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HIVNCT06971367

IBIS Megastudy of Interventions to Encourage HIV Retesting

A study testing Risk assessment messaging, U=U messaging and Community benefits messaging in people with HIV, run by University of California, San Francisco at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Risk assessment messaging, U=U messaging and Community benefits messaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40,000 participants
Where
2 sitesin 2 countries
Study dates
9 Dec 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • HIV-positive at time of enrollment

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Kara Marson, MPH contact

650-346-5774

kara.marson@ucsf.edu

Gabriel Chamie, MD, MPH contact

gabriel.chamie@ucsf.edu

2 sites in 2 countries

Kenya1 site, 1 recruiting
  • Kenya Medical Research Institution (KEMRI)

    Mbita

    Sabina Ogachi, sabinaogachi@gmail.com

    James Ayieko, MBChB, MPH, PhD

    Recruiting

Other trials in Kenya

Uganda1 site, 1 recruiting
  • Infectious Diseases Research Collaboration (IDRC)

    Mbarara

    Ronald Kisitu, rkisitu@idrc-uganda.org

    Moses Kamya, MBChB, MMed, PhD

    Recruiting

Other trials in Uganda

About this study

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

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.

Read the 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.

Conditions
HIV
Being tested
Risk assessment messaging, U=U messaging, Community benefits messaging, Fresh start effect, Education-based messaging
Keywords
behavioral economics, "nudge" interventions, megastudy, Uganda, Kenya, HIV retesting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risk assessment messagingBehavioural

    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 messagingBehavioural

    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 messagingBehavioural

    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 effectBehavioural

    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 messagingBehavioural

    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 messagingBehavioural

    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 messagingBehavioural

    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) messagingBehavioural

    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) messagingBehavioural

    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 messagingBehavioural

    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.

  • IncentiveBehavioural

    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 groups in NCT06971367
Study groupRoleWhat they receive
HIV risk assessmentExperimentalA message that adheres to the following core concepts: - Emphasize that a negative test doesn't mean that previous behavior(s) weren't high-risk - Enable people to re-assess their own personal risk at a later/future date - Suggest risk behaviors to reflect on - If participant has engaged in one or more behaviors, emphasize their need to re-test
Receives: Behavioral: Risk assessment messaging
U=U messagingExperimentalA message that adheres to the following core concepts: Explain benefits of finding out your HIV-positive status as early after infection as possible and start treatment as soon as possible. These benefits include: -Prevent transmission of HIV to anyone -Live a normal life, with freedom in sexual choices and ability to start a family
Receives: Behavioral: U=U messaging
Community benefitsExperimentalA message that adheres to the following core concepts: - Emphasize that regular testing keeps the participant's community safe and healthy by reducing chances of transmitting HIV unknowingly - Call for responsibility- the participant to do their part for the community; they are an integral part of the solution
Receives: Behavioral: Community benefits messaging
Fresh start effectExperimentalA message that adheres to the following core concepts: - Using a specific moment in time (in this case, a negative HIV test) to motivate a healthy behavior (i.e. a "fresh start" moment) - emotional unburdening of resolving uncertainty (not knowing one's status is more stressful than knowing one's status, whether positive or negative, and being able to take healthy steps after knowing if the status is negative or positive)
Receives: Behavioral: Fresh start effect
Education-basedExperimentalA message that adheres to the following core concepts: -Increase attention to HIV re-testing reminder through interactive trivia questions -Correct or reinforce understanding about HIV prevention, transmission, and retesting
Receives: Behavioral: Education-based messaging
Default appointmentExperimentalA message that adheres to the following core concepts: - Having a set appointment will reduce uncertainty about availability for retest visit - Having an opt-out option for the future retesting appointment - A planning prompt to be specific about the participant's future plan for retesting - Gentle/soft commitment: by picking a date, mentally agree to come back to retest
Receives: Behavioral: Default appointment messaging
"Reserved for you"ExperimentalA message that adheres to the following core concepts: - Make participant aware that the test is available, and the clinic is welcoming the participant to receive it - "VIP status-" the participant is lucky/special to have this opportunity
Receives: Behavioral: Reserved for you messaging
Social norms- default messengerExperimentalA message that adheres to the following core concepts: - Reduce stigma and normalize retesting by explaining that it is a common practice for people to be aware of their HIV status and get tested - Leverages social pressure to participate in retesting - Uses a relatable community member to deliver the message. Message delivered by the default avatar.
Receives: Behavioral: Social norms (default) messaging
Social norms- varied messengerExperimentalA message that adheres to the following core concepts: - Reduce stigma and normalize retesting by explaining that it is a common practice for people to be aware of their HIV status and get tested often when they are at risk - Leverages social pressure to participate in retesting - Uses a relatable community member to deliver the message. Message delivered by avatar that approximately matches the participant's age and sex
Receives: Behavioral: Social norms (varied) messaging
Goal-settingExperimentalA message that adheres to the following core concepts: -Encouraging motivation of participants to set a goal for follow-up testing -Empowering individuals through promotion of HIV retesting
Receives: Behavioral: Goal-setting messaging
IncentiveExperimentalParticipants receive a small financial incentive for returning for a repeat HIV test within 3-6 months from enrollment
Receives: Behavioral: Incentive
Standard of care (Control)No interventionParticipants will receive standard of care messaging provided by Ministry of Health (MoH) HIV testing counselors.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV retesting uptake

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

    Measured: Measured 3-6 months after baseline visit

Secondary outcomes (1)
  1. PrEP uptake at follow up

    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.

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2025
  2. Study start9 Dec 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
40,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06971367
Sponsor's protocol ID
23-39197- 2
Other IDs
R01MH132438
Status last verified
Jan 2026
First submitted
6 May 2025
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Investigators will share de-identified IPD from our baseline and follow-up questionnaires, which includes questions about subject demographics and HIV risk.

Publications

  • Marson K, Kabami J, Buttenheim AM, Bennett D, Petersen ML, Havlir DV, Kamya MR, Ayieko J, Thirumurthy H, Chamie G. A megastudy of behavioral interventions to promote frequent HIV testing among adults at high risk of HIV infection in Kenya and Uganda: study protocol for a randomized controlled trial. Trials. 2026 May 21;27(1):524. doi: 10.1186/s13063-026-09783-4.

    PubMed 42163283

Questions about this trial

What is this clinical trial studying?

A study testing Risk assessment messaging, U=U messaging and Community benefits messaging in people with HIV, run by University of California, San Francisco at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kenya, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kara Marson, MPH (650-346-5774, kara.marson@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV retesting uptake (time frame: Measured 3-6 months after baseline visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06971367, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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