search
Back to results

Appalachian Partnership to Reduce Disparities (Aim 2)

Primary Purpose

HIV/AIDS, STI, HCV

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Navigation
mHealth
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring PrEP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

intervention group

delayed-intervention

Arm Description

7 community health leaders; 56 social network members

7 community health leaders; 56 social network members

Outcomes

Primary Outcome Measures

Number of participants who have Human Immunodeficiency Virus (HIV) testing
Number of participants who have Sexually Transmitted Infection (STI) testing
Number of participants who have Hepatitis C Virus (HCV) testing
Number of participants who have HIV testing
Number of participants who have STI testing
Number of participants who have HCV testing
Number of participants who have HIV testing
Number of participants who have STI testing
Number of participants who have HCV testing

Secondary Outcome Measures

Number of participants who use prevention--Pre-exposure prophylaxis (PrEP)
Number of participants who use prevention--syringe services
Number of participants who use HIV care services
Measured through self-report and medical chart abstraction
Number of participants who use STI treatment services
Measured through self-report and medical chart abstraction
Number of participants who use HCV treatment services
Measured through self-report and medical chart abstraction
Number of participants who use gender-affirming care services
Measured through self-report and medical chart abstraction

Full Information

First Posted
May 4, 2020
Last Updated
March 27, 2023
Sponsor
Wake Forest University Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04378439
Brief Title
Appalachian Partnership to Reduce Disparities (Aim 2)
Official Title
Harnessing the Power of Peer Navigation and mHealth to Reduce Health Disparities in Appalachia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, STI, HCV
Keywords
PrEP

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
141 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
7 community health leaders; 56 social network members
Arm Title
delayed-intervention
Arm Type
Active Comparator
Arm Description
7 community health leaders; 56 social network members
Intervention Type
Behavioral
Intervention Name(s)
Peer Navigation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
mHealth
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who have Human Immunodeficiency Virus (HIV) testing
Time Frame
baseline
Title
Number of participants who have Sexually Transmitted Infection (STI) testing
Time Frame
baseline
Title
Number of participants who have Hepatitis C Virus (HCV) testing
Time Frame
baseline
Title
Number of participants who have HIV testing
Time Frame
immediate post-intervention (12 months post-baseline)
Title
Number of participants who have STI testing
Time Frame
immediate post-intervention (12 months post-baseline)
Title
Number of participants who have HCV testing
Time Frame
immediate post-intervention (12 months post-baseline)
Title
Number of participants who have HIV testing
Time Frame
12-month follow-up (24 months post-baseline)
Title
Number of participants who have STI testing
Time Frame
12-month follow-up (24 months post-baseline)
Title
Number of participants who have HCV testing
Time Frame
12-month follow-up (24 months post-baseline)
Secondary Outcome Measure Information:
Title
Number of participants who use prevention--Pre-exposure prophylaxis (PrEP)
Time Frame
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Title
Number of participants who use prevention--syringe services
Time Frame
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Title
Number of participants who use HIV care services
Description
Measured through self-report and medical chart abstraction
Time Frame
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Title
Number of participants who use STI treatment services
Description
Measured through self-report and medical chart abstraction
Time Frame
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Title
Number of participants who use HCV treatment services
Description
Measured through self-report and medical chart abstraction
Time Frame
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Title
Number of participants who use gender-affirming care services
Description
Measured through self-report and medical chart abstraction
Time Frame
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
GBMSM (Gay, Bisexual, Men who have sex with men)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott D. Rhodes, Ph.D, MPH
Phone
336-713-5080
Email
srhodes@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D. Rhodes, Ph.D, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa L Lewis
Phone
336-713-5074
Email
liwillia@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Scott D. Rhodes, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Beth A. Reboussin, PhD,BS, MS
First Name & Middle Initial & Last Name & Degree
Aimee M. Wilkin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Appalachian Partnership to Reduce Disparities (Aim 2)

We'll reach out to this number within 24 hrs