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

NCT00959361 | Completed

• 1 other identifier: 2003164
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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

  one year

Study Arms (2)

pharmaceutical care

EXPERIMENTAL

consultation with the pharmacists

Behavioral: pharmaceutical care

control

NO INTERVENTION

usual care without consultation with the pharmacists

Interventions

pharmaceutical care BEHAVIORAL

consultation with the pharmacists and usual care

Also known as: pharmaceutical attention, DADER method

pharmaceutical care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

HIV Infections; Patient Compliance; Treatment Refusal; Directly Observed Therapy; HIV Seropositivity

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Medication Adherence

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• LEILA B MOREIRA, DR

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 14, 2009
• Study Start: June 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 29, 2009

Record last verified: 2009-08

Locations

BR (1)