Social-Psychological Intervention to Improve Adherence to HAART

HIV Infections Clinical Trial

— SPIAH-Q  

Official title:

Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00716040
• Other study ID #: FAPESP 2006-61277-6
• Status: Active, not recruiting
• Phase: N/A
• First received: July 14, 2008
• Last updated: July 15, 2008
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: July 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Brazil	Centro de Referência e Treinamento DST/AIDS	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to HAART		24 weeks	No
Secondary	Viral Load		12 and 24 weeks	No