IBIS Megastudy of Interventions to Encourage HIV Retesting

Not Applicable

Not yet recruiting

• Conditions: HIV

• Registration Number: NCT06971367
• Lead Sponsor: University of California, San Francisco

Brief Summary

In this study, the investigators will test the effectiveness 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. The IBIS megastudy of interventions to encourage HIV retesting aims to test up to 12 different strategies aimed at encouraging repeat testing of HIV among individuals \>/= 15 years old who are at increased risk of HIV infection. The different strategies are aimed at modifying individual behavior to enhance HIV testing. The study aims to enroll 30,000-40,000 individuals from 8 HIV testing sites in South West Uganda and Western Kenya. The study will then evaluate the effectiveness of the interventions by comparing HIV retesting rates 3-6 months later in the different study arms. The data collected during the study will further be used to understand which of the interventions offered worked best and for whom.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-21
• Study Start: 2025-07
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

• at least 15 years of age
• Accessing HIV testing services at study-associated hospitals or clinics
• At increased risk of HIV infection (defined by national (Kenya or Uganda) MoH criteria)
• Documented negative HIV antibody test at time 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 at time of enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HIV retesting uptake	Measured 3-6 months after baseline visit	The proportion of participants in each study arm who return for repeat HIV testing within 3-6 months after the baseline visit.

Secondary Outcome Measures

Name	Time	Method
PrEP uptake at follow up	3-6 months	The proportion of participants who initiate PrEP at the time of HIV retesting, among those who are HIV-negative and not currently taking PrEP. PrEP dispensing will be done in accordance with Kenyan and Ugandan guidelines. Uptake will be recorded on study CRFs.

Trial Locations

Locations (2)

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

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