Completed

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

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What is being collected

Data Collection

Who is being recruted

Treatment Adherence and Compliance+18

+ Blood-Borne Infections

+ Urogenital Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: June 1998
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00001699
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Treatment Adherence and ComplianceBlood-Borne InfectionsUrogenital DiseasesGenital DiseasesBehaviorCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPatient Acceptance of Health CareRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHealth BehaviorLentivirus InfectionsAcquired Immunodeficiency SyndromePatient ComplianceHIV Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Cancer Institute (NCI)

Bethesda, United StatesOpen National Cancer Institute (NCI) in Google Maps
CompletedOne Study Center