Social-Psychological Intervention to Improve Adherence to HAART (SPIAH-Q)
Primary Purpose
AIDS, HIV Infections
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Social-psycho intervention to improve adherence to HAART
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for AIDS focused on measuring AIDS treatment, HAART adherence, intervention
Eligibility Criteria
Inclusion Criteria:
- Patients aged more than 18 years old, with detectable viral load and more than six months under HAART
Exclusion Criteria:
- Pregnant women
- Patients participating in other trials
- Patients in treatment for hepatitis and for active opportunistic infection
- Patients with mental or physical condition which do not allow their attendance to the health service
Sites / Locations
- Centro de Referência e Treinamento DST/AIDS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional.
The control group will be submitted to the usual care of the health service.
Outcomes
Primary Outcome Measures
Adherence to HAART
Secondary Outcome Measures
Viral Load
Full Information
NCT ID
NCT00716040
First Posted
July 14, 2008
Last Updated
July 15, 2008
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00716040
Brief Title
Social-Psychological Intervention to Improve Adherence to HAART
Acronym
SPIAH-Q
Official Title
Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
November 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
All eligible patients will be invited to use electronic monitoring of medication (MEMS) during the next six months. After two months with MEMS the enrolled patients will be randomized to intervention group or to control group. The intervention group will be submitted to four social-psycho sessions with a pre-trained health professional. The control group will receive the usual care of the health service.
The study will compare the rate of adherence to antiretroviral therapy between the intervention group and the control group. The duration of the study will be of six months. The analysis will be based on "intention-to-treat.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS, HIV Infections
Keywords
AIDS treatment, HAART adherence, intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional.
Arm Title
Control
Arm Type
Other
Arm Description
The control group will be submitted to the usual care of the health service.
Intervention Type
Behavioral
Intervention Name(s)
Social-psycho intervention to improve adherence to HAART
Intervention Description
The intervention focus on the notion of scenes and scenarios to examine and discussing the experience of taking ARV medicines. In principle, such an approach provides a tool for conscientization, action and the invention of novel group and individual repertoires that may result in individual mobilization for improving adherence to treatment and reducing his/her vulnerability.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
The control group will be submitted to the usual care of the health service
Primary Outcome Measure Information:
Title
Adherence to HAART
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Viral Load
Time Frame
12 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged more than 18 years old, with detectable viral load and more than six months under HAART
Exclusion Criteria:
Pregnant women
Patients participating in other trials
Patients in treatment for hepatitis and for active opportunistic infection
Patients with mental or physical condition which do not allow their attendance to the health service
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Ines B Nemes, PhD
Organizational Affiliation
Faculty of Medicine -University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernani T Santa Helena, PhD
Organizational Affiliation
Regional University of Blumenau
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Referência e Treinamento DST/AIDS
City
Sao Paulo
ZIP/Postal Code
04121-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
22527264
Citation
Basso CR, Helena ET, Caraciolo JM, Paiva V, Nemes MI. Exploring ART intake scenes in a human rights-based intervention to improve adherence: a randomized controlled trial. AIDS Behav. 2013 Jan;17(1):181-92. doi: 10.1007/s10461-012-0175-4.
Results Reference
derived
Learn more about this trial
Social-Psychological Intervention to Improve Adherence to HAART
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