Clinical trial NCT01411839: Depression and ART Adherence in HIV+ Latinos
Official title: Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
HIV Infections
Keywords: Depression
Latinos
Adherence
Cognitive-Behavioral Therapy
HIV/AIDS
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Texas
First posted: 2011-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a
timeFrame: MADRS and BDI-1a scores at 6 and 9-month follow-up
Secondary outcomes:
measure: Self-Report Adherence
timeFrame: Self-reported adherence at 6 and 9-month follow-up
measure: MedSignals Electronic Pill-box for Adherence
timeFrame: 6 and 9 month follow-up adherence scores
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Centro de Salud Familiar La Fe CARE Center
state: Texas
Study officials:
affiliation: University of Washington
name: Jane M Simoni, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: