HIVEAPoC-VLNCT05048472
East Africa Point of Care Viral Load Study
A study testing Abbott HIV-1/2 VL Point of care Device in people with HIV and Viral Load, run by MRC/UVRI and LSHTM Uganda Research Unit at 7 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Viral Load, Point of Care Monitoring
- What is being tested?
- Abbott HIV-1/2 VL Point of care Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 956 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 19 Aug 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Tanzania3 sites
Management and Development for Health
Dar es Salaam
National Institute of Medical Research
Dar es Salaam
Kilimanjaro Clinical Research Institute
Moshi
About this study
Official title: Implementation of Point of Care HIV Viral Load Monitoring to Improve Viral Load Suppression Among Children, Adolescents and Young People Living With HIV in East Africa
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.
Read the detailed description
Main Study Aims:
- 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.
- 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
- Study population 1: children, adolescents and young people (≤24 years) living with HIV in participating countries in East Africa.
- Study population 2: Care givers/ guardians and treatment supporters of children, adolescents and young people living with HIV in participating countries in East Africa
- 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.
- 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
- HIV, Viral Load, Point of Care Monitoring
- Being tested
- Abbott HIV-1/2 VL Point of care Device
- Keywords
- Children, East Africa, Adolescents and young people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott HIV-1/2 VL Point of care DeviceDiagnostic test
Point of care viral load monitoring
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Use of point of care viral load monitoring (initially Abbott PoC devices, then changed to Cepheid Gene Xpert) Receives: Diagnostic Test: Abbott HIV-1/2 VL Point of care Device |
| Control | No intervention | Use of the standard of care viral load monitoring (centralized viral load monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up.
The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up
Measured: 36 months
The time between enrolment into the study and viral suppression.
The time between enrolment into the study and viral suppression.
Measured: 36 months
Secondary outcomes (4)
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
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
Measured: 36 months
The time between enrolment into the study and initiation of intensive adherence counselling following virological failure.
The time between enrolment into the study and initiation of intensive adherence counselling following virological failure.
Measured: 36 months
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
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
Measured: 36 months
The proportion of children, adolescents and young people living with HIV that is retained in care at 6 and 12 months.
The proportion of children, adolescents and young people living with HIV that is retained in care at 6 and 12 months.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start19 Aug 2022
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 956 participants (actual)
Sponsor and investigators
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Kilimanjaro Christian Medical Centre, Tanzania, Amsterdam Institute for Global Health and Development, National Institute for Medical Research, Tanzania, Kenya Medical Research Institute, University of Rwanda
- Responsible party
- Sponsor
- Investigators
- Pontiano Kaleebu, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048472
- Sponsor's protocol ID
- RGPK210909
- Acronym
- EAPoC-VL
- Status last verified
- Jun 2025
- First submitted
- 1 Sep 2021
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual Participant Data will be de-identified so as to make it anonymous. This will then be reported either for individuals (e.g. quotations from qualitative interviews) or for study participants as a group.
Publications
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
UNAIDS UNAIDS data 2020. Annual Report, 2020.
Joint United Nations Programme on, H.A., Fast-track: ending the AIDS epidemic by 2030. Geneva: UNAIDS.
Humphrey JM, Genberg BL, Keter A, Musick B, Apondi E, Gardner A, Hogan JW, Wools-Kaloustian K. Viral suppression among children and their caregivers living with HIV in western Kenya. J Int AIDS Soc. 2019 Apr;22(4):e25272. doi: 10.1002/jia2.25272.
PubMed 30983148Agolory 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.
PubMed 30211248Gill 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.
PubMed 28006001Ntlantsana 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.
PubMed 31061722Bulage 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.
PubMed 28468608Nabukeera 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.
PubMed 33503074RBC, Rwanda Population-based HIV Impact Assessment, R.B. Centre, Editor. 2020, RPHIA 2018-2019.
UNAIDS, Understanding fast†track: Accelerating action to end the AIDS epidemic by 2030. 2015, UNAIDS Geneva.
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.
PubMed 29324811El-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.
PubMed 29130621Mangone 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.
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.
PubMed 32194293
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Point of Care HIV Viral Load Monitoring to Improve Viral Load Suppression Among Children, Adolescents and Young People Living With HIV in East Africa
- ClinicalTrials.gov ID
- NCT05048472
- Acronym / sponsor ID
- EAPoC-VL / RGPK210909
- Conditions
- HIV, Viral Load, Point of Care Monitoring
- Keywords
- Children, East Africa, Adolescents and young people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 956 participants (actual)
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research UnitUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Kilimanjaro Christian Medical Centre, Tanzania, Amsterdam Institute for Global Health and Development, National Institute for Medical Research, Tanzania, Kenya Medical Research Institute, University of Rwanda
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Main Study Aims:
- 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.
- 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
- Study population 1: children, adolescents and young people (≤24 years) living with HIV in participating countries in East Africa.
- Study population 2: Care givers/ guardians and treatment supporters of children, adolescents and young people living with HIV in participating countries in East Africa
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Abbott HIV-1/2 VL Point of care DeviceUse of point of care viral load monitoring (initially Abbott PoC devices, then changed to Cepheid Gene Xpert) |
| Control | No intervention | –Use of the standard of care viral load monitoring (centralized viral load monitoring) |
Who may qualify
- Ages
- 6 months to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott HIV-1/2 VL Point of care DevicePoint of care viral load monitoring | Diagnostic test | Intervention |
Primary outcome
The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up.
Time frame: 36 months
The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up
The time between enrolment into the study and viral suppression.
Time frame: 36 months
The time between enrolment into the study and viral suppression.
4 secondary outcomes
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
Time frame: 36 months
The time between enrolment into the study and initiation of intensive adherence counselling following virological failure.
Time frame: 36 months
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
Time frame: 36 months
The proportion of children, adolescents and young people living with HIV that is retained in care at 6 and 12 months.
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- BackgroundJoint 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
- BackgroundUNAIDS UNAIDS data 2020. Annual Report, 2020.
- BackgroundJoint United Nations Programme on, H.A., Fast-track: ending the AIDS epidemic by 2030. Geneva: UNAIDS.
- Background: PubMed 30983148Humphrey JM, Genberg BL, Keter A, Musick B, Apondi E, Gardner A, Hogan JW, Wools-Kaloustian K. Viral suppression among children and their caregivers living with HIV in western Kenya. J Int AIDS Soc. 2019 Apr;22(4):e25272. doi: 10.1002/jia2.25272.
- Background: PubMed 30211248Agolory 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.
- Background: PubMed 28006001Gill 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.
- Background: PubMed 31061722Ntlantsana 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.
- Background: PubMed 28468608Bulage 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.
- Background: PubMed 33503074Nabukeera 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.
- BackgroundRBC, Rwanda Population-based HIV Impact Assessment, R.B. Centre, Editor. 2020, RPHIA 2018-2019.
- BackgroundUNAIDS, Understanding fast†track: Accelerating action to end the AIDS epidemic by 2030. 2015, UNAIDS Geneva.
- Background: PubMed 29324811Mwau 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.
- Individual participant dataSharing planned: No. Individual Participant Data will be de-identified so as to make it anonymous. This will then be reported either for individuals (e.g. quotations from qualitative interviews) or for study participants as a group.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pontiano Kaleebu principal investigator
London School of Hygiene and Tropical Medicine
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbott HIV-1/2 VL Point of care Device in people with HIV and Viral Load, run by MRC/UVRI and LSHTM Uganda Research Unit at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Tanzania, Uganda, Kenya, Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up. (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05048472, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.