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

Village-based Refill of ART After Same-day ART Start vs Clinic-based ART Refill for HIV-positive Individuals Not on ART During Home-based HIV Testing (Part B of GET ON Research Project)

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Other: Standard of Care; Other: Village-based ART refill

Detailed Description

The VIBRA trial is a cluster randomized controlled, open-label, superiority trial in a resource-limited setting. The trial is linked to a another trial, the HOSENG (HOme-based SElf-testiNG) trial, that is described elsewhere (NCT03598686). Together, they consitute the GET ON (GETing tOwards Ninety) research project. The HOSENG study, with its home-based HIV testing campaign, provides the recruitment platform for the VIBRA study. The reasons for this interlinked design are: a) potential study participants for VIBRA trial (HIV-positive individuals not on ART) are to be recruited during a home-based HIV testing campaign and hence, it allows us to assess the entire HIV care cascade in one larger project, and b) both trials rely on interventions involving VHWs, who need to be randomized and specifically trained. Therefore, it is efficient and feasible to run both trials parallel and randomize at one time point only. The rational for a cluster randomized design is the reliance of the trial on the VHWs and, thus, the high risk of cross-contamination between the study arms if randomization would be done at individual level.

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lesotho
  • Butha-Buthe, Lesotho
    • District of Butha-Buthe
  • Mokhotlong, Lesotho
    • District of Mokhotlong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria for clusters:

• the cluster is clearly confined to the catchment area of one of the study clinics
• the cluster has at least one registered VHW who is willing to participate and fulfills the following criteria:
• is at least 18 years of age
• has adequate reading and writing skills
• successfully passes the training assessment
• village authority (village chief) is willing to participate in trial

Exclusion criteria for clusters:

• Village authority (=village chief) opposed to trial participation (verbal assent)
• Village health worker opposed to trial participation or not fulfilling the minimum requirements mentioned above

Inclusion Criteria for individuals:

• Individual is a household member of the visited households of the respective clusters
• Individual is confirmed HIV-positive
• Individual has never taken ART (ART-naïve) or has stopped ART more than 30 days prior (ART-defaulters)
• Individual is ≥10 years old and has a body weight of ≥35kg
• Individual is not in care for high blood pressure or diabetes (high blood sugar)
• HIV-positive individual wishes to get care outside the study districts

Exclusion criteria individuals:

• The household member is absent at the time of the campaign
• HIV-positive individual is taking ART or stopped less than 30 days ago
• HIV-positive individual is physically, mentally, or emotionally not able to participate in the study, in the opinion of the investigators or study staff
• HIV-positive individual is in care for high blood pressure (hypertension) or high blood sugar (diabetes) - proof of documentation or medication needed
• HIV-positive individual wishes to get care outside the study districts

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Offer of home-based same-day ART initiation; Clinic-based ART visit/refill Who: Nurse Where: Nurse-led health facility When: Follow-up interval of max. 3 months What: TB screening, Screening for other opportunistic infections, Screening for ART-related toxicities, adherence assessment, assessment whether patient visited any medical facility since last appointment, addressing basic psychosocial problems, ART (+CTX/IPT) dispensing; No SMS intervention	Other: Standard of Care; Clinic-based HIV care
Experimental: Village-based ART refill; Offer of home-based same-day ART initiation; Offer of Village-based ART visit/refill Who: VHW Where: At VHW's home* When: Follow-up interval of max. 3 months What: TB screening, Screening for other opportunistic infections, Screening for ART-related toxicities, adherence assessment, assessment whether patient visited any medical facility since last appointment, addressing basic psychosocial problems, ART (+CTX/IPT) dispensing*Except at 6 and 12 months follow-up: visit at health facility for laboratory assessment (viral load); Offer of Individually customized SMSMonthly reminder SMS: to pick up ARTSMS communicating VL result	Other: Village-based ART refill; Option to get ART refill and care by the village health worker; Other Names: VIBRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-months viral suppression	Viral suppression at 12 months, defined as the proportion of all participants with a VL <20 copies/mL	12 months (range: 10 - 15 months) after enrolment.
12-months viral suppression (<400copies/mL)	Viral suppression at 12 months, defined as the proportion of all participants with a VL <400 copies/mL	12 months (range: 10 - 15 months) after enrolment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-months viral suppression	Viral suppression at 6 months, defined as the proportion of all participants with a VL <20 copies/mL	6 months (range 5 - 8 months) after enrolment
Alternative viral suppression at 12 months	The proportion of all participants with a VL <1000 copies/mL	12 months (range 10 - 15 months) after enrolment.
Alternative viral suppression at 6 months	The proportion of all participants with a VL <1000 copies/mL	6 months (range 5 - 8 months) after enrolment
Sustained viral suppression	The proportion of all participants with a VL <20 copies/mL at 6 (range 5 - 8 months) as well as at 12 months (range 10 - 15 months) after enrolment	12 months (range 5 - 15 months) after enrollment
1-month linkage to care	Linkage to care within 1 month, defined as the proportion of all participants attending the first clinic- or VHW-based ART visit at least once within 1 month after enrolment	30 days after enrollment
3-months linkage to care	Linkage to care within 3 months, defined as the proportion of all participants attending the first clinic- or VHW-based ART visit at least once within 3 months after enrolment	90 days
6-months retention in care	The proportion of all participants active in care at a health facility or at the VHW 6 months (range 5 - 8 months) after enrollment	5-8 months after enrollment
12-months retention in care	the proportion of all participants active in care at a health facility or at the VHW	12 months (range 10 - 15 months) after enrolment
All-cause mortality at 12 months	The proportion of all participants who died	12 months (range 10 - 15 months) after enrolment
Loss to follow-up at 12 months	The proportion of all participants lost to follow-up	12 months (range 10 - 15 months) after enrollment
Confirmed transfer out at 12 months	The proportion of all participants who transferred out to any other health facility (than the one initially registered) outside the study districts with a proof of transfer (documented proof of follow-up visit or laboratory test)	12 months (range 10 - 15 months) after enrolment
Unconfirmed transfer out at 12 months	The proportion of all participants who transferred out to any other health facility (than the one initially registered) outside the study districts without a proof of transfer at 12 months (range 10 - 15 months) after enrolment	12 months (range 10 - 15 months) after enrolment

Collaborators and Investigators

• Sponsor: Niklaus Labhardt
• Collaborators: University Hospital, Basel, Switzerland; University of Basel; Ministry of Health, Lesotho; SolidarMed
• Investigators: Study Chair: Tracy R Glass, PhD, Swiss Tropical & Public Health Institute; Principal Investigator: Niklaus D Labhardt, MD, University Hospital Basel & Swiss Tropical and Public Health Institute; Study Chair: Josephine Muhairwe, MD, SolidarMed - Swiss Organization for Health in Africa

Publications and helpful links

General Publications

• Amstutz A, Lejone TI, Khesa L, Kopo M, Kao M, Muhairwe J, Bresser M, Raber F, Klimkait T, Battegay M, Glass TR, Labhardt ND. 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. PLoS Med. 2021 Oct 21;18(10):e1003839. doi: 10.1371/journal.pmed.1003839. eCollection 2021 Oct.
• Amstutz A, Lejone TI, Khesa L, Muhairwe J, Nsakala BL, Tlali K, Bresser M, Tediosi F, Kopo M, Kao M, Klimkait T, Battegay M, Glass TR, Labhardt ND. 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. Trials. 2019 Aug 22;20(1):522. doi: 10.1186/s13063-019-3510-5.

Helpful Links

• Official Project Website

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Actual): December 8, 2020
• Study Completion (Actual): December 8, 2020

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: HIV; Africa; Lesotho; antiretroviral therapy; Village Health Worker; Differentiated Care
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: VIBRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No