IBIS Megastudy of Interventions to Encourage HIV Retesting

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06971367

Enrollment

40000

Registered

2025-05-14

Start date

2025-12-09

Completion date

2027-12-01

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, megastudy, Uganda, Kenya, HIV retesting

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.

Interventions

BEHAVIORALRisk assessment messaging

Participants will be shown 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 about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the HIV risk assessment content category.

BEHAVIORALU=U messaging

Participants will be shown 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 about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the U=U content category.

BEHAVIORALCommunity benefits messaging

Participants will be shown 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 about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Community Benefits content category.

BEHAVIORALFresh start effect

Participants will be shown 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 about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Fresh start effect content category.

BEHAVIORALEducation-based messaging

Participants will be shown 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 about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Education-based content category.

BEHAVIORALDefault appointment messaging

Participants will be shown 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 about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Default Appointment content category.

BEHAVIORALReserved for you messaging

Participants will be shown 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 about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the "Reserved for you" content category.

BEHAVIORALSocial norms (default) messaging

Participants will be shown 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. The video message will be delivered by the default avatar. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Social Norms content category.

BEHAVIORALSocial norms (varied) messaging

Participants will be shown 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. The video message will be delivered by an avatar that approximately matches each participant's age and sex. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Social Norms content category.

BEHAVIORALGoal-setting messaging

Participants will be shown a brief video message at their baseline visit, containing information related to goal-setting core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the goal-setting content category.

BEHAVIORALIncentive

Participants will be informed that they will receive a small financial incentive if they return for repeat HIV testing in 3-6 months after enrollment.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Kenya, Uganda

Contacts

CONTACTKara Marson, MPH

kara.marson@ucsf.edu650-346-5774

CONTACTGabriel Chamie, MD, MPH

gabriel.chamie@ucsf.edu

PRINCIPAL_INVESTIGATORGabriel Chamie, MD, MPH

University of California, San Francisco

PRINCIPAL_INVESTIGATORHarsha Thirumurthy, PhD

University of Pennsylvania

Outcome results

None listed

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