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Impact of Representative Payee Services on ART Adherence Among Marginalized People Living With HIV/AIDS

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ClinicalTrials.gov Identifier: NCT03561103
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : August 15, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Johns Hopkins Bloomberg School of Public Health
Information provided by (Responsible Party):
Mary Hawk, University of Pittsburgh

Brief Summary:
Client-Centered Representative Payee is a structural intervention that provides financial management support to PLWHA by modifying the implementation of a long-standing policy within the Social Security Administration, in which an organization is authorized to serve as the client's payee. The central hypothesis of this study is that by helping clients to pay rent and other bills on time, housing stability will improve and financial stress will decrease. By reducing the cognitive burden of living with chronic financial stress and frequent threats of housing loss, clients can devote more time and attention to medical appointments and medication adherence. It is further hypothesized that these changes will improve clients' self-efficacy for health behaviors, retention in care, medication adherence, and viral loads. These hypotheses will be tested via the following specific aims: (1) Conduct a randomized controlled trial (n=320) to test the effect of Client-Centered Rep Payee on ART adherence and viral load among PLWHA who are economically disadvantaged and unstably housed. Clinical adherence will be compared through behavioral and biological measures including prescription refill data, self-reported appointment adherence, and viral load for patients receiving the intervention versus those receiving standard of care. (2) Test underlying mechanisms associated with Client-Centered Rep Payee that contribute to changes in medication adherence and viral suppression rates. This will be accomplished via use of quantitative (mediation analysis) and qualitative (semi-structured interview) methods to test hypothesized mediators of medication adherence and viral suppression including financial and housing instability, financial stress, self-efficacy for health behaviors, and retention in care. (3) Assess the cost and cost-effectiveness of the Client-Centered Rep Payee model. An economic analysis will be conducted to model the impact of the intervention as compared with standard of care on quality adjusted life years as well as new infections averted. This approach is innovative because it offers a structural intervention to improve adherence by addressing the effects of economic insecurity, requires low financial investment, and can be layered with existing clinical services. Further, it is highly scalable as it builds on a current policy in practice within the Social Security system.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: Client-Centered Representative Payee Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group receives client-centered representative payee services in addition to standard of care; control group receives standard of care only.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Representative Payee Services on ART Adherence Among Marginalized People Living With HIV/AIDS
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention
Participants in the intervention arm will receive client-centered representative payee services in addition to the standard of care.
Behavioral: Client-Centered Representative Payee
CCRP is a structural intervention wherein Social Security authorizes a representative payee to serve as financial manager for people who need help managing their money. By helping clients to consistently pay their bills including rents and utilities, CCRP may redirect the expenditure of participants' resources toward improved health behaviors. Shifting the focus of material and biopsychosocial resources may change the context in which health behaviors are produced, contributing to higher rates of adherence and viral suppression. CCRP modifies the implementation of a current policy of the Social Security Administration (SSA) to create an intervention that is highly replicable.

No Intervention: Control
Participants in the control group will receive the standard of care.



Primary Outcome Measures :
  1. Change in ART Adherence [ Time Frame: Baseline, 12-months ]
    Change in ART adherence will be calculated by comparing HIV viral load counts at Baseline versus 12 months.


Secondary Outcome Measures :
  1. Persistence of change in ART Adherence [ Time Frame: Baseline plus 12 months versus Baseline plus 24 months. ]
    Persistence of change in ART adherence will be calculated by comparing HIV viral load counts at 12 versus 24 months.

  2. ART Adherence [ Time Frame: Self-report of ART adherence will be measured at Baseline, 6-, and 12-months. ]
    Self-report of ART adherence will be measured via the CASE adherence index, which captures self-reported missed doses of medicine.

  3. CD4 [ Time Frame: CD4 will be collected at Baseline, 6-, 12-, 18-, and 24- months. ]
    CD4 counts will be used to assess immune system functioning.

  4. Self-efficacy for Adherence [ Time Frame: Self-efficacy for adherence will be measured at Baseline, 6-, and 12-months. ]
    Self-efficacy for adherence assess the participants' perception that they can take their medications as prescribed even in times of duress. This will be measured via HIV-ASES, (Johnson, 2007), a 12-item scale designed to assess self-efficacy for taking HIV medications

  5. Retention in Care [ Time Frame: Retention in Care will be measured at Baseline, 6-, and 12-months. ]
    Retention in Care assess the number of missed versus total scheduled visits. Retention is defined by having at least one primary care visit per quarter or two kept visits separated by ≥ 90 days.

  6. Health-Related Quality of Life [ Time Frame: Health-Related Quality of Life will be measured at Baseline, 6-, and 12-months. ]
    Quality of Life related to health will be measured by a single Item General Health Measure (SF-12; DiSalvo, 2006), which is, "In general, would you say your health is: (Excellent, Very good, Good, Fair, Poor)."

  7. Self-report of Financial Stress [ Time Frame: Self-report of financial stress will be measured at Baseline, 6-, and 12-months. ]
    This measure assesses the participant's self-report of stress related to financial challenges such as late payments, growing debt, etc. It will be assessed via the Financial measures from Background Stress Inventory (Terrill, 2015).

  8. Social Support [ Time Frame: Social support will be measured at Baseline, 6-, and 12-months. ]
    Emotional, informational and tangible functional forms of social support will be measured via the Medical Outcomes Study Social Support Survey (MOS-SSS).

  9. Housing Status I [ Time Frame: Housing status I will be measured at Baseline, 6-, and 12-months. ]
    Participants' self-reported housing status will be measured via a single item question "Which best describes your current living situation?" (Stably Housed/Unstably House/Homeless) as found in Wolitski, et. al., 2010.

  10. Housing Status II [ Time Frame: Housing Status II will be measured at Baseline, 6-, and 12-months. ]
    A second measure of housing status, newly developed by the study team, will be assessed via the following two questions: "In the past 90 days, have you (1) Received an eviction notice or notice to vacate because your rent was not paid? (2) Had your utilities shutoff because your bill was not paid?"

  11. Experiences of Payeeship [ Time Frame: Experiences of Payeeship will be measured at Baseline, 6-, and 12-months. ]
    A 17-item questionnaire with 4 subscales will be used to assess participants (a) Satisfaction with payee/case manager, (b) Involvement of beneficiary in money management, (c) Perceived benefit from payee arrangement, and (d) feeling coerced. These questions have been modified from a previous study (Rosen et. al., 2005).

  12. Substance Use [ Time Frame: Substance use behaviors will be measured at Baseline, 6-, and 12-months. ]
    Changes in substance use behaviors will be measured via the Risk Assessment Battery (Metzger, et.a., 1993).

  13. Sexual Risk [ Time Frame: Sexual Risk will be assessed at Baseline, 6-, and 12-months. ]
    Sexual risk behaviors will be assessed to determine the likelihood of infecting others with HIV. This will be measured via the Risk Assessment Battery (Metzger, et.a., 1993).

  14. Depressive Symptoms [ Time Frame: Depressive Symptoms will be measured at Baseline, 6-, and 12-months. ]
    Individuals experience of depressive symptoms will be measured via the Quick Inventory of Depressive Symptomology (Rush, et.al., 2003).

  15. Connections with Providers [ Time Frame: Connections with Providers will be measured at Baseline, 6-, and 12-months. ]
    The Health Care Relationship Trust Scale will be used to assess the patient-provider relationship; i.e., discussion options, committed to best care, interested in me as a person, excellent listener, accepts me, tells me complete truth, trusts me as an individual, makes me feel I am worthy of his/her time, takes time to listen, comfort talking about personal issues, feel better after seeing healthcare provider (Bova, 2012).



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Living with HIV/AIDS
  • 18 years of age and older
  • English- or Spanish-speaking
  • Recipient of Social Security entitlements (SSI and/or SSDI)
  • Income below 138% of the federal poverty level
  • One or more of the following: Not virally suppressed (viral suppression is denoted at 200 copies/ml); Unsustained viral suppression over the past 12 months; Poor ART adherence. Poor ART adherence is assessed via a CASE Index Score ≤10 or via a single question to assess the percentages of missed doses in the past week <90%. (New clients who do not have historical viral load data but are not suppressed at baseline will be eligible for the study if they meet other criteria.)
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Currently receiving Representative Payee services or having received them in the past 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561103


Contacts
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Contact: Mary E Hawk, DrPH 412-648-2342 meh96@pitt.edu
Contact: Stephanie Creasy, MPH (412) 624-7000 stc69@pitt.edu

Locations
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United States, Pennsylvania
Action Wellness Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Beth Hagan, MEd    215-981-3359    BHagan@actionwellness.org   
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Mary E Hawk, DrPH University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Mary Hawk, University of Pittsburgh:

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Responsible Party: Mary Hawk, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03561103     History of Changes
Other Study ID Numbers: PRO17080613
1R01MH112416-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases