A Healthy People Initiative: Building the Socio-Economic Capital of Low Income Population At-Risk for HIV and Hepatitis-C

Substance Use Disorders Clinical Trial

Official title:

A Healthy People Initiative: A Randomized Controlled Trial Building the Socio-Economic Capital of Low Income Population At-Risk for HIV and Hepatitis-C (HPI Pilot Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03506867
• Other study ID #: HPI Pilot Trial-001
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2023
• Source: Ottawa Hospital Research Institute
• Contact: Smita Pakhalé, MD, MSc
• Phone: 613-737-8899
• Email: spakhale[@]ohri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

"Health is a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity" (World Health Organization, 1948). Diseases such as HIV/AIDS and Hepatitis-C (HCV) thrive in conditions of poverty and marginalization. Research on the quality of life of people living with HIV/AIDS reveals that unemployed individuals report more depression, anxiety, social isolation, and low self-esteem than employed individuals. Moreover, unemployment is a key factor in the contemplation of suicide among people with HIV/AIDS. Alternatively, employment among people living with HIV/AIDS is a strong indicator of improved quality of life. A finding the study investigators confirmed in a research study (PROMPT) supporting 280 members of Ottawa's low income homeless (or at-risk for homelessness) People Who Use Drugs reduce (and in some cases quit) smoking.

PROMPT participants repeatedly stated that boredom and a lack of meaningful social connections and employment were major hindrances in their reduction and overall recovery from smoking and drug use. With these PROMPT findings, the investigators propose a Community-Based Participatory Action project that builds the social capital of 80 participants that identify as members of Ottawa and Toronto's low income People Who Use drugs living with or are at-risk for HIV/AIDS/HCV. The proposed multi-site project will include life-skills training, counseling, health services access (testing and treatment), and education on HIV/AIDS/HCV. Most importantly the project will include a poverty reduction intervention that connects participants with education opportunities, short-term work and volunteer opportunities. The education, work and volunteer opportunities' will be made possible with the support of local business owners and networks that support the study's poverty reduction and community building elements. The aim of project will be to demonstrate the feasibility and cost of a holistic healthcare that encourages a state of complete physical, mental, and social well-being.

Description:

Title of Trial: A Healthy People Initiative: A Randomized Controlled Trial Building the Socio-Economic Capital of Low Income Population At-Risk for HIV and Hepatitis-C (HPI Pilot Trial)

Short Title of Trial: HPI Pilot Trial

Principal Investigator: Smita Pakhalé

Trial Sites: Ottawa (The Bridge Engagement Centre) & Toronto (Parkdale Activity Recreation Centre)

Primary Objective: To assess the feasibility of a randomized controlled trial investigating access to improvements in 'social capital' in the low income population in Ottawa and Toronto.

Primary Feasibility Outcome: To assess the ability of participating sites to enroll an average of 6 participants per month.

Secondary Feasibility Outcomes: The consent rate of eligible participants, and the rate of protocol violations resulting in cross contamination of the groups receiving study intervention.

Tertiary Feasibility Outcomes: 1) To estimate the costs of poverty reduction intervention (life skills workshops, training, and education/volunteer/employment opportunities); and 2) to compare healthcare utilization (ER visits and hospitalizations) over one year before and after the study by linking the trial data to health administrative data available at the Institute for Clinical and Evaluative Sciences (ICES).

Patient Reported Outcomes (PROs): 1) To assess the trend in self-reported quality of life; 2) To estimate change in self-reported self-efficacy 3) To assess access to work or volunteering positions; and 4) to estimate self-reported reduced or quit tobacco use rate (corroborated with the measurement of exhaled Carbon Monoxide) and poly-substance use rate.

Qualitative Process Outcomes: The investigators will conduct in-depth focus group research with community peer researchers to learn more about the implementation process and the qualitative effects of the intervention. They will also include open-ended questions in the 6th and 12 month (study-end) survey to better understand the experience of participants.

Study Design & Population: Randomized Controlled Cross-Over Trial comparing access to improvement in 'social capital' vs. usual care in low income People Who Use Drugs at-risk for or living with HIV/AIDS and/or HCV. The usual care group will be offered the intervention after six months.

Sample Size: 280

Trial Arms: Participants will be randomized to receive life-skills workshops, training, education resources and access to small-paid or volunteering positions in the neighborhood community OR to usual care for six months. Usual care will consist of information on locally available services catering to the target population. Both groups will have access to tobacco dependence management during the study.

Trial Duration: 12 months

Follow-up Duration: 12 months

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Active smoker

• Greater than or equal to 10 cigarettes per day on average for the past year

• 16 years or older

• Living in Ottawa or Toronto over the past 3 months

• Using poly-substances within the past year

Exclusion Criteria:

• Consent declined (refusal from participant or decision maker)

• Any person who is in or planning on accessing addictions treatment (in-patient drug rehabilitation) in Ottawa or Toronto and hence will be unavailable for follow up

• Currently or recently (in the past 30 days) enrolled in any other smoking cessation program

• Terminal illness with a life expectancy of less than 3 months

Related Conditions & MeSH terms

• Hepatitis C
• Nicotine Dependence
• Substance Use Disorders
• Substance-Related Disorders
• Tobacco Use Disorder

Intervention

Behavioral:
• Life skills, training, education and work/volunteer opportunities
Intervention arm will receive proactive and sustained access to enhanced education and socio-economic supports (e.g. volunteer and/or work opportunities).
• Standard Care
Usual care will receive information on locally available services.

Locations

Country	Name	City	State
Canada	The Bridge Engagement Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Recruitment Rate	To assess the ability of participating sites to enroll an average of 6 participants per month.	12 months
Primary	Consent and Protocol Violation Rate	The consent rate of eligible participants and the rate of protocol violations resulting in cross contamination of the groups receiving study intervention	12 months
Primary	Costs of Poverty Reduction Intervention	To estimate the costs of poverty reduction intervention (life skills workshops, training, and education/volunteer/employment opportunities.	12 months
Primary	Healthcare Utilization Rate	To compare healthcare utilization (ER visits and hospitalizations) over one year before and after the study by linking the trial data to health administrative data available at the Institute for Clinical and Evaluative Sciences (ICES).	12 months
Secondary	Self-Reported Quality of Life	To assess the trend in self-reported quality of life.	12 months
Secondary	Self-Reported Efficacy	To estimate change in self-reported self-efficacy.	12 months
Secondary	Access to Work, Training, and Volunteer Opportunities	To assess access to work, training, or volunteering positions using a self-reported online survey.	12 months
Secondary	Substance Use Rate	To estimate self-reported reduced or quit tobacco use rate (corroborated with the measurement of exhaled Carbon Monoxide) and poly-substance use rate.	12 months