NCT03092115

Brief Summary

This study will help determine feasibility, acceptability, and preliminary efficacy of an app for HIV medication adherence over a 3-month period. Participation is 3 months consisting of two study visits: An initial study visit and a 3 month follow up visit with both visits lasting about 60-90 minutes. The participant must use the study application (app) at least once daily, and at study visits, must complete surveys.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

March 3, 2017

Last Update Submit

September 3, 2019

Conditions

HIV

Keywords

Men who have sex with men (MSM)mHealthantiretroviral therapy (ART)native android app

Outcome Measures

Primary Outcomes (1)

  • Suppressed viral load at 3-months

    Percentage of participants with suppressed HIV viral load (≤ 200 copies/mL) at the 3-month follow-up study visit.

    3 months

Secondary Outcomes (5)

  • Self-reported medication adherence rates by participants at 3 months

    3 months

  • Medication adherence measure using prescription refill information

    3 months

  • Self-reported medication adherence rates by participants over 3-months within the medication adherence application

    3 months

  • Measure participant satisfaction of the medication adherence application at 3-months

    3 months

  • Suppressed viral load at 6-months

    6 months

Study Arms (1)

HIV medication adherence app

EXPERIMENTAL

Youth in this arm will receive a medication adherence application to help them remember to take their HIV treatment medication (antiretroviral therapy) as a supplement to current HIV standard of care.

Device: HIV medication adherence app

Interventions

HIV medication adherence appDEVICE

A medication adherence mobile application for HIV+ youth. It is a theory-driven, patient-centered, mobile phone-based intervention targeting medication adherence and engagement in care among HIV+ youth with features including, but not limited to: custom avatar, medication reminders, calendar tracking of medication adherence, and anonymous chat function for social support.

HIV medication adherence app

Eligibility Criteria

Age14 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males (sex at birth male) age 14 to 24 years.
  • HIV-positive
  • Owns an Android smart phone
  • Within 1-month of initiating antiretroviral therapy (ART) medication, previously failed ART and about to restart an ART regimen, or currently on ART having trouble with adherence (defined as having a detectable viral load above 200 copies/ml).
  • MSM (men who have sex with men)
  • Receiving care at the Children's Hospital of Philadelphia (CHOP) Adolescent HIV clinic at the time of the study

You may not qualify if:

  • Females (sex at birth; not gender)
  • Males age 13 years or younger or 25 years and older.
  • HIV-negative or status unknown
  • Not in care at the CHOP Adolescent HIV clinic at the time of the study.
  • Does not own an Android smart phone (iPhone, Blackberry, etc. phone users)
  • Is already ART adherent (defined as having an undetectable or suppressed, \<200 copies/ml, viral load) or is not on or going to be on ART during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Officials

  • Nadia L Dowshen, MD, MSHP

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 27, 2017

Study Start

May 22, 2017

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

September 4, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

individual participant data will not be shared with other researchers. If shared, datasets will be deidentified of participant health information.

Locations

US(1)