HIVINTUIT-SANCT04504357
Integrating U=U Into HIV Counseling in South Africa
A study testing Tablet based U=U app and Text messages in people with HIV, run by Boston University at 3 sites in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Tablet based U=U app and Text messages
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 21 Nov 2022to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receiving HIV care at a public sector health facility in South Africa
- Speaks English, Zulu, or Sotho
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
Primary Health Clinic A
Johannesburg, Gauteng
Primary Health Clinic B
Johannesburg, Gauteng
Primary Health Clinic C
Johannesburg
About this study
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.
Read more
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Tablet based U=U app, Text messages
- Keywords
- Antiretroviral treatment (ART), Person living with HIV (PLWH), Treatment-as-prevention (TasP), Undetectable=Untransmittable (U=U), HIV counseling, South Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet based U=U appBehavioural
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 messagesOther
Monthly text messages reinforcing intervention content
| Study group | Role | What they receive |
|---|---|---|
| Arm A- No intervention | No intervention | Participants randomized to Arm A received no research intervention. |
| Arm B- "Undetectable & You" App | Experimental | 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. Receives: Behavioral: Tablet based U=U app; Other: Text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 3-10 months
Secondary outcomes (8)
Started ART Within 30 Days of Baseline
As documented in linked clinical records
Measured: 0-1 month
ART Refills Beyond 30 Days
Any ART refills recorded in clinical records after 30 days post-enrollment.
Measured: 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.
Measured: 0-2 months
Retained in Care at 1-2 Months
Any ART refills during months 1-2 post enrollment.
Measured: 1-2 months
Retained in Care at 3-4 Months
Any ART refills during months 3-4 post enrollment.
Measured: 3-4 months
Retained in Care at 5-6 Months
Any ART refills during months 5-6 post enrollment.
Measured: 5-6 months
Viral Load Monitoring at 3-10 Months
Based on linked clinical records, 3-10 months after baseline
Measured: 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.
Measured: after intervention (on average 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start21 Nov 2022
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jacob Bor, ScD SM, Principal investigator, BU School of Public Health, Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504357
- Sponsor's protocol ID
- H-40706
- Other IDs
- R34MH122323
- Acronym
- INTUIT-SA
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2020
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Replication data, code, and protocol (including SAP) will be posted on a public repository when the trial results manuscript is published.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating U=U Into HIV Counseling in South Africa
- ClinicalTrials.gov ID
- NCT04504357
- Acronym / sponsor ID
- INTUIT-SA / H-40706
- Conditions
- HIV
- Keywords
- Antiretroviral treatment (ART), Person living with HIV (PLWH), Treatment-as-prevention (TasP), Undetectable=Untransmittable (U=U), HIV counseling, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A- No intervention | No intervention | –Participants randomized to Arm A received no research intervention. |
| Arm B- "Undetectable & You" App | Experimental | Behavioral: Tablet based U=U app, Other: Text messagesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- receiving HIV care at a public sector health facility in South Africa
- Speaks English, Zulu, or Sotho
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet based U=U appTablet 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. | Behavioural | Arm B- "Undetectable & You" App |
| Text messagesMonthly text messages reinforcing intervention content | Other | Arm B- "Undetectable & You" App |
Primary outcome
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".
8 secondary outcomes
Started ART Within 30 Days of Baseline
Time frame: 0-1 month
ART Refills Beyond 30 Days
Time frame: 1-6 month
ART Uptake and First Refill Within 60 Days (Composite Outcome)
Time frame: 0-2 months
Retained in Care at 1-2 Months
Time frame: 1-2 months
Retained in Care at 3-4 Months
Time frame: 3-4 months
Retained in Care at 5-6 Months
Time frame: 5-6 months
Viral Load Monitoring at 3-10 Months
Time frame: 3-10 months
Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed
Time frame: after intervention (on average 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Replication data, code, and protocol (including SAP) will be posted on a public repository when the trial results manuscript is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Bor, ScD SM principal investigator
BU School of Public Health, Global Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet based U=U app and Text messages in people with HIV, run by Boston University at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documented HIV Viral Load <200 Copies/mL at 3-10 Months (time frame: 3-10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.