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Adaptive Viral Load Monitoring Frequency to Facilitate Differentiated Care: A Modeling Study From Rakai, Uganda.

ABSTRACT: BACKGROUND:After scale-up of antiretroviral therapy (ART), routine annual viral load monitoring has been adopted by most countries, but reduced frequency of viral load monitoring may offer cost savings in resource-limited settings. We investigated if viral load monitoring frequency could be reduced while maintaining detection of treatment failure. METHODS:The Rakai Health Sciences Program performed routine, biannual viral load monitoring on 2489 people living with human immunodeficiency virus (age ?15 years). On the basis of these data, we built a 2-stage simulation model to compare different viral load monitoring schemes. We fit Weibull regression models for time to viral load >1000 copies/mL (treatment failure), and simulated data for 10 000 individuals over 5 years to compare 5 monitoring schemes to the current viral load testing every 6 months and every 12 months. RESULTS:Among 7 monitoring schemes tested, monitoring every 6 months for all subjects had the fewest months of undetected failure but also had the highest number of viral load tests. Adaptive schemes using previous viral load measurements to inform future monitoring significantly decreased the number of viral load tests without markedly increasing the number of months of undetected failure. The best adaptive monitoring scheme resulted in a 67% reduction in viral load measurements, while increasing the months of undetected failure by <20%. CONCLUSIONS:Adaptive viral load monitoring based on previous viral load measurements may be optimal for maintaining patient care while reducing costs, allowing more patients to be treated and monitored. Future empirical studies to evaluate differentiated monitoring are warranted.

SUBMITTER: Ssempijja V

PROVIDER: S-EPMC7428397 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Adaptive Viral Load Monitoring Frequency to Facilitate Differentiated Care: A Modeling Study From Rakai, Uganda.

Ssempijja Victor V Nason Martha M Nakigozi Gertrude G Ndyanabo Anthony A Gray Ron R Wawer Maria M Chang Larry W LW Gabriel Erin E Quinn Thomas C TC Serwadda David D Reynolds Steven J SJ

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20200801 4

<h4>Background</h4>After scale-up of antiretroviral therapy (ART), routine annual viral load monitoring has been adopted by most countries, but reduced frequency of viral load monitoring may offer cost savings in resource-limited settings. We investigated if viral load monitoring frequency could be reduced while maintaining detection of treatment failure.<h4>Methods</h4>The Rakai Health Sciences Program performed routine, biannual viral load monitoring on 2489 people living with human immunodefi ...[more]

PMID: 31532827

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Project description:INTRODUCTION:Recommendations on the optimal frequency of plasma viral load (pVL) monitoring in children living with HIV (CLWH) who are stable on combination antiretroviral therapy (cART) are inconsistent. This study aimed to determine the impact of annual versus semi-annual pVL monitoring on treatment outcomes in Asian CLWH. METHODS:Data on children with perinatally acquired HIV aged <18 years on first-line, non-nucleoside reverse transcriptase inhibitor-based cART with viral suppression (two consecutive pVL <400 copies/mL over a six-month period) were included from a regional cohort study; those exposed to prior mono- or dual antiretroviral treatment were excluded. Frequency of pVL monitoring was determined at the site-level based on the median rate of pVL measurement: annual 0.75 to 1.5, and semi-annual >1.5 tests/patient/year. Treatment failure was defined as virologic failure (two consecutive pVL >1000 copies/mL), change of antiretroviral drug class, or death. Baseline was the date of the second consecutive pVL <400 copies/mL. Competing risk regression models were used to identify predictors of treatment failure. RESULTS:During January 2008 to March 2015, there were 1220 eligible children from 10 sites that performed at least annual pVL monitoring, 1042 (85%) and 178 (15%) were from sites performing annual (n = 6) and semi-annual pVL monitoring (n = 4) respectively. Pre-cART, 675 children (55%) had World Health Organization clinical stage 3 or 4, the median nadir CD4 percentage was 9%, and the median pVL was 5.2 log10 copies/mL. At baseline, the median age was 9.2 years, 64% were on nevirapine-based regimens, the median cART duration was 1.6 years, and the median CD4 percentage was 26%. Over the follow-up period, 258 (25%) CLWH with annual and 40 (23%) with semi-annual pVL monitoring developed treatment failure, corresponding to incidence rates of 5.4 (95% CI: 4.8 to 6.1) and 4.3 (95% CI: 3.1 to 5.8) per 100 patient-years of follow-up respectively (p = 0.27). In multivariable analyses, the frequency of pVL monitoring was not associated with treatment failure (adjusted hazard ratio: 1.12; 95% CI: 0.80 to 1.59). CONCLUSIONS:Annual compared to semi-annual pVL monitoring was not associated with an increased risk of treatment failure in our cohort of virally suppressed children with perinatally acquired HIV on first-line NNRTI-based cART.

Project description:HIV and malaria exert co-pathogenic effects. Malaria surveillance data are necessary for public health strategies to reduce the burden of disease in high HIV prevalence settings.This was a longitudinal cohort study to assess the burden of malaria in rural Rakai, Uganda. Households were visited monthly for 1 year to identify confirmed clinical malaria (CCM), or parasitaemia with temperature >37.5 °C, and asymptomatic parasitaemia (AP). Interviews of the adult or child's caregiver and clinical and laboratory assessments were conducted. Rapid diagnostic testing for malaria and anaemia was performed if participants were febrile and anti-malarial treatment given per Uganda Ministry of Health 2010 guidelines. Blood was drawn at every household visit to assess for parasitaemia, and blood smears were assessed at the Rakai Health Science Programme laboratory.A total of 1640 participants were enrolled, including 975 children aged 6 months up to 10 years, 393 adult caregivers, and 272 adolescent/adult household members from 393 randomly selected households in two representative communities. 1459 (89 %) participants completed all study visits. CCM was identified in 304 (19 %) participants, with the highest incidence rate for CCM of 0.38 per person-year (ppy) identified in children <5 years, and rates decreased with age; the rates were 0.27, 0.16, and 0.09 ppy for ages 5-<10 years, 10-<18 years, and adults 18+ years, respectively. AP was identified in 943 (57 %) participants; the incidence rate was 1.99 ppy for <5 years, 2.72 ppy for 5-<10 years, 2.55 ppy for 10-<18 years, and 0.86 ppy among adults, with 92 % of cases being attributed to Plasmodium falciparum by smear. 994 (61 %) individuals had at least one positive smear; 342 (21 %) had one positive result, 203 (12 %) had two, 115 (7 %) had three, and 334 (21 %) had >3 positive smears during follow-up. Seasonal rates generally followed the rains and peaked during July, then decreased through November before increasing again.Plasmodium falciparum infection remains high in rural Uganda. Increased malaria control interventions should be prioritized. Trial registration Clinicaltrials.gov identifier NCT01265407.

Project description:BackgroundProviding viral load (VL) results to people living with HIV (PLHIV) on antiretroviral therapy (ART) remains a challenge in low and middle-income countries. Point-of-care (POC) VL testing could improve ART monitoring and the quality and efficiency of differentiated models of HIV care. We assessed the acceptability of POC VL testing within a differentiated care model that involved task-shifting from professional nurses to less highly-trained enrolled nurses, and an option of collecting treatment from a community-based ART delivery programme.MethodsWe undertook a qualitative sub-study amongst clients on ART and nurses within the STREAM study, a randomized controlled trial of POC VL testing and task-shifting in Durban, South Africa. Between March and August 2018, we conducted 33 semi-structured interviews with clients, professional and enrolled nurses and 4 focus group discussions with clients. Interviews and focus groups were audio recorded, transcribed, translated and thematically analysed.ResultsAmongst 55 clients on ART (median age 31, 56% women) and 8 nurses (median age 39, 75% women), POC VL testing and task-shifting to enrolled nurses was acceptable. Both clients and providers reported that POC VL testing yielded practical benefits for PLHIV by reducing the number of clinic visits, saving time, travel costs and days off work. Receiving same-day POC VL results encouraged adherence amongst clients, by enabling them to see immediately if they were 'good' or 'bad' adherers and enabled quick referrals to a community-based ART delivery programme for those with viral suppression. However, there was some concern regarding the impact of POC VL testing on clinic flows when implemented in busy public-sector clinics. Regarding task-shifting, nurses felt that, with extra training, enrolled nurses could help decongest healthcare facilities by quickly issuing ART to stable clients. Clients could not easily distinguish enrolled nurses from professional nurses, instead they highlighted the importance of friendliness, respect and good communication between clients and nurses.ConclusionsPOC VL testing combined with task-shifting was acceptable to clients and healthcare providers. Implementation of POC VL testing and task shifting within differentiated care models may help achieve international treatment targets.Trial registrationNCT03066128 , registered 22/02/2017.

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Adaptive Viral Load Monitoring Frequency to Facilitate Differentiated Care: A Modeling Study From Rakai, Uganda.

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Adaptive Viral Load Monitoring Frequency to Facilitate Differentiated Care: A Modeling Study From Rakai, Uganda.

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