Clinical trial NCT02711293: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Community Health Workers
Antiretroviral Therapy, Highly Active
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Management and Development for Health
name: International Initiative for Impact Evaluation
First posted: 2016-03-17
Enrollment: 2172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: 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.
timeFrame: At the end of the study period
measure: The mean BMI of participants in clusters assigned to standard counseling by CHWs versus those in clusters assigned to standard plus enhanced nutrition counseling.
timeFrame: At the end of the study period
Secondary outcomes:
measure: Participants' healthcare expenditures
timeFrame: In the last six months
measure: Self-reported ART adherence
timeFrame: In the last one month
measure: The proportion of patients with access to a plot of land who grow vegetables or fruits for their own consumption.
timeFrame: At the end of the study period
measure: Diversity of dietary intake
timeFrame: At the end of the study period
measure: The proportion of patients who are anemic
timeFrame: At the end of the study period
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Management and Development for Health
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Till Bärnighausen, MD ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Pascal Geldsetzer, MBChB MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Management and Development for Health
name: Nzovu Ulenga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.