Effects of Home Visits on Medication Adherence in Children and Youth With HIV
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling in the home
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for HIV Infections focused on measuring HIV
Eligibility Criteria
Inclusion Criteria: HIV positive English speaking Live in Denver metro area Taking >=1 antiretroviral medication
Sites / Locations
- The Children's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006439
First Posted
November 4, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00006439
Brief Title
Effects of Home Visits on Medication Adherence in Children and Youth With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
November 2001
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Counseling in the home
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV positive
English speaking
Live in Denver metro area
Taking >=1 antiretroviral medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth McFarland
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Home Visits on Medication Adherence in Children and Youth With HIV
We'll reach out to this number within 24 hrs