The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711293
• Other study ID #: RIDIE-STUDY-ID-562a718b12fa0
• Status: Completed
• Phase: N/A
• First received: March 12, 2016
• Last updated: March 2, 2018
• Start date: March 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2172
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Tanzania	Management and Development for Health	Dar es Salaam

Sponsors (3)

Lead Sponsor	Collaborator
Harvard School of Public Health	International Initiative for Impact Evaluation, Management and Development for Health

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Participants' healthcare expenditures		In the last six months
Secondary	Self-reported ART adherence		In the last one month
Secondary	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
Secondary	Diversity of dietary intake		At the end of the study period
Secondary	The proportion of patients who are anemic		At the end of the study period