Viral Load Triggered ART Care in Lesotho

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: VITAL model


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cluster-randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Clusters in the intervention arm receive the VITAL intervention (see intervention) | Behavioral: VITAL model<br>* 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.<br>* Other names: automated differentiated service delivery;|
| No Intervention: Control<br>Clusters in the control arm continue standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Mortality rate |  | at 12 and 24 months after enrollment | 
| Proportion of participants with confirmed TB diagnosis |  | 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 | at 12 and 24 months after enrollment | 
| Time to follow-up viral load in case of an unsuppressed VL (≥ 20 copies/mL) |  | at 24 months after enrollment | 
| Time to switch of ART regimen in case of virologic failure |  | at 24 months after enrollment | 
| Rate of clinic visits |  | at 24 months after enrollment | 
| 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 | 
| Proportion of participants diagnosed with TB |  | at 12 and 24 months after enrollment | 
| Proportion of participants receiving a course of TPT |  | at 24 months after enrollment |