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Avaliation of efficacy of Trial-Based Cognitive Therapy in the adherence to drug treatment in HIV-infected patients

Controlled trial comparing the efficacy of Trial-Based Cognitive Therapy (TBCT) and standard treatment about the adherence to the treatment of patients with HIV/AIDS with antiretroviral therapy failure assisted in Salvador, Bahia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8qqzk8
Enrollment
Unknown
Registered
2016-08-24
Start date
2016-02-16
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with HIV/AIDS and non-adherence to antiretroviral therapy

Interventions

The intervention group with Trial-Based Cognitive Therapy: 48 HIV-infected people will be divided in 8 groups of 6 people, they will have 14 sessions of psicological therapy , one session weekly , e
Behavioural

Sponsors

Fundação Bahiana de Infectologia
Lead Sponsor
Universidade Federal de Bahia
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: HIV-infected patients with viral load higher than 500 copies/mL in the last two tests or virologic controlled due to non-adherence to antiretroviral therapy. Age between 18 and 65 years, to be able to write and follow the protocol's instructions and sign informed consent.

Exclusion criteria

Exclusion criteria: Difficult with reading and whitting activities; the patient can not participate in another psychological therapy, and he can not have psychiatric or clinical diagnosis that interferes in the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the higher antiretroviral therapy adherence that will be measured by the instruments: 1. Adherence Self-Report ACTG Questionnaire that considers adherents the subjects with drug using frequency igual or more than 95%; 2. the laboratory test result of HIV-RNA viral load is equal to <50 copies. The analysis will be performed in baseline, three and six months after the intervention in each group, and comparing the intervention group with the control group.;-

Secondary

MeasureTime frame
Decrease of depression measured by questionnaire: Beck Depression Inventory- version II (BDI-II) which classifies in four levels according to validated scores for Brazilian population: minimal (0-11), moderate (12-19), mild (20-35), and severe (36-63). The analysis will be performed in baseline, three and six months after the intervention in each group, and comparing the intervention group with the control group.;Decrease of Anxiety measured by questionnaire: Beck Anxiety Inventory (BAI) which classifies in four levels according to validated scores for Brazilian population: minimal (0-10), moderate (11-19), mild (20-30), and severe (31-63). The analysis will be performed in baseline, three and six months after the intervention in each group, and comparing the intervention group with the control group.;the improvement of quality of life, measured by the SF36 questionnaire Brazilian version considering the component results related to the mental health, physical health and general health. The analysis will be performed in baseline, three and six months after the intervention in each group, and comparing the intervention group with the control group.

Countries

Brazil

Contacts

Public ContactMónica Narváez Betancur

Universidade Federal de Bahia

mobinarbe@gmail.com+55(71)991890478

Outcome results

None listed

Source: REBEC (via WHO ICTRP)