An interventional study of PEBRA model in HIV/AIDS, sponsored by Amstutz Alain. Completed at 20 sites in Lesotho. Open to participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2021-06-02.
Sponsored by Amstutz Alain · Not applicable, Interventional, and Health services research
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).
STUDY DESIGN
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).
OBJECTIVES
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.
QUALITATIVE RESEARCH
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:
PILOT TRIAL
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 307 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →This is the only study on the registry with Amstutz Alain as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligibility - clusters
Inclusion criteria:
the cluster has at least one PE who is willing to participate and fulfills the following criteria:
Exclusion criteria:
Eligibility - individuals
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the intervention clusters are offered the PEBRA model. In the PEBRA model the ART visit/refill is coordinated by the Peer-Educator (PE) according to the participants' preferences, using a tablet-based application, called PEBRApp. The preference assessment entails the following three domains of DSD: 1. ART Refill 2. SMS notifications 3. Support In each of the domains, the participants' preferences will be assessed and the most feasible option will be selected. The PEBRApp not only helps the PE to assess each participants' preference, but also 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.
Other: PEBRA model
Participants in the control clusters are offered standard of care: ART visit/refill is coordinated by the nurse, is mostly clinic-based, not adapted to youth, and differentiated according to clinical values (i.e. if VL suppressed then option of ART Refill in a Community Adherence Club).
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: 1. ART Refill 2. SMS notifications 3. Support
In care with documented viral suppression
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
Time frame: 12 months (range: 9 - 15 months) after enrolment
Adherence to ART at 3 months (range 2.5 - 3.5), 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment
Assessed by 4 different setting- and age-validated ART adherence questions: 1. pill count: change in percentage 2. "When was the last time you missed any medications?" (i) past week, ii) 1-2 weeks ago, iii) 3-4 weeks ago, iv) never): Dichotomous outcome missed doses vs. no missed doses in the past month 3. "ART missed at two or more consecutive days within last month?" ("drug holiday" question) 4. "How would you rate your adherence over the last month" (i) very poor, ii) poor, iii) fair, iv) good, v) very good, vi) excellent): Dichotomous outcome adherent vs non-adherent (anything less than 'excellent')
Time frame: 3 months (range 2.5 - 3.5), 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment
Quality of Life (QoL) at 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment
Assessed by WHO QoL in PLHIV: WHO HIV QoL questionnaire (whoqol_hiv_bref questionnaire with 31 five-point Likert Scale items with categorical outcomes
Time frame: 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment
Perceived quality of ART Care / patient service satisfaction at 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment
Assessed by a setting-validated QoC and patient service satisfaction questionnaire (12 five-point Likert Scale items with categorical outcome) by an external data collector, not the peer-educator
Time frame: 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment
Engagement in care at 6 months
Engagement in care at 6 months, defined as the proportion of participants engaged in care 6 months (range 5 - 8) after enrolment out of all participants enrolled
Time frame: 6 months (range 5 - 8) after enrolment
Alternative viral suppression at 12 months
Alternative viral suppression at 12 months, defined as the proportion of participants with a documented VL \<1000 copies/mL 12 months (range 9 - 15) after enrolment out of all participants enrolled
Time frame: 12 months (range 9 - 15) after enrolment
Engagement in care at 12 months
Engagement in care at 12 months, defined as the proportion of participants engaged in care 12 months (range 9 - 15) after enrolment out of all participants enrolled
Time frame: 12 months (range 9 - 15) after enrolment
All-cause mortality
All-cause mortality at 6 and 12 months, defined as the proportion of participants dead 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment, respectively, out of all participants enrolled
Time frame: 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment
LTFU at 6 and 12 months
LTFU at 6 and 12 months, defined as the proportion of participants LTFU 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment, respectively, out of all participants enrolled
Time frame: 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment
Transfer out at 6 and 12 months
Transfer out at 6 and 12 months, defined as the proportion of participants who transferred out to any other health facility (than the initially attached one) with known outcome (documented proof of follow-up visit or laboratory test) 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment, respectively, out of all participants enrolled
Time frame: 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment
Serious Adverse Events (SAE)
The proportion out of all participants experiencing a Serious Adverse Events (SAE) within 12 months after enrolment
Time frame: within 12 months after enrolment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Supporting information: Study protocol, Informed consent form
Time frame: Any time.
Access criteria: Data from this study, including deidentified participant data, study protocol, and informed consent documents will be made available to researchers. To access data, researchers should contact the corresponding author. Researchers will need to present a concept sheet for their proposed analysis. This will have to be reviewed and approved by all co-authors. The co-authors will consider overlap of the proposed project with active or planned analyses and the appropriateness of study data for the proposed analysis.
Ran from Nov 2019 to primary completion in Apr 2021, 17 months.
Of 641 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 17 months is below that.
Counting every sponsor, half of 647 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome →