Viral Load Triggered ART Care in Lesotho
- Conditions
- HIV Infections
- Interventions
- Behavioral: VITAL model
- Registration Number
- NCT04527874
- Lead Sponsor
- Swiss Tropical & Public Health Institute
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5809
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention VITAL model Clusters in the intervention arm receive the VITAL intervention (see intervention)
- Primary Outcome Measures
Name Time Method Engagement in care with documented viral suppression 16-28 months after enrollment 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
- Secondary Outcome Measures
Name Time Method Viral re-suppression 16-28 months after enrollment 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
Sustained viral suppression 16-28 months after enrollment Proportion of participants with sustained viral suppression (defined as \>1 VL \<50 copies/mL) during 24 months (16-28 months) follow-up
Mortality rate at 12 and 24 months after enrollment All-cause mortality
Tuberculosis at 12 and 24 months after enrollment Proportion of participants with confirmed tuberculosis diagnosis
Disengagement from care at 12 and 24 months after enrollment 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 to follow-up at 24 months after enrollment Time to follow-up viral load in case of an unsuppressed VL (≥50 copies/mL)
Time to ART regimen adaption at 24 months after enrollment Time to ART regimen adaption in case of virologic failure
Rate of clinic visits at 24 months after enrollment Number of clinic visits throughout the study period
Proportion of participants with ART regimen modification at 12 and 24 months after enrollment 12. Proportion of participants with ART regimen modification due to virologic failure at 12 and 24 months among participants with virologic failure
Proportion of participants receiving a course of TPT at 24 months after enrollment Proportion of participants having received a course of TPT throughout the study period.
Trial Locations
- Locations (18)
Makhunoane Health Center
🇱🇸Butha-Buthe, Lesotho
Ngoajane Health Center
🇱🇸Butha-Buthe, Lesotho
Tsime Health Center
🇱🇸Butha-Buthe, Lesotho
St Paul Health Center
🇱🇸Butha-Buthe, Lesotho
St. Peters Health Center
🇱🇸Butha-Buthe, Lesotho
Malefiloane health center
🇱🇸Mokhotlong, Lesotho
Molikaliko health center
🇱🇸Mokhotlong, Lesotho
St. Martins
🇱🇸Mokhotlong, Lesotho
Libibing
🇱🇸Mokhotlong, Lesotho
Moeketsane
🇱🇸Mokhotlong, Lesotho
St. James
🇱🇸Mokhotlong, Lesotho
Boiketsiso Health Center
🇱🇸Butha-Buthe, Lesotho
Linakeng Health Center
🇱🇸Butha-Buthe, Lesotho
Muela Health Center
🇱🇸Butha-Buthe, Lesotho
Motete Health Center
🇱🇸Butha-Buthe, Lesotho
Mapholaneng
🇱🇸Mokhotlong, Lesotho
Rampai Health Center
🇱🇸Butha-Buthe, Lesotho
Linakaneng health center
🇱🇸Mokhotlong, Lesotho