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Surveys and QuestionnairesNCT04394520

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

A study testing Modified Introduction, Active Opt-in and Active Opt-out in people with Surveys and Questionnaires and Noncommunicable Diseases, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Modified Introduction, Active Opt-in and Active Opt-out
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,786 participants
Where
2 sitesin 2 countries
Study dates
31 Aug 2018to 5 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Less than 18 years of age

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Colombia1 site

  • Instituto de Salud Publica Pontificia Universidad Javeriana

    Bogotá, D.C.

Other trials in Colombia

Uganda1 site

  • Makerere University School of Public Health

    Kampala

Other trials in Uganda

About this study

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

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.

Read the 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.

Being tested
Modified Introduction, Active Opt-in, Active Opt-out, Passive Opt-in
Keywords
mobile phone surveys, interactive voice response, consent
Medical subject headings
Noncommunicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified IntroductionOther

    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.

  • Active Opt-inOther

    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.

  • Active Opt-outOther

    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.

  • Passive Opt-inOther

    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.

Study groups in NCT04394520
Study groupRoleWhat they receive
ControlNo interventionNo 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 ConsentExperimentalModified introductory language will be used, but the consent structure (active opt-in and active opt-out) will remain the same.
Receives: Other: Modified Introduction
Modified Intro, Active Opt-inExperimentalModified introductory language will be used, and the consent mode will be changed to active opt-in only.
Receives: Other: Modified Introduction; Other: Active Opt-in
Modified Intro, Active Opt-outExperimentalModified introductory language will be used, and the consent mode will be changed to active opt-out only.
Receives: Other: Modified Introduction; Other: Active Opt-out
Modified Intro, Passive Opt-inExperimentalModified introductory language will be used, and the consent mode will be changed to passive opt-in only.
Receives: Other: Modified Introduction; Other: Passive Opt-in

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of one month

  2. 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.

    Measured: Through study completion, an average of one month

Secondary outcomes (2)

  1. 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.

    Measured: Through study completion, an average of one month

  2. 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.

    Measured: Through study completion, an average of one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start31 Aug 2018
  3. Primary completion5 Jan 2019
  4. Study completion5 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
3,786 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04394520
Sponsor's protocol ID
00007318-6.1
Status last verified
May 2020
First submitted
15 May 2020
Last updated
19 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28476729

  • 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.

    PubMed 28476725

  • 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.

    PubMed 28476724

  • 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.

    PubMed 28476722

Questions about this trial

What is this clinical trial studying?

A study testing Modified Introduction, Active Opt-in and Active Opt-out in people with Surveys and Questionnaires and Noncommunicable Diseases, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cooperation Rate #1 (time frame: Through study completion, an average of one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04394520, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.

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