Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06186128
Other study ID # 274097B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 3, 2023
Est. completion date January 31, 2025

Study information

Verified date February 2024
Source University of Arkansas
Contact Brooke Montgomery, PhD
Phone 501-686-6801
Email bemontgomery@uams.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Universal Basic Income (UBI) is a promising strategy aimed at recalibrating economic systems that are grounded in structural racism. Black men have long been the target of oppressive and interconnected systems of finance and healthcare access, leading to a disproportionate burden of exposure to infectious disease with little healthcare support. Yet to our knowledge, no published UBI studies have ever been implemented exclusively with Black men living with HIV in the US. Motivated and inspired by the innovative health and social science being conducted in extremely resource-limited environments in other parts of the world, we recognize an urgent need to better understand the effect of cash transfers on HIV care among Black men in the US South. The proposed study will be based in Arkansas, which, like other Southern states, has a long history of institutional racism and extremely high rates of racial health disparities, poverty, and chronic disease. We will use a mixed methods research design to conduct an in-depth exploration of a UBI intervention to reduce the racial wage gap and promote the use of culturally relevant protective factors. The provision of a UBI is intended to increase receipt and retention of HIV care services and treatment for Black men through the influx of capital and subsequent increases in culturally-based protective factors such as personal agency and social connections. We hypothesize that providing UBI of $500 per month for 6 months will result in increased HIV care utilization among low-income Black men living with HIV. Secondarily, we hypothesize that the effect of UBI will also increase adherence to HIV medication, such that more UBI recipients will achieve and maintain viral suppression compared to individuals in the control condition.


Description:

The proposed supplement from the parent R01 grant will expand on the parent grant by enrolling a larger sample (n=80) of Black men living with HIV as their diagnosed chronic disease. To date, no published UBI studies have ever been implemented exclusively with Black men living with HIV in the US. Motivated and inspired by the innovative health and social science being conducted in extremely resource-limited environments in other parts of the world, we recognize an urgent need to better understand the effect of cash transfers on HIV care among Black men in the US South. The proposed study will be based in Arkansas, which, like other Southern states, has a long history of institutional racism and extremely high rates of racial health disparities, poverty, and chronic disease. We will use a mixed methods research design to conduct an in-depth exploration of a UBI intervention to reduce the racial wage gap and promote the use of culturally relevant protective factors. The provision of a UBI is intended to increase receipt and retention of HIV care services and treatment for Black men through the influx of capital and subsequent increases in culturally-based protective factors such as personal agency and social connections. We hypothesize that providing UBI of $500 per month for 6 months will result in increased HIV care utilization among low-income Black men living with HIV. Secondarily, we hypothesize that the effect of UBI will also increase adherence to HIV medication, such that more UBI recipients will achieve and maintain viral suppression compared to individuals in the control condition. This study is designed to generate generalizable evidence to inform decisions by policymakers, scientists, and the general public about the inner-workings of UBI, the biases underlying who is deemed as "qualifying" or "deserving", and its downstream effects on public health, particularly related to access to HIV care, and structural racism.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years and older
Eligibility Inclusion Criteria: 1. be at least 25 years old; 2. self-report as having received from a medical professional a diagnosis for HIV; 3. have an annual income up to 400% of the federal poverty threshold (the 2023 federal poverty threshold is defined as an annual income of less than $14,580 for single adults) in the 12-month period prior to study enrollment; 4. be able to understand and speak English and to provide written and verbal informed consent; 5. plan to remain in the central Arkansas area for the duration of the study period; 6. be willing and able to provide weekly information about all activities related to seeking employment and to share financial and income-related information with the study team; 7. self-identify as Black or African American; 8. have been assigned the male gender at birth; 9. be willing to provide medical releases to allow project staff to access healthcare records, and 10. in need of HIV care services (defined as having a detectable viral load meaning >200 copies/mL on most recent viral load test or not having attended a HIV medical care visit in the past 6 months, excluding any visits to the emergency department or rooms or urgent care clinics) Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Universal Basic Income
Universal basic income (UBI) is a system that gives everyone a minimum amount of money regularly, regardless of their income or work status.

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Receipt of HIV care Defined as having at least one HIV viral load and/or CD4 count laboratory test within the six-month period of study enrollment during which the UBI intervention will be implemented at the same period. We also will use medical chart abstraction to confirm self-reported use of HIV care services. 1 year
Secondary HIV medication adherence We will us adherence over a 30-day period as self-reported adherence. 1 year
Secondary Retention in HIV care Defined as having two CD4 viral load tests performed at least three months apart 1 year
Secondary Viral suppression Defined as having a viral load test result of <200 copies/ml 1 year
Secondary Reduced HIV risk behaviors, including both unprotected sex and substance use Will be assess at all three data collection time points (Baseline, 6-, and 12-month) 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06162897 - Case Management Dyad N/A
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT02528773 - Efficacy of ART to Interrupt HIV Transmission Networks
Active, not recruiting NCT05454839 - Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Recruiting NCT05322629 - Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women N/A
Completed NCT02579135 - Reducing HIV Risk Among Adolescents: Evaluating Project HEART N/A
Active, not recruiting NCT01790373 - Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence N/A
Not yet recruiting NCT06044792 - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Completed NCT04039217 - Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM Phase 4
Active, not recruiting NCT04519970 - Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK) N/A
Completed NCT04124536 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women N/A
Recruiting NCT05599581 - Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT02758093 - Speed of Processing Training in Adults With HIV N/A
Completed NCT02500446 - Dolutegravir Impact on Residual Replication Phase 4
Completed NCT03805451 - Life Steps for PrEP for Youth N/A
Active, not recruiting NCT03902431 - Translating the ABCS Into HIV Care N/A
Completed NCT00729391 - Women-Focused HIV Prevention in the Western Cape Phase 2/Phase 3
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2