NCT00001699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 1998

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2000

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

June 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

AIDSComplianceHIVMedicationPerceived ThreatTeenagers

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 1879392BACKGROUND
  • 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.

    PMID: 1578322BACKGROUND
  • 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.

    PMID: 1089182BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV InfectionsPatient Compliance

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

June 1, 1998

Study Completion

March 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-06

Locations