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 :
Completed
First Posted : May 31, 2019
Last Update Posted : June 2, 2021
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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 |
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HIV/AIDS | Other: PEBRA model | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 307 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 |
Actual Primary Completion Date : | April 30, 2021 |
Actual Study Completion Date : | April 30, 2021 |
Arm | Intervention/treatment |
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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:
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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:
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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).
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- 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
- 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:
- pill count: change in percentage
- "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
- "ART missed at two or more consecutive days within last month?" ("drug holiday" question)
- "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')
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 15 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Eligibility - clusters
Inclusion criteria:
- the cluster is a public or missionary health center from the study districts, that offers ART services
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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
Exclusion criteria:
- 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

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

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 |
Documents provided by Amstutz Alain, Swiss Tropical & Public Health Institute:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | June 2, 2021 |
Last Verified: | May 2021 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV Sub-Sahara Africa Lesotho Differentiated Service Delivery |
Adolescents and young adults living with HIV ART service Preference-based |
Acquired Immunodeficiency Syndrome HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |