Appalachian Partnership to Reduce Disparities (Aim 2)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV/AIDS, STI, HCV

Intervention / Treatment
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* Behavioral: Peer Navigation
* Behavioral: mHealth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention group<br>7 community health leaders; 56 social network members | Behavioral: Peer Navigation<br>* 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<br>Behavioral: mHealth<br>* 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.<br>|
| Active Comparator: delayed-intervention<br>7 community health leaders; 56 social network members | Behavioral: Peer Navigation<br>* 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<br>Behavioral: mHealth<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP