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Nurse-delivered cognitive-behavioral therapy (CBT) for depression: adherence in HIV primary care in South Africa
Investigator (PI): Safren, Steven A; O'Cleirigh, Conall Michael
Performing Organization (PO): (Current): University of Miami, College of Arts and Sciences, Department of Psychology / (305) 284-2814
Supporting Agency (SA): National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
Initial Year: 2015
Final Year: 2021
Record Source/Award ID: RePorter/R01MH103770
Funding: 2015 Award Amount: $613,718
2016 Award Amount: $597,304
2017 Award Amount: $679,562
2018 Award Amount: $590,373
2019 Award Amount: $586,351
Award Type: Grant
Abstract: This is a proposal to conduct a two-arm randomized effectiveness trial investigating whether a task shifting/sharing model of treating depression and improving adherence to ART in patients who fail first-line antiretroviral therapy (ART) can occur, using nurses in South Africa trained in CBT. South Africa is the country with the highest number of HIV infections in the world and the highest number of HIV/AIDS-related deaths, and where access to third-line ART treatment is not currently available in the public health care system. Clinical depression, like elsewhere, is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior, such as non-adherence to ART and worse retention in care, which are critical for treatment success. Preliminary work. The US-based investigators have developed and successfully tested an approach integrating adherence counseling into cognitive-behavioral therapy for depression in HIV. The South Africa-based team, in collaboration with the US-based team, has conducted preliminary work to evaluate the cultural appropriateness and feasibility of integrating this approach into the South African HIV treatment setting. Accordingly, we have 1) conducted an open-pilot of the treatment in Cape Town with 6 HIV-infected patients with depression using a clinical psychology PhD student as the therapist, 2) conducted formative qualitative research on the manifestation of depression and ways to adapt this approach for the South Africa HIV care setting, 3) successfully trained two clinic nurses in the adapted version of the intervention, and 4) completed an open pilot feasibility trial with 14 patients with these nurses as interventionists. Design: The current study builds on our successful feasibility pilot. Given that CBT is a validated treatment for depression, and that dissemination of evidence-based interventions in HIV is a noted priority, we propose a two-arm effectiveness RCT (stratified by antidepressant medication initiation/use or not) of nurse-delivered cognitive behavioral therapy for depression and adherence integrated into the HIV primary care setting in South Africa. To ensure that those who need this intervention the most will receive it, participants will be patients with HIV who have failed first-line ART, and have a unipolar depressive mood disorder. Primary outcomes (aim 1) include adherence to ART (assessed by WisePill), depression (assessed by an independent evaluator), and proportion of (second-line) treatment failures in each condition. Comparing this integrated care model to usual care (enhanced adherence counseling for first-line treatment failures in this setting), will allow for an incremental cost-effectiveness analysis in aim 2. We will collect resource utilization and cost data to examine the cost-effectiveness of reduced depression, and potentially, better HIV outcomes. Before study start-up, and twice a year, we will convene community advisory meetings of HIV patients as well as stakeholders (clinic directors, Nurses AIDS Service, NGO leaders) to maximize the chances of uptake scalability of the model should it be successful.
MeSH Terms:
  • Anti-Retroviral Agents /therapeutic use
  • Cognitive Behavioral Therapy /*methods
  • Comparative Effectiveness Research
  • Cost-Benefit Analysis
  • Cultural Characteristics
  • Depression /complications
    • /*therapy
  • Evidence-Based Medicine
  • Feasibility Studies
  • HIV Infections /complications
    • /*drug therapy /*psychology
  • Humans
  • * Medication Adherence
  • Mood Disorders /therapy
  • Nursing /*methods
  • Outcome Assessment, Health Care
  • Patient Compliance
  • Pilot Projects
  • Randomized Controlled Trials as Topic
  • Self Care
  • South Africa
  • United States
Keywords:
  • AIDS/HIV problem
  • Africa
  • African
  • HIV
  • HIV infections
  • South Africa
  • acquired immunodeficiency syndrome
  • adherence (attribute)
  • antidepressive agents
  • antiretroviral therapy
  • chronic
  • cognitive therapy
  • collaborations
  • communities
  • comorbidity
  • cost
  • cost-effectiveness
  • cost-effectiveness analysis
  • counseling
  • depressed mood
  • depressive symptoms
  • effectiveness
  • effectiveness trial
  • intervention
  • major depressive disorder
  • mental depression
  • mental health
  • mood disorders
  • nurses
  • outcome
  • pharmaceutical preparations
  • pill (pharmacologic)
  • primary care setting
  • primary health care
  • psychologist
  • randomized
  • standard of care
  • therapy adherence
  • treatment as usual
  • treatment failure
  • treatment outcome
  • treatment program
  • treatment strategy
Country: United States
State: Florida
Zip Code: 33146
UI: 20162080
CTgovId: NCT02696824
Project Status: Ongoing
Record History: ('2020: Project extended to 2021',)