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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246058
• Other study ID #: ID213-2023; ub23Belus
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Grace H Yoon, MSc
• Phone: +4161 265 38 19
• Email: grace.yoon[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Lesotho	Butha Buthe Government Hospital	Butha Buthe

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	SolidarMed Lesotho

Country where clinical trial is conducted

Lesotho, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AA-Med score	Ambiguity aversion score difference between two survey groups; AA-Med contains 6 response items, each scored from 1 to 4 (1=disagree completely; 4=agree completely)	1 time measurement immediately after intervention
Secondary	Recruitment rate	Recruitment success rate (fully participated/ approached) difference between two recruitment attire groups	1 time measurement immediately after intervention

External Links

•   OSF project page