NCT04504357: INTUIT-SA

Integrating U=U Into HIV Counseling in South Africa

Completed NA Results posted Last updated 19 August 2025

What this trial tests

NA trial testing Tablet based U=U app in HIV in 135 participants. Completed in 15 February 2024.

Timeline

21 November 2022

Primary endpoint
15 February 2024

15 February 2024

Quick facts

Lead sponsor	Boston University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	135
Start date	21 November 2022
Primary completion	15 February 2024
Estimated completion	15 February 2024
Sites	3 locations across South Africa

Drugs / interventions tested

• Tablet based U=U app
• Text messages

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Boston University

Who can join

18 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Documented HIV Viral Load <200 Copies/mL at 3-10 Months Primary · 3-10 months

As documented in linked clinical records. The first viral load (VL) value taken during the period 3-10 months after baseline. Outcome will be defined as documented viral suppression among all patients: 1 = VL\<200; 0 = VL\>=200 OR no documented VL. The 200 copy threshold matches WHO definition for "zero transmission risk".

Group	Value	95% CI
Arm A- No Intervention	22
Arm B- "Undetectable & You" App	33

Started ART Within 30 Days of Baseline Secondary · 0-1 month

As documented in linked clinical records

Group	Value	95% CI
Arm A- No Intervention	64
Arm B- "Undetectable & You" App	64

ART Refills Beyond 30 Days Secondary · 1-6 month

Any ART refills recorded in clinical records after 30 days post-enrollment.

Group	Value	95% CI
Arm A- No Intervention	55
Arm B- "Undetectable & You" App	60

ART Uptake and First Refill Within 60 Days (Composite Outcome) Secondary · 0-2 months

Indicator = 1 if the participant started ART and returned to the clinic for their first ART medication refill within 60 days after enrollment. Indicator = 0 if the participant did not start ART, or if patient started ART but did not have a medication refill within 60 days of enrollment.

Group	Value	95% CI
Arm A- No Intervention	50
Arm B- "Undetectable & You" App	53

Retained in Care at 1-2 Months Secondary · 1-2 months

Any ART refills during months 1-2 post enrollment.

Group	Value	95% CI
Arm A- No Intervention	54
Arm B- "Undetectable & You" App	55

Retained in Care at 3-4 Months Secondary · 3-4 months

Any ART refills during months 3-4 post enrollment.

Group	Value	95% CI
Arm A- No Intervention	48
Arm B- "Undetectable & You" App	54

Retained in Care at 5-6 Months Secondary · 5-6 months

Any ART refills during months 5-6 post enrollment.

Group	Value	95% CI
Arm A- No Intervention	38
Arm B- "Undetectable & You" App	47

Viral Load Monitoring at 3-10 Months Secondary · 3-10 months

Based on linked clinical records, 3-10 months after baseline

Group	Value	95% CI
Arm A- No Intervention	30
Arm B- "Undetectable & You" App	40

Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed Secondary · after intervention (on average 6 months)

Likelihood of HIV transmission (on a 0 to 100 scale) in a hypothetical mixed-status couple after a year of weekly condomless sex, where the HIV+ partner is on ART. Higher scores are associated with higher perceived risk.

Group	Value	95% CI
Arm A- No Intervention	37.7
Arm B- "Undetectable & You" App	12.7

Sponsor's own description

The near-elimination of HIV transmission with antiretroviral therapy (ART) has provided the world with a clear path to end the HIV epidemic through the mass provision of ART at diagnosis, i.e. test-and-treat. Despite the substantial prevention benefits of ART, the investigators found minimal knowledge of treatment-as-prevention (TasP) in two population-based surveys recently conducted in South Africa. In addition, current public health messaging and clinical HIV counselling in South Africa do not emphasize the prevention benefits of ART.

In this formative research study the investigators developed an app-based educational video intervention that provides information on Undetectable = Untransmittable (U=U) that is locally-appropriate and can be integrated into routine HIV counselling. The intervention was be piloted in a clinical trial of patients in South Africa receiving HIV post-test and adherence counselling services, to determine feasibility and acceptability, impact on U=U knowledge and attitudes, impact on stigma and psychological well being, and preliminary evidence for ART uptake and adherence.

The study builds on a longstanding collaboration between Boston University and the Health Economics and Epidemiology Research Office (HE2RO) at the University of Witwatersrand in Johannesburg, South Africa. The study is highly innovative because the investigators take a novel approach - disseminating information on the prevention benefits of ART - to improve the wellbeing of people living with HIV (PLWH) and motivate early uptake of ART in South Africa.

The investigators hypothesized that disseminating information about U=U and treatment-as-prevention could increase ART adherence, retention, and viral suppression, enabling countries to maximize the impact of test-and-treat.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Changing Knowledge and Attitudes Towards HIV Treatment-as-Prevention and "Undetectable = Untransmittable": A Systematic Review.
   Bor J, Fischer C, Modi M, Richman B, et al · · 2021 · cited 112× · PMID 34036459 · DOI 10.1007/s10461-021-03296-8
2. Designing effective U = U communication strategies considering the needs of PLHIV, their partners, and healthcare worker constraints in South African clinics.
   Onoya D, Sineke T, King R, Mokhele I, et al · · 2023 · cited 8× · PMID 38117817 · DOI 10.1371/journal.pone.0295920