NCT06971367

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for not_applicable hiv

Timeline
18mo left

Started Dec 2025

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

May 6, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

December 9, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

May 6, 2025

Last Update Submit

January 22, 2026

Conditions

Keywords

behavioral economics"nudge" interventionsmegastudyUgandaKenyaHIV retesting

Outcome Measures

Primary Outcomes (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 3-6 months after baseline visit

Secondary Outcomes (1)

  • PrEP uptake at follow up

    3-6 months

Other Outcomes (2)

  • HIV seroconversion at follow-up

    Measured 3-6 months after baseline

  • Linkage to ART among those who seroconvert at follow-up

    3-6 months

Study Arms (12)

HIV risk assessment

EXPERIMENTAL

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

Behavioral: Risk assessment messaging

U=U messaging

EXPERIMENTAL

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

Behavioral: U=U messaging

Community benefits

EXPERIMENTAL

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

Behavioral: Community benefits messaging

Fresh start effect

EXPERIMENTAL

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)

Behavioral: Fresh start effect

Education-based

EXPERIMENTAL

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

Behavioral: Education-based messaging

Default appointment

EXPERIMENTAL

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

Behavioral: Default appointment messaging

"Reserved for you"

EXPERIMENTAL

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

Behavioral: Reserved for you messaging

Social norms- default messenger

EXPERIMENTAL

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.

Behavioral: Social norms (default) messaging

Social norms- varied messenger

EXPERIMENTAL

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

Behavioral: Social norms (varied) messaging

Goal-setting

EXPERIMENTAL

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

Behavioral: Goal-setting messaging

Incentive

EXPERIMENTAL

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

Behavioral: Incentive

Standard of care (Control)

NO INTERVENTION

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

Interventions

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.

HIV risk assessment
U=U messagingBEHAVIORAL

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.

U=U 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.

Community benefits

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.

Fresh start effect

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.

Education-based

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.

Default appointment

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.

"Reserved for you"

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- default messenger

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.

Social norms- varied messenger

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.

Goal-setting
IncentiveBEHAVIORAL

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.

Incentive

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • HIV-positive at time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kenya Medical Research Institution (KEMRI)

Mbita, Kenya

RECRUITING

Infectious Diseases Research Collaboration (IDRC)

Mbarara, Uganda

RECRUITING

Study Officials

  • Gabriel Chamie, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Harsha Thirumurthy, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kara Marson, MPH

CONTACT

Gabriel Chamie, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 14, 2025

Study Start

December 9, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Investigators will share de-identified IPD from our baseline and follow-up questionnaires, which includes questions about subject demographics and HIV risk.

Shared Documents
STUDY PROTOCOL
Time Frame
Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis.
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP).

Locations