HIV InfectionsNCT00079729
Directly Observed Therapy in HIV Infected Adolescent Focus Groups
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
The purpose of this study is to help researchers use information from HIV infected adolescents to design a directly observed therapy (DOT) program that will help adolescents take their anti-HIV medications correctly. Read more about this study
- Who is it for?
- Ages 16 to 21 years
- Conditions the study is for
- HIV Infections
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2004to Jul 2004
- 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 16 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV infected due to high-risk behavior
- Regular attendee of local adolescent HIV support group
- Current use of antiretrovirals or history of antiretroviral therapy
- Permission of parent or legal guardian if participant is less than the legal age of consent. Assent of the minor participant should be obtained where required.
Who cannot join
- Perinatal HIV infection
- Visibly distraught or emotionally unstable
- Pregnancy or breast-feeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Los Angeles County Medical Center/USC
Los Angeles, California, 90033
St. Jude Childrens Research Hospital, Memphis
Memphis, Tennessee, 38105-2794
University of Miami (Pediatric)
Miami, Florida, 33136
About this study
Official title: Directly Observed Therapy (DOT) in HIV-Infected Adolescents: Part A-Focus Groups
The purpose of this study is to help researchers use information from HIV infected adolescents to design a directly observed therapy (DOT) program that will help adolescents take their anti-HIV medications correctly.
Read the detailed description
The rate of HIV infection among adolescents is increasing at an alarming rate. Adherence to antiretroviral therapy has been a major challenge in achieving and maintaining adequate control of the disease in this population. DOT has been shown effective in individuals with tuberculosis (TB), but DOT in HIV infected populations has not been thoroughly examined. This study will collect information from HIV infected adolescents in order to establish a DOT program that will increase successful adherence to HIV treatment and will benefit the public by preventing development of viral resistance and reducing the risk of transmission.
Adolescent participants in this study will be assigned to one of three 2-hour focus group sessions, each at a different site. The participants will complete a questionnaire and will give input about designing a DOT intervention model that will be accepted by adolescents. The model will then be used in a pilot study to determine the feasibility of implementing DOT programs in the community to help HIV infected adolescents.
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2004 (estimated)
- Study startApr 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Patricia Flynn, MD, Study chair, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079729
- Sponsor's protocol ID
- PACTG P1036A
- Other IDs
- 10193
- Status last verified
- Oct 2012
- First submitted
- 11 Mar 2004
- Last updated
- 29 Oct 2012
- Results posted
- No
Publications
Murphy DA, Wilson CM, Durako SJ, Muenz LR, Belzer M; Adolescent Medicine HIV/AIDS Research Network. Antiretroviral medication adherence among the REACH HIV-infected adolescent cohort in the USA. AIDS Care. 2001 Feb;13(1):27-40. doi: 10.1080/09540120020018161.
PubMed 11177463Babudieri S, Aceti A, D'Offizi GP, Carbonara S, Starnini G. Directly observed therapy to treat HIV infection in prisoners. JAMA. 2000 Jul 12;284(2):179-80. doi: 10.1001/jama.284.2.179. No abstract available.
PubMed 10889588Lanzafame M, Trevenzoli M, Cattelan AM, Rovere P, Parrinello A. Directly observed therapy in HIV therapy: A realistic perspective? J Acquir Immune Defic Syndr. 2000 Oct 1;25(2):200-1. doi: 10.1097/00042560-200010010-00018. No abstract available.
PubMed 11103053Mitty JA, McKenzie M, Stenzel M, Flanigan T, Carpenter CC. Modified directly observed therapy for treatment of human immunodeficiency virus. JAMA. 1999 Oct 13;282(14):1334. doi: 10.1001/jama.282.14.1334. No abstract available.
PubMed 10527179Garvie PA, Lawford J, Flynn PM, Gaur AH, Belzer M, McSherry GD, Hu C; Pediatric AIDS Clinical Trials Group 1036A Study Team. Development of a directly observed therapy adherence intervention for adolescents with human immunodeficiency virus-1: application of focus group methodology to inform design, feasibility, and acceptability. J Adolesc Health. 2009 Feb;44(2):124-132. doi: 10.1016/j.jadohealth.2008.05.006. Epub 2008 Oct 18.
PubMed 19167660
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directly Observed Therapy (DOT) in HIV-Infected Adolescents: Part A-Focus Groups
- ClinicalTrials.gov ID
- NCT00079729
- Acronym / sponsor ID
- PACTG P1036A
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2004
- Study completion
- Jul 2004 (actual)
- First posted
- 12 Mar 2004 (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 study is to help researchers use information from HIV infected adolescents to design a directly observed therapy (DOT) program that will help adolescents take their anti-HIV medications correctly.
Detailed description
The rate of HIV infection among adolescents is increasing at an alarming rate. Adherence to antiretroviral therapy has been a major challenge in achieving and maintaining adequate control of the disease in this population. DOT has been shown effective in individuals with tuberculosis (TB), but DOT in HIV infected populations has not been thoroughly examined. This study will collect information from HIV infected adolescents in order to establish a DOT program that will increase successful adherence to HIV treatment and will benefit the public by preventing development of viral resistance and reducing the risk of transmission.
Adolescent participants in this study will be assigned to one of three 2-hour focus group sessions, each at a different site. The participants will complete a questionnaire and will give input about designing a DOT intervention model that will be accepted by adolescents. The model will then be used in a pilot study to determine the feasibility of implementing DOT programs in the community to help HIV infected adolescents.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- HIV infected due to high-risk behavior
- Regular attendee of local adolescent HIV support group
- Current use of antiretrovirals or history of antiretroviral therapy
- Permission of parent or legal guardian if participant is less than the legal age of consent. Assent of the minor participant should be obtained where required.
Key exclusion criteria (3 listed)
- Perinatal HIV infection
- Visibly distraught or emotionally unstable
- Pregnancy or breast-feeding
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
Not reported in the source record.
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 29 Oct 2012.
- Background: PubMed 11177463Murphy DA, Wilson CM, Durako SJ, Muenz LR, Belzer M; Adolescent Medicine HIV/AIDS Research Network. Antiretroviral medication adherence among the REACH HIV-infected adolescent cohort in the USA. AIDS Care. 2001 Feb;13(1):27-40. doi: 10.1080/09540120020018161.
- Background: PubMed 10889588Babudieri S, Aceti A, D'Offizi GP, Carbonara S, Starnini G. Directly observed therapy to treat HIV infection in prisoners. JAMA. 2000 Jul 12;284(2):179-80. doi: 10.1001/jama.284.2.179. No abstract available.
- Background: PubMed 11103053Lanzafame M, Trevenzoli M, Cattelan AM, Rovere P, Parrinello A. Directly observed therapy in HIV therapy: A realistic perspective? J Acquir Immune Defic Syndr. 2000 Oct 1;25(2):200-1. doi: 10.1097/00042560-200010010-00018. No abstract available.
- Background: PubMed 10527179Mitty JA, McKenzie M, Stenzel M, Flanigan T, Carpenter CC. Modified directly observed therapy for treatment of human immunodeficiency virus. JAMA. 1999 Oct 13;282(14):1334. doi: 10.1001/jama.282.14.1334. No abstract available.
- Results publication: PubMed 19167660Garvie PA, Lawford J, Flynn PM, Gaur AH, Belzer M, McSherry GD, Hu C; Pediatric AIDS Clinical Trials Group 1036A Study Team. Development of a directly observed therapy adherence intervention for adolescents with human immunodeficiency virus-1: application of focus group methodology to inform design, feasibility, and acceptability. J Adolesc Health. 2009 Feb;44(2):124-132. doi: 10.1016/j.jadohealth.2008.05.006. Epub 2008 Oct 18.
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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.
Patricia Flynn, MD study chair
St. Jude Children's Research 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 Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 4 inclusion and 3 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 29 Oct 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00079729, which also lists 5 linked publications.
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 29 Oct 2012.