Peer-Educator-coordinated vs Nurse-coordinated ART Refill for Adolescents and Young Adults Living With HIV in Lesotho (PEBRA)
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|ClinicalTrials.gov Identifier: NCT03969030|
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : December 11, 2019
|First Submitted Date ICMJE||May 9, 2019|
|First Posted Date ICMJE||May 31, 2019|
|Last Update Posted Date||December 11, 2019|
|Actual Study Start Date ICMJE||November 1, 2019|
|Estimated Primary Completion Date||April 30, 2021 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||In care with documented viral suppression [ Time Frame: 12 months (range: 9 - 15 months) after enrolment ]
In care with documented viral suppression at 12 months, defined as the proportion of participants in care with a documented VL <20 copies/mL 12 months (range: 9 - 15 months) after enrolment out of all participants enrolled
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures
||Serious Adverse Events (SAE) [ Time Frame: within 12 months after enrolment ]
The proportion out of all participants experiencing a Serious Adverse Events (SAE) within 12 months after enrolment
|Original Other Pre-specified Outcome Measures||Same as current|
|Brief Title ICMJE||Peer-Educator-coordinated vs Nurse-coordinated ART Refill for Adolescents and Young Adults Living With HIV in Lesotho|
|Official Title ICMJE||Peer-Educator-coordinated vs Nurse-coordinated ART Refill for Adolescents and Young Adults Living With HIV in Lesotho - a Cluster Randomized Clinical Trial (PEBRA Trial)|
Sub-Saharan Africa (SSA) is home to 85% of the adolescents and young people living with HIV (AYPLHIV) globally and they are heavily affected by the HIV/AIDS epidemic: AYPLHIV in SSA are the only population group for whom HIV-related mortality continues to increase, and they have overall poorer outcomes than all other age groups. Lesotho with worldwide the second-highest HIV prevalence shows a viral suppression rate among AYPLHIV of only 49%.
In order to address the multiple barriers in the adolescent HIV care cascade and their unique needs, multicomponent packages of differentiated service delivery (DSD) are a promising approach.
In close collaboration with different local stakeholders, the researchers designed a DSD model specifically for AYPLHIV, called the PEBRA model. In the PEBRA model the peer-educator (PE) plays a pivotal role, by coordinating the ART refill/care according to the patient's preferences using a tablet-based application, called PEBRApp (https://github.com/chrisly-bear/PEBRApp). The PEBRApp helps the PE to assess each participant's preference, to adapt the ART refill according to these preferences in a feasible manner, to keep track of the ART refill, and to ensure regular contact between the PE and the participant. The model includes key innovative options such as individualized automatic SMS notifications and decentralized ART delivery.
The PEBRApp was developed with ❤️ by Technify Maseru, Lesotho (www.technifyls.com) & Christoph Schwizer Zurich, Switzerland (www.christophschwizer.ch).
PEBRA study is a cluster randomized, open-label, superiority trial in a resource-limited setting. The rational for a cluster randomized design with health facilities as clusters, is the high risk of cross-contamination between the study arms if randomization would be done at individual level. The clusters (health facilities) will be randomized (randomly-varying block sizes, 1:1 allocation) into the 2 groups using a computer-generated randomization list, stratified by district and size of the AYPLHIV cohort of each facility (<15 vs ≥15). The study will be conducted at 20 health facilities in three districts of Lesotho (Leribe, Butha-Buthe, Mokhotlong).
The overall objective of this study is to evaluate the feasibility and effectiveness of a DSD model ("PEBRA model") among AYPLHIV.
As primary objective this study seeks to assess the rate of viral suppression among AYPLHIV 12 months after enrolment between the intervention clusters, where AYPLHIV were offered the PEBRA model, and the control clusters, where AYPLHIV were offered standard of care.
Secondary objectives include a comparison of adherence to ART, the level of perceived quality of ART care and patient service satisfaction, engagement in care, viral suppression, lost-to-follow-up (LTFU), mortality, and transfer out between the intervention and control clusters. Further objectives include a cost-effectiveness evaluation and qualitative research regarding acceptance, scalability and feasibility of the DSD model.
Besides above outlined qualitative research (QoL, QoC, longitudinal description of participants' preference assessments) the researchers will explore the acceptability of the PEBRA model in a) Focus Group Dis-cussions (FGD) with study participants from the intervention clusters, and b) key informant interviews (KII) with the main stakeholders (District Health Management Team and different health center staff). We plan to conduct at least 2 FGD (with about 5 study participants) per district and 3 KII per district, ac-cording to the concept of saturation. Data will be collected by trained facilitators using piloted interview questionnaires and discussion guides, in the local language (Sesotho). Qualitative data will be record-ed, transcribed, translated into English and coded and analyzed using the Framework Method. All participants in this qualitative research will be required to sign a separate consent form to participate and to be recorded. These consent forms and interview questionnaires will be submitted as an amendment to the ethics committee in Lesotho at a later stage.
COST-EFFECTIVENESS ANALYSIS AND SYSTEM IMPACT EVALUATION
The researchers will perform a system impact evaluation and cost-effectiveness analysis, in order to estimate the im-pact of the PEBRA model on health benefits and costs. First, we will assess the direct costs of the PEBRA model. Secondly, we will assess the cost-effectiveness of the PEBRA model. Thirdly, we will as-sess the economic burden of the PEBRA model to the study participants, i.e. including both direct costs and the opportunity costs of their time. The assessment of direct costs includes staff costs (PEs, clinic staff, VHWs), personnel training costs (especially for the PEs), the cost of equipment needed (PEBRApp, logistics), medical costs to the participant (medication, laboratory tests, consumables, etc.), and non-medical costs to the participant (i.e. cost of transportation to ART service). Data to assess pa-tient level costs will be collected from a randomly selected sub-sample of study participants from each cluster arm, using medical expenditure records and interviews. Cost outcomes will include:
i) The average cost to the service provider per patient achieving the primary endpoint at 12 months in each cluster arm ('per patient suppressed provider cost') ii) The average cost to the patient per patient achieving the primary endpoint at 12 months in each cluster arm ('per patient suppressed patient cost') iii) The annual cost per patient in each cluster arm ('per patient year cost') iv) The cost-effectiveness of the PEBRA model with respect to viral suppression and engage-ment in care Costs will be reported as means (incl. standard deviations) and medians (incl. interquartile range) in local currency and US dollar and International Dollar.
PREFERENCE AND FEASIBILITY ASSESSMENT
The researchers will systematically assess the following exploratory analyses regarding feasibility and youth ART service preference:
PEBRA model will be piloted at one representative health facility in Butha-Buthe district, that will be pragmatically chosen in collaboration with the District Health Management Team. The pilot trial will be crucial to assess feasibility of the PEBRA model and the study procedures. The same procedures apply in the pilot trial as in the main trial, using the same consent process and baseline data collection. One PE will be specifically trained for the pilot. Recruitment for the pilot will be closed once 3-5 study participants are enrolled and follow-up will last for 2.5 months after having enrolled the last participant. All endpoints that are evaluable "at 3 months (range 2.5 - 3.5)" will be assessed and analyzed. The aim of the pilot trial is to give a first insight into PEBRA model and provide detailed information for the main trial.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
PEBRA study is a cluster randomized, open-label, superiority trial in a resource-limited settingMasking: None (Open Label)
Primary Purpose: Health Services Research
|Intervention ICMJE||Other: PEBRA model
The participants in the intervention clusters are offered the PEBRA model. In the PEBRA model the ART visit/refill is coordinated by the PE, as much as feasible according to the participants' preferences. Thus, the preferences of each participant are captured at enrolment and after a strict schedule thereafter. The PE conducts the preference assessment using a tablet-based application, called PEBRApp, accoring to a specific schedule. First, the participant will be asked his/her preference regarding different domains of DSD (see below) and this will be entered into the PEBRApp. Secondly, the chosen preferences are assessed regarding feasibility with specific questions, as not all preference options are available to everyone all the time. The preference assessment entails the following three domains of DSD:
|Study Arms ICMJE||
|Publications *||Lejone TI, Kopo M, Bachmann N, Brown JA, Glass TR, Muhairwe J, Matsela T, Scherrer R, Chere L, Namane T, Labhardt ND, Amstutz A. PEBRA trial - effect of a peer-educator coordinated preference-based ART service delivery model on viral suppression among adolescents and young adults living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho. BMC Public Health. 2020 Mar 30;20(1):425. doi: 10.1186/s12889-020-08535-6.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||June 1, 2021|
|Estimated Primary Completion Date||April 30, 2021 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Eligibility - clusters
Eligibility - individuals
|Ages ICMJE||15 Years to 24 Years (Child, Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Listed Location Countries ICMJE||Lesotho|
|Removed Location Countries|
|NCT Number ICMJE||NCT03969030|
|Other Study ID Numbers ICMJE||2019-10|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Amstutz Alain, Swiss Tropical & Public Health Institute|
|Study Sponsor ICMJE||Amstutz Alain|
|PRS Account||Swiss Tropical & Public Health Institute|
|Verification Date||December 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP