The Principal Investigator proposes to conduct a prospective randomized clinical trial of HIV- infected individuals (N=2000) to test the effectiveness of a home-based nursing intervention based on the adult education principles of Paole Freire and designed to improve adherence to highly active anti-retroviral therapies (HAART). The hone-based nursing intervention will be compared to standard nursing care provided in a ambulatory care setting. The adherence outcome will be measured using the medication event monitoring system (MEMS) data, self-report, and unannounced pill counts. Experimental participants will receive the home-based intervention weekly for twelve weeks, every other week for twelve weeks, and monthly for one year thereafter.
Other specific aims are to: (1) describe the relationship between the home-based nursing intervention and biologic measures of clinical outcome (plasma quantitative HIV RNA levels and CD4 lymphocyte counts); (2) describe the relationship between the home-based nursing intervention and a subjective measure of clinical outcome (participant's perception of health stratus); and (3) explore the relationship between the home-based nursing intervention and contextual factors related to adherence (social support, trust in provider, and knowledge of the purpose of HAART). Data collections methods include face-to-face interviews, microcomputer monitoring technology, unannounced pill counts, and medical record abstraction at baseline through 6 months post intervention (Month 18).

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
1R01NR004744-01A1
Application #
2796951
Study Section
Special Emphasis Panel (ZRG5-AARR-8 (01))
Program Officer
Sigmon, Hilary D
Project Start
1998-09-30
Project End
2001-08-31
Budget Start
1998-09-30
Budget End
1999-08-31
Support Year
1
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Yale University
Department
Type
Schools of Nursing
DUNS #
082359691
City
New Haven
State
CT
Country
United States
Zip Code
06520
Knafl, George J; Bova, Carol A; Fennie, Kristopher P et al. (2010) An analysis of electronically monitored adherence to antiretroviral medications. AIDS Behav 14:755-68
Williams, Ann B; Fennie, Kristopher P; Bova, Carol A et al. (2006) Home visits to improve adherence to highly active antiretroviral therapy: a randomized controlled trial. J Acquir Immune Defic Syndr 42:314-21
Fennie, Kristopher P; Bova, Carol A; Williams, Ann B (2006) Adjusting and censoring electronic monitoring device data. Implications for study outcomes. J Acquir Immune Defic Syndr 43 Suppl 1:S88-95
Knafl, George J; Fennie, Kristopher P; Bova, Carol et al. (2004) Electronic monitoring device event modelling on an individual-subject basis using adaptive Poisson regression. Stat Med 23:783-801