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

Niklaus Labhardt257 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

257

Conditions

HIV/AIDS

Interventions

Standard of CareOTHER

Clinic-based HIV care

Village-based ART refillOTHER

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

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (2)

District of Butha-Buthe

Butha-Buthe, Lesotho

District of Mokhotlong

Mokhotlong, Lesotho

Outcomes

Primary Outcomes

12-months viral suppression

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

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

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

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

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

Secondary Outcomes

6-months viral suppression

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

Time frame: 6 months (range 5 - 8 months) after enrolment

Alternative viral suppression at 12 months

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

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

Alternative viral suppression at 6 months

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

Time frame: 6 months (range 5 - 8 months) after enrolment

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

Time frame: 12 months (range 5 - 15 months) after enrollment

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

Data from ClinicalTrials.gov

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