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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 04, 2017, 8:03 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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. https://www.socialscienceregistry.org/trials/2409/history/21173
Experimental Details

Interventions

Intervention(s)
SMS-based messaging for linkage to care after HIV self testing.
Intervention (Hidden)
Since other HIVST programmes incorporate SMS messaging to enhance the revelation of test use and results (e.g. [18, 19]), we have assessed that the standard of care for HIVST programmes is to provide SMS reminders, and we do not include a control arm of no SMS contact. Assuming independence in the effect of message frequency and content, the factorial design enables comparisons between the rows and columns of Figure 3.
Messages sent to the non-behavioural group will be standard reminders, as currently proposed by the HIVSTAR team:
"remember to let us know if you've used your test. Call us today: 08..."

The content of the two messages in the intervention groups will have additional wording inserted, based on the EAST framework. Final message wording will be refined through testing with the HIVSTAR team, but will emphasise two key factors which may be a barrier to testing:
1) Emphasising reduction in the friction costs participants face due to the transfer of airtime. For example:
"Remember to let us know if you've used your test. We've already transferred the airtime, so call us today on: 08.....
2) Enhance attractiveness of HIVSTAR programme through emphasis of study participation. For example:
"You were selceted for a self-testing kit. Remember to let us know if you've used it. Call us today on: 08.....
As per best practice in other behavioural SMS interventions, both arms will receive direct links to the www.hivselftest.co.za website and the VOTO mobile phoneline, rather than vaguer instructions.
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

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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