Appalachian Partnership to Reduce Disparities (Aim 2)

HIV/AIDS Clinical Trial

Official title:

Harnessing the Power of Peer Navigation and mHealth to Reduce Health Disparities in Appalachia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04378439
• Other study ID #: IRB00065116
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: Scott D. Rhodes, Ph.D, MPH
• Phone: 336-713-5080
• Email: srhodes[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This CBPR study will advance prevention science and practice through testing an innovative intervention to promote and support the use of needed HIV, STI, and HCV prevention and care services among GBMSM and transgender women; and developing priorities and recommendations to improve their health that will be disseminated to inform public health practice, research, and policy. By integrating peer navigation and mHealth strategies, the proposed study provides a unique opportunity to improve health among vulnerable, hidden, and neglected populations living in rural Appalachia. Findings from this research may inform strategies and approaches to address other health disparities in other rural populations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• reside in one of the rural Appalachian catchment countiesreside in one of the rural Appalachian catchment counties

• be =18 years of age

• report being assigned male sex at birth and having had sex with at least 1 man in past 12 months

• provide informed consent

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HCV
• HIV Infections
• HIV/AIDS
• STI

Intervention

Behavioral:
• Peer Navigation
First, as health advisors, community health leaders will raise awareness of HIV, STIs, and HCV and local prevention and care services and help social network members access services. Thus, the community health leader will describe to the process for HCV testing, and how providers are required to maintain confidentiality. As opinion leaders, community health leaders will reframe health-compromising and bolster health-promoting norms and expectations about testing and use of other prevention and care services. Each community health leader will also conduct formal in-person group activities with their social network members. Our partnership decided that each community health leader will also hold at least 4 formal group sessions during the 12 months of intervention
• mHealth
In addition to in-person individual and group activities, community health leaders will use mHealth platforms preferred by each social network member (i.e., Facebook , Instagram, testing, and/or GPS-based mobile apps) to communicate with them during the intervention. They will use social media to plan activities and to support use of needed prevention and care services. For example, when planning a group activity (described above), the community health leader will use social media to remind social network members about the activity and help them problem solve barriers to attending. A community health leader and social network member may also communicate "in-real-time" via social media about the process of participating in a syringe services program or accessing PrEP.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who have Human Immunodeficiency Virus (HIV) testing		baseline
Primary	Number of participants who have Sexually Transmitted Infection (STI) testing		baseline
Primary	Number of participants who have Hepatitis C Virus (HCV) testing		baseline
Primary	Number of participants who have HIV testing		immediate post-intervention (12 months post-baseline)
Primary	Number of participants who have STI testing		immediate post-intervention (12 months post-baseline)
Primary	Number of participants who have HCV testing		immediate post-intervention (12 months post-baseline)
Primary	Number of participants who have HIV testing		12-month follow-up (24 months post-baseline)
Primary	Number of participants who have STI testing		12-month follow-up (24 months post-baseline)
Primary	Number of participants who have HCV testing		12-month follow-up (24 months post-baseline)
Secondary	Number of participants who use prevention--Pre-exposure prophylaxis (PrEP)		baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Secondary	Number of participants who use prevention--syringe services		baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Secondary	Number of participants who use HIV care services	Measured through self-report and medical chart abstraction	baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Secondary	Number of participants who use STI treatment services	Measured through self-report and medical chart abstraction	baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Secondary	Number of participants who use HCV treatment services	Measured through self-report and medical chart abstraction	baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Secondary	Number of participants who use gender-affirming care services	Measured through self-report and medical chart abstraction	baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).