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

Not Applicable

Completed

• Conditions: Surveys and Questionnaires; Noncommunicable Diseases
• Interventions: Other: Modified Introduction; Other: Active Opt-in; Other: Passive Opt-in; Other: Active Opt-out

• Registration Number: NCT04394520
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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 Timeline

• Study Start: 2018-08-31
• Primary Completion: 2019-01-05
• Study Completion: 2019-01-05
• Status Verified: 2020-05
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-15
• Last Update Submitted: 2020-05-15
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3786

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Intro, Active Opt-in	Modified Introduction	Modified introductory language will be used, and the consent mode will be changed to active opt-in only.
Modified Intro, Active Opt-in	Active Opt-in	Modified introductory language will be used, and the consent mode will be changed to active opt-in only.
Modified Intro, Passive Opt-in	Modified Introduction	Modified introductory language will be used, and the consent mode will be changed to passive opt-in only.
Modified Intro, Passive Opt-in	Passive Opt-in	Modified introductory language will be used, and the consent mode will be changed to passive opt-in only.
Modified Intro, Standard Consent	Modified Introduction	Modified introductory language will be used, but the consent structure (active opt-in and active opt-out) will remain the same.
Modified Intro, Active Opt-out	Active Opt-out	Modified introductory language will be used, and the consent mode will be changed to active opt-out only.
Modified Intro, Active Opt-out	Modified Introduction	Modified introductory language will be used, and the consent mode will be changed to active opt-out only.

Primary Outcome Measures

Name	Time	Method
Cooperation Rate #1	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	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 Outcome Measures

Name	Time	Method
Refusal Rate #2	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.
Contact Rate #2	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.

Trial Locations

Locations (2)

Instituto de Salud Publica Pontificia Universidad Javeriana; 🇨🇴 Bogota, D.c., Colombia

Makerere University School of Public Health; 🇺🇬 Kampala, Uganda