NCT04378439

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 13, 2026

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

May 4, 2020

Last Update Submit

March 10, 2026

Conditions

STIHCVHIV/AIDS

Keywords

PrEP

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (6)

  • 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

    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 HCV treatment services

    baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

  • +1 more secondary outcomes

Study Arms (2)

intervention group

ACTIVE COMPARATOR

7 community health leaders; 56 social network members

Behavioral: Peer NavigationBehavioral: mHealth

delayed-intervention

ACTIVE COMPARATOR

7 community health leaders; 56 social network members

Behavioral: Peer NavigationBehavioral: mHealth

Interventions

mHealthBEHAVIORAL

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.

delayed-interventionintervention group
Peer NavigationBEHAVIORAL

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

delayed-interventionintervention group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGBMSM (Gay, Bisexual, Men who have sex with men)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexually Transmitted Diseases

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Scott D. Rhodes, Ph.D, MPH

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott D. Rhodes, Ph.D, MPH

CONTACT

336-713-5080srhodes@wakehealth.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

April 1, 2022

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 13, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)