Peer Navigation + mHealth for HIV/AIDS, STIs, and Hepatitis C Testing

Recruiting in Palo Alto (17 mi)

Overseen by Scott D Rhodes, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: None

No Placebo Group

Trial Summary

What is the purpose of this trial?

By combining two strategies (i.e., peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially/ethnically diverse GBMSM and transgender women in rural Appalachia. Study Investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased HIV, STI, and HCV testing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Peer Navigation + mHealth for HIV/AIDS, STIs, and Hepatitis C Testing?

Research shows that peer navigation, where trained peers help guide patients through healthcare processes, is linked to better HIV care and treatment outcomes, such as starting and staying on HIV medication. Additionally, using mobile apps for patient navigation can help track and improve patient care activities, suggesting that combining these approaches could enhance healthcare experiences and outcomes. ^{1 2 3 4 5}

Is peer navigation and mHealth generally safe for humans?

The research does not report any safety concerns related to peer navigation or mHealth interventions, suggesting they are generally safe for use in supporting healthcare services. ^{1 4 5 6 7}

How is the Peer Navigation + mHealth treatment for HIV/AIDS, STIs, and Hepatitis C testing different from other treatments?

This treatment is unique because it combines peer support, where individuals with similar experiences guide and support patients, with mobile health technology (mHealth) to improve access to testing and care. Unlike traditional treatments that may focus solely on medication, this approach emphasizes social support and technology to enhance patient engagement and care coordination. ^{1 4 6 8 9}

Research Team

Scott D Rhodes, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 living in rural Appalachian counties, assigned male at birth and have had sex with a man in the past year. They must consent to participate. It's aimed at racially/ethnically diverse gay, bisexual men, and transgender women.

Inclusion Criteria

I was assigned male at birth and have had sex with a man in the last year.

Reside in one of the rural Appalachian catchment counties

I am 18 years old or older.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a culturally compatible, bilingual intervention combining peer navigation and mHealth strategies to increase the use of HIV, STI, and HCV prevention and care services

12 months

Follow-up

Participants are monitored for continued use of HIV, STI, and HCV prevention and care services

12 months

Treatment Details

Interventions

• mHealth (Behavioral Intervention)
• Peer Navigation (Behavioral Intervention)

Trial Overview The study tests a combined intervention of peer navigation support and mobile health (mHealth) technology to improve HIV, STI, and HCV prevention and care services among participants compared to those receiving delayed intervention.

Participant Groups

Group I: intervention group Active Control 2 Interventions

7 community health leaders; 56 social network members

Group II: delayed-intervention Active Control 2 Interventions

7 community health leaders; 56 social network members

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Findings from Research

The program utilizes peer navigators to enhance care for individuals with HIV, providing support and guidance to improve patient outcomes.

This approach highlights the importance of community involvement in healthcare, particularly in resource-limited settings like Kenya, to ensure that patients receive the necessary care and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging peer-based support to facilitate HIV care in Kenya. Karwa, R., Maina, M., Mercer, T., et al.[2018]

Patient navigation significantly reduces the time it takes for patients in underserved populations to receive a diagnosis and start treatment for cancer, based on a systematic review of 16 studies.

The effectiveness of patient navigation is enhanced when initial contact occurs soon after diagnostic or screening tests, highlighting the importance of timely intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence in the Cancer Care Setting: a Systematic Review of Patient Navigation to Traverse Barriers. Bush, ML., Kaufman, MR., Shackleford, T.[2022]

A successful patient navigation program for American Indian populations in the Northern and Southern Plains increased community knowledge about cancer and improved cancer screening behaviors through 24-hour workshops.

Collaboration with trusted Native Patient Navigators helped bridge the gap between patients and healthcare providers, enhancing adherence to care recommendations and ultimately improving quality of life and survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigation as an intervention to eliminate disparities in American Indian communities. Krebs, LU., Burhansstipanov, L., Watanabe-Galloway, S., et al.[2021]

Peer navigation significantly improves the quality of HIV care for female sex workers (FSWs), as evidenced by a study of 211 participants in the Dominican Republic, where 41.2% reported contact with a peer navigator in the last 6 months.

FSWs who engaged with peer navigators experienced more respectful treatment from clinic staff and reported greater satisfaction with their overall HIV care services, highlighting the importance of peer support in enhancing healthcare experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring peer navigation and support in the quality of HIV care experiences of female sex workers in the Dominican Republic. Karver, TS., Barrington, C., Donastorg, Y., et al.[2022]

A mobile app was evaluated by seven navigators across six cancer patient navigation programs over 5 to 9 months, demonstrating its effectiveness in tracking patient caseloads and identifying health challenges, which can enhance cancer care delivery.

Despite some limitations like unreliable reporting and privacy concerns, the app shows promise in improving the efficiency of patient navigation services and could help reduce barriers to accessing cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Feasibility of Using a Mobile App to Track Oncology Patient Navigation Activities and Outcomes. Rohan, EA., Slotman, B., Tristani, EG., et al.[2023]

About 48% of Black and Latinx HIV-negative MSM in western Washington expressed interest in peer navigation for accessing HIV prevention services like PrEP, indicating a significant potential for this strategy.

Factors such as higher sexual stigma increased the acceptability of peer navigation, while higher income and having a regular medical provider decreased it, suggesting that interventions should focus on addressing stigma and targeting lower-income individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's PrEP?: peer navigator acceptability among minority MSM in Washington. Pagkas-Bather, J., Jaramillo, J., Henry, J., et al.[2022]

Patient navigation is essential for linking individuals to HIV pre-exposure prophylaxis (PrEP) and re-engaging them in HIV care, as highlighted by a study involving 20 agency staff interviews and 300 patient surveys in Chicago.

Key navigation activities included screening for social determinants of health and providing guidance and referrals, although barriers such as limited staff and clinic capacity were noted, emphasizing the need for adequate resources to support these services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of patient navigation in Chicago: Insights on addressing the social determinants of health and integrating HIV prevention and care services. Greene, GJ., Reidy, E., Felt, D., et al.[2022]

Peer navigation programs for people living with HIV have shown positive effects on the continuum of care outcomes, as evidenced by a review of various study designs including randomized control trials and qualitative studies.

Further research is needed to better understand the specific roles of peer navigators in improving health outcomes, mental health, and self-management for individuals with HIV, highlighting the complexity and social nature of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Peer Navigation Programs for People Living with HIV: Form, Function and Effects. Krulic, T., Brown, G., Bourne, A.[2022]

A study involving 59 staff members from community-based HIV/AIDS service organizations showed that 66% felt confident in the electronic safeguards protecting client information, highlighting the importance of data security in sensitive health communications.

The majority of staff expressed strong interest in using eHealth communication tools for sharing health information with clients, indicating a potential for these tools to enhance health outcomes in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

eHealth Communication With Clients at Community-Based HIV/AIDS Service Organizations in the Southern United States: Cross-Sectional Survey. Wigfall, LT.[2020]

References

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

Leveraging peer-based support to facilitate HIV care in Kenya. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Adherence in the Cancer Care Setting: a Systematic Review of Patient Navigation to Traverse Barriers. [2022]

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

Navigation as an intervention to eliminate disparities in American Indian communities. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Exploring peer navigation and support in the quality of HIV care experiences of female sex workers in the Dominican Republic. [2022]

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

Evaluating the Feasibility of Using a Mobile App to Track Oncology Patient Navigation Activities and Outcomes. [2023]

6. England pubmed.ncbi.nlm.nih.gov

What's PrEP?: peer navigator acceptability among minority MSM in Washington. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of patient navigation in Chicago: Insights on addressing the social determinants of health and integrating HIV prevention and care services. [2022]

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

A Scoping Review of Peer Navigation Programs for People Living with HIV: Form, Function and Effects. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

eHealth Communication With Clients at Community-Based HIV/AIDS Service Organizations in the Southern United States: Cross-Sectional Survey. [2020]