mHealth for ART Adherence by HIV+ African Americans

Phase 2

Completed

• Conditions: HIV-1-infection
• Interventions: Behavioral: On the Dot Mobile app

• Registration Number: NCT04557332
• Lead Sponsor: Environment and Health Group, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-21
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile app	On the Dot Mobile app	In this arm, participants received a mobile app to support ART medication adherence.

Primary Outcome Measures

Name	Time	Method
Self-reported ART medication adherence	90 days	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?"

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Environment and Health Group; 🇺🇸 Cambridge, Massachusetts, United States