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

NCT03561103 | Completed DMC

• 2 other identifiers: STUDY201103641R01MH112416-01A1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 3

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Persistence of change in ART Adherence

  Baseline plus 12 months versus Baseline plus 24 months.

• ART Adherence

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

• CD4

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

• Self-efficacy for Adherence

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

• Retention in Care

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

Study Arms (4)

RCT: Intervention

EXPERIMENTAL

Participants in the RCT intervention arm will receive client-centered representative payee services in addition to the standard of care.

Behavioral: Client-Centered Representative Payee

RCT: Control

NO INTERVENTION

Participants in the RCT control group will receive the standard of care.

Choice Intervention

EXPERIMENTAL

Participants 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.

Behavioral: Client-Centered Representative Payee

Choice Control

NO INTERVENTION

Participants in the RCT control group will receive the standard of care. They will not be randomly assigned.

Interventions

Client-Centered Representative Payee BEHAVIORAL

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.

Choice Intervention; RCT: Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living with HIV/AIDS
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (3)

Birmingham AIDS Outreach

Birmingham, Alabama, 35294, United States

Location

Action Wellness

Philadelphia, Pennsylvania, 19107, United States

Location

The Open Door, Inc.

Pittsburgh, Pennsylvania, 15233, United States

Location

Related Publications (1)

• 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.

  PMID: 32967646 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mary E Hawk, DrPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 19, 2018
• Study Start: May 1, 2017
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)