Improving the HIV Care Continuum With mHealth Technology

University of South Carolina

Status: Not yet enrolling

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

Treatments: Behavioral: MindBodyU Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07631104

Pro00085794

1K01MH118073-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 16 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

MindBodyU Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: MindBodyU Intervention