mHealth for ART Adherence by HIV+ African Americans

NCT04557332 | Completed Phase 2

• 1 other identifier: 5R44MD007161-05
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this grant is to create and test a mobile app to support ART adherence among HIV+ African American adults.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Self-reported ART medication adherence

  Adherence was assessed using a 3-item self-report measure examining ART use in the prior 7 days, a time period, which is considered a reliable indictor of overall adherence (Bianco et al., 2010; Kleeburger et al., 2001; Segeral et al., 2010; Spire et al. 2008). The measure consists of a yes or no response to each of the following three questions: (i) "did you miss any ART doses during the last four days?," (ii) "Were you late for any of your intakes by more than two hours during the last four days?," and (iii) "did you miss any ART doses last week-end?"

  90 days

Secondary Outcomes (2)

• HIV medication adherence self efficacy

  90 days

• Stress Burden

  90 days

Study Arms (2)

Mobile app

EXPERIMENTAL

In this arm, participants received a mobile app to support ART medication adherence.

Behavioral: On the Dot Mobile app

Control

NO INTERVENTION

In this arm, participants received care as usual.

Interventions

On the Dot Mobile app BEHAVIORAL

On the Dot is a mobile app to support HIV medication adherence. The mobile app is linked to a clinician portal through which participants can receive adherence support.

Mobile app

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (a) self-identify as African American, (b) age 30 or older, (c) HIV positive (d) currently on ART (e) report having problems with, and interest in improving their ART adherence (f) own a smartphone (g) report English as their primary language

You may not qualify if:

• (a) not self-identified as African American, (b) under age 30 (c) HIV negative (d) not currently on ART (e) do not report having problems with, or interest in, improving their ART adherence (f) do not own a smartphone (g) do not report English as a primary language and (h) participating in another research study or clinical trial (i) receiving care at non-participating site and, (j) dementia diagnosis.

Sponsors & Collaborators

• Environment and Health Group, Inc.: lead
• Prisma Health: collaborator

Study Sites (1)

Environment and Health Group

Cambridge, Massachusetts, 02141, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators and participants were aware of which group participants were randomly assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial in which participants were randomly assigned to intervention group or control group.

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: April 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)