Appalachian Partnership to Reduce Disparities (Aim 2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS; STI; HCV
• Intervention / Treatment: Behavioral: Peer Navigation; Behavioral: mHealth

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 141
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott D. Rhodes, Ph.D, MPH; Phone Number: 336-713-5080; Email: srhodes@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Lisa L Lewis; Phone Number: 336-713-5074; Email: liwillia@wakehealth.edu
      • Principal Investigator: Scott D. Rhodes, PhD, MPH
      • Sub-Investigator: Beth A. Reboussin, PhD,BS, MS
      • Sub-Investigator: Aimee M. Wilkin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention group; 7 community health leaders; 56 social network members	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; Behavioral: 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.
Active Comparator: delayed-intervention; 7 community health leaders; 56 social network members	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; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants who have Human Immunodeficiency Virus (HIV) testing	baseline
Number of participants who have Sexually Transmitted Infection (STI) testing	baseline
Number of participants who have Hepatitis C Virus (HCV) testing	baseline
Number of participants who have HIV testing	immediate post-intervention (12 months post-baseline)
Number of participants who have STI testing	immediate post-intervention (12 months post-baseline)
Number of participants who have HCV testing	immediate post-intervention (12 months post-baseline)
Number of participants who have HIV testing	12-month follow-up (24 months post-baseline)
Number of participants who have STI testing	12-month follow-up (24 months post-baseline)
Number of participants who have HCV testing	12-month follow-up (24 months post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).
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).

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Scott D. Rhodes, Ph.D, MPH, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PrEP
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: IRB00065116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No