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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Noncommunicable Diseases; Surveys and Questionnaires

Treatments: Other: Active Opt-in; Other: Modified Introduction; Other: Active Opt-out; Other: Passive Opt-in

Study type: Interventional

Funder types: Other

Identifiers

NCT04394520

00007318-6.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,786 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,786 participants in 5 patient groups

Control

No Intervention group

Description:

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

Experimental group

Description:

Modified introductory language will be used, but the consent structure (active opt-in and active opt-out) will remain the same.

Treatment:

Other: Modified Introduction

Modified Intro, Active Opt-in

Experimental group

Description:

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

Treatment:

Other: Modified Introduction

Other: Active Opt-in

Modified Intro, Active Opt-out

Experimental group

Description:

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

Treatment:

Other: Modified Introduction

Other: Active Opt-out

Modified Intro, Passive Opt-in

Experimental group

Description:

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

Treatment:

Other: Modified Introduction

Other: Passive Opt-in