mHealth for ART Adherence by HIV+ African Americans

NCT ID: NCT04557332

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-05-30

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV-1-infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial in which participants were randomly assigned to intervention group or control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Investigators and participants were aware of which group participants were randomly assigned to.

Study Groups

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Mobile app

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

Group Type EXPERIMENTAL

On the Dot Mobile app

Intervention Type 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.

Control

In this arm, participants received care as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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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Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prisma Health

UNKNOWN

Sponsor Role collaborator

Environment and Health Group, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Environment and Health Group

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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5R44MD007161-05

Identifier Type: NIH

Identifier Source: org_study_id

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