Adherence, MedicationSAVIRNCT03242980
Short Adherence Intervention for Viral Re-suppression
A study testing Structured adherence counseling in people with Adherence, Medication and HIV/AIDS, run by Swiss Tropical & Public Health Institute at 12 sites in Lesotho.
Trial summary
In the era of test-and-treat, with anticipated high numbers of patients who will have unsuppressed viral load (VL) due to poor adherence, simple, short and standardized adherence interventions with documented efficacy will be needed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adherence, Medication, HIV/AIDS
- What is being tested?
- Structured adherence counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 928 participants
- Where
- 12 sitesLesotho
- Study dates
- 18 May 2017to 1 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients receiving VL monitoring at one of the 2 hospitals and 10 health centres in Butha-Buthe district
- Patients on first-line ART
- Patients with a VL≥ 1000 copies/mL after a minimum of 6 months on first-line ART
Who cannot join
- Patients receiving VL monitoring at a non-participating center in Butha-Buthe
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Lesotho12 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
Paballong
Butha-Buthe
Rampai Health Center
Butha-Buthe
Seboche
Butha-Buthe
St Paul Health Center
Butha-Buthe
St Peters Health Center
Butha-Buthe
Tsime Health Center
Butha-Buthe
About this study
Official title: Short Adherence Intervention for Viral Re-suppression (SAVIR) Study: A Stepped Wedge Randomized Controlled Study to Assess the Effect of Standardized Adherence Counselling in Individuals With Unsuppressed Viral Load in Lesotho
In the era of test-and-treat, with anticipated high numbers of patients who will have unsuppressed viral load (VL) due to poor adherence, simple, short and standardized adherence interventions with documented efficacy will be needed. Achieving re-suppression in patients with unsuppressed VL is beneficial for the health of the individual, important to reduce the risk of transmission and has a direct cost implication because patients with sustained unsuppressed VL will ultimately be switched to more expensive 2nd-line regimens.
Information is still largely lacking on how to best address adherence problems among patients with unsuppressed VL. VL monitoring is recognized as a useful tool to reinforce adherence in patients with unsuppressed VL. The Lesotho Guidelines recommend redoing a VL 8-12 weeks after the first enhanced adherence counselling. To date no study has been published clearly demonstrating higher re-suppression rates after enhanced adherence counselling for patients with unsuppressed VL.
This project aims to test an adherence intervention for HIV-positive individuals on first-line ART who have an unsuppressed viral load. A step wedged study will be used to compare the effectiveness of a short, standardized adherence counselling followed by an SMS reminder to the standard of care (≥ 2 unstructured adherence counselling sessions) in terms of viral re-suppression rates and switches to 2nd line ART.
Read the detailed description
Due to a lack of routine viral load (VL) monitoring in Lesotho until now, most health care workers in the districts lack the necessary information on how to manage patients with elevated viral loads. The CART-1 study found re-suppression rates of only 30% with only 70% returning for a second VL. From these estimates, it is clear that the current practice for managing these patients must be improved. A simple intervention has been designed that could be feasibly adapted at all health centres in Lesotho.
To ensure that the effect of this intervention is measured and to avoid a long delay in adopting the intervention, a stepped wedge design was chosen. In addition the study would thus not disrupt the on-going staggered roll-out of routine viral load provision to patients on ART at the 12 health facilities. Stepped wedge designs are a form of clustered study in which the intervention is delivered to groups rather than individuals. In this case, the cluster is the hospital or health centre. Each health centre will undergo a time period with the standard of care and then will be randomly selected to cross-over to the intervention at different time points, until all of the health centres have crossed-over to receive the intervention. Data on the endpoint will be collected continuously at all health centres. The use of a step wedged study is pragmatic - the intervention is offered to exert its expected benefits and research insight is a secondary aim. This innovative design will lead to much stronger evidence than observational studies.
Routine VL (viral load) monitoring started in Butha-Buthe hospital in December 2015, in Seboche Hospital in May 2016 and the remaining 10 health centres in June 2016. Once each hospital/health center has implemented routine VL monitoring for a least 12 weeks, the standardized adherence intervention will be rolled out to the hospitals/health centers in a randomized fashion. Every 12 weeks starting in May 2017, two hospitals/health centers will be randomly selected to start with the adherence intervention.
Randomization times will be separated by 12 weeks to allow for implementation and assessment of the intervention within each time period. Final data collection will occur in October 2018. All nurses at the centres will be trained in the standardized adherence counselling by an experienced professional counselor and an experienced ART nurse prior to the introduction of the intervention.
The tracing of patients who do not show up for adherence counselling sessions or confirmatory VL will be done according to the current system in use at the health centre (usually contact individual via village health worker or phone if available) and will remain the same during both the control and intervention period.
- Conditions
- Adherence, Medication, HIV/AIDS
- Being tested
- Structured adherence counseling
- Keywords
- HIV, Adherence, Viral re-suppression, Step-wedgged randomized trial
- Medical subject headings
- Medication Adherence, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured adherence counselingBehavioural
Patients will undergo one standardized enhanced adherence counselling session. Counselling guidelines and a brochure were specifically developed to guide the adherence counselling for individuals with unsuppressed VL. All nurses at the health centres will be trained on the counselling prior to the cross-over to the intervention. The brochure was developed by culturally adapted by social scientists and contains only 3 key messages. The brochure will be given to the patient to take home.
Four weeks after the adherence counselling session, a SMS will be sent to the patient reminding them to take their ART. The content of the text message will be anonymous to protect disclosure and discussed/agreed upon with the patient during the adherence counselling.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced adherence counseling | No intervention | Individuals with elevated VL are required to attend a minimum of 2 session of enhanced adherence counselling performed at monthly intervals. A follow-up VL is done at 8 to 12 weeks after the first counselling session. |
| Structured EAC plus SMS | Experimental | The behavioral intervention will consist of structured adherence counseling and a short text message (SMS). A culturally adapted graphical brochure was specifically developed to guide adherence-counselling for individuals with unsuppressed VL. Receives: Behavioral: Structured adherence counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-suppression rates after one elevated viral load
HIV viral load <1000 copies/ml
Measured: Up to 16 weeks
Secondary outcomes (4)
Rates of switch to second-line ART
Any switch to protease-inhibitor based ART
Measured: Up to 6 months
Major drug resistance mutations
Presence of any major drug resistance mutation in those with 2nd elevated VL
Measured: 3 months after 1st elevated VL
Rates of attrition from care
No attendance at the clinic within 6 months after informing the patient about his/her first elevated VL
Measured: 6 months
Rates of viral re-suppression
In those who switched to 2nd line
Measured: 6 months after switch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start18 May 2017
- Primary completion1 Aug 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adherence, MedicationStudies 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
- Sequential
- Model description
- To ensure that the effect of this intervention is measured and to avoid a long delay in adopting the intervention, a stepped wedge design was chosen. In addition the study would thus not disrupt the on-going staggered roll-out of routine viral load provision to patients on ART at the 12 health facilities. Stepped wedge designs are a form of clustered study in which the intervention is delivered to groups rather than individuals.
- Masking
- None (open label)
- Enrolment
- 928 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- SolidarMed, Ministry of Health, Lesotho, University of Basel
- Responsible party
- Principal investigator, Tracy Glass, Swiss Tropical & Public Health Institute
- Investigators
- Tracy R Glass, PhD, Principal investigator, Swiss TPHNiklaus Labhardt, MD, Study chair, Swiss TPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242980
- Sponsor's protocol ID
- SAVIR
- Acronym
- SAVIR
- Status last verified
- Dec 2019
- First submitted
- 2 Aug 2017
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Government of Lesotho: NATIONAL GUIDELINES ON THE USE OF ANTIRETROVIRAL THERAPY FOR HIV PREVENTION AND TREATMENT. Fifth Edition 2016.
Conway B. The role of adherence to antiretroviral therapy in the management of HIV infection. J Acquir Immune Defic Syndr. 2007 Jun 1;45 Suppl 1:S14-8. doi: 10.1097/QAI.0b013e3180600766.
PubMed 17525686Bonner K, Mezochow A, Roberts T, Ford N, Cohn J. Viral load monitoring as a tool to reinforce adherence: a systematic review. J Acquir Immune Defic Syndr. 2013 Sep 1;64(1):74-8. doi: 10.1097/QAI.0b013e31829f05ac.
PubMed 23774877Jobanputra K, Parker LA, Azih C, Okello V, Maphalala G, Kershberger B, Khogali M, Lujan J, Antierens A, Teck R, Ellman T, Kosgei R, Reid T. Factors associated with virological failure and suppression after enhanced adherence counselling, in children, adolescents and adults on antiretroviral therapy for HIV in Swaziland. PLoS One. 2015 Feb 19;10(2):e0116144. doi: 10.1371/journal.pone.0116144. eCollection 2015.
PubMed 25695494Ministry of Health and Social Welfare Lesotho: National Guidelines For HIV Testing And Counselling. National Guidelines For HIV Testing And Counselling 2009.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Adherence Intervention for Viral Re-suppression (SAVIR) Study: A Stepped Wedge Randomized Controlled Study to Assess the Effect of Standardized Adherence Counselling in Individuals With Unsuppressed Viral Load in Lesotho
- ClinicalTrials.gov ID
- NCT03242980
- Acronym / sponsor ID
- SAVIR / SAVIR
- Conditions
- Adherence, Medication, HIV/AIDS
- Keywords
- HIV, Adherence, Viral re-suppression, Step-wedgged randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 928 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- SolidarMed, Ministry of Health, Lesotho, University of Basel
- Study start
- 18 May 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 8 Aug 2017 (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.
In the era of test-and-treat, with anticipated high numbers of patients who will have unsuppressed viral load (VL) due to poor adherence, simple, short and standardized adherence interventions with documented efficacy will be needed. Achieving re-suppression in patients with unsuppressed VL is beneficial for the health of the individual, important to reduce the risk of transmission and has a direct cost implication because patients with sustained unsuppressed VL will ultimately be switched to more expensive 2nd-line regimens.
Information is still largely lacking on how to best address adherence problems among patients with unsuppressed VL. VL monitoring is recognized as a useful tool to reinforce adherence in patients with unsuppressed VL. The Lesotho Guidelines recommend redoing a VL 8-12 weeks after the first enhanced adherence counselling. To date no study has been published clearly demonstrating higher re-suppression rates after enhanced adherence counselling for patients with unsuppressed VL.
This project aims to test an adherence intervention for HIV-positive individuals on first-line ART who have an unsuppressed viral load. A step wedged study will be used to compare the effectiveness of a short, standardized adherence counselling followed by an SMS reminder to the standard of care (≥ 2 unstructured adherence counselling sessions) in terms of viral re-suppression rates and switches to 2nd line ART.
Detailed description
Due to a lack of routine viral load (VL) monitoring in Lesotho until now, most health care workers in the districts lack the necessary information on how to manage patients with elevated viral loads. The CART-1 study found re-suppression rates of only 30% with only 70% returning for a second VL. From these estimates, it is clear that the current practice for managing these patients must be improved. A simple intervention has been designed that could be feasibly adapted at all health centres in Lesotho.
To ensure that the effect of this intervention is measured and to avoid a long delay in adopting the intervention, a stepped wedge design was chosen. In addition the study would thus not disrupt the on-going staggered roll-out of routine viral load provision to patients on ART at the 12 health facilities. Stepped wedge designs are a form of clustered study in which the intervention is delivered to groups rather than individuals. In this case, the cluster is the hospital or health centre. Each health centre will undergo a time period with the standard of care and then will be randomly selected to cross-over to the intervention at different time points, until all of the health centres have crossed-over to receive the intervention. Data on the endpoint will be collected continuously at all health centres. The use of a step wedged study is pragmatic - the intervention is offered to exert its expected benefits and research insight is a secondary aim. This innovative design will lead to much stronger evidence than observational studies.
Routine VL (viral load) monitoring started in Butha-Buthe hospital in December 2015, in Seboche Hospital in May 2016 and the remaining 10 health centres in June 2016. Once each hospital/health center has implemented routine VL monitoring for a least 12 weeks, the standardized adherence intervention will be rolled out to the hospitals/health centers in a randomized fashion. Every 12 weeks starting in May 2017, two hospitals/health centers will be randomly selected to start with the adherence intervention.
Randomization times will be separated by 12 weeks to allow for implementation and assessment of the intervention within each time period. Final data collection will occur in October 2018. All nurses at the centres will be trained in the standardized adherence counselling by an experienced professional counselor and an experienced ART nurse prior to the introduction of the intervention.
The tracing of patients who do not show up for adherence counselling sessions or confirmatory VL will be done according to the current system in use at the health centre (usually contact individual via village health worker or phone if available) and will remain the same during both the control and intervention period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To ensure that the effect of this intervention is measured and to avoid a long delay in adopting the intervention, a stepped wedge design was chosen. In addition the study would thus not disrupt the on-going staggered roll-out of routine viral load provision to patients on ART at the 12 health facilities. Stepped wedge designs are a form of clustered study in which the intervention is delivered to groups rather than individuals.
| Arm | Type | Receives |
|---|---|---|
| Enhanced adherence counseling | No intervention | –Individuals with elevated VL are required to attend a minimum of 2 session of enhanced adherence counselling performed at monthly intervals. A follow-up VL is done at 8 to 12 weeks after the first counselling session. |
| Structured EAC plus SMS | Experimental | Behavioral: Structured adherence counselingThe behavioral intervention will consist of structured adherence counseling and a short text message (SMS). A culturally adapted graphical brochure was specifically developed to guide adherence-counselling for individuals with unsuppressed VL. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients receiving VL monitoring at one of the 2 hospitals and 10 health centres in Butha-Buthe district
- Patients on first-line ART
- Patients with a VL≥ 1000 copies/mL after a minimum of 6 months on first-line ART
Key exclusion criteria (1 listed)
- Patients receiving VL monitoring at a non-participating center in Butha-Buthe
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 |
|---|---|---|
| Structured adherence counselingPatients will undergo one standardized enhanced adherence counselling session. Counselling guidelines and a brochure were specifically developed to guide the adherence counselling for individuals with unsuppressed VL. All nurses at the health centres will be trained on the counselling prior to the cross-over to the intervention. The brochure was developed by culturally adapted by social scientists and contains only 3 key messages. The brochure will be given to the patient to take home. Four weeks after the adherence counselling session, a SMS will be sent to the patient reminding them to take their ART. The content of the text message will be anonymous to protect disclosure and discussed/agreed upon with the patient during the adherence counselling. | Behavioural | Structured EAC plus SMS |
Primary outcome
Re-suppression rates after one elevated viral load
Time frame: Up to 16 weeks
HIV viral load <1000 copies/ml
4 secondary outcomes
Rates of switch to second-line ART
Time frame: Up to 6 months
Major drug resistance mutations
Time frame: 3 months after 1st elevated VL
Rates of attrition from care
Time frame: 6 months
Rates of viral re-suppression
Time frame: 6 months after switch
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 17 Dec 2019.
- BackgroundGovernment of Lesotho: NATIONAL GUIDELINES ON THE USE OF ANTIRETROVIRAL THERAPY FOR HIV PREVENTION AND TREATMENT. Fifth Edition 2016.
- Background: PubMed 17525686Conway B. The role of adherence to antiretroviral therapy in the management of HIV infection. J Acquir Immune Defic Syndr. 2007 Jun 1;45 Suppl 1:S14-8. doi: 10.1097/QAI.0b013e3180600766.
- Background: PubMed 23774877Bonner K, Mezochow A, Roberts T, Ford N, Cohn J. Viral load monitoring as a tool to reinforce adherence: a systematic review. J Acquir Immune Defic Syndr. 2013 Sep 1;64(1):74-8. doi: 10.1097/QAI.0b013e31829f05ac.
- Background: PubMed 25695494Jobanputra K, Parker LA, Azih C, Okello V, Maphalala G, Kershberger B, Khogali M, Lujan J, Antierens A, Teck R, Ellman T, Kosgei R, Reid T. Factors associated with virological failure and suppression after enhanced adherence counselling, in children, adolescents and adults on antiretroviral therapy for HIV in Swaziland. PLoS One. 2015 Feb 19;10(2):e0116144. doi: 10.1371/journal.pone.0116144. eCollection 2015.
- BackgroundMinistry of Health and Social Welfare Lesotho: National Guidelines For HIV Testing And Counselling. National Guidelines For HIV Testing And Counselling 2009.
- Individual participant dataSharing planned: No
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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.
Tracy R Glass, PhD principal investigator
Swiss TPH
Niklaus Labhardt, MD study chair
Swiss TPH
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured adherence counseling in people with Adherence, Medication and HIV/AIDS, run by Swiss Tropical & Public Health Institute at 12 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 3 inclusion and 1 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Re-suppression rates after one elevated viral load (time frame: Up to 16 weeks). 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 NCT03242980, which also lists 5 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 17 Dec 2019; AzTrials last refreshed its copy on 29 Oct 2026.