Menu
Recruiting NCT04378439

Appalachian Partnership to Reduce Disparities (Aim 2)

No phase Interventional HIV/AIDS STI HCV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peer Navigation, mHealth.
Who it may be relevant to
Registry conditions: HIV/AIDS, STI, HCV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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 c
  • Behavioral 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 soci

Primary outcome measures

  • 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)]
Secondary outcome measures (6)
  • 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).]
  • 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).]
  • Number of participants who use HIV care services [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT04378439 · IRB00065116 · R01NR019512

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗