Drug Abuse IllicitNCT01871298
Drug User Internet and Mobile Tech Use
A study testing Pilot Website Evaluation Component in people with Drug Abuse Illicit, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this exploratory study is to examine factors associated with frequency and type of internet and mobile technology use among illegal drug users, specifically use of internet and text-messaging to obtain health care information and engage in health care utilization, specifically human immunodeficiency… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse Illicit
- What is being tested?
- Pilot Website Evaluation Component
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Nov 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any lifetime illegal drug use
- age > 18
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Exploratory Study of Drug User Health-related Internet and Mobile Technology Use
The purpose of this exploratory study is to examine factors associated with frequency and type of internet and mobile technology use among illegal drug users, specifically use of internet and text-messaging to obtain health care information and engage in health care utilization, specifically human immunodeficiency virus (HIV) prevention and treatment services. We will target high drug activity neighborhoods in New York City and enroll participants recruited through targeted street outreach. All participants (n=336) will undergo an audio computer-assisted self-interview (ACASI) that will assess sociodemographics, health care access and utilization, sex/drug use behavior, health status, and characteristics of general and health-related internet/mobile technology use including factors that promote or hinder use. Participants identified as using the internet ≥1/month (n=151) will return for a 4-week ACASI to report on use of the pilot website (which will largely display information currently available in the community in print/ pamphlet/ video form).
Read the detailed description
At the enrollment visit participants deemed eligible after screening will be consented, and given a 30 minute baseline ACASI survey. At the end of the baseline visit, those participants who reported internet use at least 1x/month (in the past month) will be offered participation in the Pilot Website Evaluation Component. For this component, participants will be instructed on how to use an educational website with health resources. Their use of the website will be tracked. They will be given an appointment to return in 4-weeks for a follow up survey at the pharmacy and a 2-week locator call.
- Conditions
- Drug Abuse Illicit
- Being tested
- Pilot Website Evaluation Component
- Keywords
- internet and mobile technology use, history of drug use, injection drug user (IDU) syringe customers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot Website Evaluation ComponentOther
The pilot health website will contain educational health information such as: health-related videos, searchable map of HIV prevention and other needed health and social services, and the option to register for automatic text message updates on relevant health information.
| Study group | Role | What they receive |
|---|---|---|
| Website access | Other | While this pilot intervention is not a randomized trial, study participants who report internet use at least once a month will told of a Pilot Website Evaluation Component that they will be able to access for a 4-week study period. This website will contain a educational information tailored to the health needs of drug users. Web content will be similar to materials and public health messages released by the NYC Department of Health and therefore, harm is not likely to arise from viewing such content. Receives: Other: Pilot Website Evaluation Component |
| No website access | No intervention | Participants who report internet use less than once a month will not receive access to the Pilot Website Evaluation Component. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants who use the pilot website
Measured: 4 weeks
Secondary outcomes (5)
Percent of participants who use the internet
Measured: Baseline
Percent of participants who use the internet at least once a month
Measured: Baseline
Percent of participants who use the internet for health-related purposes
Measured: Baseline
Percent of participants who are willing to use internet or mobile technology for health-related purposes
Measured: Baseline
Percent of participants who sign up for receipt of automatic text message updates on relevant health information
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Abuse IllicitStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Silvia Cunto-Amesty, Columbia University
- Investigators
- Silvia Cunto-Amnesty, MD, Principal investigator, Assistant Professor of Medicine and Population and Family Health, Dept of Medicine Family Med
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871298
- Sponsor's protocol ID
- AAAL6402
- Other IDs
- 1R21DA034841-01A1
- Status last verified
- Nov 2015
- First submitted
- 4 Jun 2013
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Drug User Health-related Internet and Mobile Technology Use
- ClinicalTrials.gov ID
- NCT01871298
- Acronym / sponsor ID
- AAAL6402
- Conditions
- Drug Abuse Illicit
- Keywords
- internet and mobile technology use, history of drug use, injection drug user (IDU) syringe customers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Jun 2013 (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.
The purpose of this exploratory study is to examine factors associated with frequency and type of internet and mobile technology use among illegal drug users, specifically use of internet and text-messaging to obtain health care information and engage in health care utilization, specifically human immunodeficiency virus (HIV) prevention and treatment services. We will target high drug activity neighborhoods in New York City and enroll participants recruited through targeted street outreach. All participants (n=336) will undergo an audio computer-assisted self-interview (ACASI) that will assess sociodemographics, health care access and utilization, sex/drug use behavior, health status, and characteristics of general and health-related internet/mobile technology use including factors that promote or hinder use. Participants identified as using the internet ≥1/month (n=151) will return for a 4-week ACASI to report on use of the pilot website (which will largely display information currently available in the community in print/ pamphlet/ video form).
Detailed description
At the enrollment visit participants deemed eligible after screening will be consented, and given a 30 minute baseline ACASI survey. At the end of the baseline visit, those participants who reported internet use at least 1x/month (in the past month) will be offered participation in the Pilot Website Evaluation Component. For this component, participants will be instructed on how to use an educational website with health resources. Their use of the website will be tracked. They will be given an appointment to return in 4-weeks for a follow up survey at the pharmacy and a 2-week locator call.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Website access | Other | Other: Pilot Website Evaluation ComponentWhile this pilot intervention is not a randomized trial, study participants who report internet use at least once a month will told of a Pilot Website Evaluation Component that they will be able to access for a 4-week study period. This website will contain a educational information tailored to the health needs of drug users. Web content will be similar to materials and public health messages released by the NYC Department of Health and therefore, harm is not likely to arise from viewing such content. |
| No website access | No intervention | –Participants who report internet use less than once a month will not receive access to the Pilot Website Evaluation Component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- any lifetime illegal drug use
- age > 18
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Pilot Website Evaluation ComponentThe pilot health website will contain educational health information such as: health-related videos, searchable map of HIV prevention and other needed health and social services, and the option to register for automatic text message updates on relevant health information. | Other | Website access |
Primary outcome
Percent of participants who use the pilot website
Time frame: 4 weeks
5 secondary outcomes
Percent of participants who use the internet
Time frame: Baseline
Percent of participants who use the internet at least once a month
Time frame: Baseline
Percent of participants who use the internet for health-related purposes
Time frame: Baseline
Percent of participants who are willing to use internet or mobile technology for health-related purposes
Time frame: Baseline
Percent of participants who sign up for receipt of automatic text message updates on relevant health information
Time frame: 4 weeks
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 26 Nov 2015.
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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.
Silvia Cunto-Amnesty, MD principal investigator
Assistant Professor of Medicine and Population and Family Health, Dept of Medicine Family Med
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilot Website Evaluation Component in people with Drug Abuse Illicit, 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 2 inclusion and 1 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 26 Nov 2015. 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 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?
Percent of participants who use the pilot website (time frame: 4 weeks). 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 26 Nov 2015.