Measuring Anticipated Attitudes and Behavior Towards a New Medical Treatment in Lesotho

NCT ID: NCT06246058

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

475 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-15

Study Completion Date

2024-09-13

Brief Summary

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The primary research objective is to examine how uncertainty towards a new medical treatment changes in patients when a partner (can be any close other, i.e. romantic partner, family member, or a close friend) supports the new treatment choice and is willing to be involved in the patient's treatment. I hypothesize that when the patients know that their partner supports uptake of the new medical treatment and will physically accompany them to the visit, patients will (1) experience lower levels of uncertainty and (2) report a higher likelihood of participating in a new treatment in the future, as compared to patients who face the decision about the new treatment alone.

Detailed Description

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Host trial: Uncertainty survey experiment

This study uses a survey experiment with a hypothetical scenario (vignette) to test the concept of uncertainty and the impact of partner involvement in a hypothetical new medical treatment in patients seeking healthcare in the Butha Buthe district hospital. Specifically, this host trial will be a single-blinded randomized survey experimental design. This means that there will be two versions of the vignette and participants will be randomly given only one version (1:1 allocation). The participants will not be made aware that there is a different version of the vignette but the researchers will be aware of which version the participant receives. The difference between the vignettes (called behavioral manipulation) is whether or not the partner endorses the hypothetical new medical treatment related to the patient's current illness. See the Study measures Section for the specific vignettes.

Study Within a Trial (SWAT): Impact of the researcher's attire on recruitment rates

Within the host trial, the nested study on researcher's attire will take place as a "Study Within A Trial" or SWAT. SWAT is an increasingly recognized method of research that aims to improve the research methodology within an existing trial. The SWAT on researcher attire will take place in the recruitment phase of the host experiment with day-based cluster randomization between white coat versus casual attire assignment. These attire assignments will be given along with the given week's recruitment assignments to the two Basotho research assistants who will work on the host trial. The nested study does not impact the procedures of the survey experiment. Researcher's attire during recruitment will remain the same throughout the survey delivery until the end of the participant's study visit.

Conditions

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Health Behavior Motivation Health Care Utilization Consumer Behavior Social Behavior Health Care Seeking Behavior Recruitment Researcher-Subject Relations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Survey Group 1 - Support

Receives a vignette with partner support component before answering AA-Med response items.

Partner support

Intervention Type BEHAVIORAL

The intervention group's survey vignette will include a component of partner support which serves as the key behavioral manipulation tested for this study's primary outcome.

Survey Group 2 - Control

Receives a vignette without partner support component before answering AA-Med response items.

Without Partner support

Intervention Type BEHAVIORAL

The intervention group's survey vignette will NOT include a component of partner support which serves as the key behavioral manipulation tested for this study's primary outcome.

Recruitment Group 1 - Casual

Recruited by staff wearing casual attire.

Casual recruiter attire

Intervention Type BEHAVIORAL

The SWAT will separately test recruitment rates - as measured by rate of survey completion divided by total number of individuals approached - based on how the recruiters are dressed.

CASUAL dress code of the recruiter is the intervention in this case.

Recruitment Group 2 - Formal

Recruited by staff wearing formal (clinical) attire

Formal recruiter attire

Intervention Type BEHAVIORAL

The SWAT will separately test recruitment rates - as measured by rate of survey completion divided by total number of individuals approached - based on how the recruiters are dressed.

FORMAL dress code of the recruiter is the intervention in this case, defined as clinical attire alluding to some clinical authority.

Interventions

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Partner support

The intervention group's survey vignette will include a component of partner support which serves as the key behavioral manipulation tested for this study's primary outcome.

Intervention Type BEHAVIORAL

Formal recruiter attire

The SWAT will separately test recruitment rates - as measured by rate of survey completion divided by total number of individuals approached - based on how the recruiters are dressed.

FORMAL dress code of the recruiter is the intervention in this case, defined as clinical attire alluding to some clinical authority.

Intervention Type BEHAVIORAL

Without Partner support

The intervention group's survey vignette will NOT include a component of partner support which serves as the key behavioral manipulation tested for this study's primary outcome.

Intervention Type BEHAVIORAL

Casual recruiter attire

The SWAT will separately test recruitment rates - as measured by rate of survey completion divided by total number of individuals approached - based on how the recruiters are dressed.

CASUAL dress code of the recruiter is the intervention in this case.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults over 18 years of age
* Are comfortable reading and writing in Sesotho or English
* Attending as a patient in Butha Buthe-area hospital or health center for a known clinical diagnosis or standard health screening related to one of these illness categories:
* HIV
* Other sexually-transmitted infection (i.e. gonorrhea, syphilis, hepatitis)
* Breathing problem/ tuberculosis
* Heart issues/ blood pressure
* Diabetes/ sugar level
* Bone/ muscle problem
* Mental health
* Memory/ thinking problem
* Teeth/ mouth problem
* Cancer
* Maternal health (i.e. pregnancy, post-partum care)

Exclusion Criteria

* Have participated in this study before
* Visible intoxication and/or distress, as deemed by trained research assistant
* Unable to make independent decisions; unable to complete informed consent
* Warrants emergency medical care
* Visiting the hospital for another person (i.e. their child, relative, partner)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SolidarMed

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grace H Yoon, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, University of Basel

Locations

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Butha Buthe Government Hospital

Butha-Buthe, , Lesotho

Site Status

Countries

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Lesotho

References

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Han PK, Reeve BB, Moser RP, Klein WM. Aversion to ambiguity regarding medical tests and treatments: measurement, prevalence, and relationship to sociodemographic factors. J Health Commun. 2009 Sep;14(6):556-72. doi: 10.1080/10810730903089630.

Reference Type BACKGROUND
PMID: 19731127 (View on PubMed)

Related Links

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Other Identifiers

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ID213-2023; ub23Belus

Identifier Type: -

Identifier Source: org_study_id

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