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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
5,809
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.
Boiketsiso Health Center
Butha-Buthe, Lesotho
Linakeng Health Center
Butha-Buthe, Lesotho
Makhunoane Health Center
Butha-Buthe, Lesotho
Engagement in care with documented viral suppression
Proportion of participants engaged in care (defined as documented visit attendance) with documented viral suppression (\<50 copies/mL) 24 months (16-28 months) after enrollment
Time frame: 16-28 months after enrollment
Viral re-suppression
Proportion of participants with viral re-suppression (\<50 copies/mL) 24 months (16-28 months) after enrollment among all participants with an unsuppressed VL (≥ 50 copies/mL) during the first 12 months of follow-up
Time frame: 16-28 months after enrollment
Sustained viral suppression
Proportion of participants with sustained viral suppression (defined as \>1 VL \<50 copies/mL) during 24 months (16-28 months) follow-up
Time frame: 16-28 months after enrollment
Mortality rate
All-cause mortality
Time frame: at 12 and 24 months after enrollment
Tuberculosis
Proportion of participants with confirmed tuberculosis diagnosis
Time frame: 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
Time frame: at 12 and 24 months after enrollment
Time to follow-up
Time to follow-up viral load in case of an unsuppressed VL (≥50 copies/mL)
Time frame: at 24 months after enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 8 more locations
Time to ART regimen adaption
Time to ART regimen adaption in case of virologic failure
Time frame: at 24 months after enrollment
Rate of clinic visits
Number of clinic visits throughout the study period
Time frame: at 24 months after enrollment
Proportion of participants with ART regimen modification
12\. Proportion of participants with ART regimen modification due to virologic failure at 12 and 24 months among participants with virologic failure
Time frame: at 12 and 24 months after enrollment
Proportion of participants receiving a course of TPT
Proportion of participants having received a course of TPT throughout the study period.
Time frame: at 24 months after enrollment