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Depression and ART Adherence in HIV+ Latinos

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ClinicalTrials.gov Identifier: NCT01411839
Recruitment Status : Unknown
Verified August 2011 by University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : August 8, 2011
Last Update Posted : August 24, 2011
National Institute of Mental Health (NIMH)
University of Texas
Information provided by:
University of Washington

July 25, 2011
August 8, 2011
August 24, 2011
July 2008
August 2011   (Final data collection date for primary outcome measure)
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 ]
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.
Same as current
Complete list of historical versions of study NCT01411839 on ClinicalTrials.gov Archive Site
  • Self-Report Adherence [ Time Frame: Changes in self-reported adherence from baseline through 9 months ]
    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 ]
    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.
Same as current
Not Provided
Not Provided
Depression and ART Adherence in HIV+ Latinos
Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border
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.
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.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Depressive Symptoms
  • HIV Infections
Behavioral: Cognitive-Behavioral Therapy AD
Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions
Other Name: CBT-AD
  • 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.
    Intervention: Behavioral: Cognitive-Behavioral Therapy 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV+ participants (a) currently receiving HIV care at La Fe CARE Center (study site);
  • 18 years of age or older;
  • Latino (i.e., self-identified as being of Mexican heritage);
  • English- or Spanish-speaking
  • capable of giving informed consent;
  • currently on a prescribed antiretroviral regimen;
  • suboptimally adherent (i.e., demonstrated either by a VL load taken in the last 12 months that is above the undetectable threshold of 50 mL copies or self-reporting a missed dose in the last two weeks);
  • exhibiting some depressive symptomatology (i.e., scoring on the Beck Depression Inventory-1A 10 or above), and (i) male or female (including transgender Female-to-Male and Male-To-Female.

Exclusion Criteria:

  • actively psychotic or so cognitively impaired that they cannot participate,
  • so physically ill as to be unable to come to the clinic to participate in the intervention, OR
  • Report The use of crack, cocaine, heroin, OR methamphetamines to any extent in the past 40 days.
  • Those who are planning on being away from the area for any extended period during the study (as in the case of seasonal workers) or whom
  • have household members already enrolled in the study will also be excluded. We did choose to restrict study eligibility to individuals of Mexican descent.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R34MH084674 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Jane M. Simoni, Ph.D., University of Washington
University of Washington
  • National Institute of Mental Health (NIMH)
  • University of Texas
Principal Investigator: Jane M Simoni, Ph.D. University of Washington
University of Washington
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP