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A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents With HIV and Their Mothers

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001699
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: June 1999

November 3, 1999
March 3, 2008
June 1998
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Complete list of historical versions of study NCT00001699 on ClinicalTrials.gov Archive Site
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A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents With HIV and Their Mothers
A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents With HIV and Their Mothers

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.

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.

Observational
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  • Acquired Immunodeficiency Syndrome
  • HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
March 2000
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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.

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001699
980121, 98-C-0121
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National Cancer Institute (NCI)
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National Institutes of Health Clinical Center (CC)
June 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP