Depression and ART Adherence in HIV+ Latinos
Recruitment status was Active, not recruiting
The current HIV treatment adherence project was designed to adapt culturally and then pilot test an empirically supported cognitive-behavioral therapy program for adherence and symptoms of depression (CBT-AD)with HIV+ Latinos living on the U.S.-Mexico Border.
Behavioral: Cognitive-Behavioral Therapy AD
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border|
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Changes in depression ratings at two time points: From baseline to 6 and 9 month follow-up ] [ Designated as safety issue: No ]The MADRS is a 10-item clinician administered scripted rating scale of depressive symptoms. The scale was develop to capture current depressive symptoms within the past seven days. The areas covered include: apparant and reported sadness, inner tension, reduced sleep and appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Both control and treatment conditions are interviewed with the MADRS at baseline and at 6 and 9 month follow-ups for any changes.
- Self-Report Adherence [ Time Frame: Changes in self-reported adherence from baseline through 9 months ] [ Designated as safety issue: No ]From the Visual Analogue Scale or brief items
- MedSignals Electronic Pill-box for Adherence [ Time Frame: Changes in adherence at two-time points: from baseline to 6 and 9 month follow-up ] [ Designated as safety issue: No ]The MedSignals electronic pill-box is a elecontric storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants of their dosing regimen. The pill-box stores adherence information (time, number of openings). In the control condition, the pill-box does not alarm participants. The pill-box serves as a storage bin for the control condition and stores adherence data. All data is then uploaded onto an online database for investigators.
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: Cognitive-Behavioral Therapy (CBT-AD)
CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.
Behavioral: Cognitive-Behavioral Therapy AD
Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions
Other Name: CBT-AD
No Intervention: Control-Standard Care
Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
Additionally, the investigators will assess the feasibility and efficacy of a novel medication monitoring and reminder system (MedSignals®) in the form of an electronic pillbox with monitoring and reminding functions that is available in a Spanish-language version. Our hypotheses are grounded in a conceptual model proposing that the CBT-AD intervention will improve problem-solving ability and decrease depressive symptomatology, which will directly improve biomedical outcomes of HIV-1 RNA viral load and CD4 as well as indirectly improve biomedical outcomes through increased motivation, improved memory, and better medication adherence. Evaluating and implementing generalizable and sustainable mental health and adherence interventions such as the ones proposed are urgently needed in the region to improve HIV treatment outcomes and thwart the development and transmission of drug resistant virus.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411839
|United States, Texas|
|Centro de Salud Familiar La Fe CARE Center|
|El Paso, Texas, United States, 79925|
|Principal Investigator:||Jane M Simoni, Ph.D.||University of Washington|