Youth Ending the HIV Epidemic

NCT05789875 | Completed Results

• 2 other identifiers: 22-367213P30MH062246-22S3
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS; Mobile Health; Young Adults

Outcome Measures

Primary Outcomes (8)

• Feasibility: Rate of Participant Retention

  Rate of Participant Retention will be calculated as the percent of those who were retained in the study and completed the final survey.

  3 Months

• Feasibility: Mean Logins Per Week

  Mobile app data from the AiCure Application (paradata) will be used to measure the number of participant logins per week and thereby calculate mean logins per participant per week.

  3 months

• Feasibility: Mean Number of Seconds in App Per Day

  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.

  3 months

• Feasibility: Mean Percent Doses a Participant May Have "Falsified" Med-taking

  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 "falsified" medication taking will be calculated and compared against the number of 'normal' doses.

  3 months

• Acceptability: System Usability Scale (SUS) >68, Considered Above Average and Acceptable

  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.

  3 months

• Acceptability: Client Satisfaction Questionnaire (CSQ-8) Score of ≥17, Considered Above Average and Acceptable

  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.

  3 months

• Acceptability: Likelihood of Recommending the Study to a Friend (Extremely, Very)

  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.

  3 months.

• Acceptability: Satisfaction With the App+Incentives (Mostly, Very)

  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.

  3 months

Secondary Outcomes (5)

• Mean Percent Adherence Over the Study Period (Excluding Those Lost to Follow up)

  3 months

• Median Self-Reported Adherence Score at Study Exit

  3 months

• Monitoring of Behavior: Number of Seconds in App

  3 months

• Monitoring of Behavior: Ease of Use

  3 months

• Monitoring of Behavior: Frequency of App Related Issues

  3 months

Study Arms (1)

Intervention

EXPERIMENTAL

All YLWH who choose to enroll in the study will receive access to AiCure, the mobile health application. The participants will be asked to use the app for 3 months, during which the investigators will assess the feasibility and acceptability of AiCure.

Other: aDOT-CEI

Interventions

aDOT-CEI OTHER

For the design and development of the mobile health app, we have partnered with AiCure to use an existing HIPAA-compliant mobile health app. The app will record video of the participant taking their HIV medication in order to monitor the participant's medication adherence and track incentives for this behavior in real-time.

Also known as: AiCure

Intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 29 years of age
• Have access to a smartphone
• Can speak and read English
• Client is at an AHF clinic in California or Florida
• Client has an unsuppressed HIV viral load at least 3 months post HIV diagnosis
• Client is on once daily oral antiretroviral therapy
• Consent to participate in the proposed study

You may not qualify if:

• YLWH who are newly HIV diagnosed in the past 3 months
• Smartphone is a Samsung galaxy s21 or iPhone 5SE (app is not supported by these phones)

Sponsors & Collaborators

• University of California, San Francisco: lead
• AiCure: collaborator
• RTI International: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCSF Center for AIDS Prevention Studies

San Francisco, California, 94158, United States

Location

Related Publications (1)

• Stoner MCD, Ming K, Wagner D, Smith L, Patani H, Sukhija-Cohen A, Johnson MO, Napierala S, Neilands TB, Saberi P. Youth Ending the HIV Epidemic (YEHE): Protocol for a pilot of an automated directly observed therapy intervention with conditional economic incentives among young adults with HIV. PLoS One. 2023 Dec 22;18(12):e0289919. doi: 10.1371/journal.pone.0289919. eCollection 2023.

  PMID: 38134037 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Parya Saberi
• Organization: UCSF

parya.saberi@ucsf.edu

415-502-1000

Study Officials

• Parya Saberi, PharmD

  UCSF School of Medicine, Division of Prevention Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: January 31, 2023
• Primary Completion: August 24, 2023
• Study Completion: September 8, 2023
• Last Updated: August 26, 2024
• Results First Posted: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)