Viral Load Triggered ART Care in Lesotho (VITAL)
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| ClinicalTrials.gov Identifier: NCT04527874 |
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Recruitment Status :
Recruiting
First Posted : August 27, 2020
Last Update Posted : December 16, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Behavioral: VITAL model | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 5310 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | cluster-randomized |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Assessment of a Viral Load Result-driven Automated Differentiated Service Delivery Model for Participants Taking Antiretroviral Therapy in Lesotho |
| Actual Study Start Date : | October 14, 2020 |
| Estimated Primary Completion Date : | May 2023 |
| Estimated Study Completion Date : | May 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention
Clusters in the intervention arm receive the VITAL intervention (see intervention)
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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 Name: automated differentiated service delivery |
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No Intervention: Control
Clusters in the control arm continue standard of care.
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- Engagement in care with documented viral suppression [ Time Frame: 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
- Viral re-suppression [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: at 12 and 24 months after enrollment ]
- Proportion of participants with confirmed TB diagnosis [ Time Frame: at 12 and 24 months after enrollment ]
- Disengagement from care [ Time Frame: 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) [ Time Frame: at 24 months after enrollment ]
- Time to switch of ART regimen in case of virologic failure [ Time Frame: at 24 months after enrollment ]
- Rate of clinic visits [ Time Frame: at 24 months after enrollment ]
- Proportion of participants switched to second-line ART [ Time Frame: 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 [ Time Frame: at 12 and 24 months after enrollment ]
- Proportion of participants receiving a course of TPT [ Time Frame: at 24 months after enrollment ]
- Proportion of participants requesting a VL result notification through SMS [ Time Frame: at 24 months after enrollment ]in intervention clusters
- Proportion of SMS delivered successfully [ Time Frame: at 24 months after enrollment ]in intervention clusters
- Proportion of participants using the call-back option through District ART Nurse [ Time Frame: at 24 months after enrollment ]in intervention clusters
- Proportion of participants screened positive fo TB by automated call [ Time Frame: at 24 months after enrollment ]in intervention clusters
- Proportion of participants appreciating the automated differentiated service deliver model [ Time Frame: at 24 months after enrollment ]in intervention clusters
- Proportion of health care providers appreciating the automated differentiated service delivery model [ Time Frame: at 24 months after enrollment ]in intervention clusters
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527874
| Contact: Niklaus Labhardt, MD | +41 79 870 18 59 | n.labhardt@unibas.ch | |
| Contact: Nadine Tschumi, PhD | +41 79 346 59 89 | nadine.tschumi@swisstph.ch |
Show 18 study locations
| Responsible Party: | Swiss Tropical & Public Health Institute |
| ClinicalTrials.gov Identifier: | NCT04527874 |
| Other Study ID Numbers: |
P002-20-1.0 |
| First Posted: | August 27, 2020 Key Record Dates |
| Last Update Posted: | December 16, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Analytic Code |
| Time Frame: | At publication of primary endpoint |
| URL: | https://www.zenodo.org |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |