IBIS Megastudy- Pilot

University of California San Francisco (UCSF)

Status: Terminated

Conditions: HIV

Treatments: Behavioral: Fresh start effect; Behavioral: U=U messaging; Behavioral: Education-based messaging (#1); Behavioral: Healthy Living messaging; Behavioral: Risk assessment messaging; Behavioral: Empowerment messaging; Behavioral: Reserved for you messaging; Behavioral: Community benefits messaging; Behavioral: Social norms messaging; Behavioral: Default appointment messaging; Behavioral: Education-based #2 messaging (gamification)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06785103

R01MH132438 (U.S. NIH Grant/Contract)

23-39197

Details and patient eligibility

About

In this pilot study, the investigators will determine the feasibility and acceptability 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.

Full 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 by treating those identified to have disease promptly. The proposed study aims to identify approaches that would encourage individuals aged 15 years and above at high risk of HIV infection to retest. This IBIS Megastudy pilot trial will pilot 11 intervention prototypes for acceptability, feedback, and implementation outcomes prior to using the interventions in a larger-scale Megastudy trial (main trial to be submitted as a separate CT.gov record).

Enrollment: 98 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• at least 15 years of age
• At increased risk of HIV infection (defined by self-reported risk [at least one of the following over the 3 months prior to enrollment: >1 sexual partner, known HIV-positive sexual partner, diagnosed with a sexually transmitted infection, or paid or received gifts or money in exchange for sex] or by Kenya or Uganda MoH criteria for priority group)
• Documented negative HIV antibody test within 7 days 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 11 patient groups

HIV Risk Assessment

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, 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

Treatment:

Behavioral: Risk assessment messaging

U=U messaging

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, 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

Treatment:

Behavioral: U=U messaging

Healthy Living

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Illustrate how regular HIV testing is one part of a healthy lifestyle * Use examples to connect/compare retesting to other ways to protect/improve overall health

Treatment:

Behavioral: Healthy Living messaging

Community benefits

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, 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

Treatment:

Behavioral: Community benefits messaging

Fresh start effect

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Using a specific moment in time (like a resolution, start of a new month, etc.) 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)

Treatment:

Behavioral: Fresh start effect

Education-based #1

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, that adheres to the following core concepts: * Provide basic scientific information about HIV virus and transmission * Mention private, individual benefits of early HIV treatment

Treatment:

Behavioral: Education-based messaging (#1)

Education-based #2

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, 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

Treatment:

Behavioral: Education-based #2 messaging (gamification)

Default appointment

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, 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

Treatment:

Behavioral: Default appointment messaging

Reserved for you

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, 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

Treatment:

Behavioral: Reserved for you messaging

Social norms

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, 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 * I.e., don't be part of the small proportion that isn't getting regularly tested * Leverages social pressure to participate in retesting * Uses a relatable community member to deliver the message

Treatment:

Behavioral: Social norms messaging

Empowerment/goal-setting

Experimental group

Description:

A "nudge" message, based in behavioral economics theory, 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

Treatment:

Behavioral: Empowerment messaging