NCT02711293

The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression

The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression: A Non-inferiority Cluster-randomized Controlled Trial in Dar es Salaam, Tanzania

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,172 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV
• Community Health Workers
• Antiretroviral Therapy, Highly Active

Interventions

Type	Name	Description
OTHER	ART home delivery	Community health workers visit participants who are clinically stable on antiretroviral therapy (ART) at home (maintaining patients' prior clinic visit frequency) to deliver ART. Clinically stable on ART was defined as 1) taking ART for at least six months, 2) having had a CD4-cell count \>350 cells/μL or a suppressed viral load at six or more months after ART initiation, and 3) the patient's most current CD4-cell count must have been \>350 cells/μL or the most current viral load must have shown viral suppression, with the last measurement not taken more than 12 months ago.
OTHER	Enhanced nutrition counseling	Community health workers visit participants at home to provide standard counseling (focusing on family planning, prevention of HIV transmission, and ART adherence) plus enhanced nutrition counseling (covering food production and dietary advice). In addition, participants who state that they have access to a plot of land or garden to grow vegetables receive a pack of seeds (amaranth, cowpea, or pumpkin) at enrolment.

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-03-17
• Last updated: 2018-03-06

Locations

1 site across 1 country: Tanzania