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Viral Load Triggered ART Care in Lesotho (VITAL)

S

Swiss Tropical and Public Health (TPH) Institute

Status

Active, not recruiting

Conditions

HIV Infections

Treatments

Behavioral: VITAL model

Study type

Interventional

Funder types

Other

Identifiers

NCT04527874
P002-20-1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,809 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5,809 participants in 2 patient groups

Intervention
Experimental group
Description:
Clusters in the intervention arm receive the VITAL intervention (see intervention)
Treatment:
Behavioral: VITAL model
Control
No Intervention group
Description:
Clusters in the control arm continue standard of care.

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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