051), Hlathikhulu health zone (aHR: 0.79; p = 0.013) and having received two EAC sessions (aHR: 1.31; p = 0.023). Four hundred and ten patients (58.9%) achieved VL re‐suppression. Predictors of re‐suppression were age 50 to 64 (adjusted odds ratio (aOR): 2.02; p = 0.015) compared with age 18 to 34 years, being on second‐line treatment (aOR: 3.29; p = 0.003) and two (aOR: 1.66; p = 0.045) or three (aOR: 1.86; p = 0.003) EAC sessions. Of 278 patients eligible to switch to second‐line therapy, 120 (43.2%) had switched by the end of the study. Finally, of 155 successfully sequenced dried blood spots, 144 (92.9%) were from first‐line patients. Of these, 133 (positive predictive value: 92.4%) had resistance patterns that necessitated treatment switching.ConclusionsPatients on ART with high VLs were more likely to re‐suppress if they received EAC. Failure to re‐suppress after counselling was predictive of genotypically confirmed resistance patterns requiring treatment switching. Delays in switching were significant despite the ability of the WHO algorithm to predict treatment failure. Despite significant progress in recent years, enhanced focus on quality care along the VL cascade in resource‐limited settings is crucial.
Background: Monitoring progress toward global treatment targets using HIV programme data in sub-Saharan Africa has proved challenging. Constraints in routine data collection and reporting can lead to biased estimates of treatment outcomes. In 2010, South Africa introduced an electronic patient monitoring system for HIV patient visits, TIER.Net. We compare treatment status and outcomes recorded in TIER.Net to outcomes ascertained through detailed record review and tracing in order to assess discrepancies and biases in retention and mortality rates. Methods: The Agincourt Health and Demographic Surveillance System (HDSS) in northeastern South Africa is served by eight public primary healthcare facilities. Since 2014, HIV patient visits are logged electronically at these clinics, with patient records individually linked to their HDSS record. These data were used to generate a list of patients >90 days late for their last scheduled clinic visit and deemed lost to follow-up (LTFU). Patient outcomes were ascertained through a review of the TIER.Net database, physical patient files, registers kept by two non-government organizations that assist with patient tracing, cross-referencing with the HDSS records and supplementary physical tracing. Descriptive statistics were used to compare patient outcomes reported in TIER.Net to their outcome ascertained in the study. Results: Of 1,074 patients that were eligible for this analysis, TIER.Net classified 533 (49.6%) as LTFU, 80 (7.4%) as deceased, and 186 (17.3%) as transferred out. TIER.Net misclassified 36% of patient outcomes, overestimating LTFU and underestimating mortality and transfers out. TIER.Net missed 40% of deaths and 43% of transfers out. Patients categorized as LTFU in TIER.Net were more likely to be misclassified than patients classified as deceased or transferred out. Discussion: Misclassification of patient outcomes in TIER.Net has consequences for programme forecasting, monitoring and evaluation. Undocumented transfers accounted for the majority of misclassification, suggesting that the transfer process between clinics Etoori et al. Misreporting HIV Patient Treatment Outcomes should be improved for more accurate reporting of patient outcomes. Processes that lead to correct classification of patient status including patient tracing should be strengthened. Clinics could cross-check all available data sources before classifying patients as LTFU. Programme evaluators and modelers could consider using correction factors to improve estimates of outcomes from TIER.Net.
BackgroundUniversal antiretroviral therapy (ART) for all pregnant/ breastfeeding women living with Human Immunodeficiency Virus (HIV), known as Prevention of mother-to child transmission of HIV (PMTCT) Option B+ (PMTCTB+), is being scaled up in most countries in Sub-Saharan Africa. In the transition to PMTCTB+, many countries face challenges with proper implementation of the HIV care cascade. We aimed to describe the feasibility of a PMTCTB+ approach in the public health sector in Swaziland.MethodsLifelong ART was offered to a cohort of HIV+ pregnant women aged ≥16 years at the first antenatal care (ANC1) visit in 9 public sector facilities, between 01/2013 and 06/2014. The study enrolment period was divided into 3 phases (early: 01–06/2013, mid: 07–12/2013 and late: 01–06/2014) to account for temporal trends. Kaplan-Meier estimates and Cox proportional-hazards regression models were applied for ART initiation and attrition analyses.ResultsOf 665 HIV+ pregnant women, 496 (74.6%) initiated ART. ART initiation increased in later study enrolment phases (mid: aHR: 1.41; later: aHR: 2.36), and decreased at CD4 ≥ 500 (aHR: 0.69). 52.9% were retained in care at 24 months. Attrition was associated with ANC1 in the third trimester (aHR: 2.37), attending a secondary care facility (aHR: 1.98) and ART initiation during later enrolment phases (mid aHR: 1.48; late aHR: 1.67). Of 373 women eligible, 67.3% received a first VL. 223/251 (88.8%) were virologically suppressed (< 1000 copies/mL). Of 670 infants, 53.6% received an EID test, 320/359 had a test result recorded and of whom 7 (2.2%) were HIV+.ConclusionsPMTCTB+ was found to be feasible in this setting, with high rates of maternal viral suppression and low transmission to the infant. High treatment attrition, poor follow-up of mother-baby pairs and under-utilisation of VL and EID testing are important programmatic challenges.
Gomez-Olive & Georges Reniers (2020) Challenges with tracing patients on antiretroviral therapy who are late for clinic appointments in rural South Africa and recommendations for future practice,
e339 processes, including routine reporting by disaggregated ethnic subgroups, would allow ethnic biases to be accounted for by statistical methods, and considered when assessing the validity of analyses and interpreting results. Data providers need to continually improve data quality and linkage methods (eg, through training of patient-facing staff in recording data for ethnic minorities, more inclusive data capture systems, and more flexible linkage algorithms). For example, we recently showed that, when linking administrative health and education records, relaxing requirements for exact matching on name improved linkage rates for ethnic minorities, although they remained disproportionately low. 5 Crucially, echoing Knight and colleagues, 1 we must all strive for greater diversity in the data linkage community, and more meaningful engagement with ethnic minorities to increase understanding of data linkage and address their concerns.We declare no competing interests.
Objective The vital status of patients lost to follow‐up often remains unknown in antiretroviral therapy (ART) programmes in sub‐Saharan Africa because medical records are no longer updated once the patient disengages from care. Thus, we aimed to assess the outcomes of patients lost to follow‐up after ART initiation in north‐eastern South Africa. Methods Using data from a rural area in north‐eastern South Africa, we estimated the cumulative incidence of patient outcomes (i) after treatment initiation using clinical records, and (ii) after loss to follow‐up (LTFU) using data from clients that have been individually linked to Agincourt Health and Demographic Surveillance System (AHDSS) database. Aside from LTFU, we considered mortality, re‐engagement and migration out of the study site. Cox proportional hazards regression was used to identify covariates of these patient outcomes. Results Between April 2014 and July 2017, 3700 patients initiated ART and contributed a total of 6818 person‐years of follow‐up time. Three years after ART initiation, clinical record‐based estimates of LTFU, mortality and documented transfers were 41.0% (95% CI: 38.5–43.4%), 1.9% (95% CI 1.0–3.2%) and 0.1% (95% CI 0.0–0.9%), respectively. Among those who were LTFU, the cumulative incidence of re‐engagement, out‐migration and mortality at 3 years were 38.1% (95% CI 33.1–43.0%), 49.4% (95% CI 43.1–55.3%) and 4.7% (95% CI 3.5–6.2%), respectively. Pregnant or breastfeeding women, foreigners and those who initiated ART most recently were at an increased risk of LTFU. Conclusion LTFU among patients starting ART in north‐eastern South Africa is relatively high and has increased in recent years as more asymptomatic patients have initiated treatment. Even though this tendency is of concern in light of the prevention of onwards transmission, we also found that re‐engagement in care is common and mortality among persons LTFU relatively low.
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