HIV InfectionNCT01253850
Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase I
An observational study of 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
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to 6 Mar 2013
- Phase
- Observational
- 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
Study population: HIV-infected youth between the ages of 13 and 24
Who may be able to join
- Age 13 to 24 years
- HIV-infected and aware of HIV-infection status
- Currently taking antiretroviral therapy, has been prescribed antiretroviral therapy in the past 6 months, or a medical provider has recommended antiretroviral medications within the last 6 months
- Willing and able to provide informed consent or assent (if under the age of 18)
- Age 13-24 years
- HIV-infected and aware of HIV-infection status
Show all 10Show fewer
- Currently taking antiretroviral therapy
- Self-reported difficulties adhering to HIV medications in the past 3 months
- Self-identify as heterosexual or LGB
- Willing and able to provide informed consent/consent of parent/guardian if under the age of 18
Who cannot join
- Not willing or able to provide informed consent or assent (if under the age of 18)
- Is dealing with a severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit a participant's ability to engage with study protocol (e.g. dementia)
- Has severe cognitive limitations that would limit a participant's ability to comprehend the informed consent or assent.
- Phase II
- Not willing or able to provide informed consent or assent (if under the age of 18)
- Is dealing with a severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit a participant's ability to engage with study protocol (e.g. dementia)
- Has severe cognitive limitations that would limit a participant's ability to comprehend the informed consent or assent.
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
Fenway Community Health
Boston, Massachusetts, 02215
About this study
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 first phase of the study is an intervention development phase, which includes conducting interviews with 40 HIV-infected youth for input on the adaptation of the approach. The information obtained from the qualitative interviews is used to adapt the Life-Steps intervention (designed by our group for HIV-infected adults) to be responsive to the needs of HIV-infected adolescents, with acceptability of topics and content, and feasibility of intervention delivery to be tested in an open pilot trial.
Read the detailed description
This phase of the protocol focuses on setting up the infrastructure necessary for conducting the study, including hiring and training activities with study staff. This time will be spent conducting interviews and using these data to inform the development of the intervention protocol and adaptation of all Life-Steps intervention materials, including study assessment instruments, for HIV-infected youth.
The interview is a one-time event and will last for 1.5-2 hours. It has two components: a quantitative assessment and a qualitative discussion. After all participants have completed the informed consent and assent (if under the age of 18) processes, the research staff will administer a brief quantitative assessment that will ask questions related to demographics, medication adherence, sexual risk, substance use, and psychosocial condition. The second part of the interview will be an open discussion. The interviews will be conducted by a trained member of the research staff. The interviews will be informed by a pre-determined qualitative topic guide.
- Conditions
- HIV Infection
- Keywords
- hiv, antiretroviral, adherence, adolescent
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
perceived barriers and facilitators to adherence
We will code the qualitative interview data for key themes that emerge with respect to adherence and intervention needs. The information obtained from the qualitative interviews is used to adapt the Life-Steps intervention (designed by our group for HIV-infected adults) to be responsive to the needs of HIV-infected adolescents, with acceptability of topics and content, and feasibility of intervention delivery to be tested in an open pilot trial.
Measured: One-time qualitative interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenway Community Health
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Boston Children's Hospital, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Matthew Mimiaga, Fenway Community Health
- Investigators
- Matthew J. Mimiaga, ScD MPH, Principal investigator, Fenway Health and Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253850
- Sponsor's protocol ID
- CFAR Adherence HIV Youth:1
- Status last verified
- Apr 2017
- First submitted
- 2 Dec 2010
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 I
- ClinicalTrials.gov ID
- NCT01253850
- Acronym / sponsor ID
- CFAR Adherence HIV Youth:1
- Conditions
- HIV Infection
- Keywords
- hiv, antiretroviral, adherence, adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fenway Community HealthUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Boston Children's Hospital, Harvard Medical School (HMS and HSDM)
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- 6 Mar 2013 (actual)
- First posted
- 3 Dec 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.
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 first phase of the study is an intervention development phase, which includes conducting interviews with 40 HIV-infected youth for input on the adaptation of the approach. The information obtained from the qualitative interviews is used to adapt the Life-Steps intervention (designed by our group for HIV-infected adults) to be responsive to the needs of HIV-infected adolescents, with acceptability of topics and content, and feasibility of intervention delivery to be tested in an open pilot trial.
Detailed description
This phase of the protocol focuses on setting up the infrastructure necessary for conducting the study, including hiring and training activities with study staff. This time will be spent conducting interviews and using these data to inform the development of the intervention protocol and adaptation of all Life-Steps intervention materials, including study assessment instruments, for HIV-infected youth.
The interview is a one-time event and will last for 1.5-2 hours. It has two components: a quantitative assessment and a qualitative discussion. After all participants have completed the informed consent and assent (if under the age of 18) processes, the research staff will administer a brief quantitative assessment that will ask questions related to demographics, medication adherence, sexual risk, substance use, and psychosocial condition. The second part of the interview will be an open discussion. The interviews will be conducted by a trained member of the research staff. The interviews will be informed by a pre-determined qualitative topic guide.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- HIV-infected youth between the ages of 13 and 24
Key inclusion criteria (10 listed)
- Age 13 to 24 years
- HIV-infected and aware of HIV-infection status
- Currently taking antiretroviral therapy, has been prescribed antiretroviral therapy in the past 6 months, or a medical provider has recommended antiretroviral medications within the last 6 months
- Willing and able to provide informed consent or assent (if under the age of 18)
- Age 13-24 years
Key exclusion criteria (7 listed)
- Not willing or able to provide informed consent or assent (if under the age of 18)
- Is dealing with a severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit a participant's ability to engage with study protocol (e.g. dementia)
- Has severe cognitive limitations that would limit a participant's ability to comprehend the informed consent or assent.
- Phase II
- Not willing or able to provide informed consent or assent (if under the age of 18)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
perceived barriers and facilitators to adherence
Time frame: One-time qualitative interview
We will code the qualitative interview data for key themes that emerge with respect to adherence and intervention needs. The information obtained from the qualitative interviews is used to adapt the Life-Steps intervention (designed by our group for HIV-infected adults) to be responsive to the needs of HIV-infected adolescents, with acceptability of topics and content, and feasibility of intervention delivery to be tested in an open pilot trial.
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
Fenway Health and Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 10 inclusion and 7 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?
perceived barriers and facilitators to adherence (time frame: One-time qualitative interview). 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.