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

NCT07199634 | Not Yet Recruiting

• 2 other identifiers: H-462471R01MH135774-01A1
• Study Type: interventional
• Target: 880
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

HIV

Keywords

HIV Counseling South Africa; Antiretroviral treatment (ART); Person living with HIV (PLWH); Undetectable=Untransmittable (U=U); Viral load

Outcome Measures

Primary Outcomes (1)

• HIV viral load <200 copies/mL

  Abstracted from clinical and laboratory records.

  3-9 months (on average 6 months)

Secondary Outcomes (3)

• HIV viral load <200 copies/mL

  9-15 months (on average 12 months)

• Any viral monitoring

  3-9 months (on average 6 months), 9-15 months (on average 12 months)

• Retention in care

  5-6 months, 11-12 months

Study Arms (2)

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.

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.

Other: "Undetectable & You" HIV treatment literacy app

Interventions

"Undetectable & You" HIV treatment literacy app OTHER

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.

Deferred intervention Group B; Immediate intervention Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Officials

• Jacob Bor

  BU School of Public Health, Global Health

  PRINCIPAL INVESTIGATOR

• Dorina Onoya, PhD, MBA

  University of Witwatersrand, South Africa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Bor, ScD, SM

CONTACT

(617) 414-1446; jbor@bu.edu

Dorina Onoya, PhD, MBA

CONTACT

donoya@heroza.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting information will be posted when our primary outcomes paper is published.
• Access Criteria: IPD and supporting information will be accessible to the public.