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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00716040
First received: July 14, 2008
Last updated: July 15, 2008
Last verified: July 2008

July 14, 2008
July 15, 2008
March 2008
September 2008   (final data collection date for primary outcome measure)
Adherence to HAART [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00716040 on ClinicalTrials.gov Archive Site
Viral Load [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Social-Psychological Intervention to Improve Adherence to HAART
Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • AIDS
  • HIV Infections
  • 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.
  • Other: Usual care
    The control group will be submitted to the usual care of the health service
  • Experimental: Intervention
    The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional.
    Intervention: Behavioral: Social-psycho intervention to improve adherence to HAART
  • Control
    The control group will be submitted to the usual care of the health service.
    Intervention: Other: Usual care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
121
November 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00716040
FAPESP 2006-61277-6
No
Maria Ines Battistella Nemes, Faculdade de Medicina da Universidade de São Paulo
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
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
University of Sao Paulo
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP