A Randomized Controlled Trial of Varying Consent Language and Mode to Improve Interactive Voice Response (IVR) Survey Performance in Colombia and Uganda
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 3,786
- Locations
- 2
- Primary Endpoint
- Cooperation Rate #1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Modified Intro, Active Opt-out
Modified introductory language will be used, and the consent mode will be changed to active opt-out only.
Intervention: Modified Introduction (Other)
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
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.
Intervention: Modified Introduction (Other)
Modified Intro, Active Opt-in
Modified introductory language will be used, and the consent mode will be changed to active opt-in only.
Intervention: Modified Introduction (Other)
Modified Intro, Active Opt-in
Modified introductory language will be used, and the consent mode will be changed to active opt-in only.
Intervention: Active Opt-in (Other)
Modified Intro, Active Opt-out
Modified introductory language will be used, and the consent mode will be changed to active opt-out only.
Intervention: Active Opt-out (Other)
Modified Intro, Passive Opt-in
Modified introductory language will be used, and the consent mode will be changed to passive opt-in only.
Intervention: Modified Introduction (Other)
Modified Intro, Passive Opt-in
Modified introductory language will be used, and the consent mode will be changed to passive opt-in only.
Intervention: Passive Opt-in (Other)
Outcomes
Primary Outcomes
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.
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
- Refusal Rate #2(Through study completion, an average of one month)
- Contact Rate #2(Through study completion, an average of one month)