Clinical trial NCT03561103: Impact of Representative Payee Services on ART Adherence Among Marginalized People Living With HIV/AIDS
Official title: Impact of Representative Payee Services on ART Adherence Among Marginalized People Living With HIV/AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Alabama at Birmingham
First posted: 2018-06-19
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study includes an RCT with two randomized arms plus additional non-randomized arms.

In the RCT, 160 participants will be recruited. The RCT consists of an Intervention group that receives client-centered representative payee services in addition to standard of care; the control group receives standard of care only.

For the two additional non-randomized ("Choice") arms, two arms have been added through which an additional 50 people will be recruited. The Choice Intervention arm (n=25) receives client-centered representative payee services in addition to standard of care. The Choice control group (n=25) receives standard of care. Participant in the choice arms are not randomized.
Primary purpose: SUPPORTIVE_CARE

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 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change in ART Adherence
timeFrame: Baseline, 12-months
Secondary outcomes:
measure: Persistence of change in ART Adherence
timeFrame: Baseline plus 12 months versus Baseline plus 24 months.
measure: ART Adherence
timeFrame: Self-report of ART adherence will be measured at Baseline, 6-, and 12-months.
measure: CD4
timeFrame: CD4 will be collected at Baseline, 6-, 12-, 18-, and 24- months.
measure: Self-efficacy for Adherence
timeFrame: Self-efficacy for adherence will be measured at Baseline, 6-, and 12-months.
measure: Retention in Care
timeFrame: Retention in Care will be measured at Baseline, 6-, and 12-months.
measure: Health-Related Quality of Life
timeFrame: Health-Related Quality of Life will be measured at Baseline, 6-, and 12-months.
measure: Self-report of Financial Stress
timeFrame: Self-report of financial stress will be measured at Baseline, 6-, and 12-months.
measure: Social Support
timeFrame: Social support will be measured at Baseline, 6-, and 12-months.
measure: Housing Status I
timeFrame: Housing status I will be measured at Baseline, 6-, and 12-months.
measure: Housing Status II
timeFrame: Housing Status II will be measured at Baseline, 6-, and 12-months.
measure: Experiences of Payeeship
timeFrame: Experiences of Payeeship will be measured at Baseline, 6-, and 12-months.
measure: Substance Use
timeFrame: Substance use behaviors will be measured at Baseline, 6-, and 12-months.
measure: Sexual Risk
timeFrame: Sexual Risk will be assessed at Baseline, 6-, and 12-months.
measure: Depressive Symptoms
timeFrame: Depressive Symptoms will be measured at Baseline, 6-, and 12-months.
measure: Connections with Providers
timeFrame: Connections with Providers will be measured at Baseline, 6-, and 12-months.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham AIDS Outreach
state: Alabama
city: Philadelphia
country: United States
facility: Action Wellness
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Open Door, Inc.
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mary E Hawk, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olaniyan A, Creasy SL, Batey DS, Brooks MM, Maulsby C, Musgrove K, Hagan E, Martin D, Sashin C, Farmartino C, Hawk M. Protocol of a randomized controlled trial to test the effects of client-centered Representative Payee Services on antiretroviral therapy adherence among marginalized people living with HIV. BMC Public Health. 2020 Sep 23;20(1):1443. doi: 10.1186/s12889-020-09500-z.