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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 475

Contacts and Locations

Study Locations

• Lesotho
  • Butha Buthe, Lesotho
    • Butha Buthe Government Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Recruitment will occur in the Butha Buthe district hospital and health centers in the Butha Buthe district.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Recruitment success rate (fully participated/ approached) difference between two recruitment attire groups	1 time measurement immediately after intervention

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: SolidarMed Lesotho
• Investigators: Principal Investigator: Grace H Yoon, MSc, University Hospital Basel, University of Basel

Publications and helpful links

General Publications

• 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.

Helpful Links

• OSF project page

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): September 13, 2024
• Study Completion (Actual): September 13, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Behavioral economics; Social support; Uncertainty; Low-resource setting; Ambiguity aversion; Research administration; Recruitment success
• Other Study ID Numbers: ID213-2023; ub23Belus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest. Data shared will be completely anonymized. Study components, aggregate data and results will be disseminated on OSF. Any additional data sharing is subject to approval of the request and execution of all applicable agreements (i.e. a material transfer agreement).
• IPD Sharing Time Frame: Starting six months after completion of data collection for up to 24 months thereafter.
• IPD Sharing Access Criteria: Independent researchers with academic interest.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No