NCT03561103Completed
Impact of Representative Payee Services on ART Adherence Among Marginalized People Living With HIV/AIDS
Source: ClinicalTrials.gov · Last updated 17 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 91 (actual)
- First submitted
- 22 May 2018
- Start date
- 1 May 2017
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- University of Pittsburgh
- Diseases
- HIV
- NCT number
- NCT03561103
What you commit to
- Study type: Interventional
- Participants enrolled: 91
- From 1 May 2017 to the primary completion date, 31 Mar 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving Representative Payee services or having received them in the past 12 months.
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Birmingham AIDS Outreach Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Action Wellness Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| The Open Door, Inc. Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.