Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
928 participants
INTERVENTIONAL
2017-05-18
2019-12-01
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Enhanced adherence counseling
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.
No interventions assigned to this group
Structured EAC plus SMS
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.
Structured adherence counseling
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.
Interventions
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Structured adherence counseling
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.
Eligibility Criteria
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Inclusion Criteria
* Patients on first-line ART
* Patients with a VL≥ 1000 copies/mL after a minimum of 6 months on first-line ART
Exclusion Criteria
ALL
No
Sponsors
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SolidarMed
OTHER
Ministry of Health, Lesotho
OTHER_GOV
University of Basel
OTHER
Swiss Tropical & Public Health Institute
OTHER
Responsible Party
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Tracy Glass
Project Leader
Principal Investigators
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Tracy R Glass, PhD
Role: PRINCIPAL_INVESTIGATOR
Swiss TPH
Niklaus Labhardt, MD
Role: STUDY_CHAIR
Swiss TPH
Locations
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Boiketsiso Health Center
Butha-Buthe, , Lesotho
Linakeng Health Center
Butha-Buthe, , Lesotho
Makhunoane Health Center
Butha-Buthe, , Lesotho
Motete Health Center
Butha-Buthe, , Lesotho
Muela Health Center
Butha-Buthe, , Lesotho
Ngoajane Health Center
Butha-Buthe, , Lesotho
Paballong
Butha-Buthe, , Lesotho
Rampai Health Center
Butha-Buthe, , Lesotho
Seboche
Butha-Buthe, , Lesotho
St Paul Health Center
Butha-Buthe, , Lesotho
St Peters Health Center
Butha-Buthe, , Lesotho
Tsime Health Center
Butha-Buthe, , Lesotho
Countries
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References
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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.
Bonner 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.
Jobanputra 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.
Ministry of Health and Social Welfare Lesotho: National Guidelines For HIV Testing And Counselling. National Guidelines For HIV Testing And Counselling 2009.
Other Identifiers
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SAVIR
Identifier Type: -
Identifier Source: org_study_id