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

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
pharmaceutical care
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

pharmaceutical care

control

Arm Description

consultation with the pharmacists

usual care without consultation with the pharmacists

Outcomes

Primary Outcome Measures

Relative risk for adherence to the antiretroviral treatment among HIV-positive patients who receive Pharmaceutical Care and the ones that do not receive Pharmaceutical

Secondary Outcome Measures

Full Information

First Posted
August 13, 2009
Last Updated
September 28, 2009
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT00959361
Brief Title
Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy
Acronym
PC-HIV
Official Title
Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy - Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pharmaceutical care
Arm Type
Experimental
Arm Description
consultation with the pharmacists
Arm Title
control
Arm Type
No Intervention
Arm Description
usual care without consultation with the pharmacists
Intervention Type
Behavioral
Intervention Name(s)
pharmaceutical care
Other Intervention Name(s)
pharmaceutical attention, DADER method
Intervention Description
consultation with the pharmacists and usual care
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LEILA B MOREIRA, DR
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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