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Viral Load Triggered ART Care in Lesotho

Assessment of a Viral Load Result-driven Automated Differentiated Service Delivery Model for Participants Taking Antiretroviral Therapy in Lesotho

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04527874
Acronym
VITAL
Enrollment
5809
Registered
2020-08-27
Start date
2020-10-14
Completion date
2024-08-07
Last updated
2025-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Detailed description

To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART), care delivery has to shift from a one-size-fits-all approach to differentiated care models. Such models should reallocate resources from patients who are doing well to patient groups who may need more attention, such as those with treatment failure or medical and psycho-social problems. Ideally, such a reallocation allows health systems and patients to save resources while improving quality of care. One proposed approach to differentiate care and intensity of monitoring is viral load-driven differentiated service delivery. Reducing the intensity of monitoring in patients with suppressed viral load (VL) and no other clinical problems would substantially reduce the workload at health care facilities and save time and transport cost for patients, thus potentially improve long-term engagement in care. Time and resources saved in patients with suppressed VL and no other clinical problems would allow focusing on those participants with elevated viral load and/or other clinical problems (like tuberculosis, which is the most common cause of mortality among PLHIV in sub-Saharan Africa). This may potentially improve PLHIVs' clinical outcome through intensified adherence support, clinical follow-up and timely switches to second-line ART. In many settings in sub-Saharan Africa, however, the potential of VL monitoring to differentiate care is not exploited and thus constitutes a missed opportunity. In Lesotho it was shown that the majority of unsuppressed VLs are not acted upon in a timely manner, be it due to providers and patients not being aware of the results or health care providers not being proficient in the management of treatment failure. The concept of the proposed automated differentiated service delivery model (aDSDM) is to use VL results, other clinical characteristics (TB screening results and CD4 cell counts) and participants' preference to automatically triage participants into groups requiring different levels of attention and care. Innovatively, triaging of participants will be done automatically capitalising on an existing VL database platform. The implemented aDSDM will differentiate care according to three elements: * clinical characteristics (with focus on VL measurement) * sub-population (women, men) * participants' and health care providers' preferences To ensure effective flow of information, VL 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. The proposed aDSDM is designed for being scaled up at national and regional level as it mainly builds on automated triage and communication with participants and health care workers, thus not requiring additional human resources.

Interventions

BEHAVIORALVITAL 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

Swiss Tropical & Public Health Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

cluster-randomized

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Engagement in care with documented viral suppression16-28 months after enrollmentProportion of participants engaged in care (defined as documented visit attendance) with documented viral suppression (\<50 copies/mL) 24 months (16-28 months) after enrollment

Secondary

MeasureTime frameDescription
Disengagement from careat 12 and 24 months after enrollmentProportion of participants disengaged from care (defined as no documented visit attendance) at 12 months (8-16 months) and 24 months (16-28 months) after enrollment
Rate of clinic visitsat 24 months after enrollmentNumber of clinic visits throughout the study period
Proportion of participants with ART regimen modificationat 12 and 24 months after enrollment12\. Proportion of participants with ART regimen modification due to virologic failure at 12 and 24 months among participants with virologic failure
Proportion of participants receiving a course of TPTat 24 months after enrollmentProportion of participants having received a course of TPT throughout the study period.
Viral re-suppression16-28 months after enrollmentProportion of participants with viral re-suppression (\<50 copies/mL) 24 months (16-28 months) after enrollment among all participants with an unsuppressed VL (≥ 50 copies/mL) during the first 12 months of follow-up
Sustained viral suppression16-28 months after enrollmentProportion of participants with sustained viral suppression (defined as \>1 VL \<50 copies/mL) during 24 months (16-28 months) follow-up
Mortality rateat 12 and 24 months after enrollmentAll-cause mortality
Tuberculosisat 12 and 24 months after enrollmentProportion of participants with confirmed tuberculosis diagnosis
Time to follow-upat 24 months after enrollmentTime to follow-up viral load in case of an unsuppressed VL (≥50 copies/mL)
Time to ART regimen adaptionat 24 months after enrollmentTime to ART regimen adaption in case of virologic failure

Other

MeasureTime frameDescription
Proportion of participants using the call-back option through District ART Nurseat 24 months after enrollmentin intervention clusters
Proportion of participants requesting a VL result notification through SMSat 24 months after enrollmentin intervention clusters
Proportion of SMS delivered successfullyat 24 months after enrollmentin intervention clusters

Countries

Lesotho

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026