Clinical trial NCT02544126: Computer-Based Intervention in HIV-Positive Young Adults
Official title: Computer-Based Intervention in HIV-Positive Young Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV
Depression
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 23
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate how working with a computer program may affect mood, feelings, overall health, and markers in blood in young adults with HIV.

Detailed description: Depression frequently occurs in young adults with HIV infection. When young adults with HIV experience depression, they are less likely to take their prescribed antiretroviral therapy (ART). When HIV occurs simultaneously with depression, individuals are more likely to have indicators in their blood that are linked risk for developing other illnesses in the future. The purpose of this project is to examine the ability of an avatar-based intervention, called eSMART-MH, to decrease depressive symptoms in HIV-positive depressed young adults.

Eligibility criteria: Inclusion Criteria:

* 23-53 years of age
* Fluent in English
* Be able to view images and text on a computer screen and hear audio using a headset
* Have a diagnosis of unipolar depression or have significant depressive symptoms noted in the electronic medical record (EMR) or referred to the study by a provider at the Grady Ponce de Leon Clinic because of their depressive symptoms
* Receive care at Ponce de Leon Center and at least 1 scheduled HIV medical appointment in the last 6 months
* Reside in the Atlanta, Georgia area
* Have a valid telephone number and email address
* Answer all items correctly on consent post-test

Exclusion Criteria:

* Diagnosis of bipolar depression
* Deaf, blind or unable to understand spoken English
* Currently pregnant, history of pregnancy within the last year or plan to become pregnant within the next 4 months
* Plan to move from the Atlanta, Georgia area within four months of study enrollment
* Taking corticosteroids or disease-modifying anti-rheumatic drugs
* If on antidepressant medication, taking it for less than 1 month
* Fail to pass post-consent test after three attempt

Primary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 3 months
measure: Change in the General Well-Being Schedule (GWS)
timeFrame: Baseline, 3 months
measure: Change in Center for Disease Control Health Related Quality of Life-4 (CDC HRQOL-4)
timeFrame: Baseline, 3 months
measure: Change in the Quality of Life Enjoyment Scale (Q-LES-Q-SF)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Medication Adherence
timeFrame: Baseline, 3 months
measure: Change in plasma interleukin-6 (IL-6) levels
timeFrame: Baseline, 3 months
measure: Change in cluster of differentiation 4 (CD4) Count
timeFrame: Baseline, 3 months
measure: Change in Log HIV Viral Load
timeFrame: Baseline, 3 months
measure: Change of plasma brain-derived neurotrophic factor (BDNF) levels
timeFrame: Baseline, 3 months
measure: Change in Fibrinogen levels
timeFrame: Baseline, 3 months
measure: Change in plasma oxytocin levels
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Melissa D Pinto, PhD,RN,FAAN
role: PRINCIPAL_INVESTIGATOR
References: