HIV InfectionsNCT00259389
Directly Observed Therapy for HIV Infected Adolescents
A study testing Directly observed therapy (DOT) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial summary
Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV infection. In previous studies with tuberculosis patients, directly observed therapy (DOT), a strategy in which patients are observed while taking their medications, has been proven useful in increasing patient adherence. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Directly observed therapy (DOT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2006to Sep 2007
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Infected with HIV after age 12
- Initiating, continuing, changing, or reinitiating a daily or twice-daily HAART regimen AND have demonstrated adherence problems (less than 85% of prescribed doses taken, as clinically disclosed, on 2 consecutive occasions at least 1 month apart). More information on this criterion can be found in the protocol.
- Able and willing to swallow medication
- Have access to HAART
- Parent or guardian willing to provide informed consent, if applicable
- Willing to use acceptable forms of contraception
Who cannot join
- Clinically significant diseases other than HIV infection or clinically significant findings during screening or physical examination that, in the opinion of the investigator, would require much closer follow-up and frequent monitoring than would be generally done for other HIV infected patients of comparable age
- HAART regimens that include medications taken more often than twice-daily
- Investigational agents (HAART or other medications) administered as part of other clinical trials
- Pregnant or breastfeeding
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Childrens Hospital of Michigan
Detroit, Michigan, 48201
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Los Angeles County Medical Center/USC
Los Angeles, California, 90033
St. Jude Childrens Research Hospital, Memphis
Memphis, Tennessee, 38105-2794
University of Rochester Medical Center
Rochester, New York, 14642-0001
UCSD Mother, Child & Adolescent HIV Program
San Diego, California, 92103
About this study
Official title: Directly Observed Therapy (DOT) in HIV-1 Infected Adolescents
Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV infection. In previous studies with tuberculosis patients, directly observed therapy (DOT), a strategy in which patients are observed while taking their medications, has been proven useful in increasing patient adherence. The purpose of this study is to determine the effectiveness of a new DOT strategy in HIV infected adolescents who have had difficulty adhering to anti-HIV drug regimens or regimens to prevent opportunistic infections (OIs) in the past.
Read the detailed description
For HIV infected people, control of HIV infection is best achieved by adhering to the highly active antiretroviral therapy (HAART) regimen prescribed by their doctors. Poor adherence to a HAART regimen leads to clinical failure and the development of resistance. Many HIV infected adolescents have difficulty adhering to their prescribed anti-HIV regimens or OI prophylaxis; often, they cite forgetting to take their medications as the reason for poor adherence. This is a pilot study of using DOT and assessing adherence during DOT in HIV infected adolescents who have had difficulty adhering to HAART regimens in the past. The purpose of this study is to evaluate the efficacy in increasing patient adherence and the feasibility of using DOT among HIV infected adolescents.
This study will last 24 weeks. For the first 2 weeks of the study, DOT will be provided 7 days a week at the study site; participants will visit the study site daily and will be observed taking their medication. For the next 6 weeks, the frequency of DOT will be reduced from 7 days a week to 5 days a week. Based on adherence from Weeks 4 to 8, each participant will be recommended to continue with a DOT strategy as follows:
- Adherence Level 1 (greater than 93%) - DOT 3 days a week
- Adherence Level 2 (86% to 93%) - DOT 5 days a week
- Adherence Level 3 (less than 86%) - DOT 7 days a week
Participants will decide whether to accept their DOT assignment and to continue in the study. At Week 12 and every 4 weeks thereafter, adherence will be assessed and DOT may be adjusted as follows:
- Adherence Level 1 - Reduce frequency of DOT. Those already receiving DOT 3 days a week stop DOT and start self-administered therapy.
- Adherence Level 2 - Keep same frequency of DOT as the past 4 weeks.
- Adherence Level 3 - Increase frequency of DOT by one level, as described in previous list.
HAART will not be provided by this study, so participants must have access to their HAART medications coordinated separately through the study site. Participants who are taking medication requiring twice-daily dosing will self-administer their second doses.
There will be 7 study visits; they will occur at study entry and every 4 weeks thereafter. Medical history will occur at study entry. At every visit, participants' adherence to their regimens will be assessed, and they will also be interviewed by a social worker about their use of support services. Participants will undergo several assessments at study entry and Weeks 12 and 24 to determine participant confidence, beliefs about medicine, severity of depression, feelings of hopelessness, coping responses, and emotional and behavioral problems. Blood collection will occur at study entry and Weeks 8, 12, and 24. When participants successfully complete their prescribed courses of DOT or elect to discontinue DOT, they will again be interviewed by study staff.
- Conditions
- HIV Infections
- Being tested
- Directly observed therapy (DOT)
- Keywords
- Treatment Experienced, Adherence, Compliance, Directly Observed Therapy, DOT, Treatment Naive
- Medical subject headings
- HIV Infections, Patient Compliance, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directly observed therapy (DOT)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of completed directly observed therapy (DOT) facilitator-participant interactions, among all scheduled interactions, for each participant during the second 4-week period on study
number and proportion of participants who were able to complete the recommended duration of DOT
Secondary outcomes (16)
Subject satisfaction with DOT, assessed by the Exit Survey Instrument
cost of implementing DOT per participant
effective ratio of DOT facilitators to participants, determined by the calculation of actual time spent by each DOT facilitator
reproducibility of DOT implementation across sites and participants' adherence to DOT interactions and ability to complete the prescribed duration of DOT, compared across sites
adherence for each participant in the 4-week period prior to a study visit, determined at Weeks 8 and 12 by participant self-report and adherence to DOT interactions and by pill count and participant 4-week recall at Week 24
virologic outcomes, determined by the suppression of HIV-1 viral load at Weeks 8, 12, and 24
immunologic outcome, defined by a change in absolute CD4 count from baseline to Week 24
self-efficacy (confidence), assessed by Patient Assessment Tool - Part I and Beliefs About Medicine Scale
beliefs about highly active antiretroviral therapy (HAART), assessed by Beliefs About Medicine Scale
severity of depression experienced by each participant, assessed by Beck Depression Inventory (BDI)-II
hopelessness, assessed by Beck Hopelessness Scale (BHS)
emotional and behavioral problems, assessed by Youth Self Report (YSR)/Adult Self Report (ASR)
coping of each participant, assessed by Coping Responses Inventory (CRI)-Youth and CRI-Adult
perceived barriers to adherence, assessed at baseline and Weeks 12 and 24 by Patient Assessment Tool - Part I and Beliefs About Medication Scale
substance abuse, assessed at baseline and Weeks 12 and 24 by Patient Assessment Tool - Part II
sustainability of DOT benefits, assessed as the proportion of participants adherent at Week 24 among those who successfully complete the first 8 weeks of DOT and are taken off DOT at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startApr 2006
- Study completionSep 2007
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pediatric AIDS Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Aditya Gaur, MD, Study chair, Department of Infectious Disease, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259389
- Sponsor's protocol ID
- PACTG P1036B
- Other IDs
- 10044
- Status last verified
- Sep 2012
- First submitted
- 28 Nov 2005
- Last updated
- 18 Sep 2012
- Results posted
- No
Publications
Martinez J, Bell D, Camacho R, Henry-Reid LM, Bell M, Watson C, Rodriguez F. Adherence to antiviral drug regimens in HIV-infected adolescent patients engaged in care in a comprehensive adolescent and young adult clinic. J Natl Med Assoc. 2000 Feb;92(2):55-61.
PubMed 10800292Mitty JA, Stone VE, Sands M, Macalino G, Flanigan T. Directly observed therapy for the treatment of people with human immunodeficiency virus infection: a work in progress. Clin Infect Dis. 2002 Apr 1;34(7):984-90. doi: 10.1086/339447. Epub 2002 Feb 27.
PubMed 11880965Murphy DA, Sarr M, Durako SJ, Moscicki AB, Wilson CM, Muenz LR; Adolescent Medicine HIV/AIDS Research Network. Barriers to HAART adherence among human immunodeficiency virus-infected adolescents. Arch Pediatr Adolesc Med. 2003 Mar;157(3):249-55. doi: 10.1001/archpedi.157.3.249.
PubMed 12622674Wohl AR, Garland WH, Squires K, Witt M, Larsen R, Kovacs A, Hader S, Weidle PJ. The feasibility of a community-based directly administered antiretroviral therapy program. Clin Infect Dis. 2004 Jun 1;38 Suppl 5:S388-92. doi: 10.1086/421401.
PubMed 15156427Garvie PA, Flynn PM, Belzer M, Britto P, Hu C, Graham B, Neely M, McSherry GD, Spector SA, Gaur AH; Pediatric AIDS Clinical Trials Group (PACTG) P1036B Team. Psychological factors, beliefs about medication, and adherence of youth with human immunodeficiency virus in a multisite directly observed therapy pilot study. J Adolesc Health. 2011 Jun;48(6):637-40. doi: 10.1016/j.jadohealth.2010.09.014. Epub 2010 Dec 18.
PubMed 21575827
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directly Observed Therapy (DOT) in HIV-1 Infected Adolescents
- ClinicalTrials.gov ID
- NCT00259389
- Acronym / sponsor ID
- PACTG P1036B
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced, Adherence, Compliance, Directly Observed Therapy, DOT, Treatment Naive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- 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), Pediatric AIDS Clinical Trials Group
- Study start
- Apr 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 29 Nov 2005 (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.
Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV infection. In previous studies with tuberculosis patients, directly observed therapy (DOT), a strategy in which patients are observed while taking their medications, has been proven useful in increasing patient adherence. The purpose of this study is to determine the effectiveness of a new DOT strategy in HIV infected adolescents who have had difficulty adhering to anti-HIV drug regimens or regimens to prevent opportunistic infections (OIs) in the past.
Detailed description
For HIV infected people, control of HIV infection is best achieved by adhering to the highly active antiretroviral therapy (HAART) regimen prescribed by their doctors. Poor adherence to a HAART regimen leads to clinical failure and the development of resistance. Many HIV infected adolescents have difficulty adhering to their prescribed anti-HIV regimens or OI prophylaxis; often, they cite forgetting to take their medications as the reason for poor adherence. This is a pilot study of using DOT and assessing adherence during DOT in HIV infected adolescents who have had difficulty adhering to HAART regimens in the past. The purpose of this study is to evaluate the efficacy in increasing patient adherence and the feasibility of using DOT among HIV infected adolescents.
This study will last 24 weeks. For the first 2 weeks of the study, DOT will be provided 7 days a week at the study site; participants will visit the study site daily and will be observed taking their medication. For the next 6 weeks, the frequency of DOT will be reduced from 7 days a week to 5 days a week. Based on adherence from Weeks 4 to 8, each participant will be recommended to continue with a DOT strategy as follows:
- Adherence Level 1 (greater than 93%) - DOT 3 days a week
- Adherence Level 2 (86% to 93%) - DOT 5 days a week
- Adherence Level 3 (less than 86%) - DOT 7 days a week
Participants will decide whether to accept their DOT assignment and to continue in the study. At Week 12 and every 4 weeks thereafter, adherence will be assessed and DOT may be adjusted as follows:
- Adherence Level 1 - Reduce frequency of DOT. Those already receiving DOT 3 days a week stop DOT and start self-administered therapy.
- Adherence Level 2 - Keep same frequency of DOT as the past 4 weeks.
- Adherence Level 3 - Increase frequency of DOT by one level, as described in previous list.
HAART will not be provided by this study, so participants must have access to their HAART medications coordinated separately through the study site. Participants who are taking medication requiring twice-daily dosing will self-administer their second doses.
There will be 7 study visits; they will occur at study entry and every 4 weeks thereafter. Medical history will occur at study entry. At every visit, participants' adherence to their regimens will be assessed, and they will also be interviewed by a social worker about their use of support services. Participants will undergo several assessments at study entry and Weeks 12 and 24 to determine participant confidence, beliefs about medicine, severity of depression, feelings of hopelessness, coping responses, and emotional and behavioral problems. Blood collection will occur at study entry and Weeks 8, 12, and 24. When participants successfully complete their prescribed courses of DOT or elect to discontinue DOT, they will again be interviewed by study staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Infected with HIV after age 12
- Initiating, continuing, changing, or reinitiating a daily or twice-daily HAART regimen AND have demonstrated adherence problems (less than 85% of prescribed doses taken, as clinically disclosed, on 2 consecutive occasions at least 1 month apart). More information on this criterion can be found in the protocol.
- Able and willing to swallow medication
- Have access to HAART
- Parent or guardian willing to provide informed consent, if applicable
Key exclusion criteria (4 listed)
- Clinically significant diseases other than HIV infection or clinically significant findings during screening or physical examination that, in the opinion of the investigator, would require much closer follow-up and frequent monitoring than would be generally done for other HIV infected patients of comparable age
- HAART regimens that include medications taken more often than twice-daily
- Investigational agents (HAART or other medications) administered as part of other clinical trials
- Pregnant or breastfeeding
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 |
|---|---|---|
| Directly observed therapy (DOT) | Behavioural | – |
Primary outcome
Proportion of completed directly observed therapy (DOT) facilitator-participant interactions, among all scheduled interactions, for each participant during the second 4-week period on study
number and proportion of participants who were able to complete the recommended duration of DOT
16 secondary outcomes
Subject satisfaction with DOT, assessed by the Exit Survey Instrument
cost of implementing DOT per participant
effective ratio of DOT facilitators to participants, determined by the calculation of actual time spent by each DOT facilitator
reproducibility of DOT implementation across sites and participants' adherence to DOT interactions and ability to complete the prescribed duration of DOT, compared across sites
adherence for each participant in the 4-week period prior to a study visit, determined at Weeks 8 and 12 by participant self-report and adherence to DOT interactions and by pill count and participant 4-week recall at Week 24
virologic outcomes, determined by the suppression of HIV-1 viral load at Weeks 8, 12, and 24
immunologic outcome, defined by a change in absolute CD4 count from baseline to Week 24
self-efficacy (confidence), assessed by Patient Assessment Tool - Part I and Beliefs About Medicine Scale
beliefs about highly active antiretroviral therapy (HAART), assessed by Beliefs About Medicine Scale
severity of depression experienced by each participant, assessed by Beck Depression Inventory (BDI)-II
hopelessness, assessed by Beck Hopelessness Scale (BHS)
emotional and behavioral problems, assessed by Youth Self Report (YSR)/Adult Self Report (ASR)
coping of each participant, assessed by Coping Responses Inventory (CRI)-Youth and CRI-Adult
perceived barriers to adherence, assessed at baseline and Weeks 12 and 24 by Patient Assessment Tool - Part I and Beliefs About Medication Scale
substance abuse, assessed at baseline and Weeks 12 and 24 by Patient Assessment Tool - Part II
sustainability of DOT benefits, assessed as the proportion of participants adherent at Week 24 among those who successfully complete the first 8 weeks of DOT and are taken off DOT at 12 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 18 Sep 2012.
- Background: PubMed 10800292Martinez J, Bell D, Camacho R, Henry-Reid LM, Bell M, Watson C, Rodriguez F. Adherence to antiviral drug regimens in HIV-infected adolescent patients engaged in care in a comprehensive adolescent and young adult clinic. J Natl Med Assoc. 2000 Feb;92(2):55-61.
- Background: PubMed 11880965Mitty JA, Stone VE, Sands M, Macalino G, Flanigan T. Directly observed therapy for the treatment of people with human immunodeficiency virus infection: a work in progress. Clin Infect Dis. 2002 Apr 1;34(7):984-90. doi: 10.1086/339447. Epub 2002 Feb 27.
- Background: PubMed 12622674Murphy DA, Sarr M, Durako SJ, Moscicki AB, Wilson CM, Muenz LR; Adolescent Medicine HIV/AIDS Research Network. Barriers to HAART adherence among human immunodeficiency virus-infected adolescents. Arch Pediatr Adolesc Med. 2003 Mar;157(3):249-55. doi: 10.1001/archpedi.157.3.249.
- Background: PubMed 15156427Wohl AR, Garland WH, Squires K, Witt M, Larsen R, Kovacs A, Hader S, Weidle PJ. The feasibility of a community-based directly administered antiretroviral therapy program. Clin Infect Dis. 2004 Jun 1;38 Suppl 5:S388-92. doi: 10.1086/421401.
- Results publication: PubMed 21575827Garvie PA, Flynn PM, Belzer M, Britto P, Hu C, Graham B, Neely M, McSherry GD, Spector SA, Gaur AH; Pediatric AIDS Clinical Trials Group (PACTG) P1036B Team. Psychological factors, beliefs about medication, and adherence of youth with human immunodeficiency virus in a multisite directly observed therapy pilot study. J Adolesc Health. 2011 Jun;48(6):637-40. doi: 10.1016/j.jadohealth.2010.09.014. Epub 2010 Dec 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.
Aditya Gaur, MD study chair
Department of Infectious Disease, St. Jude Children's Research Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Directly observed therapy (DOT) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 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 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Proportion of completed directly observed therapy (DOT) facilitator-participant interactions, among all scheduled interactions, for each participant during the second 4-week period on study. 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?
On the ClinicalTrials.gov record for NCT00259389, 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 18 Sep 2012.