Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0)
ConditionHIV
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Public sector facility
Primary care, outpatient clinic
Follows national guidelines for HIV counseling
Has dedicated HIV counselors
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
"Undetectable & You" HIV treatment literacy app
Other interventionThe 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.
Treatment groups
880 Participants
are divided into 2 treatment groupsGroup A: Immediate intervention Group AExperimental treatment 1 intervention
Group B: Deferred intervention Group BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
HIV viral load <200 copies/mL
Abstracted from clinical and laboratory records.
Time frame
3-9 months (on average 6 months)Secondary outcomes
1
HIV viral load <200 copies/mL
Abstracted from clinical and laboratory records.
Time frame
9-15 months (on average 12 months)2
Any viral monitoring
Abstracted from clinical and laboratory records.
Time frame
3-9 months (on average 6 months), 9-15 months (on average 12 months)3
Retention in care
Retention in care is defined as any medication pick-ups by participants and will be abstracted from the clinical records.
Time frame
5-6 months, 11-12 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: