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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561103
• Other study ID #: STUDY20110364
• Secondary ID: 1R01MH112416-01A
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 with two randomized arms (n=160) and two non-randomized arms (n=50) 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.

Description:

Marginalized populations, including those who are unstably housed and have mental health or substance use disorders, demonstrate alarming rates of disparities in the incidence of new HIV infections and treatment outcomes. These populations have HIV viral suppression rates as low as 13% and mortality 3 to 5 times higher than people living with HIV/AIDS (PLWHA) who have stable housing. Economic disadvantage can contribute to poor medication adherence and clinical outcomes through limited social resources, repeated cycles of housing instability, high levels of stress caused by financial insecurity, and lack of resources to cope with these demands. While the remediation of poverty on a broad scale is not on the near horizon, addressing factors that result from economic disadvantage and limit adherence is feasible and achievable. The investigators aim to understand whether providing financial management to marginalized PLWHA can improve their financial and housing stability, and in turn, antiretroviral therapy treatment adherence and rates of viral suppression.

Representative payee is a structural intervention that provides financial management to marginalized individuals, which has already shown promise in helping marginalized populations achieve undetectable viral loads. Structural interventions aim to alter social, political, or economic contexts in order to improve health outcomes rather than focusing on proximal health behaviors (14). "rep payee" is a Social Security Administration (SSA) policy whereby an organization is appointed to serve as a money manager for vulnerable individuals who receive SSA benefits. The client and their physician complete a request for determination of a representative payee, and once authorized bu SSA, the rep payee establishes a checking account for the client into which SSA entitlements are directly deposited. The client does not have direct access to the account. The rep payee pays the client's bills, which improves regular payment of rent and utilities, and then disburses expendable funds to the client.

In a pilot study examining associations between our "Client-Centered rep payee" services and viral load, it was found that only 7 of 18 participants had suppressed viral loads (SVL) at baseline, but 16 of the 18 had SVL at six-month follow-up (p = .004, McNemar's) (15). In a more recent analysis, investigators determined that of 40 participants who received Client Centered rep payee, 82% had suppressed viral loads at both 6- and 12-months follow up. The Open Door, Inc. (TOD), the organization that developed this intervention, has provided these services to 76 PLWHA over the past nine years. Though clients can terminate the rep payee arrangement at any time, 90% of clients has kept TOD as their rep payee indefinitely, demonstrating both the feasibility and acceptability of this approach. The hypothesis is that by helping clients to pay their rent and other bills on time, housing stability improves and financial stress decreases. 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. Ultimately, it is believed that this program improves clients' self-efficacy for health behaviors, retention in care, medication adherence, CD4 counts, and viral loads. These these hypotheses will be tested via the following aims in a randomized controlled trial of 320 PLWHA.

Aim 1. Conduct a randomized controlled trial (RCT, n=160) with two additional non-randomized arms (n=50) to test the effect of Client-Centered Rep Payee on anti-retroviral (ART) medication adherence and viral load among PLWHA who are economically disadvantaged and unstably housed. Compare clinical adherence will be assessed through behavioral and biological measures including, self-reported appointment adherence, and viral load for patients receiving the intervention versus those receiving standard of care.

Aim 2. Test underlying mechanisms associated with Client-Centered Rep Payee that contribute to changes in medication adherence and viral suppression rates. Quantitative (mediation analysis) and qualitative (semi-structured interview) methods will be used 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.

Aim 3. Assess the cost and cost-effectiveness of the Client-Centered Rep Payee model. The investigators will conduct an economic analysis to model the impact of the intervention as compared with standard of care on quality adjusted life years as well as new infections averted.

Client-Centered Rep Payee offers a structural intervention to improve adherence by addressing economic insecurity. This approach 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. It is projected that by demonstrating the impact and cost-effectiveness of Client-Centered Rep Payee an innovative approach to improving viral suppression rates and reducing health disparities among marginalized PLWHA may be documented.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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.

Locations

Country	Name	City	State
United States	Birmingham AIDS Outreach	Birmingham	Alabama
United States	Action Wellness	Philadelphia	Pennsylvania
United States	The Open Door, Inc.	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH), University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ART Adherence	Change in ART adherence will be calculated by comparing HIV viral load counts at Baseline versus 12 months.	Baseline, 12-months
Secondary	Persistence of change in ART Adherence	Persistence of change in ART adherence will be calculated by comparing HIV viral load counts at 12 versus 24 months.	Baseline plus 12 months versus Baseline plus 24 months.
Secondary	ART Adherence	Self-report of ART adherence will be measured via the CASE adherence index, which captures self-reported missed doses of medicine.	Self-report of ART adherence will be measured at Baseline, 6-, and 12-months.
Secondary	CD4	CD4 counts will be used to assess immune system functioning.	CD4 will be collected at Baseline, 6-, 12-, 18-, and 24- months.
Secondary	Self-efficacy for Adherence	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	Self-efficacy for adherence will be measured at Baseline, 6-, and 12-months.
Secondary	Retention in Care	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.	Retention in Care will be measured at Baseline, 6-, and 12-months.
Secondary	Health-Related Quality of Life	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)."	Health-Related Quality of Life will be measured at Baseline, 6-, and 12-months.
Secondary	Self-report of Financial Stress	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).	Self-report of financial stress will be measured at Baseline, 6-, and 12-months.
Secondary	Social Support	Emotional, informational and tangible functional forms of social support will be measured via the Medical Outcomes Study Social Support Survey (MOS-SSS).	Social support will be measured at Baseline, 6-, and 12-months.
Secondary	Housing Status I	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.	Housing status I will be measured at Baseline, 6-, and 12-months.
Secondary	Housing Status II	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?"	Housing Status II will be measured at Baseline, 6-, and 12-months.
Secondary	Experiences of Payeeship	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).	Experiences of Payeeship will be measured at Baseline, 6-, and 12-months.
Secondary	Substance Use	Changes in substance use behaviors will be measured via the Risk Assessment Battery (Metzger, et.a., 1993).	Substance use behaviors will be measured at Baseline, 6-, and 12-months.
Secondary	Sexual Risk	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).	Sexual Risk will be assessed at Baseline, 6-, and 12-months.
Secondary	Depressive Symptoms	Individuals experience of depressive symptoms will be measured via the Quick Inventory of Depressive Symptomology (Rush, et.al., 2003).	Depressive Symptoms will be measured at Baseline, 6-, and 12-months.
Secondary	Connections with Providers	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).	Connections with Providers will be measured at Baseline, 6-, and 12-months.