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Youth Ending the HIV Epidemic
NA trial testing aDOT-CEI in HIV/AIDS in 28 participants. Completed in 8 September 2023.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 28 |
| Start date | 31 January 2023 |
| Primary completion | 24 August 2023 |
| Estimated completion | 8 September 2023 |
| Sites | 1 location across United States |
University of California, San Francisco
Adults 18 to 29, any sex, with HIV/AIDS or Mobile Health. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of Participant Retention will be calculated as the percent of those who were retained in the study and completed the final survey.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 22 |
Mobile app data from the AiCure Application (Paradata) will be used to measure the number of seconds each participant spends in that app each day, thereby calculating the mean number of seconds in app per day per participant.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 28 | 0 – 308 |
The AiCure mobile application platform uses an artificial intelligence or AI platform to recognize dosing patterns recorded by users that do not correspond to what has been defined as 'normal' dosing by the AI. The AI accordingly flags any video recording featuring abnormal dosing for review by the AiCure Video Review team. Upon confirmation of abnormal dosing, the AiCure Video Review team notifies the research coordinator in the form of a "Red Alert". Each of these "Red Alerts" message will be counted as an event of intentional nonadherence, and the mean number of times a participant may have
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 2 | 0 – 23.8 |
The acceptability of the AiCure Mobile application will be through the System Usability Scale (SUS). The intervention was considered acceptable if ≥80% had a SUS score \>68, which is considered above average acceptability.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 18 |
Client satisfaction will be measured using a Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item scale with higher values indicating higher satisfaction. Acceptability was set as a cutoff of 80% having a score of ≥17, which is the score cutoff considered above average and acceptable for this measure.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 22 |
Recommend study to a friend. 7-point Likert Scale of how likely participants are to recommend the study to a friend. The intervention was considered acceptable if ≥80% reported likely or very likely to recommend.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 16 |
Client satisfaction with the app+incentives. 7-point Likert Scale values from 1-7 with lower values corresponding to least satisfaction and higher values corresponding to greater satisfaction.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 20 |
Adherence data will be abstracted from the automated directly observed therapy platform within the AiCure mobile health application. Percent adherence will be calculated as the percentage of days over the study period that participants recorded taking their medication within the app.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 72.7 | 25 – 100 |
The preliminary effect on ART adherence will be measured through self-report using a 3-item scale that has been previously validated. Questions ask about frequency of missed medications in the last 30 days, adherence frequency in the last 30 days, and adherence rating in the last 30 days. Reponses to the 3 questions were transformed to a 0-100 scale, with higher scores indicating better adherence. A summary score was calculated as the mean of the 3 individual items.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 82.7 | 74.4 – 91.7 |
Number of seconds in app collected using mobile app data (paradata) from AiCure platform.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 28 | 0 – 308 |
Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, an increased risk of antiretroviral therapy (ART) nonadherence and virologic failure, and a high probability of disease progression and transmission. Tracking and monitoring objective measures of ART adherence in real time is critical to strategies to support adherence and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires extra effort from providers to understand adherence patterns, making it difficult for providers to accurately determine how to support their patients in real time. In the proposed interventional study, the investigators aim to pilot test an automated directly observed therapy intervention paired with conditional economic incentives to improve ART adherence among youth living with HIV (YLWH) (18-29 years-old) who have an unsuppressed HIV viral load. Aim 1: Conduct a pilot study to assess feasibility and acceptability of the use of automated directly observed therapy with conditional economic incentives (aDOT-CEI) among YLWH (aged 18-29; N= 30) at AIDS Healthcare Foundation (AHF) clinics in California and Florida. Primary outcomes will be feasibility and acceptability, assessed using predefined feasibility metrics and acceptability surveys at three months. Aim 2: Explore experiences of YLWH and staff/providers with the aDOT-CEI intervention and implementation facilitators and barriers. The investigators will conduct in-depth qualitative interviews with a sample of YLWH from Aim 1 and staff/providers purposively selected from participating AHF clinics to explore intervention experiences, potential influences on ART adherence, individual-level and clinic-level barriers and facilitators to intervention implementation, and suggested refinements for a future efficacy trial. The investigators hypothesize that the aDOT-CEI intervention to improve ART adherence among YLWH will have high feasibility and acceptability.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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