The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression

President and Fellows of Harvard College

Status: Completed

Conditions: Community Health Workers; HIV; Antiretroviral Therapy, Highly Active

Treatments: Other: Enhanced nutrition counseling; Other: ART home delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT02711293

RIDIE-STUDY-ID-562a718b12fa0

Details and patient eligibility

About

Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the potential to reduce key barriers to ART care retention. The aim of this study is to determine whether CHW-led home delivery of ART for patients who are stable on ART combined with facility-based care for those not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression. The primary endpoint of this trial is the proportion of ART patients (regardless of whether they were clinically stable on ART at enrollment) who are in viral failure at the end of the study period. The non-inferiority design applies only to this primary endpoint. The margin of non-inferiority was set at a Risk Ratio (comparing intervention to control) of 1.45. This is a cluster-randomized controlled trial set in Dar es Salaam. The unit of randomization is a healthcare facility with its surrounding neighborhoods (the 'catchment area'). We matched all 48 healthcare facilities offering ART services and having affiliated public-sector CHWs in Dar es Salaam into pairs (stratified by district) based on having a similar number of patients currently on ART. In each pair, one cluster was randomized to the intervention and one to the control arm. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART care and CHW home visits at least every three months without ART home delivery). In addition, within each study arm, half of the healthcare facilities were randomized to enhanced CHW-led nutrition counseling and half to standard counseling.

Enrollment: 2,172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having attended one of the participating healthcare facilities for ART care during the enrolment period
• Living in a neighborhood that is in the healthcare facility's catchment area

Exclusion criteria

• ART patients who are pregnant at the time of enrollment
• Inability to provide written informed consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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2,172 participants in 4 patient groups

ART home delivery + enhanced nutrition counseling

Experimental group

Description:

Community health workers visit participants at home (maintaining patients' prior clinic visit frequency) to deliver antiretroviral therapy (ART) and to provide standard plus enhanced nutrition counseling.

Treatment:

Other: Enhanced nutrition counseling

Other: ART home delivery

ART home delivery + no enhanced nutrition counseling

Experimental group

Description:

Community health workers visit participants at home (maintaining patients' prior clinic visit frequency) to deliver antiretroviral therapy (ART) and to provide standard counseling.

Treatment:

Other: ART home delivery

No ART home delivery + enhanced nutrition counseling

Experimental group

Description:

Community health workers visit participants at home to provide enhanced nutrition counseling. Participants will not receive ART home delivery.

Treatment:

Other: Enhanced nutrition counseling

Standard of care

No Intervention group

Description:

Participants in this arm receive facility-based ART care and no enhanced nutrition counseling. They receive community health worker visits as per the standard of care in Dar es Salaam.