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Viral Load Triggered ART Care in Lesotho

NCT04527874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5809

Last updated 2025-08-01

No results posted yet for this study

Summary

This cluster randomized clinical trial at 18 nurse-led rural health centers in Lesotho will test an automated differentiated service delivery model using viral load results, other clinical characteristics and participants' preference to automatically triage participants into groups requiring different levels of attention and care.

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

VITAL model

The concept of the VITAL, an automated differentiated service delivery model (aDSDM), is to use viral load results, other clinical characteristics (TB screening results and CD4 cell counts, comorbidities) and participants' preference to automatically triage participants into groups requiring different levels of attention and care. Innovatively, triaging of participants will be done automatically making use of a dedicated mobile App and a viral load database platform. To ensure effective flow of information and empowerment of patients, viral load results and other relevant information is sent directly to participants' phones, whereas health care providers receive results directly on their study tablet together with the recommended action. Further features of the platform are preference-based tailored adherence reminders and automated calls to participants for symptomatic tuberculosis screening.

Sponsors & Collaborators

  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Niklaus Labhardt, Prof · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2024-08-07
Completion
2024-08-07

Countries

  • Lesotho

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04527874 on ClinicalTrials.gov