search
Back to results

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

Primary Purpose

Acquired Immunodeficiency Syndrome, HIV Infections

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Acquired Immunodeficiency Syndrome focused on measuring AIDS, Compliance, HIV, Medication, Perceived Threat, Teenagers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001699
Brief Title
A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents With HIV and Their Mothers
Official Title
A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents With HIV and Their Mothers
Study Type
Observational

2. Study Status

Record Verification Date
June 1999
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, HIV Infections
Keywords
AIDS, Compliance, HIV, Medication, Perceived Threat, Teenagers

7. Study Design

Enrollment
45 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1879392
Citation
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.
Results Reference
background
PubMed Identifier
1578322
Citation
Tamaroff 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.
Results Reference
background
PubMed Identifier
1089182
Citation
Becker 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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs