- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02711293
The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression
March 2, 2018 updated by: Till Barnighausen, Harvard School of Public Health (HSPH)
The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression: A Non-inferiority Cluster-randomized Controlled Trial in Dar es Salaam, Tanzania
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2172
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Dar es Salaam, Tanzania
- Management and Development for Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ART home delivery + 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.
|
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.
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.
|
Experimental: ART home delivery + no 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 counseling.
|
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.
|
Experimental: No ART home delivery + enhanced nutrition counseling
Community health workers visit participants at home to provide enhanced nutrition counseling.
Participants will not receive ART home delivery.
|
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.
|
No Intervention: Standard of care
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: At the end of the study period
|
At the end of the study period
|
The mean BMI of participants in clusters assigned to standard counseling by CHWs versus those in clusters assigned to standard plus enhanced nutrition counseling.
Time Frame: At the end of the study period
|
At the end of the study period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Participants' healthcare expenditures
Time Frame: In the last six months
|
In the last six months
|
Self-reported ART adherence
Time Frame: In the last one month
|
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.
Time Frame: At the end of the study period
|
At the end of the study period
|
Diversity of dietary intake
Time Frame: At the end of the study period
|
At the end of the study period
|
The proportion of patients who are anemic
Time Frame: At the end of the study period
|
At the end of the study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Till Bärnighausen, MD ScD, Harvard School of Public Health (HSPH)
- Principal Investigator: Pascal Geldsetzer, MBChB MPH, Harvard School of Public Health (HSPH)
- Principal Investigator: Nzovu Ulenga, MD, Management and Development for Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Geldsetzer P, Francis JM, Sando D, Asmus G, Lema IA, Mboggo E, Koda H, Lwezaula S, Ambikapathi R, Fawzi W, Ulenga N, Barnighausen T. Community delivery of antiretroviral drugs: A non-inferiority cluster-randomized pragmatic trial in Dar es Salaam, Tanzania. PLoS Med. 2018 Sep 19;15(9):e1002659. doi: 10.1371/journal.pmed.1002659. eCollection 2018 Sep.
- Geldsetzer P, Francis JM, Ulenga N, Sando D, Lema IA, Mboggo E, Vaikath M, Koda H, Lwezaula S, Hu J, Noor RA, Olofin I, Larson E, Fawzi W, Barnighausen T. The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania. BMC Health Serv Res. 2017 Feb 22;17(1):160. doi: 10.1186/s12913-017-2032-7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
March 12, 2016
First Submitted That Met QC Criteria
March 16, 2016
First Posted (Estimate)
March 17, 2016
Study Record Updates
Last Update Posted (Actual)
March 6, 2018
Last Update Submitted That Met QC Criteria
March 2, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- RIDIE-STUDY-ID-562a718b12fa0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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