# Integrating U=U into HIV counseling: a cluster-randomized efficacy trial (INTUIT 2.0)

> **NIH NIH R01** · BOSTON UNIVERSITY MEDICAL CAMPUS · 2024 · $636,301

## Abstract

Project Summary
The elimination of HIV transmission with virally-suppressive antiretroviral therapy (ART) has provided the world
with a clear path to end the HIV epidemic through the provision of ART at HIV diagnosis. Undetectable HIV
is untransmittable (U=U). However we found limited knowledge of U=U among lay people in South Africa.
The U=U campaign was launched in 2016 to disseminate the scientific evidence that people with HIV cannot
transmit the virus if their viral load is undetectable. U=U has been endorsed by NIH, CDC, Pepfar, and
organizations in over 100 countries. U=U has been shown to reduce stigma, improve quality of life for people
living with HIV, and increase HIV testing. However, there is a critical need for evidence on (a) how best to
disseminate information on U=U, and (b) the impact of U=U on ART adherence and viral suppression.
With support from an NIH R34, we developed and piloted the “Undetectable & You” App, an educational
U=U intervention designed as a support tool for HIV counseling in South Africa. The App was “co-created” with
PLHIV and health providers and features the stories of PLHIV and their partners alongside the science of U=U.
In this R01, we will (Aim 1) refine the App based on lessons learned from our pilot; and (Aim 2)
establish the impact of the App on viral suppression in a cluster-randomized efficacy trial. We will
collect outcomes data through a prospective survey sample (n=880) as well as through the National Health
Laboratory Service (NHLS) National HIV Cohort (which we previously developed with NHLS), which offers a
platform for evaluation using fully de-identified data. We will assess impacts on viral suppression (primary
outcome) as well as ART visit adherence, retention in care, knowledge, attitudes, and mental health; and
incident STIs and pregnancies. The study builds on a longstanding collaboration between the PIs (Dr. Jacob
Bor, Dr. Dorina Onoya) and between Boston University and the Health Economics and Epidemiology Research
Office (HE2RO) at the University of Witwatersrand in South Africa. The study will be implemented in close
collaboration with South Africa’s National Department of Health (HIV Cluster) and Anova Health.
This study is highly innovative because we take a novel approach – disseminating information on the
prevention benefits of ART – to improve wellbeing of PLHIV and to motivate ART adherence leading to viral
suppression. The research will have significant public health impact as the findings have potential to shape
HIV counseling guidelines and U=U dissemination in the country with the world’s largest HIV epidemic.

## Key facts

- **NIH application ID:** 10925871
- **Project number:** 1R01MH135774-01A1
- **Recipient organization:** BOSTON UNIVERSITY MEDICAL CAMPUS
- **Principal Investigator:** Jacob Bor
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $636,301
- **Award type:** 1
- **Project period:** 2024-09-13 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10925871

## Citation

> US National Institutes of Health, RePORTER application 10925871, Integrating U=U into HIV counseling: a cluster-randomized efficacy trial (INTUIT 2.0) (1R01MH135774-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10925871. Licensed CC0.

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