A Mobile Gaming App to Improve ART Adherence for Youth

NCT03760211 | Completed

• 1 other identifier: 217318
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 4

Brief Summary

Despite the need for consistent adherence to medical care, youth living with HIV have low rates of adherence to medications and treatment. There are few interventions to improve adherence to HIV medications and treatment for youth, and there is a great need for novel approaches that are engaging for this age group. The investigators developed an intervention that includes a mobile gaming app that is integrated with a 7-day electronic medication device and text messages. During gameplay, youth fight HIV in colorful organ systems. A small previous project found that the intervention helped youth who were newly starting medications for HIV by improving adherence and decreasing HIV virus in their bodies (viral load). This proposed project will test the intervention with larger number of youth (100) who are newly starting HIV treatment and medications in New England, Georgia, and in Mississippi. The investigators want to determine if adherence is improved and viral load is reduced in this larger sample.

Conditions

Medication Adherence; HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Change from Baseline HIV-1 Viral Load at 48 weeks

  Assessing change from Baseline HIV-1 viral load (copies/mL)

  48 weeks

Secondary Outcomes (3)

• Self-reported Medication Adherence

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

• Self-reported Missed ARV Doses (1 Month)

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

• Self-reported Missed ARV Doses (1 week)

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

Other Outcomes (7)

• HIV Treatment Knowledge Scale

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

• Antiretroviral Therapy Treatment Knowledge

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

• Motivation for Adherence

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

Study Arms (2)

Multilevel Gaming Adherence

EXPERIMENTAL

Participants in the intervention arm will receive Multilevel Gaming Adherence Intervention. Participants receive Battle Viro on their mobile phones, an electronic pill monitoring device, and, for 24 weeks, game-related text messages guided by medication adherence data (collected from an electronic pill monitoring device).

Behavioral: Multilevel Gaming Adherence Intervention

Treatment as Usual +

ACTIVE COMPARATOR

TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game and an electronic pill monitoring device.

Behavioral: Treatment as Usual +

Interventions

Multilevel Gaming Adherence Intervention BEHAVIORAL

Combination of electronic medication monitoring device with Information-Motivation-Behavior based mobile gaming application tailored for those living with HIV and adherence-based text messages

Multilevel Gaming Adherence

Treatment as Usual + BEHAVIORAL

Combination of electronic medication monitoring device and non-HIV related mobile gaming application

Treatment as Usual +

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Living with HIV
• English speaking
• Have started antiretroviral therapy (ART) in the last three months or restarted ART in the last three months after not taking ART for approximately six months
• Have access to a smartphone for the duration of the study
• Not involved with another HIV prevention or adherence related study
• Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment
• Detectable viral load

You may not qualify if:

• None

Sponsors & Collaborators

• Rhode Island Hospital: lead
• University of Mississippi Medical Center: collaborator
• Boston Medical Center: collaborator
• Emory University: collaborator

Study Sites (4)

Emory University

Atlanta, Georgia, 30322, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

  PMID: 32779730 DERIVED

MeSH Terms

Conditions

Medication Adherence; Acquired Immunodeficiency Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• James B Brock, MD

  University of Mississippi Medical Center

  STUDY DIRECTOR

• Rachel Epstein, MD

  Boston Medical Center

  STUDY DIRECTOR

• Stephen Pelton, MD

  Boston Medical Center

  STUDY DIRECTOR

• Larry K Brown, MD

  Rhode Island Hospital

  STUDY DIRECTOR

• Laura Whiteley, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Andres Camacho-Gonzalez, MD

  Emory University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 30, 2018
• Study Start: November 1, 2019
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: April 6, 2025

Record last verified: 2024-04

Locations

US (4)