Health BehaviorNCT06246058
Measuring Anticipated Attitudes and Behavior Towards a New Medical Treatment in Lesotho
An observational study of Health Behavior and Motivation, run by University Hospital, Basel, Switzerland at 1 site in Lesotho.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Motivation, Health Care Utilization
- What is being tested?
- Partner support, Formal recruiter attire and Without Partner support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 475 participants
- Where
- 1 siteLesotho
- Study dates
- 15 Feb 2024to 13 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment will occur in the Butha Buthe district hospital and health centers in the Butha Buthe district.
Who may be able to join
- 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
Show all 14Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Health Behavior, Motivation, Health Care Utilization, Consumer Behavior, Social Behavior, Health Care Seeking Behavior
- Being tested
- Partner support, Formal recruiter attire, Without Partner support, Casual recruiter attire
- Keywords
- Social support, Uncertainty, Low-resource setting, Ambiguity aversion, Behavioral economics, Research administration, Recruitment success
- Medical subject headings
- Health Behavior, Patient Acceptance of Health Care, Consumer Behavior, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner supportBehavioural
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 attireBehavioural
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 supportBehavioural
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 attireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Survey Group 1 - Support | Receives a vignette with partner support component before answering AA-Med response items. Receives: Behavioral: Partner support | |
| Survey Group 2 - Control | Receives a vignette without partner support component before answering AA-Med response items. Receives: Behavioral: Without Partner support | |
| Recruitment Group 1 - Casual | Recruited by staff wearing casual attire. Receives: Behavioral: Casual recruiter attire | |
| Recruitment Group 2 - Formal | Recruited by staff wearing formal (clinical) attire Receives: Behavioral: Formal recruiter attire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 time measurement immediately after intervention
Secondary outcomes (1)
Recruitment rate
Recruitment success rate (fully participated/ approached) difference between two recruitment attire groups
Measured: 1 time measurement immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start15 Feb 2024
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- SolidarMed
- Responsible party
- Sponsor
- Investigators
- Grace H Yoon, MSc, Principal investigator, University Hospital Basel, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246058
- Sponsor's protocol ID
- ID213-2023; ub23Belus
- Status last verified
- Nov 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
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.
PubMed 19731127Yoon GH, Stoffel S, Aghlmandi S, Lesaoana N, Mahlatsi P, Chakela M, Belus JM, Briel M. Effect of different recruiter attire on trial participation in Lesotho: a randomized study within a trial. Trials. 2026 Mar 20;27(1):290. doi: 10.1186/s13063-026-09638-y.
PubMed 41862952
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Anticipated Attitudes and Behavior Towards a New Medical Treatment in Lesotho
- ClinicalTrials.gov ID
- NCT06246058
- Acronym / sponsor ID
- ID213-2023; ub23Belus
- Conditions
- Health Behavior, Motivation, Health Care Utilization, Consumer Behavior, Social Behavior, Health Care Seeking Behavior
- Keywords
- Social support, Uncertainty, Low-resource setting, Ambiguity aversion, Behavioral economics, Research administration, Recruitment success
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- SolidarMed
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Survey Group 1 - Support | – | Behavioral: Partner supportReceives a vignette with partner support component before answering AA-Med response items. |
| Survey Group 2 - Control | – | Behavioral: Without Partner supportReceives a vignette without partner support component before answering AA-Med response items. |
| Recruitment Group 1 - Casual | – | Behavioral: Casual recruiter attireRecruited by staff wearing casual attire. |
| Recruitment Group 2 - Formal | – | Behavioral: Formal recruiter attireRecruited by staff wearing formal (clinical) attire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will occur in the Butha Buthe district hospital and health centers in the Butha Buthe district.
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partner supportThe 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. | Behavioural | Survey Group 1 - Support |
| Formal recruiter attireThe 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. | Behavioural | Recruitment Group 2 - Formal |
| Without Partner supportThe 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. | Behavioural | Survey Group 2 - Control |
| Casual recruiter attireThe 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. | Behavioural | Recruitment Group 1 - Casual |
Primary outcome
AA-Med score
Time frame: 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)
1 secondary outcome
Recruitment rate
Time frame: 1 time measurement immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Background: PubMed 19731127Han 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.
- Derived from this study: PubMed 41862952Yoon GH, Stoffel S, Aghlmandi S, Lesaoana N, Mahlatsi P, Chakela M, Belus JM, Briel M. Effect of different recruiter attire on trial participation in Lesotho: a randomized study within a trial. Trials. 2026 Mar 20;27(1):290. doi: 10.1186/s13063-026-09638-y.
- OSF project pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Health Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace H Yoon, MSc principal investigator
University Hospital Basel, University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior and Motivation, run by University Hospital, Basel, Switzerland at 1 site in Lesotho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lesotho. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AA-Med score (time frame: 1 time measurement immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06246058, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.