HIV InfectionNCT01347437
Improving Antiretroviral Medication Adherence Among HIV-infected Youth
A study testing Positive STEPS in people with HIV Infection, run by Fenway Community Health at 3 sites in United States.
Trial summary
HIV is increasing among adolescents and young adults in the US. Antiretroviral medications, when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- Positive STEPS
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2011to 6 Mar 2013
- 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 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13 to 24 years
- HIV-infected
- Currently taking antiretroviral therapy or prescribed medication for HIV
- Self-reported difficulties adhering to HIV medications in the past 3 months (i.e., <95% compliant)
- If 18-24: Willing and able to provide informed consent
- If 13-17: Parent/guardian willing and able to provide parental permission and participant willing and able to provide assent
- Willing to attend all study visits
Who cannot join
- If 18-24:Unwilling or unable to provide informed consent
- If 13-17: Parent/guardian unwilling or unable to provide parental permission and participant willing and able to provide assent
- Has severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit your ability to participate (e.g. dementia)
- Has severe cognitive limitation that would limit your ability to comprehend the informed consent or assent (see Decisional Capacity Determination SOP)
- Unwilling to attend all study visits
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Children's Hospital Boston
Boston, Massachusetts, 02115
The Fenway Institute, Fenway Health
Boston, Massachusetts, 02215
About this study
Official title: Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase II
HIV is increasing among adolescents and young adults in the US. Antiretroviral medications, when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy. However, adherence among HIV-infected young people is suboptimal, and few interventions are available to help adolescents adhere to treatment.
The study is a randomized controlled trial (RCT) pilot trial of Positive STEPS (the adapted form of the Life-Steps behavioral intervention) to improve medication adherence among HIV-infected youth. The study will allow us to demonstrate participant acceptance, ability to recruit, feasibility of intervention delivery with study counselors and all study procedures, and initial clinically significant improvement in medication adherence via MEMS caps. This research will lay the groundwork for a federal grant application for a multi-site randomized controlled intervention trial.
Read the detailed description
Aims:
- To conduct a randomized controlled pilot test of a behavioral adherence intervention to improve medication adherence among HIV-infected youth aged 13-24. Feasibility of all study procedures and participant acceptability will be assessed.
- To explore whether the intervention leads to improved medication adherence among youth who receive the intervention, compared to a control group of youth who do not.
40 HIV-infected adolescents will be recruited for a RCT pilot of the Positive STEPS intervention at Fenway Health and Children's Hospital Boston. Participants will be randomized into one of two arms (half and half). Randomization for all participants will occur after the beginning of the week 2 study visit. The duration of the study is 3 months
Randomization:
The investigators will conduct block randomization based on two categories of electronic adherence: 85% or above versus < 85%. All participants will have exhibited some non-adherence in order to be eligible for the study, although they may vary in the extent of non-adherence. Because insufficient information is known about the range of non-adherence in the population to determine the most valid non-adherence cut-off points, the investigators may need to reconsider adherence categories over the course of the pilot study. The investigators will regularly examine the data to determine whether finer adherence categories are needed, and the investigators will adjust the categories if such a determination is made.
Intervention arm:
- Participants will receive one on one Positive STEPS counseling sessions (~1 hour sessions per week for 5 weeks).
- Participants will receive motivational reminders to take medications sent via text message to their cell phones
- Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.
Comparison condition arm:
- Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.
- Conditions
- HIV Infection
- Being tested
- Positive STEPS
- Keywords
- HIV, antiretroviral medication, adherence, adolescent
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive STEPSBehavioural
This intervention is given to patients in the experimental condition only. The Positive STEPS intervention-developed by our team-is based on general principles of cognitive-behavioral therapy as well as more specific principles of motivational interviewing32,33 and problem solving therapy. Informational, problem solving, and cognitive-behavioral STEPS are targeted over 5, in-person, intervention sessions with a PhD-level counselor. The intervention will also include a series of short videos related to the topics that the Positive STEPS intervention covers with participants. Participants in the experimental condition can also choose to receive text messages sent to their cell phone to remind them to take their medication.
| Study group | Role | What they receive |
|---|---|---|
| Condition | No intervention | In the comparison condition, participants will receive MEMS only. |
| Positive STEPS | Experimental | * Participants will receive one on one Positive STEPS counseling sessions (~1 hour sessions per week for 5 weeks).
* Participants will receive motivational reminders to take medications sent via text message to their cell phones.
* Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence. Receives: Behavioral: Positive STEPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronically monitored (MEMS) antiretroviral medication adherence
The primary outcome will be antiretroviral medication adherence. Adherence will be measured through the medication event monitoring device(MEMS).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2013
- Study completion6 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenway Community Health
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Massachusetts General Hospital, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Matthew Mimiaga, Fenway Community Health
- Investigators
- Matthew J Mimiaga, ScD, MPH, Principal investigator, Massachusetts General Hospital and Fenway Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347437
- Sponsor's protocol ID
- CFAR Adherence HIV Youth:2
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2011
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase II
- ClinicalTrials.gov ID
- NCT01347437
- Acronym / sponsor ID
- CFAR Adherence HIV Youth:2
- Conditions
- HIV Infection
- Keywords
- HIV, antiretroviral medication, adherence, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fenway Community HealthUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Massachusetts General Hospital, Harvard Medical School (HMS and HSDM)
- Study start
- Jul 2011 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- 6 Mar 2013 (actual)
- First posted
- 4 May 2011 (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.
HIV is increasing among adolescents and young adults in the US. Antiretroviral medications, when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy. However, adherence among HIV-infected young people is suboptimal, and few interventions are available to help adolescents adhere to treatment.
The study is a randomized controlled trial (RCT) pilot trial of Positive STEPS (the adapted form of the Life-Steps behavioral intervention) to improve medication adherence among HIV-infected youth. The study will allow us to demonstrate participant acceptance, ability to recruit, feasibility of intervention delivery with study counselors and all study procedures, and initial clinically significant improvement in medication adherence via MEMS caps. This research will lay the groundwork for a federal grant application for a multi-site randomized controlled intervention trial.
Detailed description
Aims:
- To conduct a randomized controlled pilot test of a behavioral adherence intervention to improve medication adherence among HIV-infected youth aged 13-24. Feasibility of all study procedures and participant acceptability will be assessed.
- To explore whether the intervention leads to improved medication adherence among youth who receive the intervention, compared to a control group of youth who do not.
40 HIV-infected adolescents will be recruited for a RCT pilot of the Positive STEPS intervention at Fenway Health and Children's Hospital Boston. Participants will be randomized into one of two arms (half and half). Randomization for all participants will occur after the beginning of the week 2 study visit. The duration of the study is 3 months
Randomization:
The investigators will conduct block randomization based on two categories of electronic adherence: 85% or above versus < 85%. All participants will have exhibited some non-adherence in order to be eligible for the study, although they may vary in the extent of non-adherence. Because insufficient information is known about the range of non-adherence in the population to determine the most valid non-adherence cut-off points, the investigators may need to reconsider adherence categories over the course of the pilot study. The investigators will regularly examine the data to determine whether finer adherence categories are needed, and the investigators will adjust the categories if such a determination is made.
Intervention arm:
- Participants will receive one on one Positive STEPS counseling sessions (~1 hour sessions per week for 5 weeks).
- Participants will receive motivational reminders to take medications sent via text message to their cell phones
- Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.
Comparison condition arm:
- Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condition | No intervention | –In the comparison condition, participants will receive MEMS only. |
| Positive STEPS | Experimental | Behavioral: Positive STEPS* Participants will receive one on one Positive STEPS counseling sessions (~1 hour sessions per week for 5 weeks). * Participants will receive motivational reminders to take medications sent via text message to their cell phones. * Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 13 to 24 years
- HIV-infected
- Currently taking antiretroviral therapy or prescribed medication for HIV
- Self-reported difficulties adhering to HIV medications in the past 3 months (i.e., <95% compliant)
- If 18-24: Willing and able to provide informed consent
Key exclusion criteria (5 listed)
- If 18-24:Unwilling or unable to provide informed consent
- If 13-17: Parent/guardian unwilling or unable to provide parental permission and participant willing and able to provide assent
- Has severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit your ability to participate (e.g. dementia)
- Has severe cognitive limitation that would limit your ability to comprehend the informed consent or assent (see Decisional Capacity Determination SOP)
- Unwilling to attend all study visits
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 |
|---|---|---|
| Positive STEPSThis intervention is given to patients in the experimental condition only. The Positive STEPS intervention-developed by our team-is based on general principles of cognitive-behavioral therapy as well as more specific principles of motivational interviewing32,33 and problem solving therapy. Informational, problem solving, and cognitive-behavioral STEPS are targeted over 5, in-person, intervention sessions with a PhD-level counselor. The intervention will also include a series of short videos related to the topics that the Positive STEPS intervention covers with participants. Participants in the experimental condition can also choose to receive text messages sent to their cell phone to remind them to take their medication. | Behavioural | Positive STEPS |
Primary outcome
Electronically monitored (MEMS) antiretroviral medication adherence
Time frame: 3 months
The primary outcome will be antiretroviral medication adherence. Adherence will be measured through the medication event monitoring device(MEMS).
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 17 Apr 2017.
- 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.
Matthew J Mimiaga, ScD, MPH principal investigator
Massachusetts General Hospital and Fenway Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive STEPS in people with HIV Infection, run by Fenway Community Health at 3 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 7 inclusion and 5 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 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Electronically monitored (MEMS) antiretroviral medication adherence (time frame: 3 months). 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 17 Apr 2017.