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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH132438 | U.S. NIH Grant/Contract | View source |
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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.
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| Kenya Medical Research Institute | OTHER |
| Infectious Diseases Research Collaboration, Uganda | OTHER |
| University of California, Berkeley |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV Risk Assessment | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
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| 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:
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| Healthy Living | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
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| Community benefits | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk assessment messaging | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Chamie, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institution (KEMRI) | Mbita | Kenya | ||||
| Infectious Diseases Research Collaboration (IDRC) |
Investigators will share de-identified IPD from our baseline questionnaire, which includes questions about subject demographics and HIV risk.
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 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).
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| OTHER |
| Makerere University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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| Fresh start effect | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
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| Education-based #1 | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
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| Education-based #2 | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
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| Default appointment | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
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| Reserved for you | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
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| Social norms | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
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| Empowerment/goal-setting | Experimental | A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts:
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| U=U messaging | Behavioral | 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. |
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| Healthy Living messaging | Behavioral | 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. |
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| Community benefits messaging | Behavioral | 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. |
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| Fresh start effect | Behavioral | 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. |
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| Education-based messaging (#1) | Behavioral | 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. |
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| Education-based #2 messaging (gamification) | Behavioral | 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. |
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| Default appointment messaging | Behavioral | 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. |
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| Reserved for you messaging | Behavioral | 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. |
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| Social norms messaging | Behavioral | 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. |
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| Empowerment messaging | Behavioral | 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. |
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| Mbarara |
| Uganda |