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

Niklaus Labhardt

Status and phase: Completed; Phase 4

Conditions: HIV/AIDS

Treatments: Other: Standard of Care; Other: Village-based ART refill

Study type: Interventional

Funder types: Other

Identifiers

NCT03630549

VIBRA

Details and patient eligibility

About

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 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.

Enrollment: 257 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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257 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care

Village-based ART refill

Experimental group

Description:

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

Treatment:

Other: Village-based ART refill