Community Health Workers and mHealth for HIV/AIDS

(CHAMPS+ Trial)

Recruiting at 5 trial locations

Overseen By Maeve Brin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Antiretrovirals

Disqualifiers: Recent HIV diagnosis, Terminal illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the health of people with HIV in Alabama, Louisiana, and Mississippi. It tests a new approach using mobile health technology and community health workers to help participants adhere to their medication and reduce the virus in their blood. The study compares usual health services with an experimental group that receives special pill bottles, counseling sessions (CHW Sessions), and tools to track medication and health. Ideal candidates for this trial are individuals living with HIV who have a detectable viral load, own a smartphone, and reside in one of the three states mentioned. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance HIV care and management.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on improving ART adherence, it's likely that you will continue your current HIV medications.

What prior data suggests that the CHAMPS+ intervention is safe for participants?

Research shows that using community health workers (CHWs) in healthcare is generally safe and well-received. Studies indicate that CHWs can effectively help people with HIV adhere to their antiretroviral therapy (ART), which is essential for maintaining health and preventing virus transmission.

A review of various studies found that CHW programs often lead to better health outcomes without major safety issues. These workers receive training to provide education, support, and connections to healthcare services. This approach has successfully improved health without significant side effects or risks to participants.

While research on CHW programs is encouraging, these findings pertain to the general safety and effectiveness of CHW support. Individual experiences may vary, so discussing any concerns with healthcare providers is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines innovative technology with personalized support to improve HIV/AIDS management. The intervention uses the CleverCap pill bottle, which ensures patients take the correct dosage by dispensing only the prescribed amount and wirelessly tracking medication use. This is paired with mHealth integration through the WiseApp, allowing for seamless communication and monitoring. Additionally, participants receive 10-12 sessions with Community Health Workers (CHWs), offering tailored guidance and support. This approach aims to enhance adherence to medication and promote better health outcomes compared to standard care options.

What evidence suggests that the CHAMPS+ intervention could be effective for improving ART adherence and viral suppression in people with HIV?

In this trial, participants will be divided into groups to assess the impact of community health workers (CHWs) and mobile health (mHealth) tools on health outcomes for people with HIV/AIDS. Studies have shown that CHWs can significantly improve health outcomes by helping individuals adhere to their antiretroviral therapy (ART), which is crucial for controlling the virus. One study found that adding CHWs to HIV care teams led to better care and increased viral suppression, making the virus undetectable in the blood. Participants in the intervention group will receive sessions with CHWs and use mHealth tools, such as special pill bottles that monitor medication use, which have shown promise in aiding patients to take their medications as prescribed. By addressing issues like distrust in the health system and stigma, CHWs, along with mHealth technology, offer a supportive approach to improving treatment outcomes for people with HIV. ^{3 4 6 7 8}

Who Is on the Research Team?

Rebecca Schnall, PhD, MPH

Principal Investigator

Columbia University

Scott Batey, PhD, MSW

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

The CHAMPS+ trial is for people living with HIV/AIDS in the Deep South of the US who are struggling with ART adherence and viral suppression. Participants should be willing to use mHealth technology and work with community health workers.

Inclusion Criteria

Be able to speak, read, and write in English

Have an HIV-1 RNA level >200 copies/mL

Own a smartphone

Exclusion Criteria

Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment

Terminal illness with life expectancy <6 months

Planning to move out of the area in the next 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the CHAMPS+ intervention, including the CleverCap pill bottle and 10-12 sessions with community health workers

12 months

Regular sessions with CHWs and use of mHealth technology

Follow-up

Participants are monitored for ART adherence and viral load suppression

12 months

Baseline, 6 month follow-up, 12 month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• CHW Sessions

Trial Overview

CHAMPS+ aims to improve ART adherence and viral load suppression among HIV patients using a combination of mobile health tech (WiseApp, CleverCap) and support from community health workers, including risk reduction counseling.

How Is the Trial Designed?

Group I: Intervention CHAMPS+ Experimental Treatment 2 Interventions

Participants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp. Additionally, participants will receive 10-12 sessions with CHWs, and sexual health log to keep track of their sexual behavior.

Group II: Control Active Control 1 Intervention

The control condition includes standard health services offered at each site. All participants receive referrals to mental health, drug/alcohol treatment, and/or other HIV services as necessary. Standard of care at each site follows the Dept. of Health and Human Services HIV guidelines.

CHW Sessions is already approved in United States for the following indications:

Approved in United States as CHW Sessions for:

• Improving ART adherence and viral suppression among people with HIV

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Tulane University

Collaborator

Trials

129

Recruited

259,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Unity Wellness Center

Collaborator

Trials

1

Recruited

420+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Health Services Center, Inc.

Collaborator

Trials

1

Recruited

420+

Published Research Related to This Trial

The integration of community health workers (CHWs) into PMTCT services in Tanzania did not significantly improve retention in care or ART initiation among HIV-infected postpartum women, based on a study involving 1,152 mother-infant pairs at baseline and 678 at endline.

However, the intervention showed a potential increase in ART adherence (11.3 percentage points higher) at 90 days postpartum, particularly in facilities with high fidelity to the intervention, suggesting that effective implementation is crucial for enhancing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effectiveness of a community health worker intervention for HIV-infected pregnant women in Tanzania to improve treatment adherence and retention in care: A cluster-randomized trial. Nance, N., Pendo, P., Masanja, J., et al.[2023]

Community Health Workers (CHWs) who received enhanced training and support were 15% more likely to fully immunize their clients and 14% more likely to ensure that clients completed four or more antenatal care visits, indicating the effectiveness of the intervention in improving health outcomes.

The study found that recent training and experience with pregnant women significantly increased CHW knowledge, while education and literacy showed mixed associations with competency, suggesting that these factors may not be the best criteria for selecting CHWs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training and experience outperform literacy and formal education as predictors of community health worker knowledge and performance, results from Rongo sub-county, Kenya. Rogers, A., Goore, LL., Wamae, J., et al.[2023]

A community health worker program in Malawi initially showed poor data quality in reports, with four out of five areas classified as low quality at baseline.

After implementing targeted interventions over 8 months, all areas achieved high data quality, demonstrating that local assessments and improvements in reporting processes can significantly enhance data reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing and improving data quality from community health workers: a successful intervention in Neno, Malawi. Admon, AJ., Bazile, J., Makungwa, H., et al.[2022]

The establishment of a data harmonization and pooling Collaborative by the Community Health Impact Coalition aims to improve the quality of care provided by community health workers (CHWs) by enabling cross-site learning and identifying effective health system design practices.

By harmonizing epidemiological indicators and pooling data from various countries, the project seeks to enhance health information systems and facilitate the sharing of insights that can lead to better healthcare outcomes in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons from an eight-country community health data harmonization collaborative. Ballard, M., Olsen, HE., Whidden, C., et al.[2022]

Community health worker (CHW) interventions, particularly those involving home visits and women's groups, can improve equitable access to maternal and newborn health services in low-income and middle-income countries, as shown in a review of 22 studies.

While some CHW interventions have successfully reduced health inequities, others have not, indicating that the effectiveness of these programs can vary based on the type of intervention and the support provided to CHWs in their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of community health worker interventions on socioeconomic inequities in maternal and newborn health in low-income and middle-income countries: a mixed-methods systematic review. Blanchard, AK., Prost, A., Houweling, TAJ.[2022]

Community health workers (CHWs) play a crucial role in delivering HIV-related information and support in rural South Africa, despite having limited formal education and training, as evidenced by 102 interviews conducted with CHWs, clients, and caregivers.

CHWs effectively bridge the gap between local communities and formal health services, facilitating access to care and improving adherence to treatment by adapting health information to be more understandable for their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"She is my teacher and if it was not for her I would be dead": exploration of rural South African community health workers' information, education and communication activities. Zulliger, R., Moshabela, M., Schneider, H.[2015]

Ward-based outreach teams (WBOTs) made up of community health workers (CHWs) play a crucial role in improving health outcomes in South Africa by providing HIV prevention education, linking individuals to care, supporting treatment adherence, and identifying those who are not responding to treatment.

Despite their potential, WBOTs face significant challenges such as lack of community support, operational difficulties, insufficient training, and socio-cultural stigma, which need to be addressed to enhance their effectiveness in the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making ward-based outreach teams an effective component of human immunodeficiency virus programmes in South Africa. Naidoo, N., Railton, J., Jobson, G., et al.[2020]

Supervising community health workers (CHWs) in South Africa requires more than just technical management; effective support involves broader people management skills, which are enhanced by the supervisors' own experiences and support systems.

Challenges such as resource limitations, safety concerns in rural areas, and the complexities of dealing with HIV-positive mothers and peer counselors complicate the supervision of CHWs, highlighting the need for better understanding and support in these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervision of community peer counsellors for infant feeding in South Africa: an exploratory qualitative study. Daniels, K., Nor, B., Jackson, D., et al.[2022]

Community health workers (CHWs) have proven to be essential in improving health outcomes globally, particularly in low-income countries where they help reduce childhood undernutrition and improve maternal and child health.

In middle-income countries like Brazil and in the United States, CHWs play a vital role in primary health care and managing chronic diseases, contributing to better health management for populations that are often hard to reach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers in low-, middle-, and high-income countries: an overview of their history, recent evolution, and current effectiveness. Perry, HB., Zulliger, R., Rogers, MM.[2022]

Community health worker (CHW) interventions show promise in improving psychosocial outcomes for people living with HIV, particularly in areas like quality of life and self-efficacy, based on a review of 14 randomized controlled trials.

However, these interventions have not been effective in reducing depressive symptoms or stigma related to HIV, indicating a need for future studies to expand their focus and incorporate measures of intervention fidelity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health worker interventions to promote psychosocial outcomes among people living with HIV-A systematic review. Han, HR., Kim, K., Murphy, J., et al.[2019]

Community health workers (CHWs) play a crucial role in improving care retention and viral suppression for people living with HIV, but their effectiveness is hindered by unclear roles, inadequate funding, and limited training opportunities.

Key factors for successful CHW integration include establishing standardized roles, fostering interorganizational networks, and providing comprehensive training in areas like trauma-informed care and cultural humility, which can enhance their impact on HIV care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Implementation Science to Promote Integration and Sustainability of Community Health Workers in the HIV Workforce. Rajabiun, S., Killion, K., Lennon-Dearing, R., et al.[2023]

The mothers2mothers Ugandan Mentor Mother programme significantly improved retention rates of mother-baby pairs in HIV care, with 96.7% retained at 6 weeks after birth compared to 65.8% in the control group.

Women in the intervention group were much less likely to be lost to follow-up after treatment initiation, with an adjusted odds ratio of 0.05, indicating the effectiveness of peer support in enhancing care retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Mentor Mother Programme on retention of mother-baby pairs in HIV care: A secondary analysis of programme data in Uganda. Igumbor, JO., Ouma, J., Otwombe, K., et al.[2020]

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