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

This study has been completed.
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00959361
First received: August 13, 2009
Last updated: September 28, 2009
Last verified: August 2009

August 13, 2009
September 28, 2009
June 2006
May 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00959361 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy
Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy - Randomized Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV
  • HIV Infections
Behavioral: pharmaceutical care
consultation with the pharmacists and usual care
Other Names:
  • pharmaceutical attention
  • DADER method
  • Experimental: pharmaceutical care
    consultation with the pharmacists
    Intervention: Behavioral: pharmaceutical care
  • No Intervention: control
    usual care without consultation with the pharmacists
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00959361
2003164
No
Marysabel Pinto Telis Silveira, Universidade Católica de Pelotas
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Principal Investigator: LEILA B MOREIRA, DR HOSPITAL DE CLÍNICAS DE PORTO ALEGRE
Hospital de Clinicas de Porto Alegre
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP