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IBIS Megastudy- Pilot

Transformative Approaches to Rapidly and Efficiently Test Demand Creation Interventions to Promote HIV Retesting in Adults at Increased Risk of HIV

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06785103
Enrollment
98
Registered
2025-01-21
Start date
2025-03-27
Completion date
2025-07-31
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

behavioral economics, "nudge" interventions, Uganda, Kenya, HIV retesting

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.

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).

Interventions

BEHAVIORALU=U messaging

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 "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.

BEHAVIORALHealthy Living messaging

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.

BEHAVIORALEducation-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.

BEHAVIORALEducation-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.

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.

BEHAVIORALSocial norms messaging

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.

BEHAVIORALEmpowerment messaging

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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
University of Pennsylvania
CollaboratorOTHER
Kenya Medical Research Institute
CollaboratorOTHER
Infectious Diseases Research Collaboration, Uganda
CollaboratorOTHER
University of California, Berkeley
CollaboratorOTHER
Makerere University
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* HIV-positive

Design outcomes

Primary

MeasureTime frameDescription
8-11 locally adapted nudge interventions for inclusion in an upcoming randomized-controlled trial (IBIS Megastudy RCT)9 monthsThe 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.

Countries

Kenya, Uganda

Contacts

PRINCIPAL_INVESTIGATORGabriel Chamie, MD, MPH

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026