An interventional study of MindBodyU Intervention in HIV - Human Immunodeficiency Virus, HIV Antiretroviral Therapy (ART) Adherence and mHealth Application, sponsored by University of South Carolina. Not yet recruiting at 1 site in United States. Open to participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by University of South Carolina · Not applicable, Interventional, and Supportive care
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.
In this study, investigators will conduct a brief pilot trial of the MindBodyU intervention--a digital health intervention that is delivered via a smartphone application ('app'). In the study, a total of 40 youth living with HIV (YLHIV) be provided with access to the MindBodyU app. Investigators will collect survey data from youth before youth install the app on their personal phone and again at 12-weeks and 6-months to assess feasibility and acceptability of the intervention, as well as preliminary outcomes (e.g., engagement/retention in care, adherence, viral suppression).
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's planned enrollment of 40 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Exclusion Criteria:
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
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
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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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'.
Time frame: 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'.
Time frame: From enrollment to 12-weeks
HIV Stigma
This outcome evaluates youths' experiences, feelings, and opinions about HIV-related stigma. The outcome is measured by 12 items that are answered on a 4-point Likert scale (strong disagree to strongly agree) and assess participants' feelings and behaviors related to stigma (e.g., feeling like they have to keep their HIV a secret, feeling bad about themselves due to their HIV status).
Time frame: Enrollment to 12-weeks; 6-month follow-up
Depressive symptoms
Participants will complete the 9-item Patient Health Questionnaire (PHQ-9) to provide information about their current symptoms of depression.
Time frame: Enrollment to 12-weeks; follow-up at 6-months
Coping Self-Efficacy
Participants will provide information about their coping self-efficacy, which measures their ability to cope with stress and hardship. They will complete the 26-item Coping Self-Efficacy Scale, which has a 0 to 10 Likert-type response option (i.e., 'cannot do at all' to 'certain can do').
Time frame: Enrollment to 12-weeks; follow-up at 6-months
Barriers to Mental and Behavioral Health Care
Participants will answer four questions that ask about potential barriers to mental and behavioral health care. These items will ask respondents about whether they have any unmet mental and/or behavioral health needs and will allow participants to select reasons why they have not received treatment if they felt treatment was warranted.
Time frame: Enrollment to 12-weeks; follow-up at 6-months
Anxiety symptoms
Participants will complete the 7-item General Anxiety Disorder (GAD-7) Questionnaire to provide information about their current symptoms of anxiety.
Time frame: Enrollment to 12-weeks; follow-up at 6-months
Plan to share: No — IPD will not be shared due to risks of revealing personal identities and/or health information for a vulnerable patient population (i.e., youth living with HIV).
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of South Carolina