Peer-Educator-coordinated vs Nurse-coordinated ART Refill for Adolescents and Young Adults Living With HIV in Lesotho
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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:

        1. Youth ART service preferences: Longitudinal description of participants' preference
           assessments

        2. Feasibility of youth ART service according to preferences: Percentage of ART service
           delivered according to participants' preferences

        3. Differentiated Impact of the different support options on key study outcomes

      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.
    

Intervention name(s): PEBRA model
Intervention type(s): Other
Intervention description(s): 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:
ART Refill
SMS notifications
Support
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: PEBRA study is a cluster randomized, open-label, superiority trial in a resource-limited setting
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV; Sub-Sahara Africa; Lesotho; Differentiated Service Delivery; Adolescents and young adults living with HIV; ART service; Preference-based