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Table 1 Characteristics of included studies

From: Viral load monitoring for people living with HIV in the era of test and treat: progress made and challenges ahead – a systematic review

First author, year

Study design/data sources

Study participant

(N enrolled)

Study sites/

Location

Study period

Study objective

VL testing model

External

Funding/ tech. partner

Outcomes

Apollo, T.; 2021 [36]

Retrospective study using routinely collected program data from the national electronic patient monitoring system (ePMS) of Zimbabwe

PLHIV enrolled and remained in ART care between August 2004 – Jan 2017, for at least 12 months. (N = 392,832)

529 high volume (525 public & 4 private) health facilities providing HIV treatment and care services across Zimbabwe

2004–2018

To determine the number (%) of PLHIV on ART progressed along the HIV cascade

A combination of centralised VL testing with near POC VL (at 25 s-level health facilities)

None mentioned

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of treatment failure

- Switching

treatment regimen

Brazier, E.; 2021 [49]

Observational study using data from the international epidemiology Databases to evaluate AIDS (IeDEA) research consortium

ART-naïve patients enrolled in HIV care at study sites between 2006 and 2018 who had at least 9 months potential follow-up after ART initiation (N = 292,380)

Selected IeDEA HIV care and treatment sites in 18 low and lower middle-income countries which contribute patient data prior to and after national adoption of Treat all policy

2006–2018

To evaluate the effect of Treat All policy adoption on pre-ART CD4 testing and VL monitoring after ART initiation

Not reported

None mentioned

- Initial VL monitoring

Haghighat, R.; 2021 [28]

Longitudinal cohort study using data collected from routine (paper-based/electronic) clinical records and interviews with study participants

Adolescents aged 10–19 years who had initiated ART at study sites between 03/2014-09/2015 (N = 1080)

52 healthcare facilities within a health district of the Eastern Cape, South Africa (decentralised public healthcare system)

2014–2017

To examine the progression of adolescents on ART along the HIV cascade of care (from treatment initiation to viral suppression)

Not reported

None mentioned

- Initial VL monitoring

Woldesenbet, S. A.; 2021 [29]

Cross-sectional study using data extracted from medical records (conducted as part of national survey to monitor prevention of MTCT of HIV program)

HIV-positive pregnant women aged 15–49 years who initiated ART before pregnancy or during pregnancy and received ART for > = 3 months (N = 8112)

Public, primary healthcare facility of 52 districts from 9 provinces in South Africa (SA)

Oct – Nov 2019

To evaluate the coverage of maternal viral load monitoring in South Africa

Laboratory-based VL testing (Roche & Abbott assays) at 17 public laboratories in SA

None mentioned

- Initial VL monitoring

Herce, M.E.; 2020 [50]

Prospective cohort study using data collected by the study team

HIV positive incarcerated people aged > = 18 years, and expected to remain incarcerated for > = 30 days at study sites (N = 975)

10 correctional units at three correctional complexes in South Africa (Johannesburg & Breede River) and Zambia (Lusaka)

2017–2018

To report clinical outcome of a prospective cohort of incarcerated people with HIV who were offered universal test and treat intervention and follow-up

Laboratory-based VL testing at central laboratory facilitated/paid for by the study

Department of International Development UK (DFID) & Swedish International Development Agency (Sida)

- Initial VL monitoring

Mshweshwe-Pakela, N.; 2020 [30]

Retrospective study using data extracted from patient charts and national electronic laboratory service database

People > = 18 years who had a positive HIV test recorded at study sites between 1st Jan-31 July 2017 (N = 826)

10 public sector health facilities in Ekurhuleni District, South Africa

2017–2018

To examine factors associated with retention in care & VL suppression among HIV patients at study sites

Not reported

None mentioned

- Initial VL monitoring

Nakalega, R.; 2020 [47]

Cross-sectional study using data extracted from paper and electronic ART registries and patient treatment card

PLHIV who were receiving (and on ART for at least 6 months) at study sites between Jan-Dec 2017 (N = 414)

Eight (08) primary health care centres providing HIV treatment and care services in Gomba district, rural Uganda

Oct-Nov 2018

To describe factors associated with non-uptake of VL testing among PLHIV in Gomba, Uganda

Laboratory-based VL testing (COBAS Amplipera/AmpliTaq) at Central public health laboratory

None mentioned

- Initial VL monitoring

Opito, R.; 2020 [48]

Retrospective cohort study using routinely collected data from HIV service registries and electronic medical record system

All patients who were newly diagnosed HIV positive at study site between Jun 2017 and May 2018 (N = 580)

An HIV (TASO) clinic in Tororo district, Eastern Uganda

2017– 2018

To explore the outcome of the implementation of HIV test and treat policy at study site

Laboratory-based VL testing at by central public health laboratories through a hub system

None mentioned

- Initial VL monitoring

Ya, S.S.T.; 2020 [53]

Retrospective study using routinely collected integrated HIV care (IHC) program data extracted from the central electronic database of the national AIDS program

All adults and paediatric PLHIV who started 1st line ART between Jan 2016 and Dec 2017 (N = 91,290

49 IHC clinics in 37 townships of 05 regions in Myanmar

2016–2018

To describe programmatic performance and outcomes of routine VL testing in PLHIV newly initiating 1st line ART in IHC program in Myanmar

Laboratory-based VL testing at the central public health laboratory in Mandalay, Myanmar

The international Union Against Tuberculosis and Lung Disease (the Union)

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of treatment failure

- Switching

treatment regimen

Moudachiro, R.; 2020 [43]

Retrospective cohort study using routine program data collected from electronic database and patient records

Patients aged > 15 years, stable on ART, transferred to community-based centres (CBC) for 3-monthly ART supply during the study period (N = 337)

Three decentralised community ART refill centres in Kinshasa, Democratic Republic of Congo (DRC)

Jan 2015 – Jun 2017

To assess VL coverage and sustained, viral suppression and retention in care among ART patients at CBC at 6, 12, 18 months after transfer

Yearly clinical and VL monitoring at nearest health facility

CBC set up by Médecins Sans Frontières (MSF)operated by Ministry of Health of DCR

- Initial VL monitoring

Iwuji, C.C.; 2020 [22]

Cohort study conducted as part of a demographic surveillance and population-based HIV survey, using routine program data captured in an electronic patient register (Tier.Net)

Patients aged > 15 years who initiated ART at study sites during the study period (N = 29,384)

17 public sector clinics in rural Hlabisa sub-district of KwaZulu-Natal, South Africa (SA)

Jan 2010 – Dec 2016

To evaluate the implementation of VL monitoring guidelines in rural KwaZulu-Natal, SA

Laboratory-based VL testing done at district hospital with plasma samples collected at & transported from clinics daily

None mentioned

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of virological failure

- Switching treatment regimen

Nguyen, A.T.; 2020 [55]

Prospective cohort study using patient-level data collected directly by the study team

Adult patients who initiated ART at HIV clinics in remote areas during the study period (N = 578)

43 clinical sites in six northern provinces of Vietnam

Jun 2017 – Apr 2018

To assess the feasibility of DBS use for VL monitoring in remote areas of Vietnam where routine VL monitoring was not available

DBS samples collected at study sites and sent to central laboratory for testing

Global Fund to fight AIDS, Tuberculosis and Malaria

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of virological failure

Kehoe, K.; 2020 [23]

Retrospective cohort study using routinely collected program data contributed to an international epidemiology database (IeDEA-SA)

Patients aged 16–85 years who initiated ART from Jan 2004 onwards & enrolled into adherence club in Khayelitsha, Cape Town, SA between Jan 2011 and Dec 2016 (N = 8058)

Adherence club (AC) operated at community venues in Khayelitsha, Cape Town, SA

Jan 2011 – Dec 2017

To describe VL completeness and assess proportion of elevated VL and confirmed virologic failure among patients entering AC in Khayelitsha, Cape Town, SA

VL testing done in batches for each AC

None mentioned (AC model was first piloted by MSF in 2007 and adopted by the local health authority in 2011)

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of virological failure

Thinn, K.K.; 2019 [52]

Retrospective cohort study using data extracted from patient-specific treatment card at clinics and laboratory information management system at National Health Laboratory (NHL)

All patients initiated on ART at study sites between Jan–Dec 2017 under the National AIDS Program (NAP) (N = 567)

6 ART clinics operated at peripheral public health facilities under NAP in Yangon region, Myanmar

2017–19

To assess the uptake of VL monitoring after ART initiation and factors influencing the implementation of routine VL monitoring

Laboratory-based VL testing (Abbott m200rt) done at NHL using fresh plasma samples (patients referred or blood samples sent to NHL)

The International Union Against TB and Lung Disease (the Union); London School of Hygiene and Tropical Medicine, UK

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of virological failure

Tapera, T.; 2019 [33]

Retrospective cohort study using routinely collected data of a community adolescent treatment supporter (CATS) program to improve the health and well-being of PLHIV aged 0–24 years

HIV-positive contacts and sexual partners aged < 25 years of index PLHIV identified by CATS between Oct 2017 & Sept 2018 in study sites (N = 1193)

24 selected districts of Zimbabwe implementing the CATS program

2017–19

To assess the effects of CATS program on HIV care cascade outcomes of HIV-positive contacts/sexual partners of index PLHIV

Not reported

Multi-donor/implementing partner: PEPFAR, USAID, CDC, UK Department for International Development (DFID), the Union etc.

- Initial VL monitoring

Nyakura, J.; 2019 [34]

Retrospective cohort study using routine program data collected from health facility registers

Pregnant women living with HIV who have their 1st antenatal care visit at study sites in 2017 & on ART for > = 3 months (N = 1112)

Public health facilities (3 hospitals & 25 rural health clinics in Mazowe, a rural district of Zimbabwe

2017–18

To assess the uptake and turn around time of VL testing among women on option B+

Laboratory-based VL testing done at National Microbiology Reference Laboratory using DBS or venous blood samples sent from health facilities twice a week

None mentioned

- Initial VL monitoring

- Follow-up VL monitoring

Nyagadza, B.; 2019 [35]

Review of VL monitoring program using data from routine reports and patients’ record at MSF-supported health facilities

Patients on ART at selected study sites who were eligible for VL monitoring ( > = 6 months on ART) (N = 9456)

10 primary health facilities (HFs) in 5 districts of Manicaland province, Zimbabwe

2016–17

To report MSF experience in supporting VL monitoring scale-up in Zimbabwe

VL testing done at provincial hospital laboratory on whole blood or DBS samples sent from HFs

MSF

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of virological failure

- Switching treatment regimen

Nicholas, S.; 2019 [42]

Retrospective cohort using program data (patient-level data captured at study sites)

All patients (all ages) on ART for > 3 months & eligible for VL testing at study sites (N = 21,004*) 396 patients on 2nd ART excluded from this review

Four decentralized clinics (DCs) & one district hospital (DHOS) in the rural Chiradzulu district, southern Malawi

Aug 2013 – Jun 2017

To describe the outcomes of VL monitoring during the first four years of a routine POC VL testing program in real-world settings

On-site point-of-care VL testing (SAMBA I technology; Diagnostics for Real World, UK)

MSF; funding from UNITAID/ MSF

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of virological failure

- Switching treatment regimen

Ndagijimana Ntwali, J. D.; 2019 [37]

Retrospective cohort study using routinely collected HIV program data

All patients (all ages) who were initiated on ART at study sites (N = 775)

One public district hospital and one health centre located in the district of Musanze in the Northern province of Rwanda

Jul 2012 – Dec 2016

To examine the use of routine VL testing in patients on ART and describe the management of patients with detectable VL

Laboratory-based VL testing (COBAS Amplipera/AmpliTaq). Whole blood samples were sent to the laboratory for processing & testing

None mentioned

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of virological failure

- Switching treatment regimen

Le Roux, K. W.; 2019 [24]

Retrospective study using data obtained through iDART – a hospital pharmacy database

All patients who were initiated on ART at study sites (N = 882)

One district hospital and 11 health clinics in the deeply rural Zithulele, Eastern Cape of South Africa (SA)

Jul 2013 – Jun 2014

To describe the outcomes of innovative interventions to improve the quality of ART programs in rural SA

Not Reported

None mentioned

- Initial VL monitoring

Euvrad, J.; 2019 [25]

Retrospective cohort study using three data sources: primary healthcare information system, provincial health data centre and physical patient folder at health facilities

All patients on ART and in care at primary health facilities in Khayelitsha with an expected VL test monitoring during the study period (N = 21,991)

All primary health facilities in Khayelitsha, Cape Town, SA

Jul 2015 – Jun 2016

To describe the VL cascade from expected (VL test) to reported (VL result) and to estimate success/failure at each step

Laboratory-based VL testing using COBAS Ampliprep/COBAS TaqMan system

Free public ART services including VL testing was provided with support from MSF

- Initial VL monitoring

Cisse, A. M.; 2019 [41]

Cross-sectional study using biological and clinical data collected at study sites

HIV-infected children and adolescents aged 0–19 years receiving follow-up care at decentralised health facilities (N = 601)

All 72 clinics outside of Dakar region providing care for HIV-infected children in Senegal

Mar – Jun 2015

To detect virological failure and test a nationwide sample delivery circuit using DBS

Laboratory-based VL testing using Nucli-SENSEasy Q/Abbott RealTime HIV-1 m2000rt system

None mentioned

- Initial VL monitoring

Namale, G; 2019 [46]

Cross-sectional study using data routinely collected at a research clinic via clinical records and self-reported questionnaire

HIV-positive female sex worker (FSW) aged ≥ 18 years on ART for at least 6 months (N = 584)

A research clinic (Kampala, Uganda) established in 2008 for research on HIV/STIs among FSWs

Jan 2015-Dec 2016

To assess factors associated with virological failure among HIV-positive FSWs in Kampala, Uganda

VL testing performed on plasma using Abbott RealTime HIV-1 PCR assay

PEPFAR, UK Medical Research Council, DFID

- Initial VL monitoring

Sunpath, H.; 2018 [31]

Cross-sectional comparative study (pre and post-intervention) using routine program data collected from national electronic medical record register (TIER.net) and a district health information system

PLHIV actively enrolled for care; had been receiving ART since 2006 for varying period of time and were due for VL testing (N = 9184)

Three (03) publicly operated HIV clinics in rural areas of eThekwini district of Kwa-Zulu Natal, SA

Nov 2016 – Nov 2017

To assess the impact of an intervention program to enhance VL monitoring (VL champion – trained nurse to follow-up on VL testing and clinical management)

Laboratory based VL testing using fresh plasma sample (NHLS)

None mentioned

- Initial VL monitoring

Moyo, F.; 2018 [32]

Retrospective cohort study using data extracted from facility-based medical records and national HIV electronic register

HIV infected mother – infant pairs in three districts of KwaZulu-Natal province, SA (N = 367)

Three districts (eThekwini, uMgungundlovu and uMkhanyakude) with highest burden of HIV in SA

May – Sept 2016

To describe the gaps in prevention of mother to child transmission of HIV at study sites

Not reported

None mentioned

- Initial VL monitoring

Janurag, P. P.; 2018 [54]

Prospective cohort study using patient-level data collected directly by the research team

HIV-infected individuals aged ≥ 16 years from key populationsa attending services at study sites (N = 831)

25 local clinics providing HIV services to key populations in Bali, Bandung, Jakarta & Yogyakarta, Indonesia

Sep 2015 – Sep 2016

To report the first year’s results of an intervention project to improve the cascade of HIV care among key populations

Not reported.

(Free VL testing provided at ART initiation and every 6 months thereafter by the project)

Research project with support from the Australian Department of Foreign Affairs and Trade, WHO and the Indonesian Government

- Initial VL monitoring

Kadima, J.; 2018 [44]

Case-control study conducted using routine program data extracted from patients charts and an electronic database of VL results

Children aged 0–15 years on ART at study sites who received a VL test between Jun 2014 and May 2015 (N = 1272)

5 primary health care facilities (3 sub-country hospital and 2 health centres) at Homabay, Migori and Kisumu counties, Kenya

2014–16

To describe the adoption of routine VL monitoring among patients on ART aged < 15 years in western Kenya

VL samples were collected on-site and sent for central processing/testing at regional laboratory

PEPFAR/CDC, University of California at San Francisco; US

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of virological failure

- Switching treatment regimen

Etoori, D.; 2018 [40]

Prospective cohort study using data extracted from patients’ files and electronic VL database

HIV + pregnant women aged ≥ 16 years enrolled into PMTCT option B + at study sites between Jan 2013-June 2014 (N = 665)

One secondary and 8 primary care facilities in Nhlangano health zone, Southern Swaziland

Jan 2013 – Sep 2015

To describe outcomes including VL testing uptake of a feasibility study of PMTCT option B + in the public health sector

VL testing performed using the Biocentric (Bandol, France) multi-manufacturer open platform on plasma samples

PMTCTB + implementation supported by MSF; VL testing funded by UNITAID

- Initial VL monitoring

Copelyn, J.; 2018 [26]

Retrospective cohort study using data obtained from hospital database and patient folders & an electronic database at provincial health data centre

All children aged < 15 who were initiated on ART at a hospital and subsequently down-referred to two primary health clinics (PHCs) during study period (N = 116)

One hospital and two PHCs (within the immediate catchment area of the hospital and < 10 km apart) in Cape Town, SA

Jan 2006 – Dec 2012

To assess the success (clinical and ART outcomes) of a down-referral process in a cohort of young children

Not reported

None mentioned

- Initial VL monitoring

Amzel, A.; 2018 [39]

Retrospective study using program-level data extracted from PEPFAR monitoring, evaluation and reporting

All patients aged 5–24 years who were on ART for 12 months in the three study districts by end of Sep 2017 (N = 11,337)

All health facilities in three districts (Maseru, Mafeteng, Mohale’s Hoek) of Lesotho that offer community-supported interventions for children and adolescents living with HIV on ART

Oct 2016 – Sep 2017

To assess retention, VL coverage & viral suppression among children and adolescents living with HIV on ART in three study districts

Not reported

Multi-donor/

Implementing partners: PEPFAR, Elizabeth Glazer Pediatric AIDS Foundation, Baylor International Pediatric AIDS Initiative

- Initial VL monitoring

Tsondai, P.R.; 2017 [27]

Retrospective cohort study using data from AC registers, patients’ clinic folders and provincial health data centre

Patients on ART enrolled into AC model at study sites between Jan 2011 and Dec 2014 (N = 3216)

100 ACs operated by 15 health care facilities within Cape Town health district, Cape Town, SA

2011–15

To describe outcomes (loss to follow-up, viral rebound) of AC model

Not reported

Bill and Melinda Gates Foundation

- Initial VL monitoring

Swannet, S.; 2017 [45]

Retrospective cohort study using routine program data

All patients (all ages) who had spent > 6 months on 1st line ART (eligible for routine VL) with ≥ one consultation during the study period (N = 43,579)

Six MSF-supported HC in Matupo, Mozambique

2014–15

To describe the VL cascade & examine factors influencing VL testing uptake and results

VL testing done at a hospital laboratory (bioMerieux, NucliSENS EasyQ HIV-1 V2.0). HCs send DBS samples to laboratory for testing

MSF

- Initial VL monitoring

- Follow-up VL monitoring

- Confirmation of virological failure

- Switching treatment regimen

Kyaw, N.T.; 2017 [51]

Retrospective cohort study using routine program data extracted from an electronic database

Non-pregnant patients aged > = 10 years who were initiated on and receive 1st line ART for > = 6 months at study sites (N = 23,248)

33 clinics (ART centres & decentralised sites) under Integrated HIV Care (IHC) program in Mandalay, Sagaing, Magway, Shan & Yangon, Myanmar

Feb 2005 – Jul 2015

To describe the rates of treatment failure and switching to second-line ART in adolescent and adult patients receiving first-line ART under IHC program

Laboratory-based VL testing done at a private laboratory (2009–12) or the public health laboratory in Mandalay (since 2013)

The Union; DFID,

- Initial VL monitoring

- Switching treatment regimen

Cyamatare Rwabukwisi, F.; 2016 [38]

Retrospective cohort study using routinely collected data of a community-based accompaniment program (CBAP)

All patients aged < 15 years who were initiated on ART in CBA program at study sites during the study period (N = 277)

All 25 ART facilities offering CBAP in two rural districts of Rwanda

Jan 2005 – Dec 2008

To describe 5-year outcomes of children with HIV enrolled in the CBA program

Not reported

None mentioned

- Initial VL monitoring

- Follow-up VL monitoring

  1. a Key populations include: people who inject drug, female sex worker, men who have sex with men and transgender women