HIVPC-HIVNCT00959361
Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy
A study testing pharmaceutical care in people with HIV and HIV Infections, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- pharmaceutical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2006to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, HIV Infections
- Being tested
- pharmaceutical care
- 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
- Medical subject headings
- HIV Infections, Patient Compliance, Treatment Refusal, Directly Observed Therapy, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical careBehavioural
Also called pharmaceutical attention, DADER method
consultation with the pharmacists and usual care
| Study group | Role | What they receive |
|---|---|---|
| pharmaceutical care | Experimental | consultation with the pharmacists Receives: Behavioral: pharmaceutical care |
| control | No intervention | usual care without consultation with the pharmacists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative risk for adherence to the antiretroviral treatment among HIV-positive patients who receive Pharmaceutical Care and the ones that do not receive Pharmaceutical
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJun 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Investigators
- LEILA B MOREIRA, DR, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959361
- Sponsor's protocol ID
- 2003164
- Acronym
- PC-HIV
- Status last verified
- Aug 2009
- First submitted
- 13 Aug 2009
- Last updated
- 29 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of Pharmaceutical Care on the Adherence of HIV-Positive Patients to Antiretroviral Therapy - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00959361
- Acronym / sponsor ID
- PC-HIV / 2003164
- Conditions
- HIV, HIV Infections
- Keywords
- patient compliance, guidelines adherence, advance directive adherence, treatment refusal, directly observed therapy, anti-retroviral agents, HIV seropositivity, HIV infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Jun 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pharmaceutical care | Experimental | Behavioral: pharmaceutical careconsultation with the pharmacists |
| control | No intervention | –usual care without consultation with the pharmacists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients registered in the SAE-Pelotas
- adults (older 18 years)
- inhabitants of the urban zone of Pelotas
- not pregnant
- in use of antiretroviral treatment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmaceutical careAlso: pharmaceutical attention, DADER methodconsultation with the pharmacists and usual care | Behavioural | pharmaceutical care |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEILA B MOREIRA, DR principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmaceutical care in people with HIV and HIV Infections, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2009.