Socio-Economic Support for HIV and Hepatitis C

Overseen By Smita Pakhalé, MD, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Addictions treatment, Smoking cessation, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on socio-economic support and does not mention medication changes.

What data supports the effectiveness of the treatment Life skills, training, education and work/volunteer opportunities, Standard Care, Varenicline, Chantix, Apovarenicline, Champix, Nocrav for HIV and Hepatitis C?

Research shows that varenicline (also known as Chantix or Champix) is effective in helping people with HIV quit smoking, which can improve their overall health. Studies found that quitting smoking with varenicline did not negatively affect HIV treatment and even improved mental health and life satisfaction. ^{1 2 3 4 5}

Is varenicline safe for humans?

Varenicline, used to help people stop smoking, is generally safe for humans, but it can cause side effects like nausea and abnormal dreams. In studies with people living with HIV, it did not cause serious health issues, but close monitoring of liver enzymes and blood pressure is recommended. ^{2 5 6 7 8}

How does the treatment of life skills, training, education, and work/volunteer opportunities differ from other treatments for HIV and Hepatitis C?

This treatment is unique because it focuses on improving socio-economic factors like employment and education, which can help people living with HIV and Hepatitis C manage their health better by addressing social determinants of health, unlike traditional medical treatments that focus solely on medication. ^{9 10 11 12 13}

What is the purpose of this trial?

Addictions do not occur in isolation. Tackling addictions requires addressing social determinants such as isolation, homelessness, marginalization, and unemployment. Research on individuals living with or at risk for HIV/AIDS highlights that unemployment correlates with higher levels of depression, anxiety, and social isolation compared to employment. In Ottawa, the PROMPT project engaged homeless or at-risk populations, including people who use drugs and those living with or at risk for HIV/AIDS or Hepatitis C using the Bridge ModelTM, a pragmatic community-based participatory action research approach operationalized through earlier projects at the Bridge Engagement Center in Ottawa, Canada. The PROMPT project demonstrated that implementing multi-component, complex interventions is both feasible and effective, achieving broader socio-economic outcomes beyond reduction and quitting tobacco and poly-substance use. However, PROMPT participants identified a lack of social and recovery capital -family and social connections, opportunities for volunteering and jobs- as a major barrier to recovery. To address this, we conducted a six-month feasibility pilot study with 20 PROMPT participants. By its conclusion, 15 participants were engaged in small paid or volunteer roles, including educational opportunities, fostering both social integration and recovery. Insights from this pilot study informed the design of a larger community-based multi-site pragmatic randomized trial (RCT) to further evaluate the effectiveness of the Bridge ModelTM, the Healthy People Initiative (HPI) project. The Healthy People Initiative (HPI) is a community-based, participatory, pragmatic parallel-arm multi-site with a cross-over design, recruiting 250 participants (16+) at risk of homelessness or low socioeconomic status in Ottawa and Toronto, Canada.

Research Team

Smita Pakhalé, MD, MSc

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

This trial is for individuals over 16 years old who live in Ottawa or Toronto, smoke at least 10 cigarettes daily on average for the past year, and have used multiple substances within the last year. It aims to help those with low income at risk for HIV/AIDS and Hepatitis-C.

Inclusion Criteria

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

I am 16 years old or older.

Active smoker

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive life-skills workshops, training, education resources, and access to small-paid or volunteering positions

6 months

Monthly visits (in-person or virtual)

Crossover

Usual care group participants are offered the intervention after the first six months

6 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for changes in quality of life, self-efficacy, and substance use

12 months

Treatment Details

Interventions

• Life skills, training, education and work/volunteer opportunities
• Standard Care

Trial Overview The study tests a community-based program offering life skills training, counseling, health services access (including testing and treatment), education about HIV/AIDS/HCV, and poverty reduction interventions through education and work/volunteer opportunities.

Participant Groups

Group I: Usual care arm Active Control 1 Intervention

We will provide the participants in this arm with pamphlets and knowledge about available services in the city through partner agencies. The life skills, training, and work arm will be offered to the usual care arm participants after the first six months of study enrollment.

Group II: Life skills, training, and work arm Active Control 1 Intervention

Participants will receive life-skills workshops, training, education resources and access to small-paid or volunteering positions.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Findings from Research

In a study of 179 people living with HIV/AIDS, quitting smoking did not negatively impact adherence to anti-retroviral therapy (ART), which remained above 98% for all participants.

Participants who successfully quit smoking reported significant reductions in depression and anxiety symptoms, along with increased life satisfaction, suggesting that smoking cessation can have positive psychological effects for individuals with HIV/AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved clinical outcomes among persons with HIV who quit smoking. Lubitz, SF., Flitter, A., Ashare, RL., et al.[2021]

In a pilot study involving 36 HIV-infected smokers, varenicline was found to be safe and effective for smoking cessation, with a 42% rate of verified continuous abstinence over 4 weeks.

The treatment did not adversely affect HIV viral load, and CD4 counts increased significantly, indicating that varenicline can be a viable option for smoking cessation in this population, despite common side effects like nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of varenicline tartrate (Champix(®)/Chantix(®)) for smoking cessation in HIV-infected subjects: a pilot open-label study. Cui, Q., Robinson, L., Elston, D., et al.[2021]

In a study of 158 people living with HIV, combining varenicline with text message support and adherence-focused behavioral therapy significantly improved smoking abstinence rates compared to standard care alone after 12 weeks.

The research highlights the importance of intensive behavioral support in smoking cessation programs for people living with HIV, suggesting that enhancing adherence self-efficacy can lead to better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Text Messaging and Telephone Counseling to Increase Varenicline Adherence and Smoking Abstinence Among Cigarette Smokers Living with HIV: A Randomized Controlled Study. Tseng, TY., Krebs, P., Schoenthaler, A., et al.[2022]

In a clinical trial involving 179 people living with HIV/AIDS, varenicline significantly increased smoking cessation rates at Week 12 compared to placebo, with 28.1% of participants quitting versus 12.1%.

Varenicline was found to be safe, with no significant differences in treatment-related side effects or adverse events compared to placebo, making it a viable option for short-term smoking cessation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV. Ashare, RL., Thompson, M., Serrano, K., et al.[2023]

In a study involving 248 people living with HIV, varenicline combined with counseling significantly increased the rate of smoking cessation compared to placebo, with 15% of participants in the varenicline group achieving continuous abstinence from weeks 9 to 48.

The safety profile of varenicline was favorable, showing a lower incidence of depression in the varenicline group (2%) compared to the placebo group (10%), indicating that varenicline is a safe and effective option for smoking cessation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. Mercié, P., Arsandaux, J., Katlama, C., et al.[2018]

In a review of ten randomized controlled trials involving 3091 participants, varenicline did not show a significant increase in overall psychiatric disorders compared to placebo, with an incidence of 10.7% in the varenicline group versus 9.7% in the placebo group.

While varenicline was associated with a higher incidence of sleep disorders, there were no reported cases of suicidal ideation or behavior in the analyzed studies, suggesting that varenicline is generally safe for smokers without current psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. Tonstad, S., Davies, S., Flammer, M., et al.[2022]

Varenicline is an effective smoking cessation aid, showing significantly higher continuous abstinence rates compared to placebo, bupropion, and nicotine replacement therapy during the last 4 weeks of treatment, and it also helps reduce cravings and withdrawal symptoms.

The treatment is generally well tolerated, with nausea being the most common side effect that diminishes over time; however, further research is needed on potential neuropsychiatric events associated with its use. Additionally, varenicline is considered cost-effective compared to other smoking cessation methods, with analyses showing it dominates bupropion and nicotine replacement therapy in terms of cost per quality-adjusted life year (QALY) gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline: a pharmacoeconomic review of its use as an aid to smoking cessation. Keating, GM., Lyseng-Williamson, KA.[2021]

Varenicline is an effective and generally well-tolerated medication for smoking cessation, acting as a partial agonist at nicotinic acetylcholine receptors, although further research is needed on its potential neuropsychiatric side effects.

Pharmacoeconomic analyses indicate that varenicline is a cost-effective treatment for smoking cessation, outperforming other therapies like bupropion and nicotine replacement in terms of cost per quality-adjusted life-year gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacoeconomic spotlight on varenicline as an aid to smoking cessation. Keating, GM., Lyseng-Williamson, KA.[2021]

In a study of 2750 working-aged individuals living with HIV in France, the employment rate was found to be 56.5%, indicating a significant gap compared to the general population, despite the availability of highly active antiretroviral therapy (HAART).

Health factors such as a history of AIDS, hepatitis C co-infection, and lower CD4 cell counts were associated with lower employment rates, highlighting the need for better management of HIV in the workplace to support those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living and working with HIV in France in 2003: results from the ANRS-EN12-VESPA Study. Dray-Spira, R., Lert, F.[2009]

The Work2Prevent (W2P) study aims to enhance economic stability and reduce HIV risk among black and Latinx young men who have sex with men (YMSM), young trans women (YTW), and gender-nonconforming (GNC) youth by developing a tailored employment intervention based on the iFOUR program.

Preliminary data from in-depth interviews and focus groups with 67 participants, including LGBTQ-inclusive employers, will help refine the intervention to address specific barriers and facilitators to employment for these vulnerable youth, ensuring it is culturally relevant and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 1): Protocol for Determining Essential Intervention Components Using Qualitative Interviews and Focus Groups. Hill, BJ., Motley, DN., Rosentel, K., et al.[2020]

A targeted work readiness training program for people living with HIV (PLHIV) significantly improved psychosocial outcomes, including reduced depression and internalized stigma, while increasing self-esteem and medication adherence among participants.

The program, which included a six-month internship for some participants, demonstrated that peer worker training can effectively enhance both work readiness and overall health outcomes for PLHIV, highlighting its importance for HIV service providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial and Health-Related Behavioral Outcomes of a Work Readiness HIV Peer Worker Training Program. McKinney-Prupis, E., Chiu, YJ., Grov, C., et al.[2023]

In a study of 3,020 people living with HIV in France, 17% reported renouncing health care in the past year, with a significant link to high levels of social insecurity and experiences of discrimination.

Factors such as having children, smoking, and experiencing major depressive episodes were also associated with health-care renunciation, highlighting the need for targeted strategies to address discrimination and support those facing social challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renunciation of health care by people living with HIV in France is still associated with discrimination in health-care services and social insecurity - results from the ANRS-VESPA2 survey. Fiorentino, M., Suzan-Monti, M., Vilotitch, A., et al.[2019]

In a study of people living with HIV in Rio de Janeiro, lower socioeconomic status was linked to poorer adherence to antiretroviral therapy (ART), primarily due to increased food insecurity.

Alcohol misuse was also found to directly contribute to poor ART adherence, highlighting the need for socioeconomic support and interventions to address both food insecurity and alcohol use in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways to Poor Adherence to Antiretroviral Therapy Among People Living with HIV: The Role of Food Insecurity and Alcohol Misuse. Perazzo, H., Gonçalves, JL., Cardoso, SW., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Improved clinical outcomes among persons with HIV who quit smoking. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of varenicline tartrate (Champix(®)/Chantix(®)) for smoking cessation in HIV-infected subjects: a pilot open-label study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Combining Text Messaging and Telephone Counseling to Increase Varenicline Adherence and Smoking Abstinence Among Cigarette Smokers Living with HIV: A Randomized Controlled Study. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Varenicline: a pharmacoeconomic review of its use as an aid to smoking cessation. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacoeconomic spotlight on varenicline as an aid to smoking cessation. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Living and working with HIV in France in 2003: results from the ANRS-EN12-VESPA Study. [2009]

10. Canada pubmed.ncbi.nlm.nih.gov

An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 1): Protocol for Determining Essential Intervention Components Using Qualitative Interviews and Focus Groups. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Psychosocial and Health-Related Behavioral Outcomes of a Work Readiness HIV Peer Worker Training Program. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Renunciation of health care by people living with HIV in France is still associated with discrimination in health-care services and social insecurity - results from the ANRS-VESPA2 survey. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Pathways to Poor Adherence to Antiretroviral Therapy Among People Living with HIV: The Role of Food Insecurity and Alcohol Misuse. [2023]