Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
956 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-08-19
Study Completion Date
2025-04-30
Brief Summary
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The purpose of EAPoC-VL project is to examine the feasibility, acceptability, and effectiveness of using point of care viral load (PoC VL) monitoring to improve viral load suppression among children, adolescents and young people (age ≤24 years) living with HIV in Kenya, Rwanda, Tanzania and Uganda.
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Detailed Description
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Main Study Aims:
i) To determine the effectiveness of PoC VL monitoring in improving viral suppression among children, adolescents and young people living with HIV in East Africa.
ii) To evaluate feasibility and acceptability of using PoC VL monitoring among children, adolescents and young people living with HIV in East Africa.
iii) To understand the psychosocial life of children, adolescents and young people living with HIV in East Africa and how they predict adherence and viral load suppression
Objectives of Aim 1:
Primary objective i. To estimate the effect of PoC VL monitoring on viral load suppression among children, adolescents and young people living with HIV in East Africa at 6 and 12 months of follow-up.
Secondary objectives i. To describe the effect of PoC VL monitoring on the proportion of children, adolescents and young people living with HIV that experiences virological rebound after initial suppression within 6 and 12 months of follow-up.
ii. To describe the effect of PoC VL monitoring on time to initiation of intensive adherence counselling following virological failure among children, adolescents and young people living with HIV.
iii. To estimate the effect of PoC VL monitoring on the proportion of children, adolescents and young people living with HIV that experiences change of ART regimen within 6 and 12 months of follow-up.
iv. To determine the effect of PoC VL monitoring on the proportion of children, adolescents and young people living with HIV that is retained in care at 6 and 12 months.
Objectives of Aim 2 i. To assess the acceptability of the implementation and scale-up of PoC VL testing and monitoring from the perspective of children, adolescents, young people and their caregivers.
ii. To assess the critical determinants that may affect the implementation of PoC VL testing and monitoring from the perspective of healthcare workers and policy makers.
iii. To assess potential barriers and facilitators to implementation and scale-up of PoC VL testing and monitoring among children, adolescents and young people living with HIV.
iv. To assess the incremental cost-effectiveness of PoC VL from a modified societal perspective using established models, with data collected alongside the implementation of the intervention combined with data estimated based on existing studies.
Objectives of Aim 3 i. To psychometrically validate 'psychosocial life' questionnaires. ii. To iteratively develop and psychometrically validate a novel user-friendly tablet-based 'Psychosocial Life' game that predicts adherence and viral load.
iii. To develop and test a set of clinical micro-interventions for psychosocial support based on existing best practice.
iv. To measure how 'psychosocial life' mediates the PoC effect on adherence and viral load.
v. To test proof-of-concept of the use of the novel 'psychosocial life' game and associated micro-interventions in a clinical setting.
Design: A cluster randomized controlled trial with 14 intervention clusters and 14 control clusters.
Study Sites: Twenty (28) health facilities spread across 4 countries as follows: Uganda (8), Kenya (4), Tanzania (12), and Rwanda (4).
Population: The study will be conducted among three population sub-groups
1. Study population 1: children, adolescents and young people (≤24 years) living with HIV in participating countries in East Africa.
2. Study population 2: Care givers/ guardians and treatment supporters of children, adolescents and young people living with HIV in participating countries in East Africa
3. Study population 3: Health care workers attending to children, adolescents and young people living with HIV, and policy makers.
Study Intervention: PoC VL monitoring using Cepheid Gene Xpert machine Control: Standard-of-care / centralized HIV VL monitoring
Duration: The whole project will take 48 months including 24 months of data collection. Each participant will be followed up for approximately 12 months.
Sample size The study will enroll 956 children, adolescents and young people (6months - 24years); with 476 in 14 intervention clusters and 476 in 14 control clusters (34 participants per cluster). The effect of the intervention and 95% CIs will be estimated using cluster-level summary methods and a power of 80%.
Study outcomes of Aim 1 Primary outcomes i. The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up.
ii. The time between enrolment into the study and viral suppression.
Secondary outcomes i. The proportion of children, adolescents and young people living with HIV that experiences virological rebound after initial suppression within 6 and 12 months of follow-up ii. The time between enrolment into the study and initiation of intensive adherence counselling following virological failure.
iii. The proportion of children, adolescents and young people living with HIV that experiences change of ART regimen within 6 and 12 months of follow-up iv. The proportion of children, adolescents and young people living with HIV that is retained in care at 6 and 12 months.
Study outcomes of Aim 2 i. Assessed acceptability of the implementation and scale-up of PoC VL testing and monitoring from the perspective of children, adolescents and young people, and their caregivers.
ii. Identified critical determinants that may affect the implementation of PoC VL testing and monitoring from the perspective of healthcare workers and policy makers.
iii. Identified potential barriers and facilitators to implementation and scale-up of PoC VL testing and monitoring among children, adolescents and young people living with HIV.
iv. An assessment of the incremental cost-effectiveness of PoC VL from a modified societal perspective
Study outcomes of Aim 3 i. Quantified and psychometrically validated measurement of the psychosocial life of children, adolescents and young people living with HIV in East Africa ii. A novel psychometrically validated user-friendly tablet-based 'Psychosocial Life' game that predicts viral load based on psychosocial life.
iii. A list of proposed clinical micro-interventions for psychosocial support based on existing best practice.
iv. A model explaining how psychosocial life indicators mediate the PoC effect on adherence and viral load suppression.
v. A proof-of-concept of the use of the novel 'psychosocial life' game and associated micro-interventions in clinical settings.
Statistical Analysis Aim 1
To investigate the effect of the intervention on viral suppression our analysis will be carried out at the cluster level as follows:
* Reduce clusters to independent observations and provide summary statistics by comparing those in the intervention arm to those in the non-intervention arm.
* Use fixed effects regression to take into account unobserved time-invariant heterogeneity and the treatment effects across the clusters
* Analyse the main outcome (viral suppression) using time to event comparison of the two arms from enrolment to failure or completion of the follow-up time (2 years).
Mixed method Analysis Aim 2 Acceptability and feasibility will be investigated using a combined qualitative and quantitative approach, consisting of thematic content analyses of observations, in-depth interviews and focus group discussions, triangulated and generalized with descriptive statistics of survey data. As part of the feasibility study, the impact of a range of values in sensitivity analyses using each of the respective sites' 2020 per capita GDP as a benchmark cost-effectiveness threshold will be evaluated to be able to estimate the incremental cost-effectiveness of the PoC HIV VL compared to the standard of care. Quality adjusted life years (QALYS) will be calculated based on weights derived from the Global Burden of Disease.
Analysis for Aims 3 Step 1: Determining which psychosocial indicators will be used in the structure equation model on baseline data Pearson correlation analyses will be conducted to examine the strength of associations between all psychosocial life indicator variables and medication adherence. For that, a correlation table will be obtained for looking for multicollinearity. If any two explanatory variables have a Pearson's coefficient of 0.80 or greater one of the variables will be excluded from further analysis as they may measure the same underlying factor.
To determine statistically which psychosocial life indicators have the most predictive power and ascertain the extent to which selected indicators can predict adherence or viral load, a stepwise hierarchical multiple regression will be carried out. Potential predictors will be automatically added into the regression model in steps based on statistical algorithms. Only indicators that significantly improve the overall model fit (R square change) will be retained for the final model of children's psychosocial life.
Step 2: Building a structural equation model and testing how psychosocial life mediates the effect of PoC on adherence and viral load.
Following the RCT design, the goal of this analysis is to measure how psychosocial life indicators mediate the PoC effect on adherence and viral load. An initial hypothetical psychosocial life model will be developed based on variables proved to have the most predictive power obtained from phase one and a synthesis of the empirical literature. The outcome variable will be the change in adherence and viral load separately (difference between baseline and endline data). From the main study (WP1) we assume that PoC improves the medical adherence of children with HIV. We also hypothesize that PoC will improve psychosocial life indicators and that better psychosocial life improves medical adherence and viral load.
Three different types of mediational model will be verified to test the potential mediating role of psychosocial life on the relationship between PoC and medication adherence: (a) a single mediator model, (b) multiple parallel mediator model, and (c) SEM model considering psychosocial life as a latent variable indicated by selected indicators.
i) To determine the effectiveness of PoC VL monitoring in improving viral suppression among children, adolescents and young people living with HIV in East Africa.
ii) To evaluate feasibility and acceptability of using PoC VL monitoring among children, adolescents and young people living with HIV in East Africa.
iii) To understand the psychosocial life of children, adolescents and young people living with HIV in East Africa and how they predict adherence and viral load suppression
Objectives of Aim 1:
Primary objective i. To estimate the effect of PoC VL monitoring on viral load suppression among children, adolescents and young people living with HIV in East Africa at 6 and 12 months of follow-up.
Secondary objectives i. To describe the effect of PoC VL monitoring on the proportion of children, adolescents and young people living with HIV that experiences virological rebound after initial suppression within 6 and 12 months of follow-up.
ii. To describe the effect of PoC VL monitoring on time to initiation of intensive adherence counselling following virological failure among children, adolescents and young people living with HIV.
iii. To estimate the effect of PoC VL monitoring on the proportion of children, adolescents and young people living with HIV that experiences change of ART regimen within 6 and 12 months of follow-up.
iv. To determine the effect of PoC VL monitoring on the proportion of children, adolescents and young people living with HIV that is retained in care at 6 and 12 months.
Objectives of Aim 2 i. To assess the acceptability of the implementation and scale-up of PoC VL testing and monitoring from the perspective of children, adolescents, young people and their caregivers.
ii. To assess the critical determinants that may affect the implementation of PoC VL testing and monitoring from the perspective of healthcare workers and policy makers.
iii. To assess potential barriers and facilitators to implementation and scale-up of PoC VL testing and monitoring among children, adolescents and young people living with HIV.
iv. To assess the incremental cost-effectiveness of PoC VL from a modified societal perspective using established models, with data collected alongside the implementation of the intervention combined with data estimated based on existing studies.
Objectives of Aim 3 i. To psychometrically validate 'psychosocial life' questionnaires. ii. To iteratively develop and psychometrically validate a novel user-friendly tablet-based 'Psychosocial Life' game that predicts adherence and viral load.
iii. To develop and test a set of clinical micro-interventions for psychosocial support based on existing best practice.
iv. To measure how 'psychosocial life' mediates the PoC effect on adherence and viral load.
v. To test proof-of-concept of the use of the novel 'psychosocial life' game and associated micro-interventions in a clinical setting.
Design: A cluster randomized controlled trial with 14 intervention clusters and 14 control clusters.
Study Sites: Twenty (28) health facilities spread across 4 countries as follows: Uganda (8), Kenya (4), Tanzania (12), and Rwanda (4).
Population: The study will be conducted among three population sub-groups
1. Study population 1: children, adolescents and young people (≤24 years) living with HIV in participating countries in East Africa.
2. Study population 2: Care givers/ guardians and treatment supporters of children, adolescents and young people living with HIV in participating countries in East Africa
3. Study population 3: Health care workers attending to children, adolescents and young people living with HIV, and policy makers.
Study Intervention: PoC VL monitoring using Cepheid Gene Xpert machine Control: Standard-of-care / centralized HIV VL monitoring
Duration: The whole project will take 48 months including 24 months of data collection. Each participant will be followed up for approximately 12 months.
Sample size The study will enroll 956 children, adolescents and young people (6months - 24years); with 476 in 14 intervention clusters and 476 in 14 control clusters (34 participants per cluster). The effect of the intervention and 95% CIs will be estimated using cluster-level summary methods and a power of 80%.
Study outcomes of Aim 1 Primary outcomes i. The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up.
ii. The time between enrolment into the study and viral suppression.
Secondary outcomes i. The proportion of children, adolescents and young people living with HIV that experiences virological rebound after initial suppression within 6 and 12 months of follow-up ii. The time between enrolment into the study and initiation of intensive adherence counselling following virological failure.
iii. The proportion of children, adolescents and young people living with HIV that experiences change of ART regimen within 6 and 12 months of follow-up iv. The proportion of children, adolescents and young people living with HIV that is retained in care at 6 and 12 months.
Study outcomes of Aim 2 i. Assessed acceptability of the implementation and scale-up of PoC VL testing and monitoring from the perspective of children, adolescents and young people, and their caregivers.
ii. Identified critical determinants that may affect the implementation of PoC VL testing and monitoring from the perspective of healthcare workers and policy makers.
iii. Identified potential barriers and facilitators to implementation and scale-up of PoC VL testing and monitoring among children, adolescents and young people living with HIV.
iv. An assessment of the incremental cost-effectiveness of PoC VL from a modified societal perspective
Study outcomes of Aim 3 i. Quantified and psychometrically validated measurement of the psychosocial life of children, adolescents and young people living with HIV in East Africa ii. A novel psychometrically validated user-friendly tablet-based 'Psychosocial Life' game that predicts viral load based on psychosocial life.
iii. A list of proposed clinical micro-interventions for psychosocial support based on existing best practice.
iv. A model explaining how psychosocial life indicators mediate the PoC effect on adherence and viral load suppression.
v. A proof-of-concept of the use of the novel 'psychosocial life' game and associated micro-interventions in clinical settings.
Statistical Analysis Aim 1
To investigate the effect of the intervention on viral suppression our analysis will be carried out at the cluster level as follows:
* Reduce clusters to independent observations and provide summary statistics by comparing those in the intervention arm to those in the non-intervention arm.
* Use fixed effects regression to take into account unobserved time-invariant heterogeneity and the treatment effects across the clusters
* Analyse the main outcome (viral suppression) using time to event comparison of the two arms from enrolment to failure or completion of the follow-up time (2 years).
Mixed method Analysis Aim 2 Acceptability and feasibility will be investigated using a combined qualitative and quantitative approach, consisting of thematic content analyses of observations, in-depth interviews and focus group discussions, triangulated and generalized with descriptive statistics of survey data. As part of the feasibility study, the impact of a range of values in sensitivity analyses using each of the respective sites' 2020 per capita GDP as a benchmark cost-effectiveness threshold will be evaluated to be able to estimate the incremental cost-effectiveness of the PoC HIV VL compared to the standard of care. Quality adjusted life years (QALYS) will be calculated based on weights derived from the Global Burden of Disease.
Analysis for Aims 3 Step 1: Determining which psychosocial indicators will be used in the structure equation model on baseline data Pearson correlation analyses will be conducted to examine the strength of associations between all psychosocial life indicator variables and medication adherence. For that, a correlation table will be obtained for looking for multicollinearity. If any two explanatory variables have a Pearson's coefficient of 0.80 or greater one of the variables will be excluded from further analysis as they may measure the same underlying factor.
To determine statistically which psychosocial life indicators have the most predictive power and ascertain the extent to which selected indicators can predict adherence or viral load, a stepwise hierarchical multiple regression will be carried out. Potential predictors will be automatically added into the regression model in steps based on statistical algorithms. Only indicators that significantly improve the overall model fit (R square change) will be retained for the final model of children's psychosocial life.
Step 2: Building a structural equation model and testing how psychosocial life mediates the effect of PoC on adherence and viral load.
Following the RCT design, the goal of this analysis is to measure how psychosocial life indicators mediate the PoC effect on adherence and viral load. An initial hypothetical psychosocial life model will be developed based on variables proved to have the most predictive power obtained from phase one and a synthesis of the empirical literature. The outcome variable will be the change in adherence and viral load separately (difference between baseline and endline data). From the main study (WP1) we assume that PoC improves the medical adherence of children with HIV. We also hypothesize that PoC will improve psychosocial life indicators and that better psychosocial life improves medical adherence and viral load.
Three different types of mediational model will be verified to test the potential mediating role of psychosocial life on the relationship between PoC and medication adherence: (a) a single mediator model, (b) multiple parallel mediator model, and (c) SEM model considering psychosocial life as a latent variable indicated by selected indicators.
Conditions
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HIV
Viral Load
Point of Care Monitoring
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Intervention arm will use point of care viral load monitoring ((initially Abbott PoC devices, then changed to GeneXpert) while the control arm will use the standard of care (centralized viral load monitoring).
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Study Groups
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Intervention
Use of point of care viral load monitoring (initially Abbott PoC devices, then changed to Cepheid Gene Xpert)
Group Type
EXPERIMENTAL
Abbott HIV-1/2 VL Point of care Device
Intervention Type
DIAGNOSTIC_TEST
Point of care viral load monitoring
Control
Use of the standard of care viral load monitoring (centralized viral load monitoring)
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Abbott HIV-1/2 VL Point of care Device
Point of care viral load monitoring
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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Inclusion Criteria
* Age 6 months - 24 years
* Documented evidence of HIV infection
* Receiving ART for treatment of HIV infection for at least 6 months.
* Has had a detectable VL of \>1000 copies/ml in the last 6 months.
* Guardian, parent or legal representative able and willing to give voluntary consent and sign/mark an informed consent document.
* Willing and able to comply with protocol requirements/study procedures.
* Documented evidence of HIV infection
* Receiving ART for treatment of HIV infection for at least 6 months.
* Has had a detectable VL of \>1000 copies/ml in the last 6 months.
* Guardian, parent or legal representative able and willing to give voluntary consent and sign/mark an informed consent document.
* Willing and able to comply with protocol requirements/study procedures.
Exclusion Criteria
* Any medical conditions that require pausing of ART for more than three months.
* Potential participant already enrolled in another study which may interfere with the study outcome or participation as per investigator's judgement.
* Child, adolescent or young person already enrolled and completed follow up in the current study.
* Any medical or other condition in the potential participant or their parent/ guardian that precludes provision of informed consent/ assent or that may hinder achieving study objectives as per investigator's judgement.
* Potential participant already enrolled in another study which may interfere with the study outcome or participation as per investigator's judgement.
* Child, adolescent or young person already enrolled and completed follow up in the current study.
* Any medical or other condition in the potential participant or their parent/ guardian that precludes provision of informed consent/ assent or that may hinder achieving study objectives as per investigator's judgement.
Minimum Eligible Age
6 Months
Maximum Eligible Age
24 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Karolinska Institutet
OTHER
Sponsor Role
collaborator
Kilimanjaro Christian Medical Centre, Tanzania
OTHER
Sponsor Role
collaborator
Amsterdam Institute for Global Health and Development
OTHER
Sponsor Role
collaborator
National Institute for Medical Research, Tanzania
OTHER_GOV
Sponsor Role
collaborator
Kenya Medical Research Institute
OTHER
Sponsor Role
collaborator
University of Rwanda
OTHER
Sponsor Role
collaborator
MRC/UVRI and LSHTM Uganda Research Unit
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Pontiano Kaleebu
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Locations
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Kenya Medical Research Institute
Kisumu, , Kenya
Site Status
University of Rwanda
Kigali, , Rwanda
Site Status
Management and Development for Health
Dar es Salaam, , Tanzania
Site Status
National Institute of Medical Research
Dar es Salaam, , Tanzania
Site Status
Kilimanjaro Clinical Research Institute
Moshi, , Tanzania
Site Status
MRC/UVRI and LSHTM
Entebbe, , Uganda
Site Status
Unhro/ Uvri
Entebbe, , Uganda
Site Status
Countries
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Kenya
Rwanda
Tanzania
Uganda
References
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Joint United Nations Programme on, H.A. and H.I.V.A. Joint United Nations Programme on, 90-90-90: an ambitious treatment target to help end the AIDS epidemic. Geneva: UNAIDS
Reference Type
BACKGROUND
UNAIDS UNAIDS data 2020. Annual Report, 2020.
Reference Type
BACKGROUND
Joint United Nations Programme on, H.A., Fast-track: ending the AIDS epidemic by 2030. Geneva: UNAIDS.
Reference Type
BACKGROUND
Fretzayas A, Karpathios T, Dimitriou P, Nicolaidou P, Matsaniotis N. Grading of vesicoureteral reflux by radionuclide cystography. Pediatr Radiol. 1984;14(3):148-50. doi: 10.1007/BF01002299.
Reference Type
BACKGROUND
Agolory S, de Klerk M, Baughman AL, Sawadogo S, Mutenda N, Pentikainen N, Shoopala N, Wolkon A, Taffa N, Mutandi G, Jonas A, Mengistu AT, Dzinotyiweyi E, Prybylski D, Hamunime N, Medley A. Low Case Finding Among Men and Poor Viral Load Suppression Among Adolescents Are Impeding Namibia's Ability to Achieve UNAIDS 90-90-90 Targets. Open Forum Infect Dis. 2018 Aug 11;5(9):ofy200. doi: 10.1093/ofid/ofy200. eCollection 2018 Sep.
Reference Type
BACKGROUND
Gill MM, Hoffman HJ, Bobrow EA, Mugwaneza P, Ndatimana D, Ndayisaba GF, Baribwira C, Guay L, Asiimwe A. Detectable Viral Load in Late Pregnancy among Women in the Rwanda Option B+ PMTCT Program: Enrollment Results from the Kabeho Study. PLoS One. 2016 Dec 22;11(12):e0168671. doi: 10.1371/journal.pone.0168671. eCollection 2016.
Reference Type
BACKGROUND
Ntlantsana V, Hift RJ, Mphatswe WP. HIV viraemia during pregnancy in women receiving preconception antiretroviral therapy in KwaDukuza, KwaZulu-Natal. South Afr J HIV Med. 2019 Apr 10;20(1):847. doi: 10.4102/sajhivmed.v20i1.847. eCollection 2019.
Reference Type
BACKGROUND
Bulage L, Ssewanyana I, Nankabirwa V, Nsubuga F, Kihembo C, Pande G, Ario AR, Matovu JK, Wanyenze RK, Kiyaga C. Factors Associated with Virological Non-suppression among HIV-Positive Patients on Antiretroviral Therapy in Uganda, August 2014-July 2015. BMC Infect Dis. 2017 May 3;17(1):326. doi: 10.1186/s12879-017-2428-3.
Reference Type
BACKGROUND
Nabukeera S, Kagaayi J, Makumbi FE, Mugerwa H, Matovu JKB. Factors associated with virological non-suppression among HIV-positive children receiving antiretroviral therapy at the Joint Clinical Research Centre in Lubowa, Kampala Uganda. PLoS One. 2021 Jan 27;16(1):e0246140. doi: 10.1371/journal.pone.0246140. eCollection 2021.
Reference Type
BACKGROUND
RBC, Rwanda Population-based HIV Impact Assessment, R.B. Centre, Editor. 2020, RPHIA 2018-2019.
Reference Type
BACKGROUND
UNAIDS, Understanding fast†track: Accelerating action to end the AIDS epidemic by 2030. 2015, UNAIDS Geneva.
Reference Type
BACKGROUND
Mwau M, Syeunda CA, Adhiambo M, Bwana P, Kithinji L, Mwende J, Oyiengo L, Sirengo M, Boeke CE. Scale-up of Kenya's national HIV viral load program: Findings and lessons learned. PLoS One. 2018 Jan 11;13(1):e0190659. doi: 10.1371/journal.pone.0190659. eCollection 2018.
Reference Type
BACKGROUND
El-Sadr WM, Rabkin M, Nkengasong J, Birx DL. Realizing the potential of routine viral load testing in sub-Saharan Africa. J Int AIDS Soc. 2017 Nov;20 Suppl 7(Suppl 7):e25010. doi: 10.1002/jia2.25010. No abstract available.
Reference Type
BACKGROUND
Mangone E, C.C., Johns B, Mudhune V, & Avila C, Economic Evaluation of Nationally Scaled Point-of-Care Diagnostic Platforms for Viral Load Monitoring in Kenya, U. Report, Editor. 2018.
Reference Type
BACKGROUND
Zhang J, Lan T, Lu Y. Translating in vitro diagnostics from centralized laboratories to point-of-care locations using commercially-available handheld meters. Trends Analyt Chem. 2020 Mar;124:115782. doi: 10.1016/j.trac.2019.115782. Epub 2019 Dec 23.
Reference Type
BACKGROUND
Boeke CE, Joseph J, Atem C, Banda C, Coulibaly KD, Doi N, Gunda A, Kandulu J, Kiernan B, Kingwara L, Maokola W, Maparo T, Mbaye RN, Mtumbuka E, Mziray J, Ngugi C, Nkakulu J, Nzuobontane D, Okomo Assoumo MC, Peter T, Rioja MR, Sacks JA, Simbi R, Vojnov L, Khan SA. Evaluation of near point-of-care viral load implementation in public health facilities across seven countries in sub-Saharan Africa. J Int AIDS Soc. 2021 Jan;24(1):e25663. doi: 10.1002/jia2.25663.
Reference Type
BACKGROUND
Moyo S, Mohammed T, Wirth KE, Prague M, Bennett K, Holme MP, Mupfumi L, Sebogodi P, Moraka NO, Boleo C, Maphorisa CN, Seraise B, Gaseitsiwe S, Musonda RM, van Widenfelt E, Powis KM, Gaolathe T, Tchetgen Tchetgen EJ, Makhema JM, Essex M, Lockman S, Novitsky V. Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable. J Clin Microbiol. 2016 Dec;54(12):3050-3055. doi: 10.1128/JCM.01594-16. Epub 2016 Oct 12.
Reference Type
BACKGROUND
Bwana P, Ageng'o J, Danda J, Mbugua J, Handa A, Mwau M. Performance and usability of mPIMA HIV 1/2 viral load test in point of care settings in Kenya. J Clin Virol. 2019 Dec;121:104202. doi: 10.1016/j.jcv.2019.104202. Epub 2019 Oct 23.
Reference Type
BACKGROUND
Drain PK, Dorward J, Violette LR, Quame-Amaglo J, Thomas KK, Samsunder N, Ngobese H, Mlisana K, Moodley P, Donnell D, Barnabas RV, Naidoo K, Abdool Karim SS, Celum C, Garrett N. Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial. Lancet HIV. 2020 Apr;7(4):e229-e237. doi: 10.1016/S2352-3018(19)30402-3. Epub 2020 Feb 24.
Reference Type
BACKGROUND
Nicholas S, Poulet E, Wolters L, Wapling J, Rakesh A, Amoros I, Szumilin E, Gueguen M, Schramm B. Point-of-care viral load monitoring: outcomes from a decentralized HIV programme in Malawi. J Int AIDS Soc. 2019 Aug;22(8):e25387. doi: 10.1002/jia2.25387.
Reference Type
BACKGROUND
Villa G, Abdullahi A, Owusu D, Smith C, Azumah M, Sayeed L, Austin H, Awuah D, Beloukas A, Chadwick D, Phillips R, Geretti AM. Determining virological suppression and resuppression by point-of-care viral load testing in a HIV care setting in sub-Saharan Africa. EClinicalMedicine. 2020 Jan 5;18:100231. doi: 10.1016/j.eclinm.2019.12.001. eCollection 2020 Jan.
Reference Type
BACKGROUND
Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
Reference Type
BACKGROUND
Fleuren MA, Paulussen TG, Van Dommelen P, Van Buuren S. Towards a measurement instrument for determinants of innovations. Int J Qual Health Care. 2014 Oct;26(5):501-10. doi: 10.1093/intqhc/mzu060. Epub 2014 Jun 20.
Reference Type
BACKGROUND
Sekhon M, Cartwright M, Francis JJ. Acceptability of health care interventions: A theoretical framework and proposed research agenda. Br J Health Psychol. 2018 Sep;23(3):519-531. doi: 10.1111/bjhp.12295. Epub 2018 Feb 16. No abstract available.
Reference Type
BACKGROUND
Baral S, Logie CH, Grosso A, Wirtz AL, Beyrer C. Modified social ecological model: a tool to guide the assessment of the risks and risk contexts of HIV epidemics. BMC Public Health. 2013 May 17;13:482. doi: 10.1186/1471-2458-13-482.
Reference Type
BACKGROUND
Fazeli PL, Turan JM, Budhwani H, Smith W, Raper JL, Mugavero MJ, Turan B. Moment-to-moment within-person associations between acts of discrimination and internalized stigma in people living with HIV: An experience sampling study. Stigma Health. 2017 Aug;2(3):216-228. doi: 10.1037/sah0000051. Epub 2016 Aug 8.
Reference Type
BACKGROUND
WHO, Child and Adolescent Health and Development, in Progress Report, W.H. Organization, Editor. 2006.
Reference Type
BACKGROUND
Decety J. Empathy in Medicine: What It Is, and How Much We Really Need It. Am J Med. 2020 May;133(5):561-566. doi: 10.1016/j.amjmed.2019.12.012. Epub 2020 Jan 15.
Reference Type
BACKGROUND
Mariani D, de Azevedo MCVM, Vasconcellos I, Ribeiro L, Alves C, Ferreira OC Jr, Tanuri A. The performance of a new point-of-care HIV virus load technology to identify patients failing antiretroviral treatment. J Clin Virol. 2020 Jan;122:104212. doi: 10.1016/j.jcv.2019.104212. Epub 2019 Nov 9.
Reference Type
BACKGROUND
Meggi B, Bollinger T, Zitha A, Mudenyanga C, Vubil A, Mutsaka D, Nhachigule C, Mabunda N, Loquiha O, Kroidl A, Jani IV. Performance of a True Point-of-Care Assay for HIV-1/2 Viral Load Measurement at Antenatal and Postpartum Services. J Acquir Immune Defic Syndr. 2021 May 1;87(1):693-699. doi: 10.1097/QAI.0000000000002621.
Reference Type
BACKGROUND
Vasconcellos I, Mariani D, Azevedo MCVM, Ferreira OC Jr, Tanuri A. Development and validation of a simple and rapid way to generate low volume of plasma to be used in point-of-care HIV virus load technologies. Braz J Infect Dis. 2020 Jan-Feb;24(1):30-33. doi: 10.1016/j.bjid.2019.10.010. Epub 2019 Nov 21.
Reference Type
BACKGROUND
Gavina K, Franco LC, Khan H, Lavik JP, Relich RF. Molecular point-of-care devices for the diagnosis of infectious diseases in resource-limited settings - A review of the current landscape, technical challenges, and clinical impact. J Clin Virol. 2023 Dec;169:105613. doi: 10.1016/j.jcv.2023.105613. Epub 2023 Oct 18.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RGPK210909
Identifier Type: -
Identifier Source: org_study_id
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