Acquired Immunodeficiency SyndromeNCT00001699
A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents With HIV and Their Mothers
An observational study of Acquired Immunodeficiency Syndrome and HIV Infections, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
The proposed study has two specific aims 1) to gather data about treatment adherence levels among adolescents (11-21 years) with HIV and 2) to obtain information about the adolescents and mothers' health beliefs and examine their relationship to the adolescents' adherence levels. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, HIV Infections
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1998to Mar 2000
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Subjects must be between the ages of 11 and 21 years.
Subjects must be diagnosed with HIV for at least one year (to ensure sufficient opportunity to experience living with a chronic condition such that adherence level is unlikely to be the result of skill or knowledge deficits).
Subjects must be prescribed oral medications (e.g., pills, liquids, inhaler) to be taken on a daily basis.
Subjects must be living with same female caregiver for at least one year.
Subjects must have a telephone number where he/she can be contacted during the two weeks after recruitment.
The adolescent and mother must be able to provide informed consent.
Adolescents must not have mental retardation or developmental delay that would prevent the adolescent from reading and comprehending the questionnaire.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
The proposed study has two specific aims 1) to gather data about treatment adherence levels among adolescents (11-21 years) with HIV and 2) to obtain information about the adolescents and mothers' health beliefs and examine their relationship to the adolescents' adherence levels. This pilot study is designed to gather preliminary data about the feasibility of using several new measures with this population. To achieve these aims, a convenience sample of approximately 45 adolescents with HIV will re recruited. The adolescents and their mothers will complete a brief questionnaire about their health beliefs. A 24-hour recall interview format will be used to assess the adolescents' treatment adherence to prescribed oral medication. The adolescent will complete recall interviews on three random days over a two week period. Data analysis will be primarily descriptive, but will be used to generate more specific hypotheses for future research studies. The long-term goal of this research is to better identify adolescents with HIV at risk for non-adherence and design empirically derived interventions to improve their adherence levels. The health beliefs measure may also be useful in identifying irrational beliefs about the illness or treatment that can then be targeted for cognitive restructing in psychological interventions.
Read the detailed description
The proposed study has two specific aims 1) to gather data about treatment adherence levels among adolescents (11-21 years) with HIV and 2) to obtain information about the adolescents and mothers' health beliefs and examine their relationship to the adolescents' adherence levels. This pilot study is designed to gather preliminary data about the feasibility of using several new measures with this population. To achieve these aims, a convenience sample of approximately 45 adolescents with HIV will be recruited. The adolescents and their mothers will complete a brief questionnaire about their health beliefs. A 24-hour recall interview format will be used to assess the adolescents' treatment adherence to prescribed oral medication. The adolescent will complete recall interviews on three random days over a two week period. Data analysis will be primarily descriptive, but will be used to generate more specific hypotheses for future research studies. The long-term goal of this research is to better identify adolescents with HIV at risk for non-adherence and design empirically derived interventions to improve their adherence levels. The health beliefs measure may also be useful in identifying irrational beliefs about the illness or treatment that can then be targeted for cognitive restructing in psychological interventions.
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections
- Keywords
- AIDS, Compliance, HIV, Medication, Perceived Threat, Teenagers
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Patient Compliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJun 1998
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)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
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001699
- Sponsor's protocol ID
- 980121
- Other IDs
- 98-C-0121
- Status last verified
- Jun 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Freund A, Johnson SB, Silverstein J, Thomas J. Assessing daily management of childhood diabetes using 24-hour recall interviews: reliability and stability. Health Psychol. 1991;10(3):200-8. doi: 10.1037//0278-6133.10.3.200.
PubMed 1879392Tamaroff MH, Festa RS, Adesman AR, Walco GA. Therapeutic adherence to oral medication regimens by adolescents with cancer. II. Clinical and psychologic correlates. J Pediatr. 1992 May;120(5):812-7. doi: 10.1016/s0022-3476(05)80257-4.
PubMed 1578322Becker MH, Maiman LA. Sociobehavioral determinants of compliance with health and medical care recommendations. Med Care. 1975 Jan;13(1):10-24. doi: 10.1097/00005650-197501000-00002.
PubMed 1089182
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents With HIV and Their Mothers
- ClinicalTrials.gov ID
- NCT00001699
- Acronym / sponsor ID
- 980121
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections
- Keywords
- AIDS, Compliance, HIV, Medication, Perceived Threat, Teenagers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 1998
- Study completion
- Mar 2000
- First posted
- 10 Dec 2002 (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 proposed study has two specific aims 1) to gather data about treatment adherence levels among adolescents (11-21 years) with HIV and 2) to obtain information about the adolescents and mothers' health beliefs and examine their relationship to the adolescents' adherence levels. This pilot study is designed to gather preliminary data about the feasibility of using several new measures with this population. To achieve these aims, a convenience sample of approximately 45 adolescents with HIV will re recruited. The adolescents and their mothers will complete a brief questionnaire about their health beliefs. A 24-hour recall interview format will be used to assess the adolescents' treatment adherence to prescribed oral medication. The adolescent will complete recall interviews on three random days over a two week period. Data analysis will be primarily descriptive, but will be used to generate more specific hypotheses for future research studies. The long-term goal of this research is to better identify adolescents with HIV at risk for non-adherence and design empirically derived interventions to improve their adherence levels. The health beliefs measure may also be useful in identifying irrational beliefs about the illness or treatment that can then be targeted for cognitive restructing in psychological interventions.
Detailed description
The proposed study has two specific aims 1) to gather data about treatment adherence levels among adolescents (11-21 years) with HIV and 2) to obtain information about the adolescents and mothers' health beliefs and examine their relationship to the adolescents' adherence levels. This pilot study is designed to gather preliminary data about the feasibility of using several new measures with this population. To achieve these aims, a convenience sample of approximately 45 adolescents with HIV will be recruited. The adolescents and their mothers will complete a brief questionnaire about their health beliefs. A 24-hour recall interview format will be used to assess the adolescents' treatment adherence to prescribed oral medication. The adolescent will complete recall interviews on three random days over a two week period. Data analysis will be primarily descriptive, but will be used to generate more specific hypotheses for future research studies. The long-term goal of this research is to better identify adolescents with HIV at risk for non-adherence and design empirically derived interventions to improve their adherence levels. The health beliefs measure may also be useful in identifying irrational beliefs about the illness or treatment that can then be targeted for cognitive restructing in psychological interventions.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 4 Mar 2008.
- Background: PubMed 1879392Freund A, Johnson SB, Silverstein J, Thomas J. Assessing daily management of childhood diabetes using 24-hour recall interviews: reliability and stability. Health Psychol. 1991;10(3):200-8. doi: 10.1037//0278-6133.10.3.200.
- Background: PubMed 1578322Tamaroff MH, Festa RS, Adesman AR, Walco GA. Therapeutic adherence to oral medication regimens by adolescents with cancer. II. Clinical and psychologic correlates. J Pediatr. 1992 May;120(5):812-7. doi: 10.1016/s0022-3476(05)80257-4.
- Background: PubMed 1089182Becker MH, Maiman LA. Sociobehavioral determinants of compliance with health and medical care recommendations. Med Care. 1975 Jan;13(1):10-24. doi: 10.1097/00005650-197501000-00002.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Immunodeficiency Syndrome and HIV Infections, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 NCT00001699, which also lists 3 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 4 Mar 2008.