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

Locations

Region

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
, , Kristen Little and Nicholas Wilson. 2018. "Ethiopia ART Praise Message Study." AEA RCT Registry. February 12. https://doi.org/10.1257/rct.2077-2.0
Former Citation
, et al. 2018. "Ethiopia ART Praise Message Study." AEA RCT Registry. February 12. https://www.socialscienceregistry.org/trials/2077/history/25740
Sponsors & Partners

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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
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

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials