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HIV/AIDSPhase 4VIBRANCT03630549

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

A Phase 4 study testing Village-based ART refill in people with HIV/AIDS, run by Niklaus Labhardt at 2 sites in Lesotho.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 years and older
Conditions the study is for
HIV/AIDS
What is being tested?
Village-based ART refill
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
2 sitesLesotho
Study dates
16 Aug 2018to 8 Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
  • 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

Trial locations and contacts

2 sites in 1 country.

Lesotho2 sites

  • District of Butha-Buthe

    Butha-Buthe

  • District of Mokhotlong

    Mokhotlong

Other trials in Lesotho

About this study

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)

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.

Read the 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.

Conditions
HIV/AIDS
Being tested
Standard of Care, Village-based ART refill
Keywords
HIV, Village Health Worker, Differentiated Care, Lesotho, Africa, antiretroviral therapy
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of CareOther

    Clinic-based HIV care

  • Village-based ART refillOther

    Also called VIBRA

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

Study groups in NCT03630549
Study groupRoleWhat they receive
Standard of CareActive comparator1. 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
Receives: Other: Standard of Care
Village-based ART refillExperimental1. 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
Receives: Other: Village-based ART refill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-months viral suppression

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

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

  2. 12-months viral suppression (<400copies/mL)

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

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

Secondary outcomes (12)

  1. 6-months viral suppression

    Viral suppression at 6 months, defined as the proportion of all participants with a VL <20 copies/mL

    Measured: 6 months (range 5 - 8 months) after enrolment

  2. Alternative viral suppression at 12 months

    The proportion of all participants with a VL <1000 copies/mL

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

  3. Alternative viral suppression at 6 months

    The proportion of all participants with a VL <1000 copies/mL

    Measured: 6 months (range 5 - 8 months) after enrolment

  4. 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

    Measured: 12 months (range 5 - 15 months) after enrollment

  5. 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

    Measured: 30 days after enrollment

  6. 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

    Measured: 90 days

  7. 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

    Measured: 5-8 months after enrollment

  8. 12-months retention in care

    the proportion of all participants active in care at a health facility or at the VHW

    Measured: 12 months (range 10 - 15 months) after enrolment

  9. All-cause mortality at 12 months

    The proportion of all participants who died

    Measured: 12 months (range 10 - 15 months) after enrolment

  10. Loss to follow-up at 12 months

    The proportion of all participants lost to follow-up

    Measured: 12 months (range 10 - 15 months) after enrollment

  11. 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)

    Measured: 12 months (range 10 - 15 months) after enrolment

  12. 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

    Measured: 12 months (range 10 - 15 months) after enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2018
  2. Study start16 Aug 2018
  3. Primary completion8 Dec 2020
  4. Study completion8 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel cluster-randomized
Masking
None (open label)
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03630549
Sponsor's protocol ID
VIBRA
Acronym
VIBRA
Status last verified
Mar 2021
First submitted
10 Aug 2018
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 34673765

  • 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.

    PubMed 31439004

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Village-based ART refill in people with HIV/AIDS, run by Niklaus Labhardt at 2 sites in Lesotho.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Lesotho. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-months viral suppression (time frame: 12 months (range: 10 - 15 months) after enrolment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03630549, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

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