UPART

UPART (Uganda Paediatric Antiretroviral Therapy) is a national cohort and implementation platform that brings together government, researchers, clinicians and communities to generate evidence and improve services for children and adolescents living with HIV (CALHIV). Children and adolescents face unique challenges — later diagnosis, adherence difficulties, drug formulation needs and transition to adult care — which UPART addresses through data, clinical support and systems strengthening.

Screening is done in health facilities (including paediatric inpatient services), maternal and child health settings, and through outreach. UPART strengthens testing and linkage so children and adolescents who test positive are rapidly connected to care and follow-up, in line with national guidance on EID and linkage.

National guidance recommends optimized paediatric and adolescent ART regimens; UPART evaluates real-world uptake of these regimens (including DTG rollout) and monitors viral load outcomes. Common challenges include limited availability of some paediatric formulations, stock-outs and retention issues, all of which influence long-term viral suppression and health outcomes.

Transition can be a vulnerable time: adolescents must adapt to new clinic environments and manage their own care. UPART promotes adolescent-friendly services, peer support and structured transition processes to maintain continuity of care and viral suppression.

Bridging research to policy and practice.

The clinical cascade for children and adolescents living with HIV (CALHIV) remains behind that of adults. To address this, the Uganda Paediatric Antiretroviral Therapy (UPART) cohort study established a national paediatric and adolescent HIV observational cohort in October 2021 to create a representative cohort of Ugandan children and adolescents living with HIV on ART.

The nationwide cohort assesses evolving characteristics of CALHIV in Uganda and generates high-quality data from routine HIV care to address public-health questions such as the uptake and impact of newly rolled-out paediatric drugs and formulations. UPART supplements national surveillance by providing robust, programmatically relevant evidence to guide planning, improve clinical care, and contribute to international research.

Phase 1 (Oct 2021–Dec 2024) recruited participants from three high-burden facilities (Mildmay Hospital, Hoima Regional Referral Hospital and Lira Regional Referral Hospital). Recruitment for Phase 1 began October 2021, targeting 2,700 CALHIV; between November 2021 and December 2023 a total of 1,494 participants were enrolled and Phase 1 concluded in December 2024. Phase 1 findings were disseminated at international meetings including the International Workshop on HIV Paediatrics (July 2023, Brisbane) and IPHASA 2023, as well as at a stakeholder dissemination workshop (August 2024).

Phase 2 received ethical approval and began in June 2025, expanding to two additional sites (Jinja RRH and Masaka RRH). Phase 2 will enrol approximately 3,000 CALHIV from five facilities. As of 30 September 2025, 930 participants had been enrolled into the cohort. The study team presented additional findings at the International Workshop on HIV Paediatrics (July 2025, Kigali, Rwanda).

Funding and partnerships: Phase 1 was funded by the MRC Clinical Trials Unit at UCL and international stakeholders including USAID, WHO, CIPHER/IAS and UNICEF. The second phase has 2 sub-studies, UPART DTG sub-study, funded by ViiV Healthcare and UPART THRIVE sub-study funded by Unitaid.

UP ART DTG study — Evaluates uptake and outcomes of dolutegravir (DTG)-based regimens (DBRs) among children (0–9 years) and adolescents (10–19 years).
Primary objectives:

1. Describe uptake of DTG in the UPART cohort and characteristics at start of DBRs.

2. Describe mortality and loss-to-follow-up after DBR initiation.

3. Assess effectiveness of DBRs by describing viral load response (suppression and failure) over time.
   Secondary objectives include identifying factors associated with viral failure, reasons for discontinuation of DTG, and monitoring growth (weight, height, BMI) over time on DBR. This sub-study is funded by ViiV Healthcare and aims to enrol ~3,000 participants across the five sites. Study activities: 1 Jan 2024 – 31 Dec 2027.

UP-ART THRIVE (AHD) sub-study — Focuses on diagnosis, prevention and treatment of Advanced HIV Disease (AHD) among CALHIV.

Primary objectives

1. To describe the uptake of DTG in the UP ART cohort and characteristics at start of dolutegravir (DTG)- based regimens (DBRs)
2. To describe mortality and loss to follow-up among CALHIV after start of DBRs
3. To assess the effectiveness of DBRs by assessing viral load (VL) response over time on DBR (viral suppression and viral failure)

Secondary objectives:

1. To identify factors associated with viral failure
2. To assess the number/proportion of CALHIV discontinuing DTG and reasons for discontinuation
3. To assess changes in weight, height and body mass index (BMI) over time on DBR
   This sub-study is funded by ViiV Healthcare.

The sub-study aims to enrol approximately 3000 study participants from all the five sites in addition to those enrolled in phase 1. Study activities started on the 1st January, 2024 and will end on the 31st December, 2027
The second sub-study is: Uganda Paediatric Antiretroviral Therapy (UP-ART) -THRIVE Sub-study on diagnosis, Prevention and Treatment of Advanced HIV disease in Children and Adolescents living with HIV in Uganda
The research objectives are:

Primary Objective

1. To assess the cascade (receipt of all components of care with in one month of being eligible for screening), of care among CALHIV with AHD, dissecting all steps included in the Ugandan national guidelines (including screening for AHD and OI, treatment, optimization of care and prophylaxis).
   secondary objectives
2. Describe the number and proportion of CALHIV who were eligible for AHD screening per calendar year starting in 2023, among all those in follow-up in UP ART that year
3. Describe the prevalence and incidence of AHD and its characteristics at the time of AHD diagnosis.
   (i) Prevalence is based on proportion screened for AHD who met the definition of AHD at initial screening
   (ii) Incidence will be estimated in two groups:
   a. among those screened and not diagnosed with AHD at initial screening who meet the definition of AHD within 12 months of initial screening.
   b. among those eligible for screening but were not screened for AHD, who met the definition of AHD within 12 months of becoming eligible for screening
4. Assess the clinical progression and outcomes of children and adolescents with AHD diagnosis, including mortality, morbidity (new and recurrent WHO 3 and 4 events), retention in HIV care, treatment interruption, and growth changes by 12 months after AHD diagnosis.

Strengthen data quality and completeness of AHD related data captured in electronic medical records through dedicated training, data monitoring plans and regular feedback to clinic staff.
This sub-study aims to enroll approximately 2000 study participants from three HIV high burden facilities (Mildmay Uganda, Hoima RRH & Lira RRH). Study activities started on the 1st January 2024, and will end on the 31st December 2026. The sub-study is funded by Unitaid
Each participating facility is supported by a dedicated nurse and a data quality assurance clinician to strengthen enrollment, and data processes. As of 30 September 2025, a total of 930 participants have been enrolled into the cohort. The study team also disseminated additional findings at the International Workshop on HIV Paediatrics (July 2025, Kigali, Rwanda).