Skip to main content
OpenTrials
Completed

NCT Number: NCT00959361

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmaceutical Care

Behavioral

consultation with the pharmacists and usual care

Other names: pharmaceutical attention, DADER method

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Federal University of Rio Grande do Sul

Registry information

Official study title

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

Acronym: PC-HIV

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 14, 2009
Registry last updated
Sep 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.