An interventional study of VITAL model in HIV Infections, sponsored by Swiss Tropical & Public Health Institute. Completed at 18 sites in Lesotho. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Swiss Tropical & Public Health Institute · Not applicable, Interventional, and Health services research
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.
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:
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 5,809 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Swiss Tropical & Public Health Institute is the lead sponsor of 58 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Clusters in the intervention arm receive the VITAL intervention (see intervention)
Behavioral: VITAL model
Clusters in the control arm continue standard of care.
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.
Also known as: automated differentiated service delivery
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
Time frame: 16-28 months after enrollment
Viral re-suppression
Proportion 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
Time frame: 16-28 months after enrollment
Sustained viral suppression
Proportion of participants with sustained viral suppression (defined as \>1 VL \<50 copies/mL) during 24 months (16-28 months) follow-up
Time frame: 16-28 months after enrollment
Mortality rate
All-cause mortality
Time frame: at 12 and 24 months after enrollment
Tuberculosis
Proportion of participants with confirmed tuberculosis diagnosis
Time frame: at 12 and 24 months after enrollment
Disengagement from care
Proportion 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
Time frame: at 12 and 24 months after enrollment
Time to follow-up
Time to follow-up viral load in case of an unsuppressed VL (≥50 copies/mL)
Time frame: at 24 months after enrollment
Time to ART regimen adaption
Time to ART regimen adaption in case of virologic failure
Time frame: at 24 months after enrollment
Rate of clinic visits
Number of clinic visits throughout the study period
Time frame: at 24 months after enrollment
Proportion of participants with ART regimen modification
12\. Proportion of participants with ART regimen modification due to virologic failure at 12 and 24 months among participants with virologic failure
Time frame: at 12 and 24 months after enrollment
Proportion of participants receiving a course of TPT
Proportion of participants having received a course of TPT throughout the study period.
Time frame: at 24 months after enrollment
Proportion of participants requesting a VL result notification through SMS
in intervention clusters
Time frame: at 24 months after enrollment
Proportion of SMS delivered successfully
in intervention clusters
Time frame: at 24 months after enrollment
Proportion of participants using the call-back option through District ART Nurse
in intervention clusters
Time frame: at 24 months after enrollment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: upon publication of the trial results
Access criteria: upon request
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Swiss Tropical & Public Health Institute