Use of Consent Language and Mode to Improve Interactive Voice Response Survey in Colombia and Uganda

May 15, 2020 updated by: Johns Hopkins Bloomberg School of Public Health

A Randomized Controlled Trial of Varying Consent Language and Mode to Improve Interactive Voice Response (IVR) Survey Performance in Colombia and Uganda

This study evaluates the effect of one new form of introduction language and three new modes of providing consent on interactive voice response (IVR) survey cooperation, response, refusal and contact rates, as compared to control group, in Colombia and Uganda.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using random digit dialing (RDD) sampling technique, RDD participants will be randomized to one of five introduction and consent combinations and then have them complete noncommunicable disease risk factor survey with an additional module regarding their understanding of the survey and of its voluntariness. This mobile phone survey will be sent as an interactive voice response (IVR). In IVR surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. If you are male, press 1; If you are female, press 2). This study will be conducted in both Colombia and Uganda.

Study Type

Interventional

Enrollment (Actual)

3786

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • D.c.
      • Bogota, D.c., Colombia
        • Instituto de Salud Publica Pontificia Universidad Javeriana
  • Uganda
      • Kampala, Uganda
        • Makerere University School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Access to a mobile phone
  • Greater or equal to 18 years of age
  • In Colombia, conversant in the Spanish language. In Uganda, conversant in Luo, Luganda, Runyakitara or English languages.

Exclusion Criteria:

  • Less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No change will be made to the introduction content or the consent mode (active opt-in and active opt-out) from other related trials
Experimental: Modified Intro, Standard Consent
Modified introductory language will be used, but the consent structure (active opt-in and active opt-out) will remain the same.
Other: Modified Introduction
A variation in the introductory content to motivate participants to complete the survey. Participants will be presented with modified introductory language based on the findings from local focus groups and key informant interviews.
Experimental: Modified Intro, Active Opt-in
Modified introductory language will be used, and the consent mode will be changed to active opt-in only.
Other: Modified Introduction
A variation in the introductory content to motivate participants to complete the survey. Participants will be presented with modified introductory language based on the findings from local focus groups and key informant interviews.
Other: Active Opt-in
A variation in the consent mode to motivate participants to complete the survey. Participants will be given the choice to actively opt-in to the survey, if they do not respond, the survey will terminate.
Experimental: Modified Intro, Active Opt-out
Modified introductory language will be used, and the consent mode will be changed to active opt-out only.
Other: Modified Introduction
A variation in the introductory content to motivate participants to complete the survey. Participants will be presented with modified introductory language based on the findings from local focus groups and key informant interviews.
Other: Active Opt-out
A variation in the consent mode to motivate participants to complete the survey. Participants will be given the choice to actively opt-out to the survey, if they do not respond, the survey will continue.
Experimental: Modified Intro, Passive Opt-in
Modified introductory language will be used, and the consent mode will be changed to passive opt-in only.
Other: Modified Introduction
A variation in the introductory content to motivate participants to complete the survey. Participants will be presented with modified introductory language based on the findings from local focus groups and key informant interviews.
Other: Passive Opt-in
A variation in the consent mode to motivate participants to complete the survey. Participants will be given the choice to passively opt-in to the survey, if they do not hang-up, the survey will continue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cooperation Rate #1
Time Frame: Through study completion, an average of one month
As defined by American Association for Public Opinion Research, the number of complete interviews divided by the number of complete interviews, partial interviews, refusals and breakoffs.
Through study completion, an average of one month
Response Rate #4
Time Frame: Through study completion, an average of one month
As defined by American Association for Public Opinion Research, the number of complete and partial interviews divided by the number of complete interviews, partial interviews, refusals, breakoffs and the estimated eligible proportion of unknowns.
Through study completion, an average of one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refusal Rate #2
Time Frame: Through study completion, an average of one month
As defined by American Association for Public Opinion Research, the number of refusals and breakoffs divided by the number of complete interviews, partial interviews, refusals, breakoffs and the estimated eligible proportion of unknowns.
Through study completion, an average of one month
Contact Rate #2
Time Frame: Through study completion, an average of one month
As defined by American Association for Public Opinion Research, the number of complete and partial interviews, refusals and breakoffs divided by the number of complete interviews, partial interviews, refusals, breakoffs and the estimated eligible proportion of unknowns.
Through study completion, an average of one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Makerere University
Pontificia Universidad Javeriana
The Bloomberg Family Foundation, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2018

Primary Completion (Actual)

January 5, 2019

Study Completion (Actual)

January 5, 2019

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00007318-6.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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