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Clinical Trials/NCT04378439
NCT04378439
Recruiting
Not Applicable

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

Wake Forest University Health Sciences1 site in 1 country141 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Peer Navigation
Conditions
HIV/AIDS
Sponsor
Wake Forest University Health Sciences
Enrollment
141
Locations
1
Primary Endpoint
Number of participants who have HCV testing
Status
Recruiting
Last Updated
last month

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
May 1, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

intervention group

7 community health leaders; 56 social network members

Intervention: Peer Navigation

intervention group

7 community health leaders; 56 social network members

Intervention: mHealth

delayed-intervention

7 community health leaders; 56 social network members

Intervention: Peer Navigation

delayed-intervention

7 community health leaders; 56 social network members

Intervention: mHealth

Outcomes

Primary Outcomes

Number of participants who have HCV testing

Time Frame: 12-month follow-up (24 months post-baseline)

Number of participants who have Human Immunodeficiency Virus (HIV) testing

Time Frame: baseline

Number of participants who have HIV testing

Time Frame: 12-month follow-up (24 months post-baseline)

Number of participants who have Sexually Transmitted Infection (STI) testing

Time Frame: baseline

Number of participants who have Hepatitis C Virus (HCV) testing

Time Frame: baseline

Number of participants who have STI testing

Time Frame: 12-month follow-up (24 months post-baseline)

Number of participants who have HIV testing

Time Frame: immediate post-intervention (12 months post-baseline)

Number of participants who have STI testing

Time Frame: immediate post-intervention (12 months post-baseline)

Number of participants who have HCV testing

Time Frame: immediate post-intervention (12 months post-baseline)

Secondary Outcomes

  • Number of participants who use HIV care services(baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).)
  • 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 STI treatment services(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(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(baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).)

Study Sites (1)

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