Ethiopia ART Praise Message Study
Last registered on February 12, 2018

Pre-Trial

Trial Information
General Information
Title
Ethiopia ART Praise Message Study
RCT ID
AEARCTR-0002077
Initial registration date
September 14, 2017
Last updated
February 12, 2018 1:59 PM EST
Location(s)

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Primary Investigator
Affiliation
Reed College
Other Primary Investigator(s)
PI Affiliation
Office of Evaluation Sciences
PI Affiliation
Population Services International
Additional Trial Information
Status
In development
Start date
2017-04-18
End date
2018-12-31
Secondary IDs
Abstract
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.
External Link(s)
Registration Citation
Citation
Bidwell, Kelly, Kristen Little and Nicholas Wilson. 2018. "Ethiopia ART Praise Message Study." AEA RCT Registry. February 12. https://www.socialscienceregistry.org/trials/2077/history/25740
Experimental Details
Interventions
Intervention(s)
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
2017-04-18
Intervention End Date
2018-12-31
Primary Outcomes
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
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
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
Not available
Randomization Method
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.
Randomization Unit
The unit of randomization is the individual.
Was the treatment clustered?
No
Experiment Characteristics
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)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Ethiopia Public Health InstituteI-IRB
IRB Approval Date
2017-04-17
IRB Approval Number
SERO-061-03-2017