SPIAH-Q: Social-Psychological Intervention to Improve Adherence to HAART

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT00716040

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

121

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
AIDS HIV Infections	Behavioral: Social-psycho intervention to improve adherence to HAART Other: Usual care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

121 participants

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

Study Start Date :

Mar 1, 2008

Anticipated Primary Completion Date :

Sep 1, 2008

Anticipated Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.
Other: 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

Arm

Intervention/Treatment

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.

Other: 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

Outcome Measures

Primary Outcome Measures

Adherence to HAART [24 weeks]

Secondary Outcome Measures

Viral Load [12 and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00716040

Other Study ID Numbers:

FAPESP 2006-61277-6

First Posted:

Jul 16, 2008

Last Update Posted:

Jul 16, 2008

Last Verified:

Jul 1, 2008

Keywords provided by , ,

AIDS treatment

HAART adherence

intervention

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Jul 16, 2008