IBIS Megastudy- Pilot

Not Applicable

Recruiting

• Conditions: HIV

• Registration Number: NCT06785103
• Lead Sponsor: University of California, San Francisco

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).

Study Timeline

• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Study Start: 2025-03-27
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
8-11 locally adapted nudge interventions for inclusion in an upcoming randomized-controlled trial (IBIS Megastudy RCT)	9 months	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.

Trial Locations

Locations (2)

Kenya Medical Research Institution (KEMRI); 🇰🇪 Mbita, Kenya

Infectious Diseases Research Collaboration (IDRC); 🇺🇬 Mbarara, Uganda