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NCT Number: NCT07631104

Improving the HIV Care Continuum With mHealth Technology

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: MindBodyU App

Primary outcomes

  1. Study Retention

    Time frame: From enrollment to 12-weeks

    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.

  2. Acceptability of the MindBodyU Intervention

    Time frame: From enrollment to 12-weeks

    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).

  3. Adherence to Antiretroviral Therapy (ART)

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

    This outcome assesses participants' self-reported adherence to antiretroviral therapy (ART). The outcome is measured by the following items:

    • Are you currently taking medications for HIV (also called antiretroviral therapy or ART)? (Yes, No, I Don't Know)
    • 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)
    • 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)
    • 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)
  4. Viral Suppression

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

    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)

  5. HIV Care Engagement

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

    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:

    • 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).
  6. App engagement

    Time frame: From enrollment to 12-weeks

    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.

  7. Perceived Burden of the MindBodyU App

    Time frame: From enrollment to 12-weeks

    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'.

  8. Perceived Feasibility of the MindBodyU App

    Time frame: From enrollment to 12-weeks

    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'.

Secondary outcomes

  1. HIV Stigma

    Time frame: Enrollment to 12-weeks; 6-month follow-up

    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).

  2. Depressive symptoms

    Time frame: Enrollment to 12-weeks; follow-up at 6-months

    Participants will complete the 9-item Patient Health Questionnaire (PHQ-9) to provide information about their current symptoms of depression.

  3. Coping Self-Efficacy

    Time frame: Enrollment to 12-weeks; follow-up at 6-months

    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').

  4. Barriers to Mental and Behavioral Health Care

    Time frame: Enrollment to 12-weeks; follow-up at 6-months

    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.

  5. Anxiety symptoms

    Time frame: Enrollment to 12-weeks; follow-up at 6-months

    Participants will complete the 7-item General Anxiety Disorder (GAD-7) Questionnaire to provide information about their current symptoms of anxiety.

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine Weaver, BS

CONTACT

[email protected]

Sayward Harrison, PhD

CONTACT

[email protected]

9193237708

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Improving the HIV Care Continuum for Youth in the Deep South Through Mobile Health Technology

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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