Clinical trial NCT06246058: Measuring Anticipated Attitudes and Behavior Towards a New Medical Treatment in Lesotho
Official title: Measuring Anticipated Attitudes and Behavior Towards a New Medical Treatment in Lesotho
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Motivation
Health Care Utilization
Consumer Behavior
Social Behavior
Health Care Seeking Behavior
Recruitment
Researcher-Subject Relations
Keywords: Social support
Uncertainty
Low-resource setting
Ambiguity aversion
Behavioral economics
Research administration
Recruitment success
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: SolidarMed
First posted: 2024-02-07
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitment will occur in the Butha Buthe district hospital and health centers in the Butha Buthe district.

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: AA-Med score
timeFrame: 1 time measurement immediately after intervention
Secondary outcomes:
measure: Recruitment rate
timeFrame: 1 time measurement immediately after intervention
Other outcomes:
Locations:
city: Butha Buthe
country: Lesotho
facility: Butha Buthe Government Hospital
Study officials:
affiliation: University Hospital Basel, University of Basel
name: Grace H Yoon, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.