Clinical trial NCT01351454: Behavioral Depression Treatment for African American HIV-infected Substance Users
Official title: Behavioral Depression Treatment for African American HIV-infected Substance Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Substance Use
Keywords: Depression
Substance Use
HIV Medication Adherence
Behavioral Activation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-05-10
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to test a novel, behavioral approach to treat depressive symptoms and improve HIV medication adherence and subsequent physical health outcomes among African American HIV-infected substance users residing in inner-city Washington, DC. This treatment will serve as a compliment to standard residential and follow-up outpatient substance use treatment, with the goal of reducing depressive symptoms and improving HIV medication adherence, physical health, and substance use outcomes.

Detailed description: Approximately 37-50% of HIV positive individuals suffer from depression, which is associated with substance use, poor adherence to HIV medication, an increase in HIV risk behaviors, and subsequent poor health outcomes (e.g., Asch et al., 2003; Bing et al., 2001; Dew et al., 1997; Johnson, Rabkin, Lipsitz, Williams, \& Remien, 1999). Additionally, depressed HIV positive substance users are at an even greater risk for poor medication adherence than non-substance users (Cook, Grey, \& Burke-Miller, 2004). Notably, evidence indicates that HIV positive patients who receive treatment for depression exhibit significant improvements in HIV medication adherence and a reduction in risk behaviors that are directly relevant to their health and well being such as risky sexual behavior (e.g., Cook et al., 2006). Despite this link, few interventions targeting depression have been developed to meet the specific needs of HIV-infected substance users. This is especially evident for low income African American HIV positive substance users who often do not receive adequate treatment for any of these conditions due to poverty, lack of access to specialized treatment, low motivation, cognitive impairments, and a lack of coordination between medical, mental health, and substance abuse treatment providers (Calsyn et al., 2004). Thus, the objective of the present proposal is to test a novel, behavioral approach to treat depressive symptoms and improve HIV medication adherence and subsequent physical health outcomes among African American HIV infected substance users residing in inner-city Washington, DC. This treatment combines (1) LET'S ACT, a behavioral activation based treatment for depressed substance users (Daughters, Braun, Sargeant, Hopko, Blanco, \& Lejuez, 2008), with (2) Life Steps, an HIV medication adherence intervention (Safren, Otto, \& Worth, 1999). The purpose of this combined treatment will be to compliment standard residential and follow-up outpatient substance use treatment to specifically treat depressive symptoms with the additional goal of improving HIV medication adherence, substance use, and physical health outcomes. Participants will be randomly assigned to either treatment as usual (TAU) plus ACT HEALTHY or TAU plus Nondirective Therapy to test the efficacy of ACT HEALTHY. Treatment as usual for both groups consists of standard residential and outpatient substance abuse treatment. Based on the outcome of this preliminary trial, the ACT HEALTHY protocol will be further refined and readied for larger-scale clinical trials.

Eligibility criteria: Inclusion Criteria:

* between 18 and 65 years of age
* HIV positive

Exclusion Criteria:

* psychosis
* the inability to give informed, voluntary, written consent to participate
* reading ability \[below 3rd grade level on the WRAT\]

Primary outcomes:
measure: Beck Depression Inventory (BDI-II; Beck et al., 1996)
timeFrame: BDI-II will be evaluated from baseline to a 12-month follow up period
measure: MEMS
timeFrame: MEMS is assessed from residential discharge to 12-month follow up period
measure: Urinalysis
timeFrame: Urinalysis is assessed from residential discharged to a 12-month follow up period
measure: Time Line Follow Back (TLFB)
timeFrame: TLFB will be assessed from baseline to a 12-month follow up period
measure: Adherence to Anti-Retroviral Medications Questionnaire (ACTG; Chesney, Morin, & Sherr, 2000)
timeFrame: ACTG will be assessed from baseline to 12-month follow up period
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Salvation Army Harbor Light Treatment Center
state: District of Columbia
city: College Park
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Stacey B. Daughters, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daughters SB, Magidson JF, Schuster RM, Safren SA. ACT HEALTHY: A Combined Cognitive-Behavioral Depression and Medication Adherence Treatment for HIV-Infected Substance Users. Cogn Behav Pract. 2010 Aug 1;17(3):309-321. doi: 10.1016/j.cbpra.2009.12.003.
citation: Magidson JF, Belus JM, Seitz-Brown CJ, Tralka H, Safren SA, Daughters SB. Act Healthy: A Randomized Clinical Trial Evaluating a Behavioral Activation Intervention to Address Substance Use and Medication Adherence Among Low-Income, Black/African American Individuals Living with HIV/AIDS. AIDS Behav. 2022 Jan;26(1):102-115. doi: 10.1007/s10461-021-03354-1. Epub 2021 Jun 26.