search
Back to results

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

Primary Purpose

Surveys and Questionnaires, Noncommunicable Diseases

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Modified Introduction
Active Opt-in
Active Opt-out
Passive Opt-in
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surveys and Questionnaires focused on measuring mobile phone surveys, interactive voice response, consent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto de Salud Publica Pontificia Universidad Javeriana
  • Makerere University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Modified Intro, Standard Consent

Modified Intro, Active Opt-in

Modified Intro, Active Opt-out

Modified Intro, Passive Opt-in

Arm Description

No change will be made to the introduction content or the consent mode (active opt-in and active opt-out) from other related trials

Modified introductory language will be used, but the consent structure (active opt-in and active opt-out) will remain the same.

Modified introductory language will be used, and the consent mode will be changed to active opt-in only.

Modified introductory language will be used, and the consent mode will be changed to active opt-out only.

Modified introductory language will be used, and the consent mode will be changed to passive opt-in only.

Outcomes

Primary Outcome Measures

Cooperation Rate #1
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.
Response Rate #4
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.

Secondary Outcome Measures

Refusal Rate #2
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.
Contact Rate #2
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.

Full Information

First Posted
May 15, 2020
Last Updated
May 15, 2020
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
The Bloomberg Family Foundation, Inc., Makerere University, Pontificia Universidad Javeriana
search

1. Study Identification

Unique Protocol Identification Number
NCT04394520
Brief Title
Use of Consent Language and Mode to Improve Interactive Voice Response Survey in Colombia and Uganda
Official Title
A Randomized Controlled Trial of Varying Consent Language and Mode to Improve Interactive Voice Response (IVR) Survey Performance in Colombia and Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
January 5, 2019 (Actual)
Study Completion Date
January 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
The Bloomberg Family Foundation, Inc., Makerere University, Pontificia Universidad Javeriana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surveys and Questionnaires, Noncommunicable Diseases
Keywords
mobile phone surveys, interactive voice response, consent

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to one of five introduction and consent combinations: 1) standard introduction and standard consent mode (active opt-in and active opt-out); 2) modified introduction language and standard consent mode; 3) modified introduction language and active opt-in consent; 4) modified introduction language and active opt-out consent; or 5) modified introduction language and passive opt-in consent. This randomization will occur at the beginning of the survey.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3786 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No change will be made to the introduction content or the consent mode (active opt-in and active opt-out) from other related trials
Arm Title
Modified Intro, Standard Consent
Arm Type
Experimental
Arm Description
Modified introductory language will be used, but the consent structure (active opt-in and active opt-out) will remain the same.
Arm Title
Modified Intro, Active Opt-in
Arm Type
Experimental
Arm Description
Modified introductory language will be used, and the consent mode will be changed to active opt-in only.
Arm Title
Modified Intro, Active Opt-out
Arm Type
Experimental
Arm Description
Modified introductory language will be used, and the consent mode will be changed to active opt-out only.
Arm Title
Modified Intro, Passive Opt-in
Arm Type
Experimental
Arm Description
Modified introductory language will be used, and the consent mode will be changed to passive opt-in only.
Intervention Type
Other
Intervention Name(s)
Modified Introduction
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Active Opt-in
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Active Opt-out
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Passive Opt-in
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cooperation Rate #1
Description
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.
Time Frame
Through study completion, an average of one month
Title
Response Rate #4
Description
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.
Time Frame
Through study completion, an average of one month
Secondary Outcome Measure Information:
Title
Refusal Rate #2
Description
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.
Time Frame
Through study completion, an average of one month
Title
Contact Rate #2
Description
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.
Time Frame
Through study completion, an average of one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan A Hyder, PhD, MBBS
Organizational Affiliation
Johns Hopkins University Bloomberg School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George W. Pariyo, PhD
Organizational Affiliation
Johns Hopkins University Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Salud Publica Pontificia Universidad Javeriana
City
Bogota
State/Province
D.c.
Country
Colombia
Facility Name
Makerere University School of Public Health
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28476729
Citation
Gibson DG, Pariyo GW, Wosu AC, Greenleaf AR, Ali J, Ahmed S, Labrique AB, Islam K, Masanja H, Rutebemberwa E, Hyder AA. Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol. JMIR Res Protoc. 2017 May 5;6(5):e81. doi: 10.2196/resprot.7534.
Results Reference
background
PubMed Identifier
28476725
Citation
Gibson DG, Pereira A, Farrenkopf BA, Labrique AB, Pariyo GW, Hyder AA. Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review. J Med Internet Res. 2017 May 5;19(5):e139. doi: 10.2196/jmir.7428.
Results Reference
background
PubMed Identifier
28476724
Citation
Gibson DG, Farrenkopf BA, Pereira A, Labrique AB, Pariyo GW. The Development of an Interactive Voice Response Survey for Noncommunicable Disease Risk Factor Estimation: Technical Assessment and Cognitive Testing. J Med Internet Res. 2017 May 5;19(5):e112. doi: 10.2196/jmir.7340.
Results Reference
background
PubMed Identifier
28476722
Citation
Hyder AA, Wosu AC, Gibson DG, Labrique AB, Ali J, Pariyo GW. Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda. J Med Internet Res. 2017 May 5;19(5):e133. doi: 10.2196/jmir.7246.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs