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N/A Completed N=131 Randomized Prevention

Integrating U=U Into HIV Counseling in South Africa

Source: ClinicalTrials.gov NCT04504357 ↗
Enrolled (actual)
131
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Documented HIV Viral Load <200 Copies/mL at 3-10 Months — 22; 33 Participants

Summary

The near-elimination of HIV transmission with antiretroviral therapy (ART) has provided the world with a clear path to end the HIV epidemic through the mass provision of ART at diagnosis, i.e. test-and-treat. Despite the substantial prevention benefits of ART, the investigators found minimal knowledge of treatment-as-prevention (TasP) in two population-based surveys recently conducted in South Africa. In addition, current public health messaging and clinical HIV counselling in South Africa do not emphasize the prevention benefits of ART. In this formative research study the investigators developed an app-based educational video intervention that provides information on Undetectable = Untransmittable (U=U) that is locally-appropriate and can be integrated into routine HIV counselling. The intervention was be piloted in a clinical trial of patients in South Africa receiving HIV post-test and adherence counselling services, to determine feasibility and acceptability, impact on U=U knowledge and attitudes, impact on stigma and psychological well being, and preliminary evidence for ART uptake and adherence. The study builds on a longstanding collaboration between Boston University and the Health Economics and Epidemiology Research Office (HE2RO) at the University of Witwatersrand in Johannesburg, South Africa. The study is highly innovative because the investigators take a novel approach - disseminating information on the prevention benefits of ART - to improve the wellbeing of people living with HIV (PLWH) and motivate early uptake of ART in South Africa. The investigators hypothesized that disseminating information about U=U and treatment-as-prevention could increase ART adherence, retention, and viral suppression, enabling countries to maximize the impact of test-and-treat.

Outcome Measures

OutcomeResultp-value
PRIMARY
Documented HIV Viral Load <200 Copies/mL at 3-10 Months
22; 33
SECONDARY
Started ART Within 30 Days of Baseline
64; 64
SECONDARY
ART Refills Beyond 30 Days
55; 60
SECONDARY
ART Uptake and First Refill Within 60 Days (Composite Outcome)
50; 53
SECONDARY
Retained in Care at 1-2 Months
54; 55
SECONDARY
Retained in Care at 3-4 Months
48; 54
SECONDARY
Retained in Care at 5-6 Months
38; 47
SECONDARY
Viral Load Monitoring at 3-10 Months
30; 40
SECONDARY
Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed
37.7; 12.7

Eligibility Criteria

Inclusion Criteria

  • receiving HIV care at a public sector health facility in South Africa
  • Speaks English, Zulu, or Sotho

Exclusion Criteria

  • None
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04504357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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