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

Study Overview
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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.

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

Conditions
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Surveys and Questionnaires, Noncommunicable Diseases

Intervention / Treatment
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* Other: Modified Introduction
* Other: Active Opt-in
* Other: Active Opt-out
* Other: Passive Opt-in


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>Modified introductory language will be used, but the consent structure (active opt-in and active opt-out) will remain the same. | Other: Modified Introduction<br>* 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.<br>|
| Experimental: Modified Intro, Active Opt-in<br>Modified introductory language will be used, and the consent mode will be changed to active opt-in only. | Other: Modified Introduction<br>* 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.<br>Other: Active Opt-in<br>* 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.<br>|
| Experimental: Modified Intro, Active Opt-out<br>Modified introductory language will be used, and the consent mode will be changed to active opt-out only. | Other: Modified Introduction<br>* 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.<br>Other: Active Opt-out<br>* 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.<br>|
| Experimental: Modified Intro, Passive Opt-in<br>Modified introductory language will be used, and the consent mode will be changed to passive opt-in only. | Other: Modified Introduction<br>* 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.<br>Other: Passive Opt-in<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of one month | 
| 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. | Through study completion, an average of one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile phone surveys, interactive voice response, consent