Impact of Representative Payee Services on ART Adherence Among Marginalized People Living With HIV/AIDS
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|ClinicalTrials.gov Identifier: NCT03561103|
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Behavioral: Client-Centered Representative Payee||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Intervention group receives client-centered representative payee services in addition to standard of care; control group receives standard of care only.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of Representative Payee Services on ART Adherence Among Marginalized People Living With HIV/AIDS|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||March 31, 2022|
Participants in the intervention arm will receive client-centered representative payee services in addition to the standard of care.
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.
No Intervention: Control
Participants in the control group will receive the standard of care.
- Change in ART Adherence [ Time Frame: Baseline, 12-months ]Change in ART adherence will be calculated by comparing HIV viral load counts at Baseline versus 12 months.
- Persistence of change in ART Adherence [ Time Frame: Baseline plus 12 months versus Baseline plus 24 months. ]Persistence of change in ART adherence will be calculated by comparing HIV viral load counts at 12 versus 24 months.
- ART Adherence [ Time Frame: Self-report of ART adherence will be measured at Baseline, 6-, and 12-months. ]Self-report of ART adherence will be measured via the CASE adherence index, which captures self-reported missed doses of medicine.
- CD4 [ Time Frame: CD4 will be collected at Baseline, 6-, 12-, 18-, and 24- months. ]CD4 counts will be used to assess immune system functioning.
- Self-efficacy for Adherence [ Time Frame: Self-efficacy for adherence will be measured at Baseline, 6-, and 12-months. ]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
- Retention in Care [ Time Frame: Retention in Care will be measured at Baseline, 6-, and 12-months. ]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.
- Health-Related Quality of Life [ Time Frame: Health-Related Quality of Life will be measured at Baseline, 6-, and 12-months. ]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)."
- Self-report of Financial Stress [ Time Frame: Self-report of financial stress will be measured at Baseline, 6-, and 12-months. ]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).
- Social Support [ Time Frame: Social support will be measured at Baseline, 6-, and 12-months. ]Emotional, informational and tangible functional forms of social support will be measured via the Medical Outcomes Study Social Support Survey (MOS-SSS).
- Housing Status I [ Time Frame: Housing status I will be measured at Baseline, 6-, and 12-months. ]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 II [ Time Frame: Housing Status II will be measured at Baseline, 6-, and 12-months. ]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?"
- Experiences of Payeeship [ Time Frame: Experiences of Payeeship will be measured at Baseline, 6-, and 12-months. ]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).
- Substance Use [ Time Frame: Substance use behaviors will be measured at Baseline, 6-, and 12-months. ]Changes in substance use behaviors will be measured via the Risk Assessment Battery (Metzger, et.a., 1993).
- Sexual Risk [ Time Frame: Sexual Risk will be assessed at Baseline, 6-, and 12-months. ]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).
- Depressive Symptoms [ Time Frame: Depressive Symptoms will be measured at Baseline, 6-, and 12-months. ]Individuals experience of depressive symptoms will be measured via the Quick Inventory of Depressive Symptomology (Rush, et.al., 2003).
- Connections with Providers [ Time Frame: Connections with Providers will be measured at Baseline, 6-, and 12-months. ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561103
|Contact: Mary E Hawk, DrPHfirstname.lastname@example.org|
|Contact: Stephanie Creasy, MPH||(412) email@example.com|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Beth Hagan, MEd 215-981-3359 BHagan@actionwellness.org|
|Principal Investigator:||Mary E Hawk, DrPH||University of Pittsburgh|