The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression

Not Applicable

Completed

• Conditions: HIV; Community Health Workers; Antiretroviral Therapy, Highly Active
• Interventions: Other: ART home delivery; Other: Enhanced nutrition counseling

• Registration Number: NCT02711293
• Lead Sponsor: Harvard School of Public Health (HSPH)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-12
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-17
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ART home delivery + enhanced nutrition counseling	ART home delivery	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.
ART home delivery + enhanced nutrition counseling	Enhanced nutrition counseling	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.
ART home delivery + no enhanced nutrition counseling	ART home delivery	Community health workers visit participants at home (maintaining patients' prior clinic visit frequency) to deliver antiretroviral therapy (ART) and to provide standard counseling.
No ART home delivery + enhanced nutrition counseling	Enhanced nutrition counseling	Community health workers visit participants at home to provide enhanced nutrition counseling. Participants will not receive ART home delivery.

Primary Outcome Measures

Name	Time	Method
The mean BMI of participants in clusters assigned to standard counseling by CHWs versus those in clusters assigned to standard plus enhanced nutrition counseling.	At the end of the study period
The proportion of participants in viral failure, comparing participants that received the intervention (ART home delivery if stable on ART or standard facility-based care if unstable) versus those that received the standard of care.	At the end of the study period

Secondary Outcome Measures

Name	Time	Method
Participants' healthcare expenditures	In the last six months
Self-reported ART adherence	In the last one month
The proportion of patients with access to a plot of land who grow vegetables or fruits for their own consumption.	At the end of the study period
Diversity of dietary intake	At the end of the study period
The proportion of patients who are anemic	At the end of the study period

Trial Locations

Locations (1)

Management and Development for Health; 🇹🇿 Dar es Salaam, Tanzania