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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04527874
Other study ID # P002-20-1.0
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 14, 2020
Est. completion date July 2024

Study information

Verified date May 2023
Source Swiss Tropical & Public Health Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5809
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility On an individual level, the inclusion criteria for the VITAL trial are the following: - Taking antiretroviral therapy (independent of viral suppression) - = 18 years old - Written informed consent - intention to remain in the same facility for the duration of the trial - not enrolled in another study if judged as non-compatible by the (Local) Principal Investigator On a cluster level, inclusion criteria for the VITAL trial are the following: - 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) - the clinic sends VL samples to Butha-Buthe laboratory for analysis

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Lesotho 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

Sponsors (1)

Lead Sponsor Collaborator
Swiss Tropical & Public Health Institute

Country where clinical trial is conducted

Lesotho, 

Outcome

Type Measure Description Time frame Safety issue
Other Proportion of participants requesting a VL result notification through SMS in intervention clusters at 24 months after enrollment
Other Proportion of SMS delivered successfully in intervention clusters at 24 months after enrollment
Other Proportion of participants using the call-back option through District ART Nurse in intervention clusters at 24 months after enrollment
Other Proportion of participants screened positive fo TB by automated call in intervention clusters at 24 months after enrollment
Other Proportion of participants appreciating the automated differentiated service deliver model in intervention clusters at 24 months after enrollment
Other Proportion of health care providers appreciating the automated differentiated service delivery model in intervention clusters at 24 months after enrollment
Primary Engagement in care with documented viral suppression Proportion of participants engaged in care (defined as documented visit attendance) with documented viral suppression (<20 copies/mL) 24 months (16-28 months) after enrollment 16-28 months after enrollment
Secondary Viral re-suppression Proportion of participants with viral re-suppression (<20 copies/mL) 24 months (16-28 months) after enrollment among all participants with an unsuppressed VL (= 20 copies/mL) during the first 12 months of follow-up 16-28 months after enrollment
Secondary Sustained viral suppression Proportion of participants with sustained viral suppression (defined as >1 VL <20 copies/mL) during 24 months (16-28 months) follow-up 16-28 months after enrollment
Secondary Mortality rate at 12 and 24 months after enrollment
Secondary Proportion of participants with confirmed TB diagnosis at 12 and 24 months after enrollment
Secondary 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 at 12 and 24 months after enrollment
Secondary Time to follow-up viral load in case of an unsuppressed VL (= 20 copies/mL) at 24 months after enrollment
Secondary Time to switch of ART regimen in case of virologic failure at 24 months after enrollment
Secondary Rate of clinic visits at 24 months after enrollment
Secondary Proportion of participants switched to second-line ART Proportion of participants switched to second-line ART at 12 and 24 months among participants with virologic failure at 12 and 24 months after enrollment
Secondary Proportion of participants diagnosed with TB at 12 and 24 months after enrollment
Secondary Proportion of participants receiving a course of TPT at 24 months after enrollment
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