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

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ClinicalTrials.gov Identifier: NCT03630549
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : February 18, 2020
Sponsor:
Collaborators:
Ministry of Health, Lesotho
SolidarMed
University of Basel
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Niklaus Labhardt, Swiss Tropical & Public Health Institute

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Other: Standard of Care Other: Village-based ART refill Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel cluster-randomized
Masking: None (Open Label)
Primary Purpose: Health Services Research
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)
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Standard of Care
  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
Clinic-based HIV care

Experimental: Village-based ART refill
  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
Option to get ART refill and care by the village health worker
Other Name: VIBRA




Primary Outcome Measures :
  1. 12-months viral suppression [ Time Frame: 12 months (range: 10 - 15 months) after enrolment. ]
    Viral suppression at 12 months, defined as the proportion of all participants with a VL <20 copies/mL


Secondary Outcome Measures :
  1. 6-months viral suppression [ Time Frame: 6 months (range 5 - 8 months) after enrolment ]
    Viral suppression at 6 months, defined as the proportion of all participants with a VL <20 copies/mL

  2. Alternative viral suppression at 12 months [ Time Frame: 12 months (range 10 - 15 months) after enrolment. ]
    The proportion of all participants with a VL <1000 copies/mL

  3. Alternative viral suppression at 6 months [ Time Frame: 6 months (range 5 - 8 months) after enrolment ]
    The proportion of all participants with a VL <1000 copies/mL

  4. Sustained viral suppression [ Time Frame: 12 months (range 5 - 15 months) after enrollment ]
    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

  5. 1-month linkage to care [ Time Frame: 30 days after enrollment ]
    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

  6. 3-months linkage to care [ Time Frame: 90 days ]
    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

  7. 6-months retention in care [ Time Frame: 5-8 months after enrollment ]
    The proportion of all participants active in care at a health facility or at the VHW 6 months (range 5 - 8 months) after enrollment

  8. 12-months retention in care [ Time Frame: 12 months (range 10 - 15 months) after enrolment ]
    the proportion of all participants active in care at a health facility or at the VHW

  9. All-cause mortality at 12 months [ Time Frame: 12 months (range 10 - 15 months) after enrolment ]
    The proportion of all participants who died

  10. Loss to follow-up at 12 months [ Time Frame: 12 months (range 10 - 15 months) after enrollment ]
    The proportion of all participants lost to follow-up

  11. Transfer out at 12 months [ Time Frame: 12 months (range 10 - 15 months) after enrolment ]
    The proportion of all participants who transferred out to any other health facility (than the initially attached one) with known outcome (documented proof of follow-up visit or laboratory test)



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630549


Contacts
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Contact: Niklaus D Labhardt, MD 79 870 1859 ext +41 n.labhardt@unibas.ch
Contact: Alain Amstutz, MD 58604300‬ ext +266 alain.amstutz@swisstph.ch

Locations
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Lesotho
District of Butha-Buthe Recruiting
Butha-Buthe, Lesotho
Contact: Thabo I Lejone, MIH    62000584‬ ext +266    t.lejone@solidarmed.ch   
Contact: Alain Amstutz, MD    58604300 ext +266    alain.amstutz@swisstph.ch   
Principal Investigator: Thabo I Lejone, RN         
District of Mokhotlong Recruiting
Mokhotlong, Lesotho
Contact: Lefu Khesa, RN    56425205 ext +266    l.khesa@solidarmed.ch   
Contact: Alain Amstutz, MD    58604300‬ ext +266    alain.amstutz@swisstph.ch   
Sub-Investigator: Lefu Khesa, RN         
Sponsors and Collaborators
Niklaus Labhardt
Ministry of Health, Lesotho
SolidarMed
University of Basel
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Niklaus D Labhardt, MD University Hospital Basel & Swiss Tropical and Public Health Institute
Study Chair: 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 Documents (Full-Text)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Niklaus Labhardt, Principal Investigator, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT03630549    
Other Study ID Numbers: VIBRA
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Niklaus Labhardt, Swiss Tropical & Public Health Institute:
HIV
Village Health Worker
Differentiated Care
Lesotho
Africa
antiretroviral therapy
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases