Skip to main content
OpenTrials
Completed

NCT Number: NCT04504357

Integrating U=U Into HIV Counseling in South Africa

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Health Clinic A, Johannesburg, Gauteng, South Africa

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Tablet based U=U app

Behavioral

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.

Text messages

Other

Monthly text messages reinforcing intervention content

Primary outcomes

  1. Documented HIV Viral Load <200 Copies/mL at 3-10 Months

    Time frame: 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".

Secondary outcomes

  1. Started ART Within 30 Days of Baseline

    Time frame: 0-1 month

    As documented in linked clinical records

  2. ART Refills Beyond 30 Days

    Time frame: 1-6 month

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

  3. ART Uptake and First Refill Within 60 Days (Composite Outcome)

    Time frame: 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.

  4. Retained in Care at 1-2 Months

    Time frame: 1-2 months

    Any ART refills during months 1-2 post enrollment.

  5. Retained in Care at 3-4 Months

    Time frame: 3-4 months

    Any ART refills during months 3-4 post enrollment.

  6. Retained in Care at 5-6 Months

    Time frame: 5-6 months

    Any ART refills during months 5-6 post enrollment.

  7. Viral Load Monitoring at 3-10 Months

    Time frame: 3-10 months

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

  8. Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: INTUIT-SA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2020
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.