mHealth for ART Adherence by HIV+ African Americans

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557332
• Other study ID #: 5R44MD007161-05
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: September 2020
• Source: Environment and Health Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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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Related Conditions & MeSH terms

• HIV-1-infection

Intervention

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.

Locations

Country	Name	City	State
United States	Environment and Health Group	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Environment and Health Group, Inc.	Prisma Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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