The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression
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ClinicalTrials.gov Identifier: NCT02711293 |
Recruitment Status :
Completed
First Posted : March 17, 2016
Last Update Posted : March 6, 2018
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Condition or disease | Intervention/treatment | Phase |
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HIV Community Health Workers Antiretroviral Therapy, Highly Active | Other: ART home delivery Other: Enhanced nutrition counseling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2172 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
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 |
Actual Study Start Date : | March 2016 |
Actual Primary Completion Date : | February 2018 |
Actual Study Completion Date : | February 2018 |
Arm | Intervention/treatment |
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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.
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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. |
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.
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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. |
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.
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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. |
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.
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- 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 ]
- 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 ]
- Participants' healthcare expenditures [ Time Frame: In the last six months ]
- Self-reported ART adherence [ Time Frame: 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 ]
- Diversity of dietary intake [ Time Frame: At the end of the study period ]
- The proportion of patients who are anemic [ Time Frame: At the end of the study period ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711293
Tanzania | |
Management and Development for Health | |
Dar es Salaam, Tanzania |
Principal Investigator: | Till Bärnighausen, MD ScD | Harvard School of Public Health | |
Principal Investigator: | Pascal Geldsetzer, MBChB MPH | Harvard School of Public Health | |
Principal Investigator: | Nzovu Ulenga, MD | Management and Development for Health |
Responsible Party: | Till Barnighausen, Professor, Harvard School of Public Health |
ClinicalTrials.gov Identifier: | NCT02711293 |
Other Study ID Numbers: |
RIDIE-STUDY-ID-562a718b12fa0 |
First Posted: | March 17, 2016 Key Record Dates |
Last Update Posted: | March 6, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |