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Completed

NCT Number: NCT04394520

Use of Consent Language and Mode to Improve Interactive Voice Response Survey 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.

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Key information

Conditions

Surveys and Questionnaires Disease Attributes Noncommunicable Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Salud Publica Pontificia Universidad Javeriana, Bogotá, D.C., Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 19, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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