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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
Sponsor:
Collaborators:
International AIDS Society (CIPHER grant)
Swiss Tropical & Public Health Institute
SolidarMed
Sentebale
University of Basel
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Information provided by (Responsible Party):
Amstutz Alain, Swiss Tropical & Public Health Institute

Brief 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).


Condition or disease Intervention/treatment Phase
HIV/AIDS Other: PEBRA model Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Official Title: 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)
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention

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

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

No Intervention: Control
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).



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adherence to ART at 3 months (range 2.5 - 3.5), 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment [ Time Frame: 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')

  2. Quality of Life (QoL) at 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment [ Time Frame: 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

  3. Perceived quality of ART Care / patient service satisfaction at 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment [ Time Frame: 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

  4. Engagement in care at 6 months [ Time Frame: 6 months (range 5 - 8) after enrolment ]
    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

  5. Alternative viral suppression at 12 months [ Time Frame: 12 months (range 9 - 15) after enrolment ]
    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

  6. Engagement in care at 12 months [ Time Frame: 12 months (range 9 - 15) after enrolment ]
    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

  7. All-cause mortality [ Time Frame: 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment ]
    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

  8. LTFU at 6 and 12 months [ Time Frame: 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment ]
    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

  9. Transfer out at 6 and 12 months [ Time Frame: 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment ]
    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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility - clusters

Inclusion criteria:

  1. the cluster is a public or missionary health center from the study districts, that offers ART services
  2. the cluster has at least one PE who is willing to participate and fulfills the following criteria:

    1. underwent the Sentebale Peer-Educator two-weeks training
    2. attended and successfully passed the study training assessment

Exclusion criteria:

  1. health facility authority opposed to trial participation (verbal assent)
  2. the health facility is a hospital
  3. the health facility is situated in an area without cellphone signal

Eligibility - individuals

  1. Individual is living with HIV and in care in a participating cluster
  2. Individual is 15-24 years old (AYPLHIV)
  3. Informed consent given
  4. Declares to seek the next follow-up visit at the same health facility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969030


Contacts
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Contact: Alain Amstutz, MD +26658604300 alain.amstutz@swisstph.ch
Contact: Niklaus Labhardt, MD MIH +41613012964 n.labhardt@swisstph.ch

Locations
Show Show 20 study locations
Sponsors and Collaborators
Amstutz Alain
International AIDS Society (CIPHER grant)
Swiss Tropical & Public Health Institute
SolidarMed
Sentebale
University of Basel
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
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Study Chair: Niklaus Labhardt, MD MIH Swiss TPH & University Hospital Basel & University of Basel
Principal Investigator: Alain Amstutz, MD Swiss TPH & University Hospital Basel & University of Basel
Study Director: Mathebe Kopo SolidarMed Lesotho
Study Director: Jennifer Brown, MSc Swiss TPH & University of Basel
Study Director: Nadine Bachmann, MSc Swiss TPH & University of Basel
Study Director: Thabo Lejone, MIH SolidarMed Lesotho
Study Director: Lebohang Sao, MD DHMT BB
Study Director: Tracy Glass, PhD Swiss TPH & University of Basel
  Study Documents (Full-Text)

Documents provided by Amstutz Alain, Swiss Tropical & Public Health Institute:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amstutz Alain, MD, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT03969030    
Other Study ID Numbers: 2019-10
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amstutz Alain, Swiss Tropical & Public Health Institute:
HIV
Sub-Sahara Africa
Lesotho
Differentiated Service Delivery
Adolescents and young adults living with HIV
ART service
Preference-based
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases