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Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy (PC-HIV)

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ClinicalTrials.gov Identifier: NCT00959361
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : September 29, 2009
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by:
Hospital de Clinicas de Porto Alegre

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

INTRODUCTION: Studies prove that the pharmaceutical care (PC) increases the adherence to the antiretroviral; thus, they increase the undetectable viral load. The viral load diminishes, and the prevalence of undetectable viral load increases, as the levels of adherence to the treatment increase, being in general necessary high adhesion to reach the effectiveness therapeutic. Increasing the adherence levels, it increases the surviving chances and quality of life and diminishes the transmission risks. Studies demonstrate that the self-effectiveness expectation to use the medication correctly is the main predictor of adherence, and that the more complex the therapeutic regimen is, and the perception of side effects, the smaller the adherence is, highlighting the importance of preventing, identifying and solving the problems during the treatment with antiretroviral, problems related to the medication (PRM) through the PC.

OBJECTIVES: To evaluate the effectiveness of the PC on the adherence of HIV-patients to the antiretroviral therapy, identify, prevent and solve PRMs during the treatment.

METHODOLOGY: One-side randomized clinical trail controlled by non-intervention in parallel. 332 patients randomized are included in the control and intervention groups (PC). Questionnaires will be applied: sociodemographic, adherence to the antiretroviral through self-report, smoke, BECK (depression), CAGE (problems related with alcohol consumption) of self-effectiveness, expectation of results and social support. Each 4 months measure of viral load and CD4 will be carried out. The ones from the PC group will receive a card with information about the medication and all the medicines will be identified by different colors. The follow-up will last one year according to the instructions of DADER program.


Condition or disease Intervention/treatment Phase
HIV HIV Infections Behavioral: pharmaceutical care Not Applicable

Detailed Description:

Election of the sample: 332 will be selected consecutively patients registered in the SAE-Pelotas

GENERAL OBJECTIVE To evaluate the effectiveness of Pharmaceutical Care on the adherence to the antiretroviral therapy in HIV- positive patients.

PRIMARY OBJECTIVE The relative risk for adherence to the antiretroviral treatment among HIV-positive patients who receive Pharmaceutical Care and the ones that do not receive Pharmaceutical Care is different of 1.

SECONDARY OBJECTIVE The relative risk for undetectable viral load among HIV-positive patients that receive Pharmaceutical Care and the ones that do not receive Pharmaceutical Care is different of 1.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy - Randomized Clinical Trial
Study Start Date : June 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: pharmaceutical care
consultation with the pharmacists
 Behavioral: pharmaceutical care
consultation with the pharmacists and usual care
Other Names:
  • pharmaceutical attention
  • DADER method
No Intervention: control
usual care without consultation with the pharmacists


Outcome Measures
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Primary Outcome Measures :
  1. Relative risk for adherence to the antiretroviral treatment among HIV-positive patients who receive Pharmaceutical Care and the ones that do not receive Pharmaceutical [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients registered in the SAE-Pelotas
  • adults (older 18 years)
  • inhabitants of the urban zone of Pelotas
  • not pregnant
  • in use of antiretroviral treatment
  • independent of the time of treatment
  • accept to participate in the research through the signature of a written informed consent

The enclosed patients will be randomized through program computerized for the group of pharmaceutical care or control group.

Exclusion Criteria:

  • non signature of a written informed consent
  • incapacity to answer to the instruments of data collection
  • inhabitants are of the urban zone of Pelotas
  • patients who could not be followed by 12 months
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959361


Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Investigators
Principal Investigator: LEILA B MOREIRA, DR HOSPITAL DE CLÍNICAS DE PORTO ALEGRE
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Marysabel Pinto Telis Silveira, Universidade Católica de Pelotas
ClinicalTrials.gov Identifier: NCT00959361     History of Changes
Other Study ID Numbers: 2003164
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: September 29, 2009
Last Verified: August 2009

Keywords provided by Hospital de Clinicas de Porto Alegre:
patient compliance
guidelines adherence
advance directive adherence
treatment refusal
directly observed therapy
anti-retroviral agents
 HIV seropositivity
HIV infections
HIV
pharmaceutical services
HIV-positives patients
treatment experienced

Additional relevant MeSH terms:
HIV Infections
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases