mHealth for ART Adherence by HIV+ African Americans

mHealth for ART Adherence by HIV+ African Americans Age 45 & Older

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

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Behavioral: On the Dot Mobile app

Detailed Description

The Phase II project will enhance the existing (Phase 1) mobile intervention by offering: 1) a two-way communication capability through which participants can: i) indicate "pill taken" in response to pill reminders, and ii) receive a positive visual icon as behavioral-economics based reinforcement for "pill taken" responses; 2) pharmacist counseling and medication support; and, 3) the addition of educational and motivational text messages. Overall aims are to: 1) expand mhealth intervention to incorporate new Phase II features; 2) evaluate effectiveness in an RCT of HIV+ African Americans; and 3) prepare marketing and commercialization plans. Our long-term goal is to increase ART medication adherence, thus decreasing health disparities, among HIV+, African-Americans.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02141
      • Environment and Health Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

(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

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Exclusion Criteria:

(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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile app; In this arm, participants received a mobile app to support ART medication adherence.	Behavioral: On the Dot Mobile app; 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.
No Intervention: Control; In this arm, participants received care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV medication adherence self efficacy	HIV treatment self-efficacy was assessed using the 17-item self-efficacy belief subscale of the modified HIV Medication Taking Self-Efficacy Scale.	90 days
Stress Burden	Stress burden will be assessed using the Perceived Stress Scale (Cohen et al., 1983), a well-validated instrument used with diverse populations.	90 days

Collaborators and Investigators

• Sponsor: Environment and Health Group, Inc.
• Collaborators: Prisma Health

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 5R44MD007161-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No