Viral Load Triggered ART Care in Lesotho (VITAL)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: VITAL model

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:

• 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
• Enrollment (Actual): 5809
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lesotho
  • Butha-Buthe, Lesotho
    • Muela Health Center
  • Butha-Buthe, Lesotho
    • St. Peters Health Center
  • Butha-Buthe, 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
    • Ngoajane Health Center
  • Butha-Buthe, Lesotho
    • Rampai Health Center
  • Butha-Buthe, Lesotho
    • St Paul Health Center
  • Butha-Buthe, Lesotho
    • Tsime Health Center
  • Mokhotlong, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: automated differentiated service delivery
No Intervention: Control; Clusters in the control arm continue standard of care.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants requesting a VL result notification through SMS	in intervention clusters	at 24 months after enrollment
Proportion of SMS delivered successfully	in intervention clusters	at 24 months after enrollment
Proportion of participants using the call-back option through District ART Nurse	in intervention clusters	at 24 months after enrollment
Proportion of participants screened positive fo TB by automated call	in intervention clusters	at 24 months after enrollment
Proportion of participants appreciating the automated differentiated service deliver model	in intervention clusters	at 24 months after enrollment
Proportion of health care providers appreciating the automated differentiated service delivery model	in intervention clusters	at 24 months after enrollment

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: P002-20-1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: At publication of primary endpoint
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No