Behavioral Depression Treatment for African American HIV-infected Substance Users

Not Applicable

Completed

• Conditions: Substance Use; Depression

• Registration Number: NCT01351454
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Urinalysis	Urinalysis is assessed from residential discharged to a 12-month follow up period	Urinalysis is a biological measure of substance use.
MEMS	MEMS is assessed from residential discharge to 12-month follow up period	The MEMS cap (AARDEX) is an electronic pill bottle designed to record HIV medication adherence.
Beck Depression Inventory (BDI-II; Beck et al., 1996)	BDI-II will be evaluated from baseline to a 12-month follow up period	The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.
Time Line Follow Back (TLFB)	TLFB will be assessed from baseline to a 12-month follow up period	The Time Line Follow Back is a self-report measure of drug and alcohol use.
Adherence to Anti-Retroviral Medications Questionnaire (ACTG; Chesney, Morin, & Sherr, 2000)	ACTG will be assessed from baseline to 12-month follow up period	The ACTG is self-report measure of HIV medication adherence.

Trial Locations

Locations (2)

Salvation Army Harbor Light Treatment Center; 🇺🇸 Washington, District of Columbia, United States

University of Maryland; 🇺🇸 College Park, Maryland, United States