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Improving the HIV Care Continuum With mHealth Technology

2 giugno 2026 aggiornato da: Sayward Harrison, University of South Carolina

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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • South Carolina
      • Columbia, South Carolina, Stati Uniti, 29208
        • University of South Carolina

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: MindBodyU Intervention
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.
Comportamentale: 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.
Altri nomi:
  • MindBodyU App

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Study Retention
Lasso di tempo: 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.
From enrollment to 12-weeks
Acceptability of the MindBodyU Intervention
Lasso di tempo: 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).
From enrollment to 12-weeks
Adherence to Antiretroviral Therapy (ART)
Lasso di tempo: 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:

  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
Lasso di tempo: 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)
From enrollment to 12-weeks; follow-up at 6-months
HIV Care Engagement
Lasso di tempo: 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:

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
Lasso di tempo: 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.
From enrollment to 12-weeks
Perceived Burden of the MindBodyU App
Lasso di tempo: 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'.
From enrollment to 12-weeks
Perceived Feasibility of the MindBodyU App
Lasso di tempo: 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'.
From enrollment to 12-weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
HIV Stigma
Lasso di tempo: 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).
Enrollment to 12-weeks; 6-month follow-up
Depressive symptoms
Lasso di tempo: 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.
Enrollment to 12-weeks; follow-up at 6-months
Coping Self-Efficacy
Lasso di tempo: 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').
Enrollment to 12-weeks; follow-up at 6-months
Barriers to Mental and Behavioral Health Care
Lasso di tempo: 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.
Enrollment to 12-weeks; follow-up at 6-months
Anxiety symptoms
Lasso di tempo: 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.
Enrollment to 12-weeks; follow-up at 6-months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of South Carolina

Collaboratori

National Institute of Mental Health (NIMH)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Pro00085794
  • 1K01MH118073-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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).

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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