HIVNCT06785103
IBIS Megastudy- Pilot
A study testing Risk assessment messaging, U=U messaging and Healthy Living messaging in people with HIV, run by University of California, San Francisco at 2 sites in 2 countries.
Trial summary
In this pilot study, the investigators will determine the feasibility and acceptability of multiple low-cost behavioral interventions, designed with end-user input, to promote HIV retesting among adults in rural Kenya and Uganda who have higher risk of HIV exposure. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Risk assessment messaging, U=U messaging and Healthy Living messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Mar 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- at least 15 years of age
- At increased risk of HIV infection (defined by self-reported risk [at least one of the following over the 3 months prior to enrollment: >1 sexual partner, known HIV-positive sexual partner, diagnosed with a sexually transmitted infection, or paid or received gifts or money in exchange for sex] or by Kenya or Uganda MoH criteria for priority group)
- Documented negative HIV antibody test within 7 days of enrollment
- No intent to migrate out of community in next 3 months
- Daily access to a mobile phone (required since some of the interventions will be delivered by phone)
Who cannot join
- HIV-positive
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Transformative Approaches to Rapidly and Efficiently Test Demand Creation Interventions to Promote HIV Retesting in Adults at Increased Risk of HIV
In this pilot study, the investigators will determine the feasibility and acceptability of multiple low-cost behavioral interventions, designed with end-user input, to promote HIV retesting among adults in rural Kenya and Uganda who have higher risk of HIV exposure.
Read the detailed description
HIV re-testing is crucial in ensuring early identification of disease to promote well-being of an individual as well as preventing onward spread of infection by treating those identified to have disease promptly. The proposed study aims to identify approaches that would encourage individuals aged 15 years and above at high risk of HIV infection to retest. This IBIS Megastudy pilot trial will pilot 11 intervention prototypes for acceptability, feedback, and implementation outcomes prior to using the interventions in a larger-scale Megastudy trial (main trial to be submitted as a separate CT.gov record).
- Conditions
- HIV
- Being tested
- Risk assessment messaging, U=U messaging, Healthy Living messaging, Community benefits messaging, Fresh start effect
- Keywords
- behavioral economics, "nudge" interventions, Uganda, Kenya, HIV retesting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk assessment messagingBehavioural
Participants who are randomized to the "HIV risk assessment" arm will receive a brief video message at their baseline visit, containing information related to HIV risk assessment core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the HIV risk assessment content category.
U=U messagingBehavioural
Participants who are randomized to the "U=U" arm will receive a brief video message at their baseline visit, containing information related to U=U core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the U=U content category.
Healthy Living messagingBehavioural
Participants who are randomized to the "Healthy Living" arm will receive a brief video message at their baseline visit, containing information related to Healthy Living core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Healthy Living content category.
Community benefits messagingBehavioural
Participants who are randomized to the "Community benefits" arm will receive a brief video message at their baseline visit, containing information related to Community Benefits core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Community Benefits content category.
Fresh start effectBehavioural
Participants who are randomized to the "Fresh start effect" arm will receive a brief video message at their baseline visit, containing information related to Fresh Start core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Fresh start effect content category.
Education-based messaging (#1)Behavioural
Participants who are randomized to the "Education-based #1" arm will receive a brief video message at their baseline visit, containing information related to HIV education core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Education-based #1 content category.
Education-based #2 messaging (gamification)Behavioural
Participants who are randomized to the "Education-based #2" arm will receive a brief video message at their baseline visit, containing information related to HIV education/gamification core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Education-based/gamification content category.
Default appointment messagingBehavioural
Participants who are randomized to the "Default appointment" arm will receive a brief video message at their baseline visit, containing information related to Default Appointment core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Default Appointment content category.
Reserved for you messagingBehavioural
Participants who are randomized to the "Reserved for you" arm will receive a brief video message at their baseline visit, containing information related to the Reserved for you core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Reserved for you content category.
Social norms messagingBehavioural
Participants who are randomized to the "Social norms" arm will receive a brief video message at their baseline visit, containing information related to Social Norms core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Social Norms content category.
Empowerment messagingBehavioural
Participants who are randomized to the "Empowerment/goal setting" arm will receive a brief video message at their baseline visit, containing information related to Empowerment core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Empowerment content category.
| Study group | Role | What they receive |
|---|---|---|
| HIV Risk Assessment | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
* Emphasize that a negative test doesn't mean that previous behavior(s) weren't high-risk
* Enable people to re-assess their own personal risk at a later/future date
* Suggest risk behaviors to reflect on
* If participant has engaged in one or more behaviors, emphasize their need to re-test Receives: Behavioral: Risk assessment messaging |
| U=U messaging | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
Explain benefits of finding out your HIV-positive status as early after infection as possible and start treatment as soon as possible. These benefits include:
* Prevent transmission of HIV to anyone
* Live a normal life, with freedom in sexual choices and ability to start a family Receives: Behavioral: U=U messaging |
| Healthy Living | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
* Illustrate how regular HIV testing is one part of a healthy lifestyle
* Use examples to connect/compare retesting to other ways to protect/improve overall health Receives: Behavioral: Healthy Living messaging |
| Community benefits | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
* Emphasize that regular testing keeps the participant's community safe and healthy by reducing chances of transmitting HIV unknowingly
* Call for responsibility- the participant to do their part for the community; they are an integral part of the solution Receives: Behavioral: Community benefits messaging |
| Fresh start effect | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
* Using a specific moment in time (like a resolution, start of a new month, etc.) to motivate a healthy behavior (i.e. a "fresh start" moment)
* emotional unburdening of resolving uncertainty (not knowing one's status is more stressful than knowing one's status, whether positive or negative, and being able to take healthy steps after knowing if the status is negative or positive) Receives: Behavioral: Fresh start effect |
| Education-based #1 | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
* Provide basic scientific information about HIV virus and transmission
* Mention private, individual benefits of early HIV treatment Receives: Behavioral: Education-based messaging (#1) |
| Education-based #2 | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
* Increase attention to HIV re-testing reminder through interactive trivia questions
* Correct or reinforce understanding about HIV prevention, transmission, and retesting Receives: Behavioral: Education-based #2 messaging (gamification) |
| Default appointment | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
* Having a set appointment will reduce uncertainty about availability for retest visit
* Having an opt-out option for the future retesting appointment
* A planning prompt to be specific about the participant's future plan for retesting
* Gentle/soft commitment: by picking a date, mentally agree to come back to retest Receives: Behavioral: Default appointment messaging |
| Reserved for you | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
* Make participant aware that the test is available, and the clinic is welcoming the participant to receive it
* "VIP status-" the participant is lucky/special to have this opportunity Receives: Behavioral: Reserved for you messaging |
| Social norms | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
* Reduce stigma and normalize retesting by explaining that it is a common practice for people to be aware of their HIV status and get tested often when they are at risk
* I.e., don't be part of the small proportion that isn't getting regularly tested
* Leverages social pressure to participate in retesting
* Uses a relatable community member to deliver the message Receives: Behavioral: Social norms messaging |
| Empowerment/goal-setting | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
* Encouraging motivation of participants to set a goal for follow-up testing
* Empowering individuals through promotion of HIV retesting Receives: Behavioral: Empowerment messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Locally Adapted Nudge Interventions for Inclusion in an Upcoming Randomized-controlled Trial (IBIS Megastudy RCT)
The primary outcome from this pilot trial will be feasibility of the locally adapted nudge interventions, which will later be used in an upcoming RCT (IBIS Megastudy RCT) with a separate clinicaltrials.gov registration record (NCT06971367). Feasibility will be measured by the number of participants who successfully received the intervention in each study arm. The final nudge interventions which will be developed through this pilot trial will include local language and content refinement of the video and SMS scripts.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start27 Mar 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Why it stopped: On 5/1/25, the US NIH issued Notice: NOT-OD-25-104, which prohibited foreign subawards from being nested under a parent grant. Our pilot trial was scheduled for renewal on 8/1/25, and the NOA was delayed. Without funding, we had to halt the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Kenya Medical Research Institute, Infectious Diseases Research Collaboration, Uganda, University of California, Berkeley, Makerere University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gabriel Chamie, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785103
- Sponsor's protocol ID
- 23-39197
- Other IDs
- R01MH132438
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2025
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share de-identified IPD from our baseline questionnaire, which includes questions about subject demographics and HIV risk.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transformative Approaches to Rapidly and Efficiently Test Demand Creation Interventions to Promote HIV Retesting in Adults at Increased Risk of HIV
- ClinicalTrials.gov ID
- NCT06785103
- Acronym / sponsor ID
- 23-39197
- Conditions
- HIV
- Keywords
- behavioral economics, "nudge" interventions, Uganda, Kenya, HIV retesting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: On 5/1/25, the US NIH issued Notice: NOT-OD-25-104, which prohibited foreign subawards from being nested under a parent grant. Our pilot trial was scheduled for renewal on 8/1/25, and the NOA was delayed. Without funding, we had to halt the trial.
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Kenya Medical Research Institute, Infectious Diseases Research Collaboration, Uganda, University of California, Berkeley, Makerere University, National Institute of Mental Health (NIMH)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 21 Jan 2025 (actual)
- Results
- Posted 19 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this pilot study, the investigators will determine the feasibility and acceptability of multiple low-cost behavioral interventions, designed with end-user input, to promote HIV retesting among adults in rural Kenya and Uganda who have higher risk of HIV exposure.
Detailed description
HIV re-testing is crucial in ensuring early identification of disease to promote well-being of an individual as well as preventing onward spread of infection by treating those identified to have disease promptly. The proposed study aims to identify approaches that would encourage individuals aged 15 years and above at high risk of HIV infection to retest. This IBIS Megastudy pilot trial will pilot 11 intervention prototypes for acceptability, feedback, and implementation outcomes prior to using the interventions in a larger-scale Megastudy trial (main trial to be submitted as a separate CT.gov record).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| HIV Risk Assessment | Experimental | Behavioral: Risk assessment messagingA "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Emphasize that a negative test doesn't mean that previous behavior(s) weren't high-risk * Enable people to re-assess their own personal risk at a later/future date * Suggest risk behaviors to reflect on * If participant has engaged in one or more behaviors, emphasize their need to re-test |
| U=U messaging | Experimental | Behavioral: U=U messagingA "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: Explain benefits of finding out your HIV-positive status as early after infection as possible and start treatment as soon as possible. These benefits include: * Prevent transmission of HIV to anyone * Live a normal life, with freedom in sexual choices and ability to start a family |
| Healthy Living | Experimental | Behavioral: Healthy Living messagingA "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Illustrate how regular HIV testing is one part of a healthy lifestyle * Use examples to connect/compare retesting to other ways to protect/improve overall health |
| Community benefits | Experimental | Behavioral: Community benefits messagingA "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Emphasize that regular testing keeps the participant's community safe and healthy by reducing chances of transmitting HIV unknowingly * Call for responsibility- the participant to do their part for the community; they are an integral part of the solution |
| Fresh start effect | Experimental | Behavioral: Fresh start effectA "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Using a specific moment in time (like a resolution, start of a new month, etc.) to motivate a healthy behavior (i.e. a "fresh start" moment) * emotional unburdening of resolving uncertainty (not knowing one's status is more stressful than knowing one's status, whether positive or negative, and being able to take healthy steps after knowing if the status is negative or positive) |
| Education-based #1 | Experimental | Behavioral: Education-based messaging (#1)A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Provide basic scientific information about HIV virus and transmission * Mention private, individual benefits of early HIV treatment |
| Education-based #2 | Experimental | Behavioral: Education-based #2 messaging (gamification)A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Increase attention to HIV re-testing reminder through interactive trivia questions * Correct or reinforce understanding about HIV prevention, transmission, and retesting |
| Default appointment | Experimental | Behavioral: Default appointment messagingA "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Having a set appointment will reduce uncertainty about availability for retest visit * Having an opt-out option for the future retesting appointment * A planning prompt to be specific about the participant's future plan for retesting * Gentle/soft commitment: by picking a date, mentally agree to come back to retest |
| Reserved for you | Experimental | Behavioral: Reserved for you messagingA "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Make participant aware that the test is available, and the clinic is welcoming the participant to receive it * "VIP status-" the participant is lucky/special to have this opportunity |
| Social norms | Experimental | Behavioral: Social norms messagingA "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Reduce stigma and normalize retesting by explaining that it is a common practice for people to be aware of their HIV status and get tested often when they are at risk * I.e., don't be part of the small proportion that isn't getting regularly tested * Leverages social pressure to participate in retesting * Uses a relatable community member to deliver the message |
| Empowerment/goal-setting | Experimental | Behavioral: Empowerment messagingA "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Encouraging motivation of participants to set a goal for follow-up testing * Empowering individuals through promotion of HIV retesting |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- at least 15 years of age
- At increased risk of HIV infection (defined by self-reported risk [at least one of the following over the 3 months prior to enrollment: >1 sexual partner, known HIV-positive sexual partner, diagnosed with a sexually transmitted infection, or paid or received gifts or money in exchange for sex] or by Kenya or Uganda MoH criteria for priority group)
- Documented negative HIV antibody test within 7 days of enrollment
- No intent to migrate out of community in next 3 months
- Daily access to a mobile phone (required since some of the interventions will be delivered by phone)
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Risk assessment messagingParticipants who are randomized to the "HIV risk assessment" arm will receive a brief video message at their baseline visit, containing information related to HIV risk assessment core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the HIV risk assessment content category. | Behavioural | HIV Risk Assessment |
| U=U messagingParticipants who are randomized to the "U=U" arm will receive a brief video message at their baseline visit, containing information related to U=U core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the U=U content category. | Behavioural | U=U messaging |
| Healthy Living messagingParticipants who are randomized to the "Healthy Living" arm will receive a brief video message at their baseline visit, containing information related to Healthy Living core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Healthy Living content category. | Behavioural | Healthy Living |
| Community benefits messagingParticipants who are randomized to the "Community benefits" arm will receive a brief video message at their baseline visit, containing information related to Community Benefits core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Community Benefits content category. | Behavioural | Community benefits |
| Fresh start effectParticipants who are randomized to the "Fresh start effect" arm will receive a brief video message at their baseline visit, containing information related to Fresh Start core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Fresh start effect content category. | Behavioural | Fresh start effect |
| Education-based messaging (#1)Participants who are randomized to the "Education-based #1" arm will receive a brief video message at their baseline visit, containing information related to HIV education core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Education-based #1 content category. | Behavioural | Education-based #1 |
| Education-based #2 messaging (gamification)Participants who are randomized to the "Education-based #2" arm will receive a brief video message at their baseline visit, containing information related to HIV education/gamification core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Education-based/gamification content category. | Behavioural | Education-based #2 |
| Default appointment messagingParticipants who are randomized to the "Default appointment" arm will receive a brief video message at their baseline visit, containing information related to Default Appointment core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Default Appointment content category. | Behavioural | Default appointment |
| Reserved for you messagingParticipants who are randomized to the "Reserved for you" arm will receive a brief video message at their baseline visit, containing information related to the Reserved for you core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Reserved for you content category. | Behavioural | Reserved for you |
| Social norms messagingParticipants who are randomized to the "Social norms" arm will receive a brief video message at their baseline visit, containing information related to Social Norms core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Social Norms content category. | Behavioural | Social norms |
| Empowerment messagingParticipants who are randomized to the "Empowerment/goal setting" arm will receive a brief video message at their baseline visit, containing information related to Empowerment core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at 8 and 11 week after baseline reminding them about HIV retesting and re-emphasizing concepts from the Empowerment content category. | Behavioural | Empowerment/goal-setting |
Primary outcome
Feasibility of Locally Adapted Nudge Interventions for Inclusion in an Upcoming Randomized-controlled Trial (IBIS Megastudy RCT)
Time frame: 4 months
The primary outcome from this pilot trial will be feasibility of the locally adapted nudge interventions, which will later be used in an upcoming RCT (IBIS Megastudy RCT) with a separate clinicaltrials.gov registration record (NCT06971367). Feasibility will be measured by the number of participants who successfully received the intervention in each study arm. The final nudge interventions which will be developed through this pilot trial will include local language and content refinement of the video and SMS scripts.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Investigators will share de-identified IPD from our baseline questionnaire, which includes questions about subject demographics and HIV risk.
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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.
Gabriel Chamie, MD, MPH principal investigator
University of California, San Francisco
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk assessment messaging, U=U messaging and Healthy Living messaging in people with HIV, run by University of California, San Francisco at 2 sites in 2 countries.
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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, 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?
Yes. Results are posted in the registry (first posted 19 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Locally Adapted Nudge Interventions for Inclusion in an Upcoming Randomized-controlled Trial (IBIS Megastudy RCT) (time frame: 4 months). 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 19 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.