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.
Between the ages of 16 and 25 years
Diagnosed with HIV
Resident of South Carolina
Proficient in English
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
Single group
MindBodyU Intervention
BehavioralThe 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.
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.
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).
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)
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)
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).
Depressive symptoms
Participants will complete the 9-item Patient Health Questionnaire (PHQ-9) to provide information about their current symptoms of depression.
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').
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.
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University of South Carolina
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
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