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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
Sponsor:
Collaborators:
Management and Development for Health
International Initiative for Impact Evaluation
Information provided by (Responsible Party):
Till Barnighausen, Harvard School of Public Health

Tracking Information
First Submitted Date  ICMJE March 12, 2016
First Posted Date  ICMJE March 17, 2016
Last Update Posted Date March 6, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • The proportion of enrolled participants with a suppressed HIV viral load, comparing participants in clusters that received ART home delivery versus those that received the standard of care (facility-based ART care). [ Time Frame: Six months after enrollment into the trial ]
  • The mean BMI of participants who received standard counseling by CHWs versus those who received standard plus enhanced nutrition counseling. [ Time Frame: Six months after enrollment into the trial ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • 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: Six months after enrollment ]
  • Diversity of dietary intake [ Time Frame: Six months after enrollment ]
  • The proportion of patients who are anemic [ Time Frame: Six months after enrollment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression
Official Title  ICMJE The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression: A Non-inferiority Cluster-randomized Controlled Trial in Dar es Salaam, Tanzania
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • HIV
  • Community Health Workers
  • Antiretroviral Therapy, Highly Active
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: ART home delivery
    • Other: Enhanced nutrition counseling
  • 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.
    Intervention: Other: ART home delivery
  • 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.
    Intervention: Other: Enhanced nutrition counseling
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2018)
2172
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2016)
1000
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02711293
Other Study ID Numbers  ICMJE RIDIE-STUDY-ID-562a718b12fa0
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Till Barnighausen, Harvard School of Public Health
Study Sponsor  ICMJE Harvard School of Public Health
Collaborators  ICMJE
  • Management and Development for Health
  • International Initiative for Impact Evaluation
Investigators  ICMJE
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
PRS Account Harvard School of Public Health
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP