Overview

This trial is active, not recruiting.

Conditions depressive symptoms, hiv infections
Treatment cognitive-behavioral therapy ad
Sponsor University of Washington
Collaborator National Institute of Mental Health (NIMH)
Start date July 2008
End date August 2011
Trial size 40 participants
Trial identifier NCT01411839, 35279-C, R34MH084674

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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 CBT-AD
Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions
(No Intervention)
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.

Primary Outcomes

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

Secondary Outcomes

Measure
Self-Report Adherence
time frame: Changes in self-reported adherence from baseline through 9 months
MedSignals Electronic Pill-box for Adherence
time frame: Changes in adherence at two-time points: from baseline to 6 and 9 month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border
Principal investigator Jane M Simoni, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by University of Washington.