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NCT03630549: VIBRA

Village-based vs Clinic-based ART Care - a Cluster Randomized Controlled Trial in Lesotho

Completed Phase 4 Last updated 1 April 2021
What this trial tests

Phase 4 trial testing Standard of Care in HIV/AIDS in 257 participants. Completed in 8 December 2020.

Timeline
16 August 2018
Primary endpoint
8 December 2020
8 December 2020

Quick facts

Lead sponsorNiklaus Labhardt
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment257
Start date16 August 2018
Primary completion8 December 2020
Estimated completion8 December 2020
Sites2 locations across Lesotho

Drugs / interventions tested

Conditions studied

Sponsor

Niklaus Labhardt

Who can join

10 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This cluster-randomized trial tests a differentiated care model for HIV-positive individuals not on ART during a home-based HIV testing campaign in rural Lesotho, Southern Africa. In intervention clusters, patients are offered a differentiated ART delivery package with two features. Firstly, drug-refill and follow-up are provided by village health workers (VHW), reducing clinic visits to twice a year for laboratory assessment. Secondly, participants have the option of receiving individually tailored adherence reminders and viral load result notifications via SMS.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antiretroviral adherence for adolescents growing up with HIV: understanding real life, drug delivery and forgiveness.
    Foster C, Ayers S, Fidler S. · · 2020 · cited 30× · PMID 32523693 · DOI 10.1177/2049936120920177
  2. Reaching the second 90: the strategies for linkage to care and antiretroviral therapy initiation.
    Bunda BA, Bassett IV. · · 2019 · cited 25× · PMID 31408009 · DOI 10.1097/coh.0000000000000579
  3. Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial.
    Amstutz A, Lejone TI, Khesa L, Kopo M, et al · · 2021 · cited 14× · PMID 34673765 · DOI 10.1371/journal.pmed.1003839
  4. VIBRA trial - Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho.
    Amstutz A, Lejone TI, Khesa L, Muhairwe J, et al · · 2019 · cited 8× · PMID 31439004 · DOI 10.1186/s13063-019-3510-5
  5. Oral abstracts of the 11th IAS Conference on HIV Science, 18-21 July 2021.
    · 2021 · cited 1× · PMID 34288453 · DOI 10.1002/jia2.25755
  6. VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho
    Amstutz A, Lejone TI, Khesa L, Muhairwe J, et al · · 2019 · DOI 10.21203/rs.2.212/v2

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Other trials of Standard of Care

Trials testing the same drug.

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Other Niklaus Labhardt trials

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