Social-Psychological Intervention to Improve Adherence to HAART (SPIAH-Q)
|ClinicalTrials.gov Identifier: NCT00716040|
Recruitment Status : Unknown
Verified July 2008 by University of Sao Paulo.
Recruitment status was: Active, not recruiting
First Posted : July 16, 2008
Last Update Posted : July 16, 2008
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 or disease||Intervention/treatment||Phase|
|AIDS HIV Infections||Behavioral: Social-psycho intervention to improve adherence to HAART Other: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||September 2008|
|Estimated Study Completion Date :||November 2008|
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.
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
- Adherence to HAART [ Time Frame: 24 weeks ]
- Viral Load [ Time Frame: 12 and 24 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716040
|Centro de Referência e Treinamento DST/AIDS|
|Sao Paulo, Brazil, 04121-000|
|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|