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

NCT ID: NCT04394520

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3786 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2019-01-05

Brief Summary

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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

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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.

Conditions

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Surveys and Questionnaires Noncommunicable Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Modified Introduction

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

Group Type EXPERIMENTAL

Modified Introduction

Intervention Type 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.

Active Opt-in

Intervention Type 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-out

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

Group Type EXPERIMENTAL

Modified Introduction

Intervention Type 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.

Active Opt-out

Intervention Type 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, Passive Opt-in

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

Group Type EXPERIMENTAL

Modified Introduction

Intervention Type 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.

Passive Opt-in

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Bloomberg Family Foundation, Inc.

OTHER

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role collaborator

Pontificia Universidad Javeriana

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adnan A Hyder, PhD, MBBS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University Bloomberg School of Public Health

George W. Pariyo, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University Bloomberg School of Public Health

Locations

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Instituto de Salud Publica Pontificia Universidad Javeriana

Bogotá, D.C., Colombia

Site Status

Makerere University School of Public Health

Kampala, , Uganda

Site Status

Countries

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Colombia Uganda

References

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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.

Reference Type BACKGROUND
PMID: 28476729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28476725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28476724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28476722 (View on PubMed)

Other Identifiers

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00007318-6.1

Identifier Type: -

Identifier Source: org_study_id

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