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Effects of Home Visits on Medication Adherence in Children and Youth With HIV
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
National Center for Research Resources (NCRR)
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006439
First received: November 4, 2000
Last updated: June 23, 2005
Last verified: November 2001
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Purpose
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.
| Condition | Intervention |
|---|---|
| HIV Infections | Behavioral: Counseling in the home |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Primary Purpose: Educational/Counseling/Training |
Resource links provided by NLM:
Further study details as provided by National Center for Research Resources (NCRR):
Eligibility| Ages Eligible for Study: | up to 24 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV positive
- English speaking
- Live in Denver metro area
- Taking >=1 antiretroviral medication
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00006439
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006439
Locations
| United States, Colorado | |
| The Children's Hospital | |
| Denver, Colorado, United States, 80218 | |
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Investigators
| Principal Investigator: | Elizabeth McFarland |
More Information
| ClinicalTrials.gov Identifier: | NCT00006439 History of Changes |
| Other Study ID Numbers: |
NCRR-M01RR00069-0622 M01RR000069 ( U.S. NIH Grant/Contract ) |
| Study First Received: | November 4, 2000 |
| Last Updated: | June 23, 2005 |
Keywords provided by National Center for Research Resources (NCRR):
|
HIV |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on September 21, 2017