Viral Load Triggered ART Care in Lesotho

NCT ID: NCT04527874

Last Updated: 2025-08-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5809 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-14

Study Completion Date

2024-08-07

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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

cluster-randomized
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Clusters in the intervention arm receive the VITAL intervention (see intervention)

Group Type EXPERIMENTAL

VITAL model

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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automated differentiated service delivery

Eligibility Criteria

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Inclusion Criteria

* 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); and
* the clinic sends plasma VL samples to Butha-Buthe government hospital laboratory for analysis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Linakeng Health Center

Butha-Buthe, , Lesotho

Site Status

Makhunoane Health Center

Butha-Buthe, , Lesotho

Site Status

Motete Health Center

Butha-Buthe, , Lesotho

Site Status

Muela Health Center

Butha-Buthe, , Lesotho

Site Status

Ngoajane Health Center

Butha-Buthe, , Lesotho

Site Status

Rampai Health Center

Butha-Buthe, , Lesotho

Site Status

St Paul Health Center

Butha-Buthe, , Lesotho

Site Status

St. Peters Health Center

Butha-Buthe, , Lesotho

Site Status

Tsime Health Center

Butha-Buthe, , Lesotho

Site Status

Libibing

Mokhotlong, , Lesotho

Site Status

Linakaneng health center

Mokhotlong, , Lesotho

Site Status

Malefiloane health center

Mokhotlong, , Lesotho

Site Status

Mapholaneng

Mokhotlong, , Lesotho

Site Status

Moeketsane

Mokhotlong, , Lesotho

Site Status

Molikaliko health center

Mokhotlong, , Lesotho

Site Status

St. James

Mokhotlong, , Lesotho

Site Status

St. Martins

Mokhotlong, , Lesotho

Site Status

Countries

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Lesotho

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.

Reference Type BACKGROUND
PMID: 35511950 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39354488 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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P002-20-1.0

Identifier Type: -

Identifier Source: org_study_id

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