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

U

University of Sao Paulo

Status

Unknown

Conditions

AIDS
HIV Infections

Treatments

Behavioral: Social-psycho intervention to improve adherence to HAART
Other: Usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT00716040
FAPESP 2006-61277-6

Details and patient eligibility

About

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.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

121 participants in 2 patient groups

Intervention
Experimental group
Description:
The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional.
Treatment:
Behavioral: Social-psycho intervention to improve adherence to HAART
Control
Other group
Description:
The control group will be submitted to the usual care of the health service.
Treatment:
Other: Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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