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

NCT04394520 | Completed

• 1 other identifier: 00007318-6.1
• Study Type: interventional
• Target: 3,786
• Locations: 2 countries
• Sites: 2

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.

Conditions

Surveys and Questionnaires; Noncommunicable Diseases

Keywords

mobile phone surveys; interactive voice response; consent

Outcome Measures

Primary Outcomes (2)

• 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.

  Through study completion, an average of one month

• 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.

  Through study completion, an average of one month

Secondary Outcomes (2)

• Refusal Rate #2

  Through study completion, an average of one month

• Contact Rate #2

  Through study completion, an average of one month

Study Arms (5)

Control

NO INTERVENTION

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 Intro, Standard Consent

EXPERIMENTAL

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

Other: Modified Introduction

Modified Intro, Active Opt-in

EXPERIMENTAL

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

Other: Modified Introduction; Other: Active Opt-in

Modified Intro, Active Opt-out

EXPERIMENTAL

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

Other: Modified Introduction; Other: Active Opt-out

Modified Intro, Passive Opt-in

EXPERIMENTAL

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

Other: Modified Introduction; Other: Passive Opt-in

Interventions

Modified Introduction OTHER

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.

Modified Intro, Active Opt-in; Modified Intro, Active Opt-out; Modified Intro, Passive Opt-in; Modified Intro, Standard Consent

Active Opt-in OTHER

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.

Modified Intro, Active Opt-in

Active Opt-out OTHER

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.

Modified Intro, Active Opt-out

Passive Opt-in OTHER

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.

Modified Intro, Passive Opt-in

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Less than 18 years of age

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• The Bloomberg Family Foundation, Inc.: collaborator
• Makerere University: collaborator
• Pontificia Universidad Javeriana: collaborator

Study Sites (2)

Instituto de Salud Publica Pontificia Universidad Javeriana

Bogotá, D.C., Colombia

Location

Makerere University School of Public Health

Kampala, Uganda

Location

Related Publications (4)

• 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.

  PMID: 28476729 BACKGROUND

• 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.

  PMID: 28476725 BACKGROUND

• 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.

  PMID: 28476724 BACKGROUND

• 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.

  PMID: 28476722 BACKGROUND

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adnan A Hyder, PhD, MBBS

  Johns Hopkins University Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• George W. Pariyo, PhD

  Johns Hopkins University Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 19, 2020
• Study Start: August 31, 2018
• Primary Completion: January 5, 2019
• Study Completion: January 5, 2019
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1); UG (1)