HIV/AIDSNCT04378439
Appalachian Partnership to Reduce Disparities (Aim 2)
A study testing Peer Navigation and mHealth in people with HIV/AIDS and STI, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Peer Navigation and mHealth
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- reside 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Harnessing the Power of Peer Navigation and mHealth to Reduce Health Disparities in Appalachia
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.
Read the 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.
- Being tested
- Peer Navigation, mHealth
- Keywords
- PrEP
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer NavigationBehavioural
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
mHealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | 7 community health leaders; 56 social network members Receives: Behavioral: Peer Navigation; Behavioral: mHealth |
| delayed-intervention | Active comparator | 7 community health leaders; 56 social network members Receives: Behavioral: Peer Navigation; Behavioral: mHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have Human Immunodeficiency Virus (HIV) testing
Measured: baseline
Number of participants who have Sexually Transmitted Infection (STI) testing
Measured: baseline
Number of participants who have Hepatitis C Virus (HCV) testing
Measured: baseline
Number of participants who have HIV testing
Measured: immediate post-intervention (12 months post-baseline)
Number of participants who have STI testing
Measured: immediate post-intervention (12 months post-baseline)
Number of participants who have HCV testing
Measured: immediate post-intervention (12 months post-baseline)
Number of participants who have HIV testing
Measured: 12-month follow-up (24 months post-baseline)
Number of participants who have STI testing
Measured: 12-month follow-up (24 months post-baseline)
Number of participants who have HCV testing
Measured: 12-month follow-up (24 months post-baseline)
Secondary outcomes (6)
Number of participants who use prevention--Pre-exposure prophylaxis (PrEP)
Measured: 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
Measured: 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
Measured through self-report and medical chart abstraction
Measured: 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
Measured through self-report and medical chart abstraction
Measured: 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
Measured through self-report and medical chart abstraction
Measured: 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
Measured through self-report and medical chart abstraction
Measured: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Apr 2022
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Scott D. Rhodes, Ph.D, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378439
- Sponsor's protocol ID
- IRB00065116
- Other IDs
- R01NR019512
- Status last verified
- Oct 2026
- First submitted
- 4 May 2020
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing the Power of Peer Navigation and mHealth to Reduce Health Disparities in Appalachia
- ClinicalTrials.gov ID
- NCT04378439
- Acronym / sponsor ID
- IRB00065116
- Keywords
- PrEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Behavioral: Peer Navigation, Behavioral: mHealth7 community health leaders; 56 social network members |
| delayed-intervention | Active comparator | Behavioral: Peer Navigation, Behavioral: mHealth7 community health leaders; 56 social network members |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- reside 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer NavigationFirst, 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 | Behavioural | delayed-intervention, intervention group |
| mHealthIn 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. | Behavioural | delayed-intervention, intervention group |
Primary outcome
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)
6 secondary outcomes
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott D. Rhodes, Ph.D, MPH principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Navigation and mHealth in people with HIV/AIDS and STI, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who have Human Immunodeficiency Virus (HIV) testing (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.