Integrating U=U Into HIV Counseling in South Africa (INTUIT-SA)

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Tablet based U=U app; Other: Text messages

Detailed Description

We developed a U=U-focused HIV treatment literacy App called "Undetectable & You", to integrate U=U into HIV counseling in South Africa. We then piloted the App in a randomized clinical trial.

The randomized pilot trial was conducted at three public sector clinics in Johannesburg, South Africa, to establish intervention acceptability, effects on knowledge and attitudes, and preliminary impact on ART uptake, adherence, retention, and viral suppression (n=135).

Patients completing HIV post-test or adherence counseling were referred to study staff and randomized 1:1 to no intervention (Arm A) vs. a ~20min interaction with "Undetectable & You", a tablet-based App developed to disseminate information about U=U via PLHIV testimonials (Arm B). Participants in Arm B also received monthly text messages reinforcing intervention content. The order of the messages was randomized to ascertain whether different messages were better at driving engagement with the App.

Investigators assessed feasibility and acceptability of the "Undetectable & You" App, resonance of different key messages and videos in the App, and its impact on knowledge and attitudes related to TasP. Additionally, ART uptake, appointment adherence, retention on treatment, and viral monitoring were assessed in clinical records through six months, with VL data collected through 10 months. Qualitative exit interviews were conducted with participants and clinic staff (n=30).

In addition to the primary and secondary outcomes specified below, we assessed for effect modification in the primary outcome of viral suppression by key constructs of our theoretical model and participant demographics.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Johannesburg, South Africa
    • Primary Health Clinic C
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Primary Health Clinic A
    • Johannesburg, Gauteng, South Africa
      • Primary Health Clinic B

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• receiving HIV care at a public sector health facility in South Africa
• Speaks English, Zulu, or Sotho

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm A- No intervention; Participants randomized to Arm A received no research intervention.
Experimental: Arm B- "Undetectable & You" App; Participants randomized to Arm B interacted with "Undetectable & You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.	Behavioral: Tablet based U=U app; Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.; Other: Text messages; Monthly text messages reinforcing intervention content

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Documented HIV Viral Load <200 Copies/mL at 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".	3-10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Started ART Within 30 Days of Baseline	As documented in linked clinical records	0-1 month
ART Refills Beyond 30 Days	Any ART refills recorded in clinical records after 30 days post-enrollment.	1-6 month
ART Uptake and First Refill Within 60 Days (Composite Outcome)	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.	0-2 months
Retained in Care at 1-2 Months	Any ART refills during months 1-2 post enrollment.	1-2 months
Retained in Care at 3-4 Months	Any ART refills during months 3-4 post enrollment.	3-4 months
Retained in Care at 5-6 Months	Any ART refills during months 5-6 post enrollment.	5-6 months
Viral Load Monitoring at 3-10 Months	Based on linked clinical records, 3-10 months after baseline	3-10 months
Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed	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.	after intervention (on average 6 months)

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jacob Bor, ScD SM, BU School of Public Health, Global Health

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: South Africa; HIV counseling; Antiretroviral treatment (ART); Person living with HIV (PLWH); Treatment-as-prevention (TasP); Undetectable=Untransmittable (U=U)
• Other Study ID Numbers: H-40706; R34MH122323 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Replication data, code, and protocol (including SAP) will be posted on a public repository when the trial results manuscript is published.
• IPD Sharing Time Frame: At manuscript publication.
• IPD Sharing Access Criteria: Publicly accessible
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No