Clinical trial NCT04378439: 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
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
STI
HCV
Keywords: PrEP
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of participants who have Human Immunodeficiency Virus (HIV) testing
timeFrame: baseline
measure: Number of participants who have Sexually Transmitted Infection (STI) testing
timeFrame: baseline
measure: Number of participants who have Hepatitis C Virus (HCV) testing
timeFrame: baseline
measure: Number of participants who have HIV testing
timeFrame: immediate post-intervention (12 months post-baseline)
measure: Number of participants who have STI testing
timeFrame: immediate post-intervention (12 months post-baseline)
measure: Number of participants who have HCV testing
timeFrame: immediate post-intervention (12 months post-baseline)
measure: Number of participants who have HIV testing
timeFrame: 12-month follow-up (24 months post-baseline)
measure: Number of participants who have STI testing
timeFrame: 12-month follow-up (24 months post-baseline)
measure: Number of participants who have HCV testing
timeFrame: 12-month follow-up (24 months post-baseline)
Secondary outcomes:
measure: Number of participants who use prevention--Pre-exposure prophylaxis (PrEP)
timeFrame: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
measure: Number of participants who use prevention--syringe services
timeFrame: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
measure: Number of participants who use HIV care services
timeFrame: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
measure: Number of participants who use STI treatment services
timeFrame: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
measure: Number of participants who use HCV treatment services
timeFrame: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
measure: Number of participants who use gender-affirming care services
timeFrame: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Scott D. Rhodes, Ph.D, MPH
role: PRINCIPAL_INVESTIGATOR
References: