VITAL: Viral Load Triggered ART Care in Lesotho
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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clinical characteristics (with focus on VL measurement)
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sub-population (women, men)
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Clusters in the intervention arm receive the VITAL intervention (see 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.
Other Names:
|
| No Intervention: Control Clusters in the control arm continue standard of care. |
Outcome Measures
Primary Outcome Measures
- Engagement in care with documented viral suppression [16-28 months after enrollment]
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
Secondary Outcome Measures
- Viral re-suppression [16-28 months after enrollment]
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
- Sustained viral suppression [16-28 months after enrollment]
Proportion of participants with sustained viral suppression (defined as >1 VL <20 copies/mL) during 24 months (16-28 months) follow-up
- 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 [at 12 and 24 months after enrollment]
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 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 [at 12 and 24 months after enrollment]
Proportion of participants switched to second-line ART at 12 and 24 months among participants with virologic failure
- 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]
Other Outcome Measures
- Proportion of participants requesting a VL result notification through SMS [at 24 months after enrollment]
in intervention clusters
- Proportion of SMS delivered successfully [at 24 months after enrollment]
in intervention clusters
- Proportion of participants using the call-back option through District ART Nurse [at 24 months after enrollment]
in intervention clusters
- Proportion of participants screened positive fo TB by automated call [at 24 months after enrollment]
in intervention clusters
- Proportion of participants appreciating the automated differentiated service deliver model [at 24 months after enrollment]
in intervention clusters
- Proportion of health care providers appreciating the automated differentiated service delivery model [at 24 months after enrollment]
in intervention clusters
Eligibility Criteria
Criteria
On an individual level, the inclusion criteria for the VITAL trial are the following:
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Taking antiretroviral therapy (independent of viral suppression)
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≥ 18 years old
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Written informed consent
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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:
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nurse-led public or missionary clinic in the districts of Butha-Buthe and Mokhotlong
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consent of clinic management (signed agreement with clinic management)
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access to the internet (internet connection must not be constant, but there must be possibility to down- and upload information daily)
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the clinic sends VL samples to Butha-Buthe laboratory for analysis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boiketsiso Health Center | Butha-Buthe | Lesotho | ||
| 2 | Linakeng Health Center | Butha-Buthe | Lesotho | ||
| 3 | Makhunoane Health Center | Butha-Buthe | Lesotho | ||
| 4 | Motete Health Center | Butha-Buthe | Lesotho | ||
| 5 | Muela Health Center | Butha-Buthe | Lesotho | ||
| 6 | Ngoajane Health Center | Butha-Buthe | Lesotho | ||
| 7 | Rampai Health Center | Butha-Buthe | Lesotho | ||
| 8 | St Paul Health Center | Butha-Buthe | Lesotho | ||
| 9 | St. Peters Health Center | Butha-Buthe | Lesotho | ||
| 10 | Tsime Health Center | Butha-Buthe | Lesotho | ||
| 11 | Libibing | Mokhotlong | Lesotho | ||
| 12 | Linakaneng health center | Mokhotlong | Lesotho | ||
| 13 | Malefiloane health center | Mokhotlong | Lesotho | ||
| 14 | Mapholaneng | Mokhotlong | Lesotho | ||
| 15 | Moeketsane | Mokhotlong | Lesotho | ||
| 16 | Molikaliko health center | Mokhotlong | Lesotho | ||
| 17 | St. James | Mokhotlong | Lesotho | ||
| 18 | St. Martins | Mokhotlong | Lesotho |
Sponsors and Collaborators
- Swiss Tropical & Public Health Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P002-20-1.0