HAART Non-AdherenceNCT01049568
Cell Phone Reminders Intervention
A study testing Cell Phone Intervention in people with HAART Non-Adherence and HIV, run by University of North Carolina, Chapel Hill at 5 sites in United States.
Trial summary
This study will use a longitudinal, experimental design. Participants will be randomized to either the intervention or the control group. The intervention will involve cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- HAART Non-Adherence, HIV, HIV Infections
- What is being tested?
- Cell Phone Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2009to Nov 2010
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Documented HIV-positive infected either behaviorally or perinatally as determined by medical record review or verbal verification from referring professional.
- Age 15 and 0 days to 24 years and 364 days. Enrolled in care at an AMTU or affiliated site.
- History of non-adherence to one or more components of antiretroviral therapy, defined as meeting one of the following criteria:
- Currently prescribed HAART and reports to care provider less than 90% adherence in previous month and has viral load greater than 1000 copies/ml when last evaluated (within the last four weeks);
- Discontinued HAART in the past while documented to be less than 90% adherent during the most recent antiretroviral treatment; and
- Agreed to initiate antiretroviral treatment in the past, but never initiated. Able to speak and understand English. Willing to provide informed consent or assent.
Who cannot join
- Evidence of cognitive impairment or other mental condition (including substance abuse) that limits his/her ability to complete intervention and assessments (per PI or designee discretion). Participants with stable and treated mental health/substance abuse disorders are acceptable for inclusion with protocol team approval.
- Any condition, including active substance abuse that is expected to limit the likelihood that the participant may maintain involvement for the entire year on-study (per PI or designee discretion with protocol team approval).
- No participant consent, parental permission or youth assent (as appropriate). Minors unable to acquire parental/guardian consent, even if not living at home, will not be able to participate as a change in housing status during the study might require premature discontinuation.
- Current participation in another behavioral interventional trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
University of California San Francisco
San Francisco, California, 94117
Childrens National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: A Pilot Study Using Cell Phone Interactions to Improve Medication Adherence in Adolescents Who Have Previously Failed Antiretroviral Therapy Due to Non-Adherence
This study will use a longitudinal, experimental design. Participants will be randomized to either the intervention or the control group.
The intervention will involve cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator.
Control group participants will participate in all on-study evaluations, except the intervention exit interviews.
Read the detailed description
Forty participants, non-adherent to HAART at study start, will be randomly assigned to either a 1) "Cell Phone Adherence Facilitator" group (intervention group) or a 2) control group. In the intervention group, a Cell Phone Adherence Facilitator will initiate a short (typically five minutes or less) contact Monday through Friday (excluding major holidays) with each participant to enhance their adherence to HAART. Occasionally, calls may be longer if crises arise that can be addressed by the Adherence Facilitator. Calls from the Adherence Facilitator will occur once or twice a day (depending on dosing schedule) and go on for 24 weeks in the intervention group. Calls will occur at a time soon after the prescribed dose is supposed to be taken, but also one convenient to the participant and the Adherence Facilitator.
All participants regardless of condition will be followed for 48 weeks. This intervention will be examined as a tool to address participant-specific, healthcare systems and participant-provider relationship barriers to ARV adherence.
- Conditions
- HAART Non-Adherence, HIV, HIV Infections
- Being tested
- Cell Phone Intervention
- Keywords
- HIV, Cell phone, HAART
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell Phone InterventionBehavioural
Cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator.
Data will be collected using the ACASI and CRFs at entry, weeks 6, 12, 24, 36, 48 and the premature discontinuation visits. Measures will assess social support, coping, self-efficacy, substance use, adherence, life stressors, perceived stress, psychological symptoms and health service utilization.
| Study group | Role | What they receive |
|---|---|---|
| Cell Phone Intervention | Experimental | Not described Receives: Behavioral: Cell Phone Intervention |
| Control | No intervention | Control group participants will participate in all on-study evaluations, except the intervention exit interviews. Data will be collected using the ACASI and CRFs at entry, weeks 6, 12, 24, 36, 48 and the premature discontinuation visits. Measures will assess social support, coping, self-efficacy, substance use, adherence, life stressors, perceived stress, psychological symptoms and health service utilization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the content of the Adherence Facilitator's conversation; including reported stressful life circumstances, what solutions were offered, and acceptability of the intervention among intervention participants.
Measured: 1 year
To examine the trends of therapeutic success at 6 and 12 months, as measured by lowered viral load, and self-reported adherence among intervention versus control group participants.
Measured: 1 year
Secondary outcomes (5)
To examine the trends of self-reported and chart-documented service utilization among intervention versus control participants.
Measured: 1 year
To identify the characteristics of youth who may require longer-term adherence support with cell phone conversations based on their self-reported scores of depression, life stressors, substance use, and their utilization of services.
Measured: 1 year
To track the costs of implementation of cell phone contacts with Adherence Facilitators in the adolescent clinical setting by collecting the monthly cost of youths' cell phones.
Measured: 1 year
To evaluate barriers to and promoters of implementation of cell phone support through qualitative interviews with intervention participants and Adherence Facilitators.
Measured: 1 year
To examine the trends for self-reported adherence self-efficacy, perceived stress, and problem-solving orientation towards medication among intervention versus control group participants.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HAART Non-AdherenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Marvin Belzer, MD, Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049568
- Sponsor's protocol ID
- ATN 078
- Status last verified
- Mar 2016
- First submitted
- 13 Jan 2010
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Cell Phone Interactions to Improve Medication Adherence in Adolescents Who Have Previously Failed Antiretroviral Therapy Due to Non-Adherence
- ClinicalTrials.gov ID
- NCT01049568
- Acronym / sponsor ID
- ATN 078
- Conditions
- HAART Non-Adherence, HIV, HIV Infections
- Keywords
- HIV, Cell phone, HAART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Oct 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Jan 2010 (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 study will use a longitudinal, experimental design. Participants will be randomized to either the intervention or the control group.
The intervention will involve cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator.
Control group participants will participate in all on-study evaluations, except the intervention exit interviews.
Detailed description
Forty participants, non-adherent to HAART at study start, will be randomly assigned to either a 1) "Cell Phone Adherence Facilitator" group (intervention group) or a 2) control group. In the intervention group, a Cell Phone Adherence Facilitator will initiate a short (typically five minutes or less) contact Monday through Friday (excluding major holidays) with each participant to enhance their adherence to HAART. Occasionally, calls may be longer if crises arise that can be addressed by the Adherence Facilitator. Calls from the Adherence Facilitator will occur once or twice a day (depending on dosing schedule) and go on for 24 weeks in the intervention group. Calls will occur at a time soon after the prescribed dose is supposed to be taken, but also one convenient to the participant and the Adherence Facilitator.
All participants regardless of condition will be followed for 48 weeks. This intervention will be examined as a tool to address participant-specific, healthcare systems and participant-provider relationship barriers to ARV adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell Phone Intervention | Experimental | Behavioral: Cell Phone Intervention |
| Control | No intervention | –Control group participants will participate in all on-study evaluations, except the intervention exit interviews. Data will be collected using the ACASI and CRFs at entry, weeks 6, 12, 24, 36, 48 and the premature discontinuation visits. Measures will assess social support, coping, self-efficacy, substance use, adherence, life stressors, perceived stress, psychological symptoms and health service utilization. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Documented HIV-positive infected either behaviorally or perinatally as determined by medical record review or verbal verification from referring professional.
- Age 15 and 0 days to 24 years and 364 days. Enrolled in care at an AMTU or affiliated site.
- History of non-adherence to one or more components of antiretroviral therapy, defined as meeting one of the following criteria:
- Currently prescribed HAART and reports to care provider less than 90% adherence in previous month and has viral load greater than 1000 copies/ml when last evaluated (within the last four weeks);
- Discontinued HAART in the past while documented to be less than 90% adherent during the most recent antiretroviral treatment; and
Key exclusion criteria (4 listed)
- Evidence of cognitive impairment or other mental condition (including substance abuse) that limits his/her ability to complete intervention and assessments (per PI or designee discretion). Participants with stable and treated mental health/substance abuse disorders are acceptable for inclusion with protocol team approval.
- Any condition, including active substance abuse that is expected to limit the likelihood that the participant may maintain involvement for the entire year on-study (per PI or designee discretion with protocol team approval).
- No participant consent, parental permission or youth assent (as appropriate). Minors unable to acquire parental/guardian consent, even if not living at home, will not be able to participate as a change in housing status during the study might require premature discontinuation.
- Current participation in another behavioral interventional trial.
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 |
|---|---|---|
| Cell Phone InterventionCell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator. Data will be collected using the ACASI and CRFs at entry, weeks 6, 12, 24, 36, 48 and the premature discontinuation visits. Measures will assess social support, coping, self-efficacy, substance use, adherence, life stressors, perceived stress, psychological symptoms and health service utilization. | Behavioural | Cell Phone Intervention |
Primary outcome
To examine the content of the Adherence Facilitator's conversation; including reported stressful life circumstances, what solutions were offered, and acceptability of the intervention among intervention participants.
Time frame: 1 year
To examine the trends of therapeutic success at 6 and 12 months, as measured by lowered viral load, and self-reported adherence among intervention versus control group participants.
Time frame: 1 year
5 secondary outcomes
To examine the trends of self-reported and chart-documented service utilization among intervention versus control participants.
Time frame: 1 year
To identify the characteristics of youth who may require longer-term adherence support with cell phone conversations based on their self-reported scores of depression, life stressors, substance use, and their utilization of services.
Time frame: 1 year
To track the costs of implementation of cell phone contacts with Adherence Facilitators in the adolescent clinical setting by collecting the monthly cost of youths' cell phones.
Time frame: 1 year
To evaluate barriers to and promoters of implementation of cell phone support through qualitative interviews with intervention participants and Adherence Facilitators.
Time frame: 1 year
To examine the trends for self-reported adherence self-efficacy, perceived stress, and problem-solving orientation towards medication among intervention versus control group participants.
Time frame: 1 year
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 28 Feb 2017.
- ATN WebsiteLink provided by the sponsor.
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.
Marvin Belzer, MD study chair
Adolescent Trials Network
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell Phone Intervention in people with HAART Non-Adherence and HIV, run by University of North Carolina, Chapel Hill at 5 sites 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 6 inclusion and 4 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
To examine the content of the Adherence Facilitator's conversation; including reported stressful life circumstances, what solutions were offered, and acceptability of the intervention among intervention participants. (time frame: 1 year). 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 28 Feb 2017.