Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
Condition: Human Immunodeficiency Virus; Alcohol-Related Disorders; Drug Use
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Substance-Related Disorders; Alcohol-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness and implementation of a brief,
      integrated behavioral intervention for HIV medication adherence and substance use in the HIV
      care setting in South Africa. The intervention is specifically designed to be implemented by
      non-specialist counselors using a task sharing model in local HIV clinics. The behavioral
      intervention will be compared to usual care, enhanced with referral to a local outpatient
      substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as
      described in study endpoint section below).
    

Detailed description: 
      The HIV epidemic in South Africa (SA) is among the highest in the world. SA has a large
      antiretroviral therapy (ART) program, but some individuals exhibit poor ART adherence, which
      increases the likelihood of developing drug resistance and failing the only available first
      and second line ART regimens in SA. ART nonadherence contributes to greater morbidity,
      mortality, and higher likelihood of sexual HIV transmission when virus is detectable. At the
      same time, alcohol and other drug use is prevalent among HIV-infected individuals in SA and
      associated with worse ART adherence, lower rates of viral suppression, and HIV transmission
      risk behavior. Yet, despite the impact of untreated substance use on poor HIV treatment
      outcomes and continued HIV transmission, there is little if any integration of substance use
      and HIV care services in SA, which creates a fragmented and incomplete system of care. This
      study had three phases, first being formative, qualitative work which led to a systematic
      treatment adaptation phase. This third phase, the clinical trial, is based on this formative
      work and other empirical support using behavioral interventions to improve ART adherence and
      reduce substance use in resource-limited settings, including SA. This study is a Type 1
      hybrid effectiveness-implementation trial of a lay counselor-delivered behavioral
      intervention for adherence and substance use integrated into the HIV primary care setting in
      SA. To ensure that those who need this intervention most will receive it, participants will
      be patients with HIV who are struggling with adherence (as defined in the investigator's
      inclusion criteria) and who have an elevated substance use risk.
    

Intervention name(s): Project Khanya
Intervention type(s): Behavioral
Intervention description(s): This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunologic Deficiency Syndromes; Substance Use; Acquired Immunodeficiency Syndrome; Immune System Diseases; Behavioral Symptoms; RNA Virus Infections; HIV Infections; Alcohol Use; Drug Use