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Offering ART Refill Through Community Health Workers Versus Clinic-Based Follow-Up After Home-Based Same-Day ART Initiation: The VIBRA Cluster-Randomised Clinical Trial

22 Pages Posted: 12 Apr 2021

See all articles by Alain Amstutz

Alain Amstutz

University of Basel - Swiss Tropical and Public Health Institute

Thabo Ishmael Lejone

SolidarMed, Partnerships for Health

Lefu Khesa

SolidarMed, Partnerships for Health

Mathebe Kopo

SolidarMed, Partnerships for Health

Mpho Kao

SolidarMed, Partnerships for Health

Josephine Muhairwe

SolidarMed, Partnerships for Health

Moniek Bresser

University of Basel - Swiss Tropical and Public Health Institute

Fabian Räber

University of Basel

Thomas Klimkait

University of Basel - Molecular Virology

Manuel Battegay

University of Basel - Division of Infectious Diseases and Hospital Epidemiology

Tracy Renée Glass

University of Basel - Swiss Tropical and Public Health Institute

Niklaus Daniel Labhardt

University of Basel - Swiss Tropical and Public Health Institute

More...

Abstract

Background: Community-based antiretroviral treatment (ART) dispensing by lay workers is an important differentiated service delivery model in sub-Sahara Africa. However, patients new in care are generally excluded from such models. Home-based same-day ART initiation is becoming widespread practice, but linkage to the clinic is challenging. The pragmatic VIBRA (Village-based refill of ART) cluster-randomised trial in rural Lesotho compared the option of ART refill by existing lay village health workers (VHW) versus clinic-based refill after home-based same-day ART initiation.

Methods: In village-clusters randomised to intervention, individuals found HIV-positive during a door-to-door HIV-testing campaign were offered same-day ART initiation with the option of refill by VHWs. The trained VHWs dispensed drugs and scheduled clinic-visits for viral load measurement at 6- and 12-months. In control-villages, participants were offered same-day ART initiation with clinic-based ART refill. The primary outcome was 12-month viral suppression. Secondary endpoints comprised linkage and 12-month engagement in care. Analyses were intention-to-treat. Clinicaltrials.gov/NCT03630549

Findings: From August 16 th , 2018, until May 28 th , 2019, 118 individuals from 108 households in 57 clusters from intervention arm, and 139 individuals from 130 households in 60 clusters in control were enrolled (150 [58%] female, median age 36 years (interquartile range 30-48), 200 [78%] newly diagnosed). 48/118 (41%) opted for VHW-based refill. At 12 months, 46/118 (39%) and 64/139 (46%) participants in the intervention and control arm achieved viral suppression (adjusted difference -0·07[95%CI -0·20-0·06];p=0·256). Arms were similar in linkage, but engagement in care tended to be lower in intervention. Zero and seven deaths occurred in control and intervention arm.

Interpretation: The offer of village-based ART refill did not amplify the effect of home-based same-day ART initiation alone. Our trial rather raises concerns regarding engagement in care and safety if follow-up is provided by existing lay health cadres for patients newly initiated on ART.

Trial Registration: Clinicaltrials.gov/NCT03630549

Funding: Swiss National Science Foundation; Janggen-Pöhn Foundation

Declaration of Interest: The authors declare that they have no competing interests.

Ethical Approval: This trial was approved by the National Health Research and Ethics Committee of the Ministry of Health of Lesotho (ID06-2018) and the Ethics committee in Switzerland (Ethikkomission Nordwest- und Zentralschweiz; 2018-00283) and registered with Clinicaltrials.gov (NCT03630549).

Keywords: HIV, Lesotho, Southern Africa, cluster-randomised, community health worker, viral suppression, differentiated service delivery, task-shifting, antiretroviral therapy delivery

Suggested Citation

Amstutz, Alain and Lejone, Thabo Ishmael and Khesa, Lefu and Kopo, Mathebe and Kao, Mpho and Muhairwe, Josephine and Bresser, Moniek and Räber, Fabian and Klimkait, Thomas and Battegay, Manuel and Glass, Tracy Renée and Labhardt, Niklaus Daniel, Offering ART Refill Through Community Health Workers Versus Clinic-Based Follow-Up After Home-Based Same-Day ART Initiation: The VIBRA Cluster-Randomised Clinical Trial. Available at SSRN: https://ssrn.com/abstract=3824772 or http://dx.doi.org/10.2139/ssrn.3824772

Alain Amstutz

University of Basel - Swiss Tropical and Public Health Institute ( email )

Basel
Switzerland

Thabo Ishmael Lejone

SolidarMed, Partnerships for Health ( email )

Lesotho

Lefu Khesa

SolidarMed, Partnerships for Health ( email )

Lesotho

Mathebe Kopo

SolidarMed, Partnerships for Health ( email )

Lesotho

Mpho Kao

SolidarMed, Partnerships for Health ( email )

Lesotho

Josephine Muhairwe

SolidarMed, Partnerships for Health ( email )

Lesotho

Moniek Bresser

University of Basel - Swiss Tropical and Public Health Institute ( email )

Basel
Switzerland

Fabian Räber

University of Basel ( email )

Petersplatz 1
Basel, CH-4003
Switzerland

Thomas Klimkait

University of Basel - Molecular Virology ( email )

Petersplatz 1
Basel, CH-4003
Switzerland

Manuel Battegay

University of Basel - Division of Infectious Diseases and Hospital Epidemiology ( email )

Wilhelm-Klein-Strasse 27
Basel, 4025
Switzerland

Tracy Renée Glass

University of Basel - Swiss Tropical and Public Health Institute ( email )

Basel
Switzerland

Niklaus Daniel Labhardt (Contact Author)

University of Basel - Swiss Tropical and Public Health Institute ( email )

Basel
Switzerland

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