HIVNCT02468544
Development and Feasibility Testing of a Mobile Phone-Based HIV Primary Care Engagement Intervention
A study testing Text messaging in people with HIV and Adherence, run by Columbia University at 1 site in United States.
Trial summary
This is an open-trial pilot study in which adult methadone maintenance treatment patients who are living with HIV but are not engaged in HIV primary care (i.e., missed appointments, non-adherence to medication) will be recruited to participate in a HIV primary care engagement study. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- Text messaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2017to Apr 2017
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Client of a methadone maintenance treatment program
- HIV positive (status confirmed by medical records)
- At least 18 years of age
- English speaking
- Comfortable using a mobile phone (to send and receive text messages)
- Lives in New York City
- Willingness to attend at least two design sessions
- Willingness to attend one usability testing session, and participate in a post-usability survey and exit interview.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-trial pilot study in which adult methadone maintenance treatment patients who are living with HIV but are not engaged in HIV primary care (i.e., missed appointments, non-adherence to medication) will be recruited to participate in a HIV primary care engagement study. The purpose of this study is to develop and test the feasibility and acceptability of a mobile phone-based health (mHealth) text messaging intervention to improve engagement in HIV primary care among substance abusing populations with HIV.
- Being tested
- Text messaging
- Keywords
- Engagement in care, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messagingOther
Text messaging mHealth intervention to improve HIV Primary Care Engagement among clients of methadone maintenance treatment programs who are living with HIV.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Intervention Study | Experimental | All participants will receive individualized text messages based on a schedule determined during the development and refinement of the mHealth text messaging intervention (i.e., once or twice a week). All participants will receive text messages for: 1) medication reminders, 2) appointment reminders, and 3) text messages addressing barriers (educational information to improve HIV knowledge) or promoting facilitators (e.g., routinizing taking of HIV antiretroviral medication) of care engagement. Each participant will complete baseline assessments, and will select their preferences for personalized messages on the day of baseline assessments. Text messages will be deployed for the duration of the 30-day trial. Participants will be followed-up at the completion of the 30-day intervention. Each participant will be asked to complete a follow-up survey, including questions on the acceptability of the mHealth intervention. Receives: Other: Text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention
Acceptability of the intervention will be measured using the Technology Acceptance Model (TAM) scale.
Measured: 30 days
Feasibility of Intervention
Feasibility of the intervention will be assessed focusing on study implementation, including recruitment and attrition rates.
Measured: 30 days
Secondary outcomes (1)
Efficacy of the intervention
Preliminary efficacy of the intervention will be measured using the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES) and the HIV appointment adherence questionnaire.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startMar 2017 (estimated)
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Why it stopped: Investigator left the institution prior to enrollment of the first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jemima A. Frimpong, PhD., MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468544
- Sponsor's protocol ID
- AAAO7902
- Status last verified
- Nov 2020
- First submitted
- 31 May 2015
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Testing of a Mobile Phone-Based HIV Primary Care Engagement Intervention
- ClinicalTrials.gov ID
- NCT02468544
- Acronym / sponsor ID
- AAAO7902
- Keywords
- Engagement in care, mHealth
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left the institution prior to enrollment of the first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 11 Jun 2015 (estimated)
- 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.
This is an open-trial pilot study in which adult methadone maintenance treatment patients who are living with HIV but are not engaged in HIV primary care (i.e., missed appointments, non-adherence to medication) will be recruited to participate in a HIV primary care engagement study. The purpose of this study is to develop and test the feasibility and acceptability of a mobile phone-based health (mHealth) text messaging intervention to improve engagement in HIV primary care among substance abusing populations with HIV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Intervention Study | Experimental | Other: Text messagingAll participants will receive individualized text messages based on a schedule determined during the development and refinement of the mHealth text messaging intervention (i.e., once or twice a week). All participants will receive text messages for: 1) medication reminders, 2) appointment reminders, and 3) text messages addressing barriers (educational information to improve HIV knowledge) or promoting facilitators (e.g., routinizing taking of HIV antiretroviral medication) of care engagement. Each participant will complete baseline assessments, and will select their preferences for personalized messages on the day of baseline assessments. Text messages will be deployed for the duration of the 30-day trial. Participants will be followed-up at the completion of the 30-day intervention. Each participant will be asked to complete a follow-up survey, including questions on the acceptability of the mHealth intervention. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Client of a methadone maintenance treatment program
- HIV positive (status confirmed by medical records)
- At least 18 years of age
- English speaking
- Comfortable using a mobile phone (to send and receive text messages)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Text messagingText messaging mHealth intervention to improve HIV Primary Care Engagement among clients of methadone maintenance treatment programs who are living with HIV. | Other | Single Arm Intervention Study |
Primary outcome
Acceptability of Intervention
Time frame: 30 days
Acceptability of the intervention will be measured using the Technology Acceptance Model (TAM) scale.
Feasibility of Intervention
Time frame: 30 days
Feasibility of the intervention will be assessed focusing on study implementation, including recruitment and attrition rates.
1 secondary outcome
Efficacy of the intervention
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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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.
Jemima A. Frimpong, PhD., MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text messaging in people with HIV and Adherence, run by Columbia University 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 8 inclusion and 0 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: withdrawn, as of the sponsor's last update on 9 Nov 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Acceptability of Intervention (time frame: 30 days). The study lists 2 primary outcomes in all. 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 9 Nov 2020.