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Integrating U=U Into HIV Counseling in South Africa

Integrating U=U Into HIV Counseling in South Africa

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04504357
Acronym
INTUIT-SA
Enrollment
135
Registered
2020-08-07
Start date
2022-11-21
Completion date
2024-02-15
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

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

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.

Detailed description

We developed a U=U-focused HIV treatment literacy App called Undetectable & You, to integrate U=U into HIV counseling in South Africa. We then piloted the App in a randomized clinical trial. The randomized pilot trial was conducted at three public sector clinics in Johannesburg, South Africa, to establish intervention acceptability, effects on knowledge and attitudes, and preliminary impact on ART uptake, adherence, retention, and viral suppression (n=135). Patients completing HIV post-test or adherence counseling were referred to study staff and randomized 1:1 to no intervention (Arm A) vs. a \ 20min interaction with Undetectable & You, a tablet-based App developed to disseminate information about U=U via PLHIV testimonials (Arm B). Participants in Arm B also received monthly text messages reinforcing intervention content. The order of the messages was randomized to ascertain whether different messages were better at driving engagement with the App. Investigators assessed feasibility and acceptability of the Undetectable & You App, resonance of different key messages and videos in the App, and its impact on knowledge and attitudes related to TasP. Additionally, ART uptake, appointment adherence, retention on treatment, and viral monitoring were assessed in clinical records through six months, with VL data collected through 10 months. Qualitative exit interviews were conducted with participants and clinic staff (n=30). In addition to the primary and secondary outcomes specified below, we assessed for effect modification in the primary outcome of viral suppression by key constructs of our theoretical model and participant demographics.

Interventions

BEHAVIORALTablet based U=U app

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.

OTHERText messages

Monthly text messages reinforcing intervention content

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Documented HIV Viral Load <200 Copies/mL at 3-10 Months3-10 monthsAs 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.

Secondary

MeasureTime frameDescription
ART Refills Beyond 30 Days1-6 monthAny ART refills recorded in clinical records after 30 days post-enrollment.
ART Uptake and First Refill Within 60 Days (Composite Outcome)0-2 monthsIndicator = 1 if the participant started ART and returned to the clinic for their first ART medication refill within 60 days after enrollment. Indicator = 0 if the participant did not start ART, or if patient started ART but did not have a medication refill within 60 days of enrollment.
Retained in Care at 1-2 Months1-2 monthsAny ART refills during months 1-2 post enrollment.
Started ART Within 30 Days of Baseline0-1 monthAs documented in linked clinical records
Retained in Care at 5-6 Months5-6 monthsAny ART refills during months 5-6 post enrollment.
Viral Load Monitoring at 3-10 Months3-10 monthsBased on linked clinical records, 3-10 months after baseline
Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressedafter intervention (on average 6 months)Likelihood of HIV transmission (on a 0 to 100 scale) in a hypothetical mixed-status couple after a year of weekly condomless sex, where the HIV+ partner is on ART. Higher scores are associated with higher perceived risk.
Retained in Care at 3-4 Months3-4 monthsAny ART refills during months 3-4 post enrollment.

Countries

South Africa

Participant flow

Pre-assignment details

After 135 participants were enrolled and prior to randomization, 4 participants exited the study (2 during the baseline survey and 2 who did not have clinical charts) leaving 131 to be randomized into the two study arms. 67 participants were randomized into Arm A/No intervention and 64 were randomized into Arm B/Undetectable & You app.

Participants by arm

ArmCount
Arm A- No Intervention
Participants randomized to Arm A received no research intervention.
67
Arm B- Undetectable & You App
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. Tablet based U=U app: 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. Text messages: Monthly text messages reinforcing intervention content
64
Total131

Baseline characteristics

CharacteristicArm B- Undetectable & You AppTotalArm A- No Intervention
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
64 Participants131 Participants67 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
South Africa
64 participants131 participants67 participants
Sex/Gender, Customized
Female
33 Participants76 Participants43 Participants
Sex/Gender, Customized
Male
30 Participants54 Participants24 Participants
Sex/Gender, Customized
Neither male nor female
1 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 670 / 64
other
Total, other adverse events
0 / 670 / 64
serious
Total, serious adverse events
0 / 670 / 64

Outcome results

Primary

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.

Time frame: 3-10 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm A- No InterventionDocumented HIV Viral Load <200 Copies/mL at 3-10 Months22 Participants
Arm B- Undetectable & You AppDocumented HIV Viral Load <200 Copies/mL at 3-10 Months33 Participants
Secondary

ART Refills Beyond 30 Days

Any ART refills recorded in clinical records after 30 days post-enrollment.

Time frame: 1-6 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm A- No InterventionART Refills Beyond 30 Days55 Participants
Arm B- Undetectable & You AppART Refills Beyond 30 Days60 Participants
Secondary

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

Indicator = 1 if the participant started ART and returned to the clinic for their first ART medication refill within 60 days after enrollment. Indicator = 0 if the participant did not start ART, or if patient started ART but did not have a medication refill within 60 days of enrollment.

Time frame: 0-2 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm A- No InterventionART Uptake and First Refill Within 60 Days (Composite Outcome)50 Participants
Arm B- Undetectable & You AppART Uptake and First Refill Within 60 Days (Composite Outcome)53 Participants
Secondary

Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed

Likelihood of HIV transmission (on a 0 to 100 scale) in a hypothetical mixed-status couple after a year of weekly condomless sex, where the HIV+ partner is on ART. Higher scores are associated with higher perceived risk.

Time frame: after intervention (on average 6 months)

Population: Only wave 2 participants (34 in Arm A and 34 in Arm B) were assessed for this outcome measure.

ArmMeasureValue (NUMBER)
Arm A- No InterventionMean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed37.7 percentage of perceived risk
Arm B- Undetectable & You AppMean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed12.7 percentage of perceived risk
Secondary

Retained in Care at 1-2 Months

Any ART refills during months 1-2 post enrollment.

Time frame: 1-2 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm A- No InterventionRetained in Care at 1-2 Months54 Participants
Arm B- Undetectable & You AppRetained in Care at 1-2 Months55 Participants
Secondary

Retained in Care at 3-4 Months

Any ART refills during months 3-4 post enrollment.

Time frame: 3-4 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm A- No InterventionRetained in Care at 3-4 Months48 Participants
Arm B- Undetectable & You AppRetained in Care at 3-4 Months54 Participants
Secondary

Retained in Care at 5-6 Months

Any ART refills during months 5-6 post enrollment.

Time frame: 5-6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm A- No InterventionRetained in Care at 5-6 Months38 Participants
Arm B- Undetectable & You AppRetained in Care at 5-6 Months47 Participants
Secondary

Started ART Within 30 Days of Baseline

As documented in linked clinical records

Time frame: 0-1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm A- No InterventionStarted ART Within 30 Days of Baseline64 Participants
Arm B- Undetectable & You AppStarted ART Within 30 Days of Baseline64 Participants
Secondary

Viral Load Monitoring at 3-10 Months

Based on linked clinical records, 3-10 months after baseline

Time frame: 3-10 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm A- No InterventionViral Load Monitoring at 3-10 Months30 Participants
Arm B- Undetectable & You AppViral Load Monitoring at 3-10 Months40 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026