Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04378439

Conditions

HIV/AIDS

STI

HCV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Peer Navigation

mHealth

Study Details

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.

Conditions

HIV/AIDS

STI

HCV

Study ID

NCT04378439

Start date

Apr 1, 2022

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

141 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: intervention group

7 community health leaders; 56 social network members

active comparator: delayed-intervention

7 community health leaders; 56 social network members

Interventions

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.

Primary outcome measure

  • Number of participants who have Human Immunodeficiency Virus (HIV) testing [ Time Frame: 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 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) ]
  • Number of participants who have HIV testing [ Time Frame: 12-month follow-up (24 months post-baseline) ]
  • Number of participants who have STI testing [ Time Frame: 12-month follow-up (24 months post-baseline) ]
  • Number of participants who have HCV testing [ Time Frame: 12-month follow-up (24 months post-baseline) ]

Central Contacts and Locations

Central contacts

Scott D. Rhodes, Ph.D, MPH

336-713-5080scott.rhodes@wfusm.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Lisa L Norfleet

336-713-5074Lisa.Lynn.Lewis@advocatehealth.org

Principal Investigator:

Scott D. Rhodes, PhD, MPH

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • PrEP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-05-26.