Clinical trial NCT04527874: Viral Load Triggered ART Care in Lesotho
Official title: Assessment of a Viral Load Result-driven Automated Differentiated Service Delivery Model for Participants Taking Antiretroviral Therapy in Lesotho
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 5809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster-randomized
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Exclusion criteria:

Primary outcomes:
measure: Engagement in care with documented viral suppression
timeFrame: 16-28 months after enrollment
Secondary outcomes:
measure: Viral re-suppression
timeFrame: 16-28 months after enrollment
measure: Sustained viral suppression
timeFrame: 16-28 months after enrollment
measure: Mortality rate
timeFrame: at 12 and 24 months after enrollment
measure: Tuberculosis
timeFrame: at 12 and 24 months after enrollment
measure: Disengagement from care
timeFrame: at 12 and 24 months after enrollment
measure: Time to follow-up
timeFrame: at 24 months after enrollment
measure: Time to ART regimen adaption
timeFrame: at 24 months after enrollment
measure: Rate of clinic visits
timeFrame: at 24 months after enrollment
measure: Proportion of participants with ART regimen modification
timeFrame: at 12 and 24 months after enrollment
measure: Proportion of participants receiving a course of TPT
timeFrame: at 24 months after enrollment
Other outcomes:
measure: Proportion of participants requesting a VL result notification through SMS
timeFrame: at 24 months after enrollment
measure: Proportion of SMS delivered successfully
timeFrame: at 24 months after enrollment
measure: Proportion of participants using the call-back option through District ART Nurse
timeFrame: at 24 months after enrollment
Locations:
city: Butha-Buthe
country: Lesotho
facility: Boiketsiso Health Center
city: Butha-Buthe
country: Lesotho
facility: Linakeng Health Center
city: Butha-Buthe
country: Lesotho
facility: Makhunoane Health Center
city: Butha-Buthe
country: Lesotho
facility: Motete Health Center
city: Butha-Buthe
country: Lesotho
facility: Muela Health Center
city: Butha-Buthe
country: Lesotho
facility: Ngoajane Health Center
city: Butha-Buthe
country: Lesotho
facility: Rampai Health Center
city: Butha-Buthe
country: Lesotho
facility: St Paul Health Center
city: Butha-Buthe
country: Lesotho
facility: St. Peters Health Center
city: Butha-Buthe
country: Lesotho
facility: Tsime Health Center
city: Mokhotlong
country: Lesotho
facility: Libibing
city: Mokhotlong
country: Lesotho
facility: Linakaneng health center
city: Mokhotlong
country: Lesotho
facility: Malefiloane health center
city: Mokhotlong
country: Lesotho
facility: Mapholaneng
city: Mokhotlong
country: Lesotho
facility: Moeketsane
city: Mokhotlong
country: Lesotho
facility: Molikaliko health center
city: Mokhotlong
country: Lesotho
facility: St. James
city: Mokhotlong
country: Lesotho
facility: St. Martins
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Niklaus Labhardt, Prof
role: STUDY_CHAIR
References:
citation: 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.