x

NEW UPDATE: Completed trials may now upload and register supplementary documents (e.g. null results reports, populated pre-analysis plans, or post-trial results reports) in the Post Trial section under Reports, Papers, & Other Materials.
Nudging HIV self-testing: Using behavioural economics to increase linkage to care in the HIVSTAR004 project
Last registered on September 04, 2017

Pre-Trial

Trial Information
General Information
Title
Nudging HIV self-testing: Using behavioural economics to increase linkage to care in the HIVSTAR004 project
RCT ID
AEARCTR-0002409
Initial registration date
August 31, 2017
Last updated
September 04, 2017 8:03 PM EDT
Location(s)
Region
Primary Investigator
Affiliation
London School of Hygiene and Tropical Medicine
Other Primary Investigator(s)
Additional Trial Information
Status
In development
Start date
2017-10-01
End date
2018-04-01
Secondary IDs
I19
Abstract
This protocol describes a study to be nested within a large implementation science project – HIVSTAR004 – conducted by Wits RHI, University of the Witwatersrand, South Africa, which is evaluating the use of mHealth interventions in improving uptake of HIV self-testing (HIVST) kits, and linkage to care after a positive test (n= 12,000).
It will trial the impact of the frequency and wording of SMS messages to encourage reporting of HIVST use and result.

External Link(s)
Registration Citation
Citation
Quaife, Matthew. 2017. "Nudging HIV self-testing: Using behavioural economics to increase linkage to care in the HIVSTAR004 project." AEA RCT Registry. September 04. https://doi.org/10.1257/rct.2409-1.0.
Former Citation
Quaife, Matthew. 2017. "Nudging HIV self-testing: Using behavioural economics to increase linkage to care in the HIVSTAR004 project." AEA RCT Registry. September 04. http://www.socialscienceregistry.org/trials/2409/history/21173.
Experimental Details
Interventions
Intervention(s)
SMS-based messaging for linkage to care after HIV self testing.
Intervention Start Date
2017-10-01
Intervention End Date
2018-03-04
Primary Outcomes
Primary Outcomes (end points)
The primary outcome measure for this trial is contact with the mHealth tool (via SMS, online form, or phonecall) reporting use of the HIVST, and the secondary outcome measure the reporting of a positive or negative HIVST result.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
This study has a 2x2 factorial design. As per figures 2, participants will be randomised to receive one of four linkage packages: arm 1) A non-behavioural SMS at 3 days after test distribution; arm 2) a non-behavioural SMS at 3 and 5 days; arm 3) a behavioural SMS at 3 days; and arm 4) a behavioural SMS at 3 and 5 days.
Experimental Design Details
This study has a 2x2 factorial design. As per figures 2, participants will be randomised to receive one of four linkage packages: arm 1) A non-behavioural SMS at 3 days after test distribution; arm 2) a non-behavioural SMS at 3 and 5 days; arm 3) a behavioural SMS at 3 days; and arm 4) a behavioural SMS at 3 and 5 days.
Randomization Method
Computerised on registration
Randomization Unit
Individual level
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
N/A
Sample size: planned number of observations
12,000
Sample size (or number of clusters) by treatment arms
12,000
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
9006 users are required to have a 90% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure from 52.9% in the control group to 56.3% in the experimental group, as found in UK HIV self-testing trial[20]. Since 12,000 participants will be recruited in the HIVSTAR 004 programme, this study should be sufficiently powered.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
London School of Hygiene and Tropical Medicine
IRB Approval Date
2017-08-31
IRB Approval Number
0
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is 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