Depression and ART Adherence in HIV+ Latinos

University of Washington

Status: Completed

Conditions: Depressive Symptoms; HIV Infections

Treatments: Behavioral: Cognitive-Behavioral Therapy (CBT-AD)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01411839

R34MH084674 (U.S. NIH Grant/Contract)

35279

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Cognitive-Behavioral Therapy (CBT-AD)

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive-Behavioral Therapy (CBT-AD)

Control-Standard Care

No Intervention group

Description:

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.