HIVNCT06969690
Question-Order Effect Experiment to Measure HIV Stigma
A study testing Survey questionnaire V1 and Survey questionnaire V2 in people with HIV, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
Question-order effect experiment to measure HIV-related stigma among people living with HIV (PWH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Survey questionnaire V1 and Survey questionnaire V2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUganda
- Study dates
- 2 Nov 2023to 31 Dec 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All HIV-positive (self-reported) adults who consider Nyakabare their primary place of residence and who are capable of providing consent
Who cannot join
- Minors younger than 18 years of age, with the exception of emancipated minors
- Persons who do not consider Nyakabare Parish their primary place of residence, e.g. persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside of the parish
- Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
- Persons who are not HIV positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Question-Order Effect Experiment to Measure HIV Stigma Among Persons With HIV (PWH) in Rural Uganda
Question-order effect experiment to measure HIV-related stigma among people living with HIV (PWH).
Read the detailed description
HIV-related stigma is a barrier to engagement in HIV prevention and treatment. Given the negative impact of stigma on the HIV continuum of care, accurate assessment of HIV-related stigma among people living with HIV (PWH) in resource-limited settings is paramount. The purpose of this study is to conduct a question order experiment to assess the extent to which the order of presented questions affects measurement of HIV-related stigma.
- Conditions
- HIV
- Being tested
- Survey questionnaire V1, Survey questionnaire V2
- Keywords
- HIV stigma, discrimination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey questionnaire V1Other
Each version of the questionnaire includes a different order of statements about which study participants are asked to provide a Yes, No, or It depends response.
Survey questionnaire V2Other
Each version of the questionnaire includes a different order of statements about which study participants are asked to provide a Yes, No, or It depends response.
| Study group | Role | What they receive |
|---|---|---|
| V1 | Experimental | As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The first treatment is a questionnaire with questions about internalized stigma followed by questions of experienced stigma. Each question is answered as Yes/No/It depends on knowing more details. Receives: Other: Survey questionnaire V1 |
| V2 | Experimental | As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The second treatment is a questionnaire with questions about experienced stigma followed by questions about internalized stigma. Each question is answered as Yes/No/It depends on knowing more details. Receives: Other: Survey questionnaire V2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-esteem
...do you think less of yourself because of your HIV status? (single item)
Measured: Baseline (assessed at the time the survey is administered)
Self-respect
...have you felt ashamed because of your HIV status? (single item)
Measured: Baseline (assessed at the time the survey is administered)
Experiences of harassment due to HV status
- have you lost respect or standing in the community because of your HIV status?
- have people talked badly about you because of your HIV status?
- have you been verbally insulted, harassed and/or threatened because of your HIV status?
- have you been physically assaulted because of your HIV status?
- has someone else disclosed your HIV status without your permission?
- have you felt that people have not wanted to sit next to you, for example on public transport, at church or in the waiting room, because of your HIV status? (six items)
Measured: Baseline (assessed at the time the survey is administered)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start2 Nov 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Alexander Tsai, Massachusetts General Hospital
- Investigators
- Alexander C Tsai, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969690
- Sponsor's protocol ID
- 2013P000395_5
- Other IDs
- R01MH125667
- Status last verified
- May 2026
- First submitted
- 5 May 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Question-Order Effect Experiment to Measure HIV Stigma Among Persons With HIV (PWH) in Rural Uganda
- ClinicalTrials.gov ID
- NCT06969690
- Acronym / sponsor ID
- 2013P000395_5
- Conditions
- HIV
- Keywords
- HIV stigma, discrimination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology, National Institute of Mental Health (NIMH)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 May 2025 (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.
Question-order effect experiment to measure HIV-related stigma among people living with HIV (PWH).
Detailed description
HIV-related stigma is a barrier to engagement in HIV prevention and treatment. Given the negative impact of stigma on the HIV continuum of care, accurate assessment of HIV-related stigma among people living with HIV (PWH) in resource-limited settings is paramount. The purpose of this study is to conduct a question order experiment to assess the extent to which the order of presented questions affects measurement of HIV-related stigma.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V1 | Experimental | Other: Survey questionnaire V1As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The first treatment is a questionnaire with questions about internalized stigma followed by questions of experienced stigma. Each question is answered as Yes/No/It depends on knowing more details. |
| V2 | Experimental | Other: Survey questionnaire V2As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The second treatment is a questionnaire with questions about experienced stigma followed by questions about internalized stigma. Each question is answered as Yes/No/It depends on knowing more details. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All HIV-positive (self-reported) adults who consider Nyakabare their primary place of residence and who are capable of providing consent
Key exclusion criteria (4 listed)
- Minors younger than 18 years of age, with the exception of emancipated minors
- Persons who do not consider Nyakabare Parish their primary place of residence, e.g. persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside of the parish
- Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
- Persons who are not HIV positive
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 |
|---|---|---|
| Survey questionnaire V1Each version of the questionnaire includes a different order of statements about which study participants are asked to provide a Yes, No, or It depends response. | Other | V1 |
| Survey questionnaire V2Each version of the questionnaire includes a different order of statements about which study participants are asked to provide a Yes, No, or It depends response. | Other | V2 |
Primary outcome
Self-esteem
Time frame: Baseline (assessed at the time the survey is administered)
...do you think less of yourself because of your HIV status? (single item)
Self-respect
Time frame: Baseline (assessed at the time the survey is administered)
...have you felt ashamed because of your HIV status? (single item)
Experiences of harassment due to HV status
Time frame: Baseline (assessed at the time the survey is administered)
* have you lost respect or standing in the community because of your HIV status? * have people talked badly about you because of your HIV status? * have you been verbally insulted, harassed and/or threatened because of your HIV status? * have you been physically assaulted because of your HIV status? * has someone else disclosed your HIV status without your permission? * have you felt that people have not wanted to sit next to you, for example on public transport, at church or in the waiting room, because of your HIV status? (six items)
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 1 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Alexander C Tsai, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey questionnaire V1 and Survey questionnaire V2 in people with HIV, run by Massachusetts General Hospital at 1 site in Uganda.
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 1 inclusion and 4 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 1 Jun 2026. 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 Uganda. 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?
Self-esteem (time frame: Baseline (assessed at the time the survey is administered)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026.