HIVNCT07199634
Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0)
A study testing "Undetectable & You" HIV treatment literacy app in people with HIV, run by Boston University.
Trial summary
Undetectable = Untransmittable (U=U) is the scientific consensus that people with human immunodeficiency virus (HIV) who achieve viral suppression through antiretroviral treatment (ART) cannot transmit the virus sexually. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- "Undetectable & You" HIV treatment literacy app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinic inclusion criteria:
- Public sector facility
- Primary care, outpatient clinic
- Follows national guidelines for HIV counseling
- Has dedicated HIV counselors
- At least 10 patients receiving HIV counseling per week (based on pre-study data)
Show all 23Show fewer
- Follows national guidelines for lab monitoring (CD4 at diagnosis; VLs at 3 and 10 months on ART)
- Is interested in participating, as indicated by "sign-off" from the head nurse / facility director
- Individual participant inclusion criteria:
- Adult (at least 18 years)
- Received HIV post-test counselling or adherence counseling
- Able to consent
- Provides informed consent
- Speaks one of the primary study languages: English, Zulu, Sotho, Tsonga
- Receives care at the facility as evidence by having a clinical record there
- Individual participant exclusion Criteria:
- Require acute medical care that would be hindered by participation in the study
- Determined by clinical staff not to be physically or emotionally able to initiate ART
- Children (under 18 years).
- Prisoners or other institutionalized persons.
- Do not speak one of the primary study languages: English, Zulu, Sotho
- Are not able to consent (e.g. intoxicated or of limited mental capacity)
- Do not consent to participate in the study, including linkage to clinical records for follow-up
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dorina Onoya, PhD, MBA contact
About this study
Official title: Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0): a Cluster-Randomized Trial
Undetectable = Untransmittable (U=U) is the scientific consensus that people with human immunodeficiency virus (HIV) who achieve viral suppression through antiretroviral treatment (ART) cannot transmit the virus sexually. While global studies confirm this, awareness of U=U remains very limited in sub-Saharan Africa, including South Africa, where only two-thirds of people living with HIV (PLHIV) are virally suppressed despite having the largest treatment program globally. Many PLHIV delay or avoid ART because they feel healthy and perceive little benefit, while also fearing stigma, disclosure, and social costs. U=U offers powerful motivation for ART uptake and adherence by reframing treatment as both a personal health and prevention tool, reducing internalised stigma, strengthening self-image, and supporting HIV prevention altruism. Yet, dissemination in Africa has lagged. To address this, the investigators developed an HIV treatment literacy App called "Undetectable \& You", which delivers accurate U=U information alongside real-life video testimonials of PLHIV and their partners. This research will assess the impact of the "Undetectable \& You" App in a cluster-randomized trial in South Africa. The study will establish whether disseminating U=U information via a video-based app at the time of HIV counselling improves retention in care and viral suppression among PLHIV in South Africa.
Aim 1. Refine the "Undetectable \& You" App to help PLHIV navigate U=U within relationships.
Aim 2. Establish the real-world impact of "Undetectable \& You" on retention on ART and viral suppression in a cluster-randomized trial.
Read the detailed description
The study will be a cluster-randomized trial (CRT), where clinics are pair-matched and randomized into immediate intervention (Group A) and deferred intervention (Group B, control) groups. The rationale for this design is to assess the impact of the Undetectable \& You app-based HIV counselling intervention while ensuring that all clinics eventually receive the intervention. The deferred intervention control condition ensures that comparison clinics continue providing standard-of-care HIV counselling during the initial phase of the trial, without exposure to the Undetectable \& You app. This allows for a comparison between the intervention and control groups while controlling for external factors.
Data will be collected from an Active Recruitment Cohort (ARC) (n=880) including survey data linked to routine clinical and laboratory records. The primary outcome is documented HIV viral load <200 copies/mL at 3-9 months after entry into the study. Secondary outcomes include documented HIV viral load <200 copies/mL at 9-15 months, any viral monitoring at 3-9months and 9-15months, and retention in care (any medication pick-ups) at 5-6 months and at 11-12 months. In addition to the ARC, a Passive Surveillance Platform (PSP) using de-identified South African National Health Laboratory Service (NHLS) data (N ~28,000) will allow for higher-powered assessment of impacts on viral suppression across all patients at study clinics.
- Conditions
- HIV
- Being tested
- "Undetectable & You" HIV treatment literacy app
- Keywords
- HIV Counseling South Africa, Antiretroviral treatment (ART), Person living with HIV (PLWH), Undetectable=Untransmittable (U=U), Viral load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Undetectable & You" HIV treatment literacy appOther
The app delivers information on the transmission prevention benefits of HIV treatment through the Undetectable Equals Untransmutable (U=U) message, alongside real-life video testimonials of patients living with HIV (PLHIV) and their partners. It underscores the key behavioral skills required for U=U, namely, ART adherence and viral load monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention Group A | Experimental | Participants whose clinic was randomized into Group A will have immediate access to the "Undetectable \& You" intervention app as part of HIV counseling. Receives: Other: "Undetectable & You" HIV treatment literacy app |
| Deferred intervention Group B | Active comparator | Participants whose clinic was randomized into Group B will get the intervention app at 16 months, after data collection for primary outcomes is complete. Receives: Other: "Undetectable & You" HIV treatment literacy app |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral load <200 copies/mL
Abstracted from clinical and laboratory records.
Measured: 3-9 months (on average 6 months)
Secondary outcomes (3)
HIV viral load <200 copies/mL
Abstracted from clinical and laboratory records.
Measured: 9-15 months (on average 12 months)
Any viral monitoring
Abstracted from clinical and laboratory records.
Measured: 3-9 months (on average 6 months), 9-15 months (on average 12 months)
Retention in care
Retention in care is defined as any medication pick-ups by participants and will be abstracted from the clinical records.
Measured: 5-6 months, 11-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a cluster-randomized trial (CRT), where clinics are pair-matched and randomized into immediate intervention (Group A) and deferred intervention (Group B, control) groups.
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
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, Principal investigator, BU School of Public Health, Global HealthDorina Onoya, PhD, MBA, Principal investigator, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199634
- Sponsor's protocol ID
- H-46247
- Other IDs
- 1R01MH135774-01A1
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be posted to a public repository, e.g. OSF.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0): a Cluster-Randomized Trial
- ClinicalTrials.gov ID
- NCT07199634
- Acronym / sponsor ID
- H-46247
- Conditions
- HIV
- Keywords
- HIV Counseling South Africa, Antiretroviral treatment (ART), Person living with HIV (PLWH), Undetectable=Untransmittable (U=U), Viral load
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Undetectable = Untransmittable (U=U) is the scientific consensus that people with human immunodeficiency virus (HIV) who achieve viral suppression through antiretroviral treatment (ART) cannot transmit the virus sexually. While global studies confirm this, awareness of U=U remains very limited in sub-Saharan Africa, including South Africa, where only two-thirds of people living with HIV (PLHIV) are virally suppressed despite having the largest treatment program globally. Many PLHIV delay or avoid ART because they feel healthy and perceive little benefit, while also fearing stigma, disclosure, and social costs. U=U offers powerful motivation for ART uptake and adherence by reframing treatment as both a personal health and prevention tool, reducing internalised stigma, strengthening self-image, and supporting HIV prevention altruism. Yet, dissemination in Africa has lagged. To address this, the investigators developed an HIV treatment literacy App called "Undetectable \& You", which delivers accurate U=U information alongside real-life video testimonials of PLHIV and their partners. This research will assess the impact of the "Undetectable \& You" App in a cluster-randomized trial in South Africa. The study will establish whether disseminating U=U information via a video-based app at the time of HIV counselling improves retention in care and viral suppression among PLHIV in South Africa.
Aim 1. Refine the "Undetectable \& You" App to help PLHIV navigate U=U within relationships.
Aim 2. Establish the real-world impact of "Undetectable \& You" on retention on ART and viral suppression in a cluster-randomized trial.
Detailed description
The study will be a cluster-randomized trial (CRT), where clinics are pair-matched and randomized into immediate intervention (Group A) and deferred intervention (Group B, control) groups. The rationale for this design is to assess the impact of the Undetectable \& You app-based HIV counselling intervention while ensuring that all clinics eventually receive the intervention. The deferred intervention control condition ensures that comparison clinics continue providing standard-of-care HIV counselling during the initial phase of the trial, without exposure to the Undetectable \& You app. This allows for a comparison between the intervention and control groups while controlling for external factors.
Data will be collected from an Active Recruitment Cohort (ARC) (n=880) including survey data linked to routine clinical and laboratory records. The primary outcome is documented HIV viral load <200 copies/mL at 3-9 months after entry into the study. Secondary outcomes include documented HIV viral load <200 copies/mL at 9-15 months, any viral monitoring at 3-9months and 9-15months, and retention in care (any medication pick-ups) at 5-6 months and at 11-12 months. In addition to the ARC, a Passive Surveillance Platform (PSP) using de-identified South African National Health Laboratory Service (NHLS) data (N ~28,000) will allow for higher-powered assessment of impacts on viral suppression across all patients at study clinics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a cluster-randomized trial (CRT), where clinics are pair-matched and randomized into immediate intervention (Group A) and deferred intervention (Group B, control) groups.
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention Group A | Experimental | Other: "Undetectable & You" HIV treatment literacy appParticipants whose clinic was randomized into Group A will have immediate access to the "Undetectable \& You" intervention app as part of HIV counseling. |
| Deferred intervention Group B | Active comparator | Other: "Undetectable & You" HIV treatment literacy appParticipants whose clinic was randomized into Group B will get the intervention app at 16 months, after data collection for primary outcomes is complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Public sector facility
- Primary care, outpatient clinic
- Follows national guidelines for HIV counseling
- Has dedicated HIV counselors
- At least 10 patients receiving HIV counseling per week (based on pre-study data)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| "Undetectable & You" HIV treatment literacy appThe app delivers information on the transmission prevention benefits of HIV treatment through the Undetectable Equals Untransmutable (U=U) message, alongside real-life video testimonials of patients living with HIV (PLHIV) and their partners. It underscores the key behavioral skills required for U=U, namely, ART adherence and viral load monitoring. | Other | Deferred intervention Group B, Immediate intervention Group A |
Primary outcome
HIV viral load <200 copies/mL
Time frame: 3-9 months (on average 6 months)
Abstracted from clinical and laboratory records.
3 secondary outcomes
HIV viral load <200 copies/mL
Time frame: 9-15 months (on average 12 months)
Any viral monitoring
Time frame: 3-9 months (on average 6 months), 9-15 months (on average 12 months)
Retention in care
Time frame: 5-6 months, 11-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD will be posted to a public repository, e.g. OSF.
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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.
Dorina Onoya, PhD, MBA contact
Jacob Bor principal investigator
BU School of Public Health, Global Health
Dorina Onoya, PhD, MBA principal investigator
University of Witwatersrand, South Africa
Questions about this trial
What is this clinical trial studying?
A study testing "Undetectable & You" HIV treatment literacy app in people with HIV, run by Boston University.
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 23 inclusion and 0 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Bor, ScD, SM ((617) 414-1446, jbor@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV viral load <200 copies/mL (time frame: 3-9 months (on average 6 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 29 Sep 2026.