Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0)

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.

Inclusion criteria

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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)
• 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