Viral Load Triggered ART Care in Lesotho

HIV Infections Clinical Trial

— VITAL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04527874
• Other study ID #: P002-20-1.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5809
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

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.

Locations

Country	Name	City	State
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute

Country where clinical trial is conducted

Lesotho, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participants requesting a VL result notification through SMS	in intervention clusters	at 24 months after enrollment
Other	Proportion of SMS delivered successfully	in intervention clusters	at 24 months after enrollment
Other	Proportion of participants using the call-back option through District ART Nurse	in intervention clusters	at 24 months after enrollment
Other	Proportion of participants screened positive fo TB by automated call	in intervention clusters	at 24 months after enrollment
Other	Proportion of participants appreciating the automated differentiated service deliver model	in intervention clusters	at 24 months after enrollment
Other	Proportion of health care providers appreciating the automated differentiated service delivery model	in intervention clusters	at 24 months after enrollment
Primary	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	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
Secondary	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
Secondary	Mortality rate		at 12 and 24 months after enrollment
Secondary	Proportion of participants with confirmed TB diagnosis		at 12 and 24 months after enrollment
Secondary	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
Secondary	Time to follow-up viral load in case of an unsuppressed VL (= 20 copies/mL)		at 24 months after enrollment
Secondary	Time to switch of ART regimen in case of virologic failure		at 24 months after enrollment
Secondary	Rate of clinic visits		at 24 months after enrollment
Secondary	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
Secondary	Proportion of participants diagnosed with TB		at 12 and 24 months after enrollment
Secondary	Proportion of participants receiving a course of TPT		at 24 months after enrollment