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Human Immunodeficiency VirusNCT03561103

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

A study testing Client-Centered Representative Payee in people with Human Immunodeficiency Virus, run by University of Pittsburgh at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
Client-Centered Representative Payee
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
3 sitesUnited States
Study dates
1 May 2017to 31 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Birmingham AIDS Outreach

    Birmingham, Alabama, 35294

  • Action Wellness

    Philadelphia, Pennsylvania, 19107

  • The Open Door, Inc.

    Pittsburgh, Pennsylvania, 15233

Other trials in United States

About this study

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.

Read the 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.

Being tested
Client-Centered Representative Payee
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Client-Centered Representative PayeeBehavioural

    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.

Study groups in NCT03561103
Study groupRoleWhat they receive
RCT: InterventionExperimentalParticipants in the RCT intervention arm will receive client-centered representative payee services in addition to the standard of care.
Receives: Behavioral: Client-Centered Representative Payee
RCT: ControlNo interventionParticipants in the RCT control group will receive the standard of care.
Choice InterventionExperimentalParticipants in the Choice intervention arm will receive client-centered representative payee services in addition to the standard of care. They will not be randomly assigned.
Receives: Behavioral: Client-Centered Representative Payee
Choice ControlNo interventionParticipants in the RCT control group will receive the standard of care. They will not be randomly assigned.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in ART Adherence

    Change in ART adherence will be calculated by comparing HIV viral load counts at Baseline versus 12 months.

    Measured: Baseline, 12-months

Secondary outcomes (15)
  1. 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.

    Measured: Baseline plus 12 months versus Baseline plus 24 months.

  2. ART Adherence

    Self-report of ART adherence will be measured via the CASE adherence index, which captures self-reported missed doses of medicine.

    Measured: Self-report of ART adherence will be measured at Baseline, 6-, and 12-months.

  3. CD4

    CD4 counts will be used to assess immune system functioning.

    Measured: CD4 will be collected at Baseline, 6-, 12-, 18-, and 24- months.

  4. 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

    Measured: Self-efficacy for adherence will be measured at Baseline, 6-, and 12-months.

  5. 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.

    Measured: Retention in Care will be measured at Baseline, 6-, and 12-months.

  6. 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)."

    Measured: Health-Related Quality of Life will be measured at Baseline, 6-, and 12-months.

  7. 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).

    Measured: Self-report of financial stress will be measured at Baseline, 6-, and 12-months.

  8. Social Support

    Emotional, informational and tangible functional forms of social support will be measured via the Medical Outcomes Study Social Support Survey (MOS-SSS).

    Measured: Social support will be measured at Baseline, 6-, and 12-months.

  9. 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.

    Measured: Housing status I will be measured at Baseline, 6-, and 12-months.

  10. 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?"

    Measured: Housing Status II will be measured at Baseline, 6-, and 12-months.

  11. 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).

    Measured: Experiences of Payeeship will be measured at Baseline, 6-, and 12-months.

  12. Substance Use

    Changes in substance use behaviors will be measured via the Risk Assessment Battery (Metzger, et.a., 1993).

    Measured: Substance use behaviors will be measured at Baseline, 6-, and 12-months.

  13. 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).

    Measured: Sexual Risk will be assessed at Baseline, 6-, and 12-months.

  14. Depressive Symptoms

    Individuals experience of depressive symptoms will be measured via the Quick Inventory of Depressive Symptomology (Rush, et.al., 2003).

    Measured: Depressive Symptoms will be measured at Baseline, 6-, and 12-months.

  15. 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).

    Measured: Connections with Providers will be measured at Baseline, 6-, and 12-months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start1 May 2017
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03561103
Sponsor's protocol ID
STUDY20110364
Other IDs
1R01MH112416-01A1
Status last verified
Apr 2025
First submitted
22 May 2018
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32967646

Questions about this trial

What is this clinical trial studying?

A study testing Client-Centered Representative Payee in people with Human Immunodeficiency Virus, run by University of Pittsburgh at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in ART Adherence (time frame: Baseline, 12-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03561103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.

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