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Depression and ART Adherence in HIV+ Latinos

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ClinicalTrials.gov Identifier: NCT01411839
Recruitment Status : Completed
First Posted : August 8, 2011
Results First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Texas
Information provided by (Responsible Party):
Jane Simoni, University of Washington

July 25, 2011
August 8, 2011
November 10, 2017
March 19, 2018
March 19, 2018
July 2008
August 2011   (Final data collection date for primary outcome measure)
Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a [ Time Frame: MADRS and BDI-1a scores at 6 and 9-month follow-up ]
  1. Clinician-administered ratings are scored on the MADRS. The MADRS is a 10-item, past 7-day clinician administered scripted rating scale of depressive symptoms (each of the ten items is scored from 0-6, with total scores ranging from 0 to 60). The areas are: apparent and reported sadness, inner tension, reduced sleep/appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms.
  2. Participant self-report ratings are scored on the BDI-1a. The BDI-1a is assessed at each time point using the revised Beck Depression Inventory-Ia (BDI-Ia), which consists of 21 items, each with a 4-point response scale anchored with descriptive statements. Scores can range from 0-63, and scores of 10 or higher are presumptive of mild depressive severity. The BDI scores presented were added up and higher scores indicate worse depression. The MADRS and BDI-Ia is scored a total units on the scale.
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.
Complete list of historical versions of study NCT01411839 on ClinicalTrials.gov Archive Site
  • Self-Report Adherence [ Time Frame: Self-reported adherence at 6 and 9-month follow-up ]
    Self-reported adherence was assessed with the visual analog scale (VAS). The VAS is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken. Higher scores indicate better adherence.
  • MedSignals Electronic Pill-box for Adherence [ Time Frame: 6 and 9 month follow-up adherence scores ]
    The MedSignals electronic pill-box is a storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication. The pill-box stores adherence data (time, number of openings). In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise. All data is uploaded electronically. Higher numbers indicate better adherence that correspond to pill-box openings corresponding to the designated time of taking their medication.
  • 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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Depressive Symptoms
  • HIV Infections
Behavioral: Cognitive-Behavioral Therapy (CBT-AD)
CBT-AD is a therapy program intervention that uses one-on-one and face-to-face patient-therapist sessions.
Other Name: CBT-AD
  • Experimental: Cognitive-Behavioral Therapy (CBT-AD)
    This arm type is a cognitive-behavioral therapy program intervention for issues of medication adherence and depression. The intervention is a therapy program intervention involves 10-weekly or biweekly sessions, with 2 booster session, and focused on psychoeducation, behavioral activation, cognitive restructuring, and problem-solving. A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms.
    Intervention: Behavioral: Cognitive-Behavioral Therapy (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 was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms. 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.
 
Completed
40
Same as current
January 2012
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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01411839
35279
R34MH084674 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Jane Simoni, 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
March 2018

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