ClinicalTrials.gov
ClinicalTrials.gov Menu

Depression and ART Adherence in HIV+ Latinos

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms HIV Infections Behavioral: Cognitive-Behavioral Therapy (CBT-AD) Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border
Study Start Date : July 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
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

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411839


Locations
United States, Texas
Centro de Salud Familiar La Fe CARE Center
El Paso, Texas, United States, 79925
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
University of Texas
Investigators
Principal Investigator: Jane M Simoni, Ph.D. University of Washington

Responsible Party: Jane Simoni, Professor, Psychology; Adjunct Professor, Global Health, University of Washington
ClinicalTrials.gov Identifier: NCT01411839     History of Changes
Other Study ID Numbers: 35279
R34MH084674 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2011    Key Record Dates
Results First Posted: March 19, 2018
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Jane Simoni, University of Washington:
Depression
Latinos
Adherence
Cognitive-Behavioral Therapy
HIV/AIDS

Additional relevant MeSH terms:
HIV Infections
Depression
Behavioral Symptoms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases