Effects of Home Visits on Medication Adherence in Children and Youth With HIV

NCT ID: NCT00006439

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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Adherence to complex medication regimens is critical to successful treatment of HIV infection. Unfortunately, adherence to medical regimens with conventional interventions averages 50% in chronic disease. We have observed that adherence barriers that were unrecognized by providers in the clinic setting have been detected during home visits. It is possible that recognition and interventions to resolve adherence barriers observed during home visits may improve adherence. This proposal will test the hypothesis that home-visits which identify previously unrecognized adherence barriers and provide support and education will increase medication adherence among children and youth with HIV infection and improve the patient/health care provider relationship. Specific aims of the study are: 1. Determine the impact of a series of home-visits on adherence to medication regimens for HIV infected youth and children. 1a. Adherence to medical regimens will be assessed before and after the series of home-visits using a self-report questionnaire and Microelectronic Monitoring System (MEMS) or in-home pill count. 1b. For each of these measures a percentage of adherence will be calculated and compared from a baseline to after the final home visit and after the six month follow up period. 2. Assess the changes in patient satisfaction from baseline to after the home-visits using a questionnaire completed by the patient/family. 3. Incorporate a pilot study to assess the changes in the provider's knowledge of the patient's family characteristics and home circumstances relevant to adherence following the home visits.

Detailed Description

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Conditions

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HIV Infections

Keywords

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

ECT

Interventions

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Counseling in the home

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* HIV positive
* English speaking
* Live in Denver metro area
* Taking \>=1 antiretroviral medication
Minimum Eligible Age

0 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Elizabeth McFarland

Role: PRINCIPAL_INVESTIGATOR

Locations

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The Children's Hospital

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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M01RR000069

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCRR-M01RR00069-0622

Identifier Type: -

Identifier Source: org_study_id