NCT02120742

Brief Summary

This study seeks to evaluate the impact of a text-message (SMS) program delivered to motorcycle drivers in Dar es Salaam, Tanzania. The SMS program, delivered by nonprofit Amend, sends daily reminders to motorcycle drivers to remind them to wear their helmets. In this study, the investigators will conduct a randomized controlled trial to see if this program leads to increased helmet use over time. The investigators will recruit between 350-400 motorcycle drivers to receive the text program. The investigators will obtain each of their cell phone numbers, and the participants will be split into three groups. The first group will receive reminders framed as social norming (ie "Most of your peers wear helmets"). The second group will receive reminders framed as fear appeals (ie "Not wearing your helmet increases your chance of dying in an accident"). The third group will act as the control and receive texts that relate to general road safety, but not helmet use. All groups will receive the same general road safety information being delivered to the control arm. The purpose of sending different types of reminders is to assess which type of messages are more likely to cause a motorcycle driver to regularly wear their helmet. The investigators will survey the participants at the initiation of the study and after weeks 3 and 6 during the study, asking about their helmet use. This will be a short survey, and any personal information gathered during the study (ie, phone numbers), will be securely stored so as to protect their privacy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
391

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

April 19, 2014

Last Update Submit

September 28, 2015

Conditions

Road Traffic Injury PreventionHelmet UsemHealth Intervention

Keywords

Road traffic injury preventionHelmet usemHealth intervention

Outcome Measures

Primary Outcomes (2)

  • Self-reported adherence to helmet use

    The primary outcome of the study will be self-reported adherence to helmet use as measured by the proportion of participants who wear their helmet on all trips

    Midpoint of study (3 weeks)

  • Self-reported adherence to helmet use

    The primary outcome of the study will be self-reported adherence to helmet use as measured by the proportion of participants who wear their helmet on all trips

    Endpoint of study (6 weeks)

Secondary Outcomes (1)

  • Attitude change

    6 weeks

Study Arms (3)

Social Norming

EXPERIMENTAL

The first group will receive SMS message reminders framed as social norming (ie "Most of your peers wear helmets").

Behavioral: SMS message reminder

Fear Appeal

EXPERIMENTAL

The second group will receive SMS message reminders framed as fear appeals (ie "Not wearing your helmet increases your chance of dying in an accident").

Behavioral: SMS message reminder

Control

PLACEBO COMPARATOR

The third group will act as the control and receive texts that relate to general road safety, but not helmet use.

Behavioral: SMS message reminder

Interventions

SMS message reminderBEHAVIORAL

SMS texts will be delivered to study participants over a 6-week period.

ControlFear AppealSocial Norming

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Must own a cell phone with text-message features
  • Must demonstrate ability to retrieve and read text-messages
  • Must have access to a helmet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Upanga West, 65001, Tanzania

Location

Related Publications (1)

  • Campbell B, Heitner J, Amos Mwelelo P, Fogel A, Mujumdar V, Adams LV, Boniface R, Su Y. Impact of SMS Text Messaging Reminders on Helmet Use Among Motorcycle Drivers in Dar es Salaam, Tanzania: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 7;24(4):e27387. doi: 10.2196/27387.

    PMID: 35389364DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2014

First Posted

April 23, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2014

Study Completion

September 1, 2015

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

TA(1)