Improving the HIV Care Continuum With mHealth Technology

NCT07631104 | Not Yet Recruiting

• 2 other identifiers: Pro000857941K01MH118073-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Youth living with HIV (YLHIV) face barriers to engagement and retention in HIV care, show poor medication adherence, and often fail to achieve and maintain viral suppression. YLHIV in the southern United States have particularly poor care engagement outcomes. South Carolina is one of nine states identified as "key drivers" of the US HIV epidemic, and HIV rates for youth in South Carolina have risen in recent years. Tailored interventions are urgently needed to improve outcomes for this population. One promising approach is to reach YLHIV via mobile Health (mHealth) technology, yet few efforts have sought to tailor mHealth interventions to the needs of YLHIV in the southern US. Thus, the scientific objective of this study is to pilot test a new mHealth intervention, called MindBodyU, designed to increase engagement/retention in care and ART adherence among YLHIV in South Carolina. In this study, investigators will evaluate the feasibility, acceptability, and initial efficacy of the mHealth intervention with a six-month pilot trial with 40 YLHIV in South Carolina.

Conditions

mHealth Application; Continuum of Care; Youth With HIV; HIV Antiretroviral Therapy (ART) Adherence; mHealth Intervention; HIV - Human Immunodeficiency Virus

Keywords

Youth living with HIV (YLHIV); immunology; HIV; adolescents; emerging/young adults; eHealth/mHealth/digital health; adherence/self-management; psychosocial intervention

Outcome Measures

Primary Outcomes (8)

• Study Retention

  Study retention will be measured by how many participants are retained in the study at 12-weeks (i.e., complete the 12-week follow-up. Investigators will define good retention as at least 70% of participants retained in the study at 12-weeks. Study retention will be viewed as one aspect of feasibility of the MindBodyU intervention, which refers to whether adolescents and young adults will use the intervention in their real-world environments.

  From enrollment to 12-weeks

• Acceptability of the MindBodyU Intervention

  This outcome is acceptability of the MindBodyU Intervention, which refers to whether adolescents and young adults find the intervention to be likable, enjoyable, engaging, and culturally appropriate. Acceptability will be measured by the Acceptability of Intervention Measure (AIM), and operationalized as a mean score of 3 or more on 5-point Likert scale for the following items: 'MindBodyU meets my approval', 'MindBodyU is appealing to me', and 'I like the MindBodyU app'. It will also be measured by participant scores on the item, 'The MindBodyU app aligns with my values' and 'The MindBodyU app is a good fit for me' (i.e., score of 3 or more on 5-point Likert scale).

  From enrollment to 12-weeks

• Adherence to Antiretroviral Therapy (ART)

  This outcome assesses participants' self-reported adherence to antiretroviral therapy (ART). The outcome is measured by the following items: 1. Are you currently taking medications for HIV (also called antiretroviral therapy or ART)? (Yes, No, I Don't Know) 2. In the last 30 days, on how many days did you miss at least one dose of any of your HIV medications (ART)? I missed \_\_\_\_\_\_ days out of the last 30 days (0-30) 3. In the last 30 days, how often did you take your HIV medication in the way you were supposed to? (Never, Rarely, Sometimes, Usually, Almost always, Always) 4. In the last 30 days, how good a job did you do at taking HIV medication in the way you were supposed to? (Very poor, Poor, Fair, Good, Very good, Excellent)

  From enrollment to 12-weeks; follow-up at 6-months

• Viral Suppression

  This outcome measures participants' self-reported viral suppression. It will be measured by one item: 'To the best of your knowledge, are you currently virally suppressed? Viral suppression means that you have a viral load that is ≤ 200 copies/ml. This is also called having an 'undetectable' viral load.' (Yes, I am virally suppressed; No, I am not virally suppressed; I don't know if I am virally suppressed)

  From enrollment to 12-weeks; follow-up at 6-months

• HIV Care Engagement

  This outcome measures youths' engagement with their HIV care and their self-efficacy to engage in HIV care. It is measured by two survey items: 1\) To the best of your knowledge, how many times have you missed a visit with your HIV care provider in the past 12 months? (Never missed a visit, Missed 1 visit, Missed 2-3 visits, Missed 4 or more visits, N/A - I haven't had any scheduled visits in the past 12 months); and 2) How sure are you that you could always schedule and keep your HIV appointments in the next year? (Very Unsure, Unsure, Neutral, Sure, Very Sure).

  From enrollment to 12-weeks; follow-up at 6-months

• App engagement

  App engagement will be measured by the percent of participants who use the app on a weekly basis across the 12-week period. Investigators will define good app engagement as at least 60% of participants having weekly active use of the app during the 12-week period. App engagement will be viewed as one aspect of feasibility of the MindBodyU intervention, which refers to whether adolescents and young adults will use the intervention in their real-world environments.

  From enrollment to 12-weeks

• Perceived Burden of the MindBodyU App

  This outcome measures youths' perceived burden of using the MindBodyU app. Three items will be used to measure perceived burden, and low perceived burden will be defined as a mean score of 3 or less on a 5-point Likert scale for these 3 items: 'This app fits easily into my daily routine \[Reverse\]', 'Using this app took too much time', and 'This app was a burden to use'.

  From enrollment to 12-weeks

• Perceived Feasibility of the MindBodyU App

  This outcome measures youths' perceived feasibility of the MindBodyU app. It will be measured with the 3-item Feasibility of Intervention Measure (FIM). Feasibility will be defined as a mean score of 3 or more on 5-point Likert scale for the following 3 items: 'Using MindBodyU was possible', 'Using MindBodyU was doable', and 'Using MindBodyU was easy to use'.

  From enrollment to 12-weeks

Secondary Outcomes (5)

• HIV Stigma

  Enrollment to 12-weeks; 6-month follow-up

• Depressive symptoms

  Enrollment to 12-weeks; follow-up at 6-months

• Coping Self-Efficacy

  Enrollment to 12-weeks; follow-up at 6-months

• Barriers to Mental and Behavioral Health Care

  Enrollment to 12-weeks; follow-up at 6-months

• Anxiety symptoms

  Enrollment to 12-weeks; follow-up at 6-months

Study Arms (1)

MindBodyU Intervention

EXPERIMENTAL

This is a single group, one arm trial in which participants (youth living with HIV aged 16-25 years who are current residents of South Carolina) will receive access to a mobile health (mHealth) intervention called MindBodyU that is delivered via smartphone application (app) and designed to improve engagement in care, medication adherence, and psychosocial wellbeing. The intervention includes app-based learning content, daily prompts for medication adherence, appointment reminders, behavioral health symptom tracking, ability to connect with content experts, and ability to seek feedback/support from other users. Participants will be instructed to use the intervention over a 12-week period, and will complete surveys at baseline, 12-weeks, and 6-months to assess for feasibility and acceptability of the intervention, as well as participants' engagement/retention in care, adherence to antiretroviral therapy, viral suppression, and psychosocial wellbeing.

Behavioral: MindBodyU Intervention

Interventions

MindBodyU Intervention BEHAVIORAL

The MindBodyU app is an mHealth intervention that was developed based on input from youth living with HIV, HIV providers, and community-based organizations. The app includes multiple features designed to promote HIV care engagement, medication adherence, and psychosocial wellbeing for youth living with HIV in South Carolina. Users of the app will have the opportunity to create anonymous profiles in which they can access resources related to HIV, behavioral health, sexual health, and other social determinants of health. The app also has features that enable youth to monitor and track health behaviors (e.g., appointment reminders, medication adherence), message healthcare professionals with general health questions, and engage in moderated online forums with HIV providers and other YLHIV.

Also known as: MindBodyU App

MindBodyU Intervention

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages of 16 and 25 years
• Diagnosed with HIV
• Resident of South Carolina
• Proficient in English

You may not qualify if:

• Under 16 years of age or over 25 years of age
• Is not a person living with HIV
• Is not a resident of South Carolina
• Is not proficient in English

Sponsors & Collaborators

• University of South Carolina: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

• Miller SJ, Weaver KE, Harrison SE. A multi-informant qualitative analysis of desired features for an mHealth tool for youth living with HIV in South Carolina. J Pediatr Psychol. 2024 Sep 1;49(9):616-627. doi: 10.1093/jpepsy/jsae047.

  PMID: 38976587 BACKGROUND

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

Central Study Contacts

Sayward Harrison, PhD

CONTACT

9193237708; harri764@mailbox.sc.edu

Katherine Weaver, BS

CONTACT

kew28@email.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor / Health Psychologist

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)