Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5809 participants
INTERVENTIONAL
2020-10-14
2024-08-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention
Clusters in the intervention arm receive the VITAL intervention (see intervention)
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.
Control
Clusters in the control arm continue standard of care.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Swiss Tropical & Public Health Institute
OTHER
Responsible Party
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Principal Investigators
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Niklaus Labhardt, Prof
Role: STUDY_CHAIR
University Hospital, Basel, Switzerland
Locations
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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, , Lesotho
Countries
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References
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Tschumi N, Lerotholi M, Kopo M, Kao M, Lukau B, Nsakala B, Chejane N, Motaboli L, Lee T, Barnabas R, Shapiro AE, van Heerden A, Lejone TI, Amstutz A, Brown JA, Heitner J, Belus JM, Chammartin F, Labhardt ND. Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial. PLoS One. 2022 May 5;17(5):e0268100. doi: 10.1371/journal.pone.0268100. eCollection 2022.
Harder MT, Mokete M, Chammartin F, Lerotholi M, Motaboli L, Kopo M, Kao M, Mokebe M, Chejane N, Mahlatsi P, Nyakane M, Tarumbiswa T, Labhardt ND, Tschumi N, Belus JM. Cervical cancer screening delay and associated factors among women with HIV in Lesotho: a mixed-methods study. BMC Womens Health. 2024 Oct 1;24(1):543. doi: 10.1186/s12905-024-03382-8.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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P002-20-1.0
Identifier Type: -
Identifier Source: org_study_id
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