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

Overseen By Scott D. Rhodes, Ph.D, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: None

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

Compensation: Varies

Number of Visits: Unknown

141 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to encourage testing for HIV, STIs (sexually transmitted infections), and Hepatitis C in rural Appalachian areas. It combines peer support (help from someone with similar experiences) and mHealth (using mobile technology for health care). The goal is to determine if this approach increases the use of testing services. The trial seeks individuals who live in rural Appalachia, were assigned male at birth, and have had sexual experiences with men in the past year. Participants will either start the program immediately or after a delay, allowing researchers to compare outcomes. As an unphased trial, this study offers an opportunity to contribute to innovative research that could improve health outcomes in rural communities.

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 prior data suggests that this intervention is safe?

Research has shown that peer navigation and mobile health (mHealth) are generally safe. Studies have not identified any safety concerns with these methods. Peer navigation connects people with health services and has involved groups in testing and care without safety issues. mHealth uses technology to support health care and is considered safe and effective for increasing access to testing for conditions like HIV and hepatitis. Overall, both methods are well-received and have demonstrated positive results in helping people access health services. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mHealth and peer navigation for HIV/AIDS, STIs, and Hepatitis C testing because these approaches offer a fresh take on healthcare delivery. Unlike traditional methods that rely heavily on clinical settings, mHealth leverages mobile technology to provide easily accessible health information and support, making it more convenient for users. Peer navigation involves community health leaders guiding individuals through testing and treatment processes, which can help address barriers such as stigma and lack of trust in healthcare systems. Together, these methods have the potential to improve testing rates and early diagnosis by meeting people where they are, both physically and socially.

What evidence suggests that this trial's treatments could be effective for increasing HIV, STI, and HCV testing?

This trial will evaluate the effectiveness of two strategies: mobile health (mHealth) tools and peer navigation. Studies have shown that mHealth tools can effectively increase HIV and STI testing, particularly among urban men who have sex with men (MSM). Research indicates that mobile platforms encourage more people to get tested for the first time and simplify access to testing services. Additionally, previous trials found that peer navigation, where trained peers provide help and support, improves participation in testing and treatment for HIV and hepatitis. Peer navigation is linked to better experiences at clinics and results in more people getting tested and treated. These combined strategies show promise for increasing testing among various groups. Participants in this trial will join either an intervention group or a delayed-intervention group to assess the impact of these strategies. ^{1 2 6 7 8}

Who Is on the Research Team?

Scott D Rhodes, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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

Provide informed consent

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• mHealth
• Peer Navigation

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10896188/

Do Peer Navigators Improve Initiation and Retention in HIV ... Previous randomized controlled trials (RCTs) among general populations have indicated positive effects of peer navigation for HIV/VH/STIs, but these findings ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8753897/

Exploring peer navigation and support in the quality of HIV ... Peer navigation was positively associated with experiencing more respectful treatment by clinic staff (AOR: 6.65, 95% CI: 2.32–19.02), and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0955395923002323

Peer-delivered point-of-care testing and linkage to ... This study found that a peer-led point-of-care service is a model of care that can engage marginalized groups in HCV testing and linkage to treatment.

4. sciencedirect.com sciencedirect.com/science/article/pii/S258953702500166X

Community engagement and chronic viral hepatitis public ... This review indicated that community-engaged interventions significantly improved HBV vaccine completion, HBV/HCV test uptake, HBV/HCV linkage to care, HBV/HCV ...

5. link.springer.com link.springer.com/article/10.1007/s11904-024-00719-8

Peer-Led Adjunctive Interventions for Increasing the Reach ... Outcomes included HIV testing uptake (74%), treatment linkage (39%), PrEP uptake (22%), and PEP uptake (4%). Translational phases included ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10126838/

Peer recovery coaching for comprehensive HIV, hepatitis C ... A peer recovery coaching intervention is feasible and acceptable, with positive preliminary findings regarding MOUD, PrEP and HCV treatment uptake.

7. joghr.org joghr.org/article/28347-results-from-a-peer-based-digital-systems-navigation-intervention-to-increase-hiv-prevention-and-care-behaviors-of-young-trans-women-in-rio-de-janeiro

Results from a peer-based digital systems navigation ... We measured HIV testing, PrEP use and HIV care outcomes. HIV care engagement included linkage to care, visit attendance, antiretroviral therapy ...

8. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-022-00595-8

The impact of peer support on testing, linkage to and ... Findings indicate that peer support can enhance access to testing, linkage to, and engagement in HIV care for people who use drugs living with HIV in Indonesia.