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

NCT ID: NCT00959361

Last Updated: 2009-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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HIV HIV Infections

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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pharmaceutical care

consultation with the pharmacists

Group Type EXPERIMENTAL

pharmaceutical care

Intervention Type BEHAVIORAL

consultation with the pharmacists and usual care

control

usual care without consultation with the pharmacists

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pharmaceutical care

consultation with the pharmacists and usual care

Intervention Type BEHAVIORAL

Other Intervention Names

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pharmaceutical attention DADER method

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Universidade Católica de Pelotas

Principal Investigators

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LEILA B MOREIRA, DR

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2003164

Identifier Type: -

Identifier Source: org_study_id