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

HIV/AIDS Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630549
• Other study ID #: VIBRA
• Status: Completed
• Phase: Phase 4
• Start date: August 16, 2018
• Est. completion date: December 8, 2020

Study information

• Verified date: March 2021
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: December 8, 2020
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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

Locations

Country	Name	City	State
Lesotho	District of Butha-Buthe	Butha-Buthe
Lesotho	District of Mokhotlong	Mokhotlong

Sponsors (5)

Lead Sponsor	Collaborator
Niklaus Labhardt	Ministry of Health, Lesotho, SolidarMed, University Hospital, Basel, Switzerland, University of Basel

Country where clinical trial is conducted

Lesotho, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-months viral suppression	Viral suppression at 12 months, defined as the proportion of all participants with a VL <20 copies/mL	12 months (range: 10 - 15 months) after enrolment.
Primary	12-months viral suppression (<400copies/mL)	Viral suppression at 12 months, defined as the proportion of all participants with a VL <400 copies/mL	12 months (range: 10 - 15 months) after enrolment.
Secondary	6-months viral suppression	Viral suppression at 6 months, defined as the proportion of all participants with a VL <20 copies/mL	6 months (range 5 - 8 months) after enrolment
Secondary	Alternative viral suppression at 12 months	The proportion of all participants with a VL <1000 copies/mL	12 months (range 10 - 15 months) after enrolment.
Secondary	Alternative viral suppression at 6 months	The proportion of all participants with a VL <1000 copies/mL	6 months (range 5 - 8 months) after enrolment
Secondary	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	12 months (range 5 - 15 months) after enrollment
Secondary	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	30 days after enrollment
Secondary	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	90 days
Secondary	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	5-8 months after enrollment
Secondary	12-months retention in care	the proportion of all participants active in care at a health facility or at the VHW	12 months (range 10 - 15 months) after enrolment
Secondary	All-cause mortality at 12 months	The proportion of all participants who died	12 months (range 10 - 15 months) after enrolment
Secondary	Loss to follow-up at 12 months	The proportion of all participants lost to follow-up	12 months (range 10 - 15 months) after enrollment
Secondary	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)	12 months (range 10 - 15 months) after enrolment
Secondary	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	12 months (range 10 - 15 months) after enrolment

External Links

•   Official Project Website
•   Website of the Research Group