HIV InfectionsVITALNCT04527874
Viral Load Triggered ART Care in Lesotho
A study testing VITAL model in people with HIV Infections, run by Swiss Tropical & Public Health Institute at 18 sites in Lesotho.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- VITAL model
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,809 participants
- Where
- 18 sitesLesotho
- Study dates
- 14 Oct 2020to 7 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Lesotho18 sites
Boiketsiso Health Center
Butha-Buthe
Linakeng Health Center
Butha-Buthe
Makhunoane Health Center
Butha-Buthe
Motete Health Center
Butha-Buthe
Muela Health Center
Butha-Buthe
Ngoajane Health Center
Butha-Buthe
Rampai Health Center
Butha-Buthe
St Paul Health Center
Butha-Buthe
St. Peters Health Center
Butha-Buthe
Tsime Health Center
Butha-Buthe
Libibing
Mokhotlong
Linakaneng health center
Mokhotlong
Malefiloane health center
Mokhotlong
Mapholaneng
Mokhotlong
Moeketsane
Mokhotlong
Molikaliko health center
Mokhotlong
St. James
Mokhotlong
St. Martins
Mokhotlong
About this study
Official title: Assessment of a Viral Load Result-driven Automated Differentiated Service Delivery Model for Participants Taking Antiretroviral Therapy 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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- VITAL model
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VITAL modelBehavioural
Also called automated differentiated service delivery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Clusters in the intervention arm receive the VITAL intervention (see intervention) Receives: Behavioral: VITAL model |
| Control | No intervention | Clusters in the control arm continue standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16-28 months after enrollment
Secondary outcomes (10)
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
Measured: 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
Measured: 16-28 months after enrollment
Mortality rate
All-cause mortality
Measured: at 12 and 24 months after enrollment
Tuberculosis
Proportion of participants with confirmed tuberculosis diagnosis
Measured: 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
Measured: 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)
Measured: at 24 months after enrollment
Time to ART regimen adaption
Time to ART regimen adaption in case of virologic failure
Measured: at 24 months after enrollment
Rate of clinic visits
Number of clinic visits throughout the study period
Measured: at 24 months after enrollment
Proportion of participants with ART regimen modification
- Proportion of participants with ART regimen modification due to virologic failure at 12 and 24 months among participants with virologic failure
Measured: 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.
Measured: at 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start14 Oct 2020
- Primary completion7 Aug 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster-randomized
- Masking
- None (open label)
- Enrolment
- 5,809 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niklaus Labhardt, Prof, Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527874
- Sponsor's protocol ID
- P002-20-1.0
- Acronym
- VITAL
- Status last verified
- Jul 2025
- First submitted
- 9 Mar 2020
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A subset of the key pseudo-anonymised individual participant data collected during the study, along with a data dictionary, will be made available upon request to the Division of Clinical Epidemiology at the University Hospital Basel.
Publications
Tschumi N, Lerotholi M, Kopo M, Kao M, Lukau B, Nsakala B, Chejane N, Motaboli L, Lee T, Barnabas R, Shapiro AE, van Heerden A, Lejone TI, Amstutz A, Brown JA, Heitner J, Belus JM, Chammartin F, Labhardt ND. Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial. PLoS One. 2022 May 5;17(5):e0268100. doi: 10.1371/journal.pone.0268100. eCollection 2022.
PubMed 35511950Tschumi N, Lerotholi M, Kopo M, Kao M, Motaboli L, Mokebe M, Chejane N, Chakela M, Nsakala BL, Lukau B, van Heerden A, Barnabas RV, Heitner J, Shapiro AE, Urda L, Sanchez G, Lee T, Brown JA, Amstutz A, Belus JM, Chammartin F, Labhardt ND. Integrating clinical decision support and mobile health for differentiated HIV service delivery in Lesotho (VITAL): a cluster-randomised non-inferiority trial. EClinicalMedicine. 2026 Apr 2;94:103850. doi: 10.1016/j.eclinm.2026.103850. eCollection 2026 Apr.
PubMed 42005925Harder MT, Mokete M, Chammartin F, Lerotholi M, Motaboli L, Kopo M, Kao M, Mokebe M, Chejane N, Mahlatsi P, Nyakane M, Tarumbiswa T, Labhardt ND, Tschumi N, Belus JM. Cervical cancer screening delay and associated factors among women with HIV in Lesotho: a mixed-methods study. BMC Womens Health. 2024 Oct 1;24(1):543. doi: 10.1186/s12905-024-03382-8.
PubMed 39354488
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Viral Load Result-driven Automated Differentiated Service Delivery Model for Participants Taking Antiretroviral Therapy in Lesotho
- ClinicalTrials.gov ID
- NCT04527874
- Acronym / sponsor ID
- VITAL / P002-20-1.0
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,809 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster-randomized
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: VITAL modelClusters in the intervention arm receive the VITAL intervention (see intervention) |
| Control | No intervention | –Clusters in the control arm continue standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VITAL modelAlso: automated differentiated service deliveryThe 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. | Behavioural | Intervention |
Primary outcome
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
10 secondary outcomes
Viral re-suppression
Time frame: 16-28 months after enrollment
Sustained viral suppression
Time frame: 16-28 months after enrollment
Mortality rate
Time frame: at 12 and 24 months after enrollment
Tuberculosis
Time frame: at 12 and 24 months after enrollment
Disengagement from care
Time frame: at 12 and 24 months after enrollment
Time to follow-up
Time frame: at 24 months after enrollment
Time to ART regimen adaption
Time frame: at 24 months after enrollment
Rate of clinic visits
Time frame: at 24 months after enrollment
Proportion of participants with ART regimen modification
Time frame: at 12 and 24 months after enrollment
Proportion of participants receiving a course of TPT
Time frame: at 24 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Background: PubMed 35511950Tschumi N, Lerotholi M, Kopo M, Kao M, Lukau B, Nsakala B, Chejane N, Motaboli L, Lee T, Barnabas R, Shapiro AE, van Heerden A, Lejone TI, Amstutz A, Brown JA, Heitner J, Belus JM, Chammartin F, Labhardt ND. Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial. PLoS One. 2022 May 5;17(5):e0268100. doi: 10.1371/journal.pone.0268100. eCollection 2022.
- Derived from this study: PubMed 42005925Tschumi N, Lerotholi M, Kopo M, Kao M, Motaboli L, Mokebe M, Chejane N, Chakela M, Nsakala BL, Lukau B, van Heerden A, Barnabas RV, Heitner J, Shapiro AE, Urda L, Sanchez G, Lee T, Brown JA, Amstutz A, Belus JM, Chammartin F, Labhardt ND. Integrating clinical decision support and mobile health for differentiated HIV service delivery in Lesotho (VITAL): a cluster-randomised non-inferiority trial. EClinicalMedicine. 2026 Apr 2;94:103850. doi: 10.1016/j.eclinm.2026.103850. eCollection 2026 Apr.
- Derived from this study: PubMed 39354488Harder MT, Mokete M, Chammartin F, Lerotholi M, Motaboli L, Kopo M, Kao M, Mokebe M, Chejane N, Mahlatsi P, Nyakane M, Tarumbiswa T, Labhardt ND, Tschumi N, Belus JM. Cervical cancer screening delay and associated factors among women with HIV in Lesotho: a mixed-methods study. BMC Womens Health. 2024 Oct 1;24(1):543. doi: 10.1186/s12905-024-03382-8.
- Individual participant dataSharing planned: Yes. A subset of the key pseudo-anonymised individual participant data collected during the study, along with a data dictionary, will be made available upon request to the Division of Clinical Epidemiology at the University Hospital Basel.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niklaus Labhardt, Prof study chair
University Hospital, Basel, Switzerland
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VITAL model in people with HIV Infections, run by Swiss Tropical & Public Health Institute at 18 sites in Lesotho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Lesotho. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in care with documented viral suppression (time frame: 16-28 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527874, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.