Trial Outcomes & Findings for Integrating U=U Into HIV Counseling in South Africa (NCT NCT04504357)

NCT ID: NCT04504357

Last Updated: 2025-08-19

Results Overview

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".

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 135 participants
• Primary outcome timeframe: 3-10 months
• Results posted on: 2025-08-19

Participant Flow

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.

Participant milestones

Measure	Arm A- No Intervention Participants randomized to Arm A received no research intervention.	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
Wave 1 Participants STARTED	67	64
Wave 1 Participants COMPLETED	67	64
Wave 1 Participants NOT COMPLETED	0	0
Wave 2 Participants STARTED	34	34
Wave 2 Participants COMPLETED	34	34
Wave 2 Participants NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Arm A- No Intervention n=67 Participants Participants randomized to Arm A received no research intervention.	Arm B- "Undetectable & You" App n=64 Participants 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	Total n=131 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=67 Participants	0 Participants n=64 Participants	0 Participants n=131 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=67 Participants	64 Participants n=64 Participants	131 Participants n=131 Participants
Age, Categorical >=65 years	0 Participants n=67 Participants	0 Participants n=64 Participants	0 Participants n=131 Participants
Sex/Gender, Customized Female	43 Participants n=67 Participants	33 Participants n=64 Participants	76 Participants n=131 Participants
Sex/Gender, Customized Male	24 Participants n=67 Participants	30 Participants n=64 Participants	54 Participants n=131 Participants
Sex/Gender, Customized Neither male nor female	0 Participants n=67 Participants	1 Participants n=64 Participants	1 Participants n=131 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Africa	67 participants n=67 Participants	64 participants n=64 Participants	131 participants n=131 Participants

PRIMARY outcome

Timeframe: 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".

Outcome measures

Measure	Arm A- No Intervention n=67 Participants Participants randomized to Arm A received no research intervention.	Arm B- "Undetectable & You" App n=64 Participants 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
Documented HIV Viral Load <200 Copies/mL at 3-10 Months	22 Participants	33 Participants

SECONDARY outcome

Timeframe: 0-1 month

As documented in linked clinical records

Outcome measures

Measure	Arm A- No Intervention n=67 Participants Participants randomized to Arm A received no research intervention.	Arm B- "Undetectable & You" App n=64 Participants 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
Started ART Within 30 Days of Baseline	64 Participants	64 Participants

SECONDARY outcome

Timeframe: 1-6 month

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

Outcome measures

Measure	Arm A- No Intervention n=67 Participants Participants randomized to Arm A received no research intervention.	Arm B- "Undetectable & You" App n=64 Participants 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
ART Refills Beyond 30 Days	55 Participants	60 Participants

SECONDARY outcome

Timeframe: 0-2 months

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.

Outcome measures

Measure	Arm A- No Intervention n=67 Participants Participants randomized to Arm A received no research intervention.	Arm B- "Undetectable & You" App n=64 Participants 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
ART Uptake and First Refill Within 60 Days (Composite Outcome)	50 Participants	53 Participants

SECONDARY outcome

Timeframe: 1-2 months

Any ART refills during months 1-2 post enrollment.

Outcome measures

Measure	Arm A- No Intervention n=67 Participants Participants randomized to Arm A received no research intervention.	Arm B- "Undetectable & You" App n=64 Participants 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
Retained in Care at 1-2 Months	54 Participants	55 Participants

SECONDARY outcome

Timeframe: 3-4 months

Any ART refills during months 3-4 post enrollment.

Outcome measures

Measure	Arm A- No Intervention n=67 Participants Participants randomized to Arm A received no research intervention.	Arm B- "Undetectable & You" App n=64 Participants 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
Retained in Care at 3-4 Months	48 Participants	54 Participants

SECONDARY outcome

Timeframe: 5-6 months

Any ART refills during months 5-6 post enrollment.

Outcome measures

Measure	Arm A- No Intervention n=67 Participants Participants randomized to Arm A received no research intervention.	Arm B- "Undetectable & You" App n=64 Participants 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
Retained in Care at 5-6 Months	38 Participants	47 Participants

SECONDARY outcome

Timeframe: 3-10 months

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

Outcome measures

Measure	Arm A- No Intervention n=67 Participants Participants randomized to Arm A received no research intervention.	Arm B- "Undetectable & You" App n=64 Participants 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
Viral Load Monitoring at 3-10 Months	30 Participants	40 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Arm A- No Intervention n=34 Participants Participants randomized to Arm A received no research intervention.	Arm B- "Undetectable & You" App n=34 Participants 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
Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed	37.7 percentage of perceived risk	12.7 percentage of perceived risk

Adverse Events

Arm A- No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B- "Undetectable & You" App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jacob Bor, ScD SM

Boston University School of Public Health, Departments of Global Health and Epidemiology

Phone: (617) 358-2176

Email: jbor@bu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place