East Africa Point of Care Viral Load Study

NCT05048472 | Completed FDA Device

• 1 other identifier: RGPK210909
• Study Type: interventional
• Target: 956
• Locations: 4 countries
• Sites: 7

Brief 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.

Conditions

HIV; Viral Load; Point of Care Monitoring

Keywords

Children; East Africa; Adolescents and young people

Outcome Measures

Primary Outcomes (2)

• 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

  36 months

• The time between enrolment into the study and viral suppression.

  The time between enrolment into the study and viral suppression.

  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

  36 months

• The time between enrolment into the study and initiation of intensive adherence counselling following virological failure.

  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

  36 months

• The proportion of children, adolescents and young people living with HIV that is retained in care at 6 and 12 months.

  36 months

Other Outcomes (9)

• The proportion of children, adolescents and young people and their care givers who accept implementation of PoC VL testing and monitoring

  36 months

• The number of factors which may affect the implementation of PoC VL testing and monitoring from the perspective of healthcare workers and policy makers.

  24 months

• The number of potential barriers and facilitators to implementation and scale-up of PoC VL testing and monitoring identified by children, adolescents and young people living with HIV.

  36 months

Study Arms (2)

Intervention

EXPERIMENTAL

Use of point of care viral load monitoring (initially Abbott PoC devices, then changed to Cepheid Gene Xpert)

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)

Interventions

Abbott HIV-1/2 VL Point of care Device DIAGNOSTIC_TEST

Point of care viral load monitoring

Intervention

Eligibility Criteria

• Age: 6 Months - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MRC/UVRI and LSHTM Uganda Research Unit: lead
• Karolinska Institutet: collaborator
• Kilimanjaro Christian Medical Centre, Tanzania: collaborator
• Amsterdam Institute for Global Health and Development: collaborator
• National Institute for Medical Research, Tanzania: collaborator
• Kenya Medical Research Institute: collaborator
• University of Rwanda: collaborator

Study Sites (7)

Kenya Medical Research Institute

Kisumu, Kenya

Location

University of Rwanda

Kigali, Rwanda

Location

Management and Development for Health

Dar es Salaam, Tanzania

Location

National Institute of Medical Research

Dar es Salaam, Tanzania

Location

Kilimanjaro Clinical Research Institute

Moshi, Tanzania

Location

MRC/UVRI and LSHTM

Entebbe, Uganda

Location

Unhro/ Uvri

Entebbe, Uganda

Location

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Study Officials

• Pontiano Kaleebu

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 17, 2021
• Study Start: August 19, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (2); KE (1); RW (1); TA (3)