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

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Phase 4
Locations
Lesotho
Study Type
Interventional
Intervention
Standard of Care
Village-based ART refill
Sponsored by
Niklaus Labhardt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring HIV, Village Health Worker, Differentiated Care, Lesotho, Africa, antiretroviral therapy

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • District of Butha-Buthe
  • District of Mokhotlong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Village-based ART refill

Arm Description

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

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 SMS Monthly reminder SMS: to pick up ART SMS communicating VL result

Outcomes

Primary Outcome Measures

12-months viral suppression
Viral suppression at 12 months, defined as the proportion of all participants with a VL <20 copies/mL
12-months viral suppression (<400copies/mL)
Viral suppression at 12 months, defined as the proportion of all participants with a VL <400 copies/mL

Secondary Outcome Measures

6-months viral suppression
Viral suppression at 6 months, defined as the proportion of all participants with a VL <20 copies/mL
Alternative viral suppression at 12 months
The proportion of all participants with a VL <1000 copies/mL
Alternative viral suppression at 6 months
The proportion of all participants with a VL <1000 copies/mL
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
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
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
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
12-months retention in care
the proportion of all participants active in care at a health facility or at the VHW
All-cause mortality at 12 months
The proportion of all participants who died
Loss to follow-up at 12 months
The proportion of all participants lost to follow-up
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)
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

Full Information

First Posted
August 10, 2018
Last Updated
March 26, 2021
Sponsor
Niklaus Labhardt
Collaborators
Ministry of Health, Lesotho, SolidarMed, University of Basel, University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03630549
Brief Title
Village-based vs Clinic-based ART Care - a Cluster Randomized Controlled Trial in Lesotho
Acronym
VIBRA
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
December 8, 2020 (Actual)
Study Completion Date
December 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Niklaus Labhardt
Collaborators
Ministry of Health, Lesotho, SolidarMed, University of Basel, University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV, Village Health Worker, Differentiated Care, Lesotho, Africa, antiretroviral therapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel cluster-randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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
Arm Title
Village-based ART refill
Arm Type
Experimental
Arm Description
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 SMS Monthly reminder SMS: to pick up ART SMS communicating VL result
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Clinic-based HIV care
Intervention Type
Other
Intervention Name(s)
Village-based ART refill
Other Intervention Name(s)
VIBRA
Intervention Description
Option to get ART refill and care by the village health worker
Primary Outcome Measure Information:
Title
12-months viral suppression
Description
Viral suppression at 12 months, defined as the proportion of all participants with a VL <20 copies/mL
Time Frame
12 months (range: 10 - 15 months) after enrolment.
Title
12-months viral suppression (<400copies/mL)
Description
Viral suppression at 12 months, defined as the proportion of all participants with a VL <400 copies/mL
Time Frame
12 months (range: 10 - 15 months) after enrolment.
Secondary Outcome Measure Information:
Title
6-months viral suppression
Description
Viral suppression at 6 months, defined as the proportion of all participants with a VL <20 copies/mL
Time Frame
6 months (range 5 - 8 months) after enrolment
Title
Alternative viral suppression at 12 months
Description
The proportion of all participants with a VL <1000 copies/mL
Time Frame
12 months (range 10 - 15 months) after enrolment.
Title
Alternative viral suppression at 6 months
Description
The proportion of all participants with a VL <1000 copies/mL
Time Frame
6 months (range 5 - 8 months) after enrolment
Title
Sustained viral suppression
Description
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
Time Frame
12 months (range 5 - 15 months) after enrollment
Title
1-month linkage to care
Description
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
Time Frame
30 days after enrollment
Title
3-months linkage to care
Description
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
Time Frame
90 days
Title
6-months retention in care
Description
The proportion of all participants active in care at a health facility or at the VHW 6 months (range 5 - 8 months) after enrollment
Time Frame
5-8 months after enrollment
Title
12-months retention in care
Description
the proportion of all participants active in care at a health facility or at the VHW
Time Frame
12 months (range 10 - 15 months) after enrolment
Title
All-cause mortality at 12 months
Description
The proportion of all participants who died
Time Frame
12 months (range 10 - 15 months) after enrolment
Title
Loss to follow-up at 12 months
Description
The proportion of all participants lost to follow-up
Time Frame
12 months (range 10 - 15 months) after enrollment
Title
Confirmed transfer out at 12 months
Description
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)
Time Frame
12 months (range 10 - 15 months) after enrolment
Title
Unconfirmed transfer out at 12 months
Description
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
Time Frame
12 months (range 10 - 15 months) after enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niklaus D Labhardt, MD
Organizational Affiliation
University Hospital Basel & Swiss Tropical and Public Health Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tracy R Glass, PhD
Organizational Affiliation
Swiss Tropical & Public Health Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Manuel Battegay, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Josephine Muhairwe, MD
Organizational Affiliation
SolidarMed - Swiss Organization for Health in Africa
Official's Role
Study Chair
Facility Information:
Facility Name
District of Butha-Buthe
City
Butha-Buthe
Country
Lesotho
Facility Name
District of Mokhotlong
City
Mokhotlong
Country
Lesotho

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34673765
Citation
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.
Results Reference
derived
PubMed Identifier
31439004
Citation
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.
Results Reference
derived
Links:
URL
https://getonproject.wordpress.com
Description
Official Project Website

Learn more about this trial

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

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