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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depressive Symptoms
HIV Infections
Intervention: Behavioral: Cognitive-Behavioral Therapy (CBT-AD)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Data were collected in a two-stage process from 10/21/2009 – 8/31/2011 at a publicly-funded community health clinic in El Paso, TX, on the U.S.-Mexico border.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants were randomly assigned to the intervention or treatment as usual (TAU) control condition, both enhanced with the notification letter to provider. An external statistician had used a computerized random number generator to select random permuted blocks of four.

Reporting Groups
  Description
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.

Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions
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.

Participant Flow:   Overall Study
    Cognitive-Behavioral Therapy (CBT-AD)   Control-Standard Care
STARTED   20   20 
COMPLETED   16   17 
NOT COMPLETED   4   3 
Lost to Follow-up                4                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions
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.
Total Total of all reporting groups

Baseline Measures
   Cognitive-Behavioral Therapy (CBT-AD)   Control-Standard Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 20   20   40 
Age 
[Units: Participants]
Count of Participants 		     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      20 100.0%      20 100.0%      40 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 47.3  (10.7)   44.8  (10.7)   46  (10.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      5  25.0%      6  30.0%      11  27.5% 
Male      15  75.0%      14  70.0%      29  72.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
Hispanic or Latino      20 100.0%      20 100.0%      40 100.0% 
Not Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Beck Depression Inventory 1a [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 22  (9.2)   16.8  (6.3)   19.4  (8.2) 
[1] Self-reported depressive symptoms were 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.
Visual Analog Scale 30-day Adherence [1] 
[Units: Percent of doses taken]
Mean (Standard Deviation) 		 84.4  (24.4)   90.6  (11.1)   87.2  (19.5) 
[1] Self-reported adherence was assessed with the visual analog scale. This 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.
Electronic Drug Adherence Monitoring [1] 
[Units: Percent Adherence]
Mean (Standard Deviation) 		 43.2  (43.5)   55.6  (47.6)   49.4  (40.6) 
[1] 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 the designated time of taking their medication.
Montgomery-Asberg Depression Rating Scale (MADRS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 25.1  (9.7)   22.1  (9.8)   23.6  (9.7) 
[1] The MADRS is a 10-item 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 scale was developed to capture current depressive symptoms within the past seven days. The areas covered include: apparent and reported sadness, inner tension, reduced sleep and appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms.


  Outcome Measures

1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Secondary:   Self-Report Adherence   [ Time Frame: Self-reported adherence at 6 and 9-month follow-up ]
  Show Outcome Measure 2

3.  Secondary:   MedSignals Electronic Pill-box for Adherence   [ Time Frame: 6 and 9 month follow-up adherence scores ]
  Show Outcome Measure 3


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. John A. Sauceda
Organization: University of California, San Francisco
phone: 415-460-6045
e-mail: john.sauceda@ucsf.edu



Responsible Party: Jane Simoni, University of Washington
ClinicalTrials.gov Identifier: NCT01411839     History of Changes
Other Study ID Numbers: 35279
R34MH084674 ( U.S. NIH Grant/Contract )
First Submitted: July 25, 2011
First Posted: August 8, 2011
Results First Submitted: November 10, 2017
Results First Posted: March 19, 2018
Last Update Posted: March 19, 2018