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

Completed

• Conditions: Social Behavior; Motivation; Consumer Behavior; Health Care Seeking Behavior; Recruitment; Health Behavior; Health Care Utilization; Researcher-Subject Relations
• Interventions: Behavioral: Formal recruiter attire; Behavioral: Without Partner support; Behavioral: Casual recruiter attire; Behavioral: Partner support

• Registration Number: NCT06246058
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-07
• Study Start: 2024-02-15
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recruitment Group 2 - Formal	Formal recruiter attire	Recruited by staff wearing formal (clinical) attire
Survey Group 2 - Control	Without Partner support	Receives a vignette without partner support component before answering AA-Med response items.
Recruitment Group 1 - Casual	Casual recruiter attire	Recruited by staff wearing casual attire.
Survey Group 1 - Support	Partner support	Receives a vignette with partner support component before answering AA-Med response items.

Primary Outcome Measures

Name	Time	Method
AA-Med score	1 time measurement immediately after intervention	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)

Secondary Outcome Measures

Name	Time	Method
Recruitment rate	1 time measurement immediately after intervention	Recruitment success rate (fully participated/ approached) difference between two recruitment attire groups

Trial Locations

Locations (1)

Butha Buthe Government Hospital; 🇱🇸 Butha Buthe, Lesotho