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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 8, 2020

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.

Interventions

  • Other: Standard of Care
    • Clinic-based HIV care
  • Other: Village-based ART refill
    • Option to get ART refill and care by the village health worker

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 12-months viral suppression (<400copies/mL)
    • 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 <400 copies/mL

Secondary Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • All-cause mortality at 12 months
    • Time Frame: 12 months (range 10 – 15 months) after enrolment
    • The proportion of all participants who died
  • 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
  • Confirmed 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 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
    • 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 one initially registered) outside the study districts without a proof of transfer at 12 months (range 10 – 15 months) after enrolment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Niklaus Labhardt
  • Collaborator
    • Ministry of Health, Lesotho
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Niklaus Labhardt, Principal Investigator – Swiss Tropical & Public Health Institute
  • Overall Official(s)
    • Niklaus D Labhardt, MD, Principal Investigator, University Hospital Basel & Swiss Tropical and Public Health Institute
    • Tracy R Glass, PhD, Study Chair, Swiss Tropical & Public Health Institute
    • Manuel Battegay, MD, Study Chair, University Hospital, Basel, Switzerland
    • Josephine Muhairwe, MD, Study Chair, SolidarMed – Swiss Organization for Health in Africa

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