IBIS Megastudy of Interventions to Encourage HIV Retesting

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: HIV

Treatments: Behavioral: Reserved for you messaging; Behavioral: Social norms (varied) messaging; Behavioral: Incentive; Behavioral: U=U messaging; Behavioral: Goal-setting messaging; Behavioral: Risk assessment messaging; Behavioral: Fresh start effect; Behavioral: Social norms (default) messaging; Behavioral: Default appointment messaging; Behavioral: Education-based messaging; Behavioral: Community benefits messaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06971367

R01MH132438 (U.S. NIH Grant/Contract)

23-39197- 2

Details and patient eligibility

About

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.

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. 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.

Enrollment: 40,000 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40,000 participants in 12 patient groups

HIV risk assessment

Experimental group

Description:

A 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

Treatment:

Behavioral: Risk assessment messaging

U=U messaging

Experimental group

Description:

A 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

Treatment:

Behavioral: U=U messaging

Community benefits

Experimental group

Description:

A 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

Treatment:

Behavioral: Community benefits messaging

Fresh start effect

Experimental group

Description:

A 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)

Treatment:

Behavioral: Fresh start effect

Education-based

Experimental group

Description:

A 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

Treatment:

Behavioral: Education-based messaging

Default appointment

Experimental group

Description:

A 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

Treatment:

Behavioral: Default appointment messaging

"Reserved for you"

Experimental group

Description:

A 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

Treatment:

Behavioral: Reserved for you messaging

Social norms- default messenger

Experimental group

Description:

A 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.

Treatment:

Behavioral: Social norms (default) messaging

Social norms- varied messenger

Experimental group

Description:

A 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

Treatment:

Behavioral: Social norms (varied) messaging

Goal-setting

Experimental group

Description:

A 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

Treatment:

Behavioral: Goal-setting messaging

Incentive

Experimental group

Description:

Participants receive a small financial incentive for returning for a repeat HIV test within 3-6 months from enrollment

Treatment:

Behavioral: Incentive

Standard of care (Control)

No Intervention group

Description:

Participants will receive standard of care messaging provided by Ministry of Health (MoH) HIV testing counselors.