Status:
NOT_YET_RECRUITING
Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0)
Lead Sponsor:
Boston University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 transmi...
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 rationa...
Eligibility Criteria
Inclusion
- Inclusion Criteria-
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT07199634
Start Date
April 1 2026
End Date
January 1 2029
Last Update
September 30 2025
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