Clinical trial NCT04394520: Use of Consent Language and Mode to Improve Interactive Voice Response Survey in Colombia and Uganda
Official title: A Randomized Controlled Trial of Varying Consent Language and Mode to Improve Interactive Voice Response (IVR) Survey Performance in Colombia and Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surveys and Questionnaires
Noncommunicable Diseases
Keywords: mobile phone surveys
interactive voice response
consent
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: The Bloomberg Family Foundation, Inc.
name: Makerere University
name: Pontificia Universidad Javeriana
First posted: 2020-05-19
Enrollment: 3786
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cooperation Rate #1
timeFrame: Through study completion, an average of one month
measure: Response Rate #4
timeFrame: Through study completion, an average of one month
Secondary outcomes:
measure: Refusal Rate #2
timeFrame: Through study completion, an average of one month
measure: Contact Rate #2
timeFrame: Through study completion, an average of one month
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Instituto de Salud Publica Pontificia Universidad Javeriana
state: D.c.
city: Kampala
country: Uganda
facility: Makerere University School of Public Health
Study officials:
affiliation: Johns Hopkins University Bloomberg School of Public Health
name: Adnan A Hyder, PhD, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University Bloomberg School of Public Health
name: George W. Pariyo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibson DG, Pariyo GW, Wosu AC, Greenleaf AR, Ali J, Ahmed S, Labrique AB, Islam K, Masanja H, Rutebemberwa E, Hyder AA. Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol. JMIR Res Protoc. 2017 May 5;6(5):e81. doi: 10.2196/resprot.7534.
citation: Gibson DG, Pereira A, Farrenkopf BA, Labrique AB, Pariyo GW, Hyder AA. Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review. J Med Internet Res. 2017 May 5;19(5):e139. doi: 10.2196/jmir.7428.
citation: Gibson DG, Farrenkopf BA, Pereira A, Labrique AB, Pariyo GW. The Development of an Interactive Voice Response Survey for Noncommunicable Disease Risk Factor Estimation: Technical Assessment and Cognitive Testing. J Med Internet Res. 2017 May 5;19(5):e112. doi: 10.2196/jmir.7340.
citation: Hyder AA, Wosu AC, Gibson DG, Labrique AB, Ali J, Pariyo GW. Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda. J Med Internet Res. 2017 May 5;19(5):e133. doi: 10.2196/jmir.7246.