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NCT Number: NCT06971367

IBIS Megastudy of Interventions to Encourage HIV Retesting

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.

Recruiting

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Key information

Conditions

HIV

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institution (KEMRI), Mbita, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risk assessment messaging

Behavioral

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.

U=U messaging

Behavioral

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.

Community benefits messaging

Behavioral

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.

Fresh start effect

Behavioral

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.

Education-based messaging

Behavioral

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.

Default appointment messaging

Behavioral

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.

Reserved for you messaging

Behavioral

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.

Social norms (default) messaging

Behavioral

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.

Social norms (varied) messaging

Behavioral

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.

Goal-setting messaging

Behavioral

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.

Incentive

Behavioral

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.

Primary outcomes

  1. HIV retesting uptake

    Time frame: 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 outcomes

  1. PrEP uptake at follow up

    Time frame: 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.

Other outcomes

  1. HIV seroconversion at follow-up

    Time frame: Measured 3-6 months after baseline

    The proportion of participants returning for follow up who have a newly positive HIV test result. HIV seroconversion will be measured as documented rapid HIV antibody test at the time of study follow-up retesting (3-6 months after baseline).

  2. Linkage to ART among those who seroconvert at follow-up

    Time frame: 3-6 months

    The proportion of participants that seroconvert at follow up who link to ART. ART dispensing will be done in accordance with Kenyan and Ugandan guidelines. Uptake will be recorded on study CRFs.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel Chamie, MD, MPH

CONTACT

[email protected]

Kara Marson, MPH

CONTACT

[email protected]

650-346-5774

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Infectious Diseases Research Collaboration, Uganda
  • Kenya Medical Research Institute
  • Makerere University
  • National Institute of Mental Health (NIMH)
  • University of California, Berkeley
  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 14, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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