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

NCT03630549 | Completed Phase 4

• 1 other identifier: VIBRA
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV/AIDS

Keywords

HIV; Village Health Worker; Differentiated Care; Lesotho; Africa; antiretroviral therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 6-months viral suppression

  6 months (range 5 - 8 months) after enrolment

• Alternative viral suppression at 12 months

  12 months (range 10 - 15 months) after enrolment.

• Alternative viral suppression at 6 months

  6 months (range 5 - 8 months) after enrolment

• Sustained viral suppression

  12 months (range 5 - 15 months) after enrollment

• 1-month linkage to care

  30 days after enrollment

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

1. Offer of home-based same-day ART initiation 2. 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 3. No SMS intervention

Other: Standard of Care

Village-based ART refill

EXPERIMENTAL

1. Offer of home-based same-day ART initiation 2. 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) 3. Offer of Individually customized SMS * Monthly reminder SMS: to pick up ART * SMS communicating VL result

Other: Village-based ART refill

Interventions

Standard of Care OTHER

Clinic-based HIV care

Standard of Care

Village-based ART refill OTHER

Option to get ART refill and care by the village health worker

Also known as: VIBRA

Village-based ART refill

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Niklaus Labhardt: lead
• Ministry of Health, Lesotho: collaborator
• SolidarMed: collaborator
• University of Basel: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (2)

District of Butha-Buthe

Butha-Buthe, Lesotho

Location

District of Mokhotlong

Mokhotlong, Lesotho

Location

Related Publications (2)

• 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.

  PMID: 34673765 DERIVED

• 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.

  PMID: 31439004 DERIVED

Related Links

• Official Project Website

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Niklaus D Labhardt, MD

  University Hospital Basel & Swiss Tropical and Public Health Institute

  PRINCIPAL INVESTIGATOR

• Tracy R Glass, PhD

  Swiss Tropical & Public Health Institute

  STUDY CHAIR

• Manuel Battegay, MD

  University Hospital, Basel, Switzerland

  STUDY CHAIR

• Josephine Muhairwe, MD

  SolidarMed - Swiss Organization for Health in Africa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel cluster-randomized

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 15, 2018
• Study Start: August 16, 2018
• Primary Completion: December 8, 2020
• Study Completion: December 8, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

LE (2)