HIV-1-infectionPhase 2NCT04557332
mHealth for ART Adherence by HIV+ African Americans
A Phase 2 study testing On the Dot Mobile app in people with HIV-1-infection, run by Environment and Health Group, Inc. at 1 site in United States.
Trial summary
The objective of this grant is to create and test a mobile app to support ART adherence among HIV+ African American adults. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- On the Dot Mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 30 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Environment and Health Group
Cambridge, Massachusetts, 02141
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV-1-infection
- Being tested
- On the Dot Mobile app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On the Dot Mobile appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile app | Experimental | In this arm, participants received a mobile app to support ART medication adherence. Receives: Behavioral: On the Dot Mobile app |
| Control | No intervention | In this arm, participants received care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 90 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Apr 2019
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial in which participants were randomly assigned to intervention group or control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Environment and Health Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prisma Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557332
- Sponsor's protocol ID
- 5R44MD007161-05
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth for ART Adherence by HIV+ African Americans Age 45 & Older
- ClinicalTrials.gov ID
- NCT04557332
- Acronym / sponsor ID
- 5R44MD007161-05
- Conditions
- HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Environment and Health Group, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Prisma Health
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial in which participants were randomly assigned to intervention group or control group.
| Arm | Type | Receives |
|---|---|---|
| Mobile app | Experimental | Behavioral: On the Dot Mobile appIn this arm, participants received a mobile app to support ART medication adherence. |
| Control | No intervention | –In this arm, participants received care as usual. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- -
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On the Dot Mobile appOn 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. | Behavioural | Mobile app |
Primary outcome
Self-reported ART medication adherence
Time frame: 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?"
2 secondary outcomes
HIV medication adherence self efficacy
Time frame: 90 days
Stress Burden
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing On the Dot Mobile app in people with HIV-1-infection, run by Environment and Health Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported ART medication adherence (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.