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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH122323 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Started ART Within 30 Days of Baseline | As documented in linked clinical records | 0-1 month |
| ART Refills Beyond 30 Days | Any ART refills recorded in clinical records after 30 days post-enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Bor, ScD SM | BU School of Public Health, Global Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Health Clinic A | Johannesburg | Gauteng | South Africa | |||
| Primary Health Clinic B |
Replication data, code, and protocol (including SAP) will be posted on a public repository when the trial results manuscript is published.
At manuscript publication.
Publicly accessible
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A- No Intervention | Participants randomized to Arm A received no research intervention. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wave 1 Participants |
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| Wave 2 Participants |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A- No Intervention | Participants randomized to Arm A received no research intervention. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Posted | Count of Participants | Participants | 3-10 months |
|
10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A- No Intervention | Participants randomized to Arm A received no research intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacob Bor, ScD SM | Boston University School of Public Health, Departments of Global Health and Epidemiology | (617) 358-2176 | jbor@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2025 | Jul 31, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2022 | Jun 28, 2024 | ICF_000.pdf |
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| Text messages | Other | Monthly text messages reinforcing intervention content |
|
| 1-6 month |
| 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. | 0-2 months |
| Retained in Care at 1-2 Months | Any ART refills during months 1-2 post enrollment. | 1-2 months |
| Retained in Care at 3-4 Months | Any ART refills during months 3-4 post enrollment. | 3-4 months |
| Retained in Care at 5-6 Months | Any ART refills during months 5-6 post enrollment. | 5-6 months |
| Viral Load Monitoring at 3-10 Months | Based on linked clinical records, 3-10 months after baseline | 3-10 months |
| 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. | after intervention (on average 6 months) |
| Johannesburg |
| Gauteng |
| South Africa |
| Primary Health Clinic C | Johannesburg | South Africa |
| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Started ART Within 30 Days of Baseline | As documented in linked clinical records | Posted | Count of Participants | Participants | 0-1 month |
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| Secondary | ART Refills Beyond 30 Days | Any ART refills recorded in clinical records after 30 days post-enrollment. | Posted | Count of Participants | Participants | 1-6 month |
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| 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. | Posted | Count of Participants | Participants | 0-2 months |
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| Secondary | Retained in Care at 1-2 Months | Any ART refills during months 1-2 post enrollment. | Posted | Count of Participants | Participants | 1-2 months |
|
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| Secondary | Retained in Care at 3-4 Months | Any ART refills during months 3-4 post enrollment. | Posted | Count of Participants | Participants | 3-4 months |
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| Secondary | Retained in Care at 5-6 Months | Any ART refills during months 5-6 post enrollment. | Posted | Count of Participants | Participants | 5-6 months |
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| Secondary | Viral Load Monitoring at 3-10 Months | Based on linked clinical records, 3-10 months after baseline | Posted | Count of Participants | Participants | 3-10 months |
|
|
|
| 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. | Only wave 2 participants (34 in Arm A and 34 in Arm B) were assessed for this outcome measure. | Posted | Number | percentage of perceived risk | after intervention (on average 6 months) |
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| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | 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 | 0 | 64 | 0 | 64 | 0 | 64 |
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