Viral Load Triggered ART Care in Lesotho
VITAL
Assessment of a Viral Load Result-driven Automated Differentiated Service Delivery Model for Participants Taking Antiretroviral Therapy in Lesotho
1 other identifier
interventional
5,809
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Oct 2020
Typical duration for not_applicable hiv-infections
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
August 27, 2020
CompletedStudy Start
First participant enrolled
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2024
CompletedAugust 1, 2025
July 1, 2025
3.8 years
March 9, 2020
July 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Engagement in care with documented viral suppression
Proportion of participants engaged in care (defined as documented visit attendance) with documented viral suppression (\<50 copies/mL) 24 months (16-28 months) after enrollment
16-28 months after enrollment
Secondary Outcomes (10)
Viral re-suppression
16-28 months after enrollment
Sustained viral suppression
16-28 months after enrollment
Mortality rate
at 12 and 24 months after enrollment
Tuberculosis
at 12 and 24 months after enrollment
Disengagement from care
at 12 and 24 months after enrollment
- +5 more secondary outcomes
Other Outcomes (3)
Proportion of participants requesting a VL result notification through SMS
at 24 months after enrollment
Proportion of SMS delivered successfully
at 24 months after enrollment
Proportion of participants using the call-back option through District ART Nurse
at 24 months after enrollment
Study Arms (2)
Intervention
EXPERIMENTALClusters in the intervention arm receive the VITAL intervention (see intervention)
Control
NO INTERVENTIONClusters in the control arm continue standard of care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- nurse-led public or missionary clinic in the districts of Butha-Buthe and Mokhotlong;
- consent of clinic management (signed agreement with clinic management);
- access to the internet (internet connection must not be constant, but there must be possibility to down- and upload information daily); and
- the clinic sends plasma VL samples to Butha-Buthe government hospital laboratory for analysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Boiketsiso Health Center
Butha-Buthe, Lesotho
Linakeng Health Center
Butha-Buthe, Lesotho
Makhunoane Health Center
Butha-Buthe, Lesotho
Motete Health Center
Butha-Buthe, Lesotho
Muela Health Center
Butha-Buthe, Lesotho
Ngoajane Health Center
Butha-Buthe, Lesotho
Rampai Health Center
Butha-Buthe, Lesotho
St Paul Health Center
Butha-Buthe, Lesotho
St. Peters Health Center
Butha-Buthe, Lesotho
Tsime Health Center
Butha-Buthe, Lesotho
Libibing
Mokhotlong, Lesotho
Linakaneng health center
Mokhotlong, Lesotho
Malefiloane health center
Mokhotlong, Lesotho
Mapholaneng
Mokhotlong, Lesotho
Moeketsane
Mokhotlong, Lesotho
Molikaliko health center
Mokhotlong, Lesotho
St. James
Mokhotlong, Lesotho
St. Martins
Mokhotlong, Lesotho
Related Publications (2)
Tschumi N, Lerotholi M, Kopo M, Kao M, Lukau B, Nsakala B, Chejane N, Motaboli L, Lee T, Barnabas R, Shapiro AE, van Heerden A, Lejone TI, Amstutz A, Brown JA, Heitner J, Belus JM, Chammartin F, Labhardt ND. Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial. PLoS One. 2022 May 5;17(5):e0268100. doi: 10.1371/journal.pone.0268100. eCollection 2022.
PMID: 35511950BACKGROUNDHarder MT, Mokete M, Chammartin F, Lerotholi M, Motaboli L, Kopo M, Kao M, Mokebe M, Chejane N, Mahlatsi P, Nyakane M, Tarumbiswa T, Labhardt ND, Tschumi N, Belus JM. Cervical cancer screening delay and associated factors among women with HIV in Lesotho: a mixed-methods study. BMC Womens Health. 2024 Oct 1;24(1):543. doi: 10.1186/s12905-024-03382-8.
PMID: 39354488DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Niklaus Labhardt, Prof
University Hospital, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2020
First Posted
August 27, 2020
Study Start
October 14, 2020
Primary Completion
August 7, 2024
Study Completion
August 7, 2024
Last Updated
August 1, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- upon publication of the trial results
- Access Criteria
- upon request
A subset of the key pseudo-anonymised individual participant data collected during the study, along with a data dictionary, will be made available upon request to the Division of Clinical Epidemiology at the University Hospital Basel.