Study 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.
IBIS Megastudy- Pilot
Transformative Approaches to Rapidly and Efficiently Test Demand Creation Interventions to Promote HIV Retesting in Adults at Increased Risk of HIV
2 other identifiers
interventional
98
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Mar 2025
Shorter than P25 for not_applicable hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2025
CompletedFirst Posted
Study publicly available on registry
January 21, 2025
CompletedStudy Start
First participant enrolled
March 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedJanuary 26, 2026
January 1, 2026
4 months
January 15, 2025
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
8-11 locally adapted nudge interventions for inclusion in an upcoming randomized-controlled trial (IBIS Megastudy RCT)
The primary outcome from this pilot trial will be 8-11 locally adapted nudge interventions, which will later be used in an upcoming RCT (IBIS Megastudy RCT) with a separate clinicaltrials.gov registration record (not yet entered). 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.
9 months
Study Arms (11)
HIV Risk Assessment
EXPERIMENTALA "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
EXPERIMENTALA "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
EXPERIMENTALA "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
EXPERIMENTALA "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
EXPERIMENTALA "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
EXPERIMENTALA "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
EXPERIMENTALA "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
EXPERIMENTALA "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
EXPERIMENTALA "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
EXPERIMENTALA "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
EXPERIMENTALA "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
Interventions
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- HIV-positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- University of Pennsylvaniacollaborator
- Kenya Medical Research Institutecollaborator
- Infectious Diseases Research Collaboration, Ugandacollaborator
- University of California, Berkeleycollaborator
- Makerere Universitycollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
Kenya Medical Research Institution (KEMRI)
Mbita, Kenya
Infectious Diseases Research Collaboration (IDRC)
Mbarara, Uganda
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Chamie, MD, MPH
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2025
First Posted
January 21, 2025
Study Start
March 27, 2025
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP).
Investigators will share de-identified IPD from our baseline questionnaire, which includes questions about subject demographics and HIV risk.