Clinical trial NCT06971367: IBIS Megastudy of Interventions to Encourage HIV Retesting
Official title: Transformative Approaches to Rapidly and Efficiently Test Demand Creation Interventions to Promote HIV Retesting in Adults at Increased Risk of HIV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Keywords: behavioral economics
&#34;nudge&#34; interventions
megastudy
Uganda
Kenya
HIV retesting
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Kenya Medical Research Institute
name: Infectious Diseases Research Collaboration, Uganda
name: University of California, Berkeley
name: Makerere University
name: National Institute of Mental Health (NIMH)
First posted: 2025-05-14
Enrollment: 40000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: HIV retesting uptake
timeFrame: Measured 3-6 months after baseline visit
Secondary outcomes:
measure: PrEP uptake at follow up
timeFrame: 3-6 months
Other outcomes:
measure: HIV seroconversion at follow-up
timeFrame: Measured 3-6 months after baseline
measure: Linkage to ART among those who seroconvert at follow-up
timeFrame: 3-6 months
Locations:
city: Mbita
country: Kenya
facility: Kenya Medical Research Institution (KEMRI)
city: Mbarara
country: Uganda
facility: Infectious Diseases Research Collaboration (IDRC)
Study officials:
affiliation: University of California, San Francisco
name: Gabriel Chamie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Harsha Thirumurthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: