The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression

• ClinicalTrials.gov Identifier: NCT02711293
• Recruitment Status: Completed
• First Posted: March 17, 2016
• Last Update Posted: March 6, 2018
• Sponsor: Harvard School of Public Health
• 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: March 12, 2016
• First Posted Date: March 17, 2016
• Last Update Posted Date: March 6, 2018
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

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

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.
• 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

• 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 *

• Geldsetzer P, Francis JM, Sando D, Asmus G, Lema IA, Mboggo E, Koda H, Lwezaula S, Ambikapathi R, Fawzi W, Ulenga N, Bärnighausen 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, Bärnighausen 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 2, 2018): 2172
• Original Estimated Enrollment (submitted: March 16, 2016): 1000
• Actual Study Completion Date: February 2018
• Actual Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Tanzania

Administrative Information

• NCT Number: NCT02711293
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Till Barnighausen, Harvard School of Public Health
• Study Sponsor: Harvard School of Public Health

Collaborators

• Management and Development for Health
• International Initiative for Impact Evaluation

Investigators

• 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