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Social-Psychological Intervention to Improve Adherence to HAART (SPIAH-Q)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716040
First Posted: July 16, 2008
Last Update Posted: July 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
  Purpose

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.


Condition Intervention
AIDS HIV Infections Behavioral: Social-psycho intervention to improve adherence to HAART Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Adherence to HAART [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Viral Load [ Time Frame: 12 and 24 weeks ]

Enrollment: 121
Study Start Date: March 2008
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional.
Behavioral: Social-psycho intervention to improve adherence to HAART
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.
Control
The control group will be submitted to the usual care of the health service.
Other: Usual care
The control group will be submitted to the usual care of the health service

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716040


Locations
Brazil
Centro de Referência e Treinamento DST/AIDS
Sao Paulo, Brazil, 04121-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Maria Ines B Nemes, PhD Faculty of Medicine -University of Sao Paulo
Study Director: Ernani T Santa Helena, PhD Regional University of Blumenau
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Ines Battistella Nemes, Faculdade de Medicina da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT00716040     History of Changes
Other Study ID Numbers: FAPESP 2006-61277-6
First Submitted: July 14, 2008
First Posted: July 16, 2008
Last Update Posted: July 16, 2008
Last Verified: July 2008

Keywords provided by University of Sao Paulo:
AIDS treatment
HAART adherence
intervention

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases