NCT03969030

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

1.5 years

First QC Date

May 9, 2019

Last Update Submit

May 31, 2021

Conditions

HIV/AIDS

Keywords

HIVSub-Sahara AfricaLesothoDifferentiated Service DeliveryAdolescents and young adults living with HIVART servicePreference-based

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months (range: 9 - 15 months) after enrolment

Secondary Outcomes (9)

  • Adherence to ART at 3 months (range 2.5 - 3.5), 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment

    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

    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

    6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment

  • Engagement in care at 6 months

    6 months (range 5 - 8) after enrolment

  • Alternative viral suppression at 12 months

    12 months (range 9 - 15) after enrolment

  • +4 more secondary outcomes

Other Outcomes (1)

  • Serious Adverse Events (SAE)

    within 12 months after enrolment

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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).

Interventions

PEBRA modelOTHER

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

Intervention

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • the cluster is a public or missionary health center from the study districts, that offers ART services
  • the cluster has at least one PE who is willing to participate and fulfills the following criteria:
  • underwent the Sentebale Peer-Educator two-weeks training
  • attended and successfully passed the study training assessment

You may not qualify if:

  • health facility authority opposed to trial participation (verbal assent)
  • the health facility is a hospital
  • the health facility is situated in an area without cellphone signal
  • Eligibility - individuals
  • Individual is living with HIV and in care in a participating cluster
  • Individual is 15-24 years old (AYPLHIV)
  • Informed consent given
  • Declares to seek the next follow-up visit at the same health facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Boiketsiso HC

Butha-Buthe, 400, Lesotho

Location

Linakeng HC

Butha-Buthe, 400, Lesotho

Location

Makhunoane HC

Butha-Buthe, 400, Lesotho

Location

Motete HC

Butha-Buthe, 400, Lesotho

Location

Muela HC

Butha-Buthe, 400, Lesotho

Location

Ngoajane HC

Butha-Buthe, 400, Lesotho

Location

Rampai HC

Butha-Buthe, 400, Lesotho

Location

St. Paul HC

Butha-Buthe, 400, Lesotho

Location

St. Peters HC

Butha-Buthe, 400, Lesotho

Location

Tsime HC

Butha-Buthe, 400, Lesotho

Location

Ha Lejone HC

Hlotse, Lesotho

Location

Pontmain

Hlotse, Lesotho

Location

Libibing HC

Mokhotlong, Lesotho

Location

Linakaneng HC

Mokhotlong, Lesotho

Location

Malefiloane HC

Mokhotlong, Lesotho

Location

Mapholaneng HC

Mokhotlong, Lesotho

Location

Moeketsane HC

Mokhotlong, Lesotho

Location

Molikaliko HC

Mokhotlong, Lesotho

Location

St. James HC

Mokhotlong, Lesotho

Location

St. Martins HC

Mokhotlong, Lesotho

Location

Related Publications (3)

  • Seiler O, Kopo M, Kao M, Lejone TI, Tschumi N, Glass TR, Brown JA, Labhardt ND, Amstutz A. HIV Care Preferences among Young People Living with HIV in Lesotho: A Secondary Data Analysis of the PEBRA Cluster Randomized Trial. AIDS Res Treat. 2023 Apr 14;2023:8124192. doi: 10.1155/2023/8124192. eCollection 2023.

    PMID: 39691584DERIVED

  • Kopo M, Lejone TI, Tschumi N, Glass TR, Kao M, Brown JA, Seiler O, Muhairwe J, Moletsane N, Labhardt ND, Amstutz A. Effectiveness of a peer educator-coordinated preference-based differentiated service delivery model on viral suppression among young people living with HIV in Lesotho: The PEBRA cluster-randomized trial. PLoS Med. 2023 Jan 3;20(1):e1004150. doi: 10.1371/journal.pmed.1004150. eCollection 2023 Jan.

    PMID: 36595523DERIVED

  • 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.

    PMID: 32228531DERIVED

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Niklaus Labhardt, MD MIH

    Swiss TPH & University Hospital Basel & University of Basel

    STUDY CHAIR

  • Alain Amstutz, MD

    Swiss TPH & University Hospital Basel & University of Basel

    PRINCIPAL INVESTIGATOR

  • Mathebe Kopo

    SolidarMed

    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

    STUDY DIRECTOR

  • Lebohang Sao, MD

    DHMT BB

    STUDY DIRECTOR

  • Tracy Glass, PhD

    Swiss TPH & University of Basel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: PEBRA study is a cluster randomized, open-label, superiority trial in a resource-limited setting
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 31, 2019

Study Start

November 1, 2019

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, 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.

Locations

LE(20)