Clinical trial NCT03630549: Village-based vs Clinic-based ART Care - a Cluster Randomized Controlled Trial in Lesotho
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV/AIDS
Keywords: HIV
Village Health Worker
Differentiated Care
Lesotho
Africa
antiretroviral therapy
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Lesotho
name: SolidarMed
name: University of Basel
name: University Hospital, Basel, Switzerland
First posted: 2018-08-15
Enrollment: 257
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel cluster-randomized
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: 12-months viral suppression
timeFrame: 12 months (range: 10 - 15 months) after enrolment.
measure: 12-months viral suppression (<400copies/mL)
timeFrame: 12 months (range: 10 - 15 months) after enrolment.
Secondary outcomes:
measure: 6-months viral suppression
timeFrame: 6 months (range 5 - 8 months) after enrolment
measure: Alternative viral suppression at 12 months
timeFrame: 12 months (range 10 - 15 months) after enrolment.
measure: Alternative viral suppression at 6 months
timeFrame: 6 months (range 5 - 8 months) after enrolment
measure: Sustained viral suppression
timeFrame: 12 months (range 5 - 15 months) after enrollment
measure: 1-month linkage to care
timeFrame: 30 days after enrollment
measure: 3-months linkage to care
timeFrame: 90 days
measure: 6-months retention in care
timeFrame: 5-8 months after enrollment
measure: 12-months retention in care
timeFrame: 12 months (range 10 - 15 months) after enrolment
measure: All-cause mortality at 12 months
timeFrame: 12 months (range 10 - 15 months) after enrolment
measure: Loss to follow-up at 12 months
timeFrame: 12 months (range 10 - 15 months) after enrollment
measure: Confirmed transfer out at 12 months
timeFrame: 12 months (range 10 - 15 months) after enrolment
measure: Unconfirmed transfer out at 12 months
timeFrame: 12 months (range 10 - 15 months) after enrolment
Other outcomes:
Locations:
city: Butha-Buthe
country: Lesotho
facility: District of Butha-Buthe
city: Mokhotlong
country: Lesotho
facility: District of Mokhotlong
Study officials:
affiliation: University Hospital Basel & Swiss Tropical and Public Health Institute
name: Niklaus D Labhardt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swiss Tropical & Public Health Institute
name: Tracy R Glass, PhD
role: STUDY_CHAIR
affiliation: University Hospital, Basel, Switzerland
name: Manuel Battegay, MD
role: STUDY_CHAIR
affiliation: SolidarMed - Swiss Organization for Health in Africa
name: Josephine Muhairwe, MD
role: STUDY_CHAIR
References:
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.
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.