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Completed

NCT Number: NCT04527874

Viral Load Triggered ART Care in Lesotho

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boiketsiso Health Center, Butha-Buthe, Lesotho

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VITAL model

Behavioral

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.

Other names: automated differentiated service delivery

Primary outcomes

  1. Engagement in care with documented viral suppression

    Time frame: 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 outcomes

  1. Viral re-suppression

    Time frame: 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

  2. Sustained viral suppression

    Time frame: 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

  3. Mortality rate

    Time frame: at 12 and 24 months after enrollment

    All-cause mortality

  4. Tuberculosis

    Time frame: at 12 and 24 months after enrollment

    Proportion of participants with confirmed tuberculosis diagnosis

  5. Disengagement from care

    Time frame: 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

  6. Time to follow-up

    Time frame: at 24 months after enrollment

    Time to follow-up viral load in case of an unsuppressed VL (≥50 copies/mL)

  7. Time to ART regimen adaption

    Time frame: at 24 months after enrollment

    Time to ART regimen adaption in case of virologic failure

  8. Rate of clinic visits

    Time frame: at 24 months after enrollment

    Number of clinic visits throughout the study period

  9. Proportion of participants with ART regimen modification

    Time frame: at 12 and 24 months after enrollment

    • Proportion of participants with ART regimen modification due to virologic failure at 12 and 24 months among participants with virologic failure
  10. Proportion of participants receiving a course of TPT

    Time frame: at 24 months after enrollment

    Proportion of participants having received a course of TPT throughout the study period.

Other outcomes

  1. Proportion of participants requesting a VL result notification through SMS

    Time frame: at 24 months after enrollment

    in intervention clusters

  2. Proportion of SMS delivered successfully

    Time frame: at 24 months after enrollment

    in intervention clusters

  3. Proportion of participants using the call-back option through District ART Nurse

    Time frame: at 24 months after enrollment

    in intervention clusters

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Registry information

Official study title

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

Acronym: VITAL

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2020
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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