The American Economic Association's registry for randomized controlled trials
Ethiopia ART Praise Message Study
Last registered on February 12, 2018
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Ethiopia ART Praise Message Study
Initial registration date
September 14, 2017
February 12, 2018 1:59 PM EST
Contact Primary Investigator
Other Primary Investigator(s)
Office of Evaluation Sciences
Population Services International
Additional Trial Information
This study examines the effect of telephone calls on adherence to antiretroviral therapy (ART) medication and ART prescription refills. Our study population are consenting HIV positive, ART-naive female sex workers (FSW) at 25 participating health clinics in Ethiopia. We randomly assign consenting study participants to either the telephone call "treatment" arm or the standard of care control arm.
Bidwell, Kelly, Kristen Little and Nicholas Wilson. 2018. "Ethiopia ART Praise Message Study." AEA RCT Registry. February 12.
Sponsors & Partners
The proposed praise intervention will contact female sex worker (FSW) clients living with HIV (and referred for care and treatment at a MULU Test-and-Start Drop-in-Clinic) via phone within 24 hours of a completed antiretroviral therapy (ART) appointment (clinical assessment and/or prescription fill or re-fill), and again two weeks after each completed appointment. The structured praise calls will be delivered according to a predetermined schedule, with structured messages provided at set points throughout a client’s progress through the HIV care continuum.
Intervention Start Date
Intervention End Date
Primary Outcomes (end points)
Key outcomes of interest are: ART Initiation, 1 Month Retention on Treatment, 3 Month Retention on Treatment, 6 Month Retention on Treatment, Viral Suppression at 6 months.
Primary Outcomes (explanation)
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
This study examines the effect of telephone calls on adherence to antiretroviral therapy (ART) medication and ART prescription refills. Our study population are HIV positive, ART-naive female sex workers (FSW) in Ethiopia. We randomly assign consenting study participants to either the telephone call "treatment" arm or the standard of care control arm. We will use administrative data from participating health clinics to measure adherence to ART medication and ART prescription refills. Systematic differences in adherence/refill outcomes in the telephone call group to adherence/refill outcomes in the control arm will provide evidence on the causal effect of the telephone calls on adherence/refill outcomes.
Experimental Design Details
Randomization of the order of each Drop-in-Clinic's (DIC) envelopes assigning study participants to treatment intervention arm or to control arm done in office by a computer using paired randomization. Envelopes are distributed to each DIC in a pre-specified and fixed order. Therefore stratification by DIC is automatic.
The unit of randomization is the individual.
Was the treatment clustered?
Sample size: planned number of clusters
The treatment is not clustered.
Sample size: planned number of observations
The planned number of observations (i.e. individuals) is 810.
Sample size (or number of clusters) by treatment arms
The planned sample sizes are 405 individuals in the control study arm and 405 individuals in the praise message study arm.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
INSTITUTIONAL REVIEW BOARDS (IRBs)
Ethiopia Public Health InstituteI-IRB
IRB Approval Date
IRB Approval Number
Post Trial Information
Is the intervention completed?
Is data collection complete?
Is public data available?
Reports and Papers