Integrating U=U Into HIV Counseling in South Africa

NCT04504357 | Completed Results

• 2 other identifiers: H-40706R34MH122323
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV

Keywords

Antiretroviral treatment (ART); Person living with HIV (PLWH); Treatment-as-prevention (TasP); Undetectable=Untransmittable (U=U); HIV counseling; South Africa

Outcome Measures

Primary Outcomes (1)

• Documented HIV Viral Load <200 Copies/mL at 3-10 Months

  As documented in linked clinical records. The first viral load (VL) value taken during the period 3-10 months after baseline. Outcome will be defined as documented viral suppression among all patients: 1 = VL\<200; 0 = VL\>=200 OR no documented VL. The 200 copy threshold matches WHO definition for "zero transmission risk".

  3-10 months

Secondary Outcomes (8)

• Started ART Within 30 Days of Baseline

  0-1 month

• ART Refills Beyond 30 Days

  1-6 month

• ART Uptake and First Refill Within 60 Days (Composite Outcome)

  0-2 months

• Retained in Care at 1-2 Months

  1-2 months

• Retained in Care at 3-4 Months

  3-4 months

Study Arms (2)

Arm A- No intervention

NO INTERVENTION

Participants randomized to Arm A received no research intervention.

Arm B- "Undetectable & You" App

EXPERIMENTAL

Participants randomized to Arm B interacted with "Undetectable \& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.

Behavioral: Tablet based U=U app; Other: Text messages

Interventions

Tablet based U=U app BEHAVIORAL

Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.

Arm B- "Undetectable & You" App

Text messages OTHER

Monthly text messages reinforcing intervention content

Arm B- "Undetectable & You" App

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (3)

Primary Health Clinic A

Johannesburg, Gauteng, South Africa

Location

Primary Health Clinic B

Johannesburg, Gauteng, South Africa

Location

Primary Health Clinic C

Johannesburg, South Africa

Location

Results Point of Contact

• Title: Jacob Bor, ScD SM
• Organization: Boston University School of Public Health, Departments of Global Health and Epidemiology

jbor@bu.edu

(617) 358-2176

Study Officials

• Jacob Bor, ScD SM

  BU School of Public Health, Global Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: November 21, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: At manuscript publication.
• Access Criteria: Publicly accessible

Locations

ZA (3)