Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy (PC-HIV)
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Purpose
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 | Intervention |
|---|---|
|
HIV HIV Infections |
Behavioral: pharmaceutical care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- 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 ]
| Enrollment: | 332 |
| Study Start Date: | June 2006 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: pharmaceutical care
consultation with the pharmacists
|
Behavioral: pharmaceutical care
consultation with the pharmacists and usual care
Other Names:
|
|
No Intervention: control
usual care without consultation with the pharmacists
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00959361
| Brazil | |
| Hospital de Clinicas de Porto Alegre | |
| Porto Alegre, Rio Grande Do Sul, Brazil | |
| Principal Investigator: | LEILA B MOREIRA, DR | HOSPITAL DE CLÍNICAS DE PORTO ALEGRE |
More Information
| Responsible Party: | Marysabel Pinto Telis Silveira, Universidade Católica de Pelotas |
| ClinicalTrials.gov Identifier: | NCT00959361 History of Changes |
| Other Study ID Numbers: | 2003164 |
| Study First Received: | August 13, 2009 |
| Last Updated: | September 28, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
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 |
ClinicalTrials.gov processed this record on September 29, 2016