Supporting Tailored And Responsive PrEP in Rural North Carolina (STARR-NC)

• ClinicalTrials.gov Identifier: NCT05984030
• Recruitment Status: Recruiting
• First Posted: August 9, 2023
• Last Update Posted: October 4, 2023
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

Brief Summary:

This project consists of two phases to be completed over five years. Phase 1 (Aims 1 and 2) will be completed during Years 1-3 (R61). The Phase 1 study is a randomized trial of a multilevel HIV Pre-Exposure Prophylaxis (PrEP) intervention strategy in rural and peri-urban North Carolina sexually transmitted infection (STI) clinics, with primary outcome of PrEP uptake within 3 months of an index STI clinic visit.

Condition or disease	Intervention/treatment	Phase
HIV Pre-Exposure Prophylaxis	Other: PrEP Navigation Services; Other: Telehealth PrEP Services Referral; Behavioral: HealthMpowerment Digital Health Intervention - Enhanced; Behavioral: HealthMpowerment Digital Health Intervention - Basic	Not Applicable

Detailed Description:

Participants will be randomized 1:1 to an intervention or control condition. Participants enrolled in the intervention arm will receive a multilevel intervention with three components: a PrEP Navigator to facilitate linkage to PrEP services and completion of applications for health insurance/drug assistance; a Digital Health Intervention (DHI) platform (HealthMpowerment) - a HIPAA-compliant evidence-based DHI that provides interactive educational resources, social support, and tools for developing PrEP behavioral skills and self-efficacy; and referral to Telehealth PrEP services as an option for linking to PrEP care.

Control arm participants will receive the standard PrEP referral services available at the STI clinic setting where they were recruited. They will also receive linkage to a limited version of the DHI, with basic PrEP resources and information.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 336 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

Participants are randomized 1:1 to Intervention Condition or Control Condition. The study will use blocked randomization stratified by clinic, with randomly ordered blocks of sizes 4 and 6.

All participants will be asked to complete baseline and quarterly assessments at 3- and 6-month follow-up. Participants who are enrolled into the study with sufficient follow-up time remaining in the funding period will also be asked to complete a 12-month assessment. Primary outcome measures are assessed at month 3. Secondary outcome measures are assessed at months 3 and 6.

• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Meet me Where I am: A Multilevel Strategy to Increase PrEP Uptake and Persistence Among Young Sexual and Gender Minority Men in Rural NC
• Actual Study Start Date: August 31, 2023
• Estimated Primary Completion Date: June 30, 2025
• Estimated Study Completion Date: June 30, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: STARR NC Intervention Condition; Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator to facilitate linkage to PrEP services and completion of applications for health insurance/drug assistance; a Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care. The Intervention Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center; Interactive skill-building health activities; social support newsfeed/group chat; Ask the Expert anonymous health question and answer; Medication Tracker; Health Behavior Tracker; Gamification features for participant engagement. Intervention Arm participants will complete baseline and quarterly follow-up assessments. Intervention Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.	Other: PrEP Navigation Services; Trained professional PrEP navigators will connect with intervention arm participants following study onboarding. Primary navigator responsibilities include helping participants engage in PrEP care, assisting with completing necessary paperwork for insurance, referral to PrEP care, and application for drug assistance programs, as needed. Navigation services will be available to participants for the first 6 months of participation (active intervention period). Navigation services are tailored to the individual needs of each intervention arm participant; Other: Telehealth PrEP Services Referral; PrEP Navigators can link interested intervention arm participants to telehealth PrEP services via self-referral. The study facilitates referral for intervention arm participants to pre-existing telehealth PrEP services. The telehealth PrEP services participants receive are not provided, financed, or staffed by the study. Participants will receive telehealth PrEP services via the technology platform or service that the provider typically employs. PrEP clinical eligibility, visit frequency, monitoring labs, and all other PrEP management will be at the discretion of the established PrEP provider. PrEP navigators can assist with appointment scheduling, reminders, and other provider-access issues, as requested, for the first 6 months of study participation.; Behavioral: HealthMpowerment Digital Health Intervention - Enhanced; The Enhanced version of the HealthMpowerment Digital Health Intervention includes all features from the Basic version, plus the following additional features: Interactive skill-building health activities; social support newsfeed/group chat; Ask the Expert anonymous health question and answer; Medication Tracker; Health Behavior Tracker; Gamification features for participant engagement.
Active Comparator: STARR NC Standard-of-Care Control Condition; Standard-of-Care Control arm will receive the standard PrEP referral services available at the STI clinic setting where they were recruited. They will also receive study staff guided support to install the control arm version of the HealthMPowerment DHI platform. The Control Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center. Control Arm participants will complete baseline and quarterly follow-up assessments. Control Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.	Behavioral: HealthMpowerment Digital Health Intervention - Basic; The Control Arm version of the HealthMpowerment Digital Health Intervention includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center.

Outcome Measures

Primary Outcome Measures :

1. Proportion of participants reporting PrEP initiation by 3 months [ Time Frame: 3 months ]
   Proportion of participants with verified self-reported pre-exposure prophylaxis (PrEP) use (first dose, oral or injectable PrEP)1 at or before 3 months, defined as the number verified to start PrEP divided by the total number of participants in each arm

Secondary Outcome Measures :

1. Proportion of participants reporting PrEP initiation by 6 months [ Time Frame: 6 months ]
   Proportion of participants with verified self-reported PrEP use (first dose, oral or injectable PrEP) at or before 6 months, defined as the number verified to start PrEP divided by the total number of participants in each arm
2. Proportion of PrEP initiators adhering to chosen PrEP strategy over first 3 months [ Time Frame: 3 months ]
   Number of participants with on-time PrEP refills and/or injections noted in Electronic Health Record (EHR) over first 3 months divided by number initiating PrEP over first 3 months
3. Proportion of PrEP initiators adhering to chosen PrEP strategy over first 6 months [ Time Frame: 6 months ]
   Number of participants with on-time PrEP refills and/or injections noted in EHR over first 6 months divided by number initiating PrEP over first 6 months
4. Average number of consecutive months PrEP used over first 3 months [ Time Frame: 3 months ]
   Among those who initiate PrEP, average number of consecutive months PrEP used, based on date of first and last dose over first 3 months of follow-up, as indicated through survey self-report and visits/prescriptions noted in the EHR
5. Average number of consecutive months PrEP used over first 6 months [ Time Frame: 6 months ]
   Among those who initiate PrEP, average number of consecutive months PrEP used, based on date of first and last dose over first 3 months of follow-up, as indicated through survey self-report and visits/prescriptions noted in the EHR
6. Average number of days PrEP used among persons initiating daily oral PrEP in the 30 days prior to the 3-month visit. [ Time Frame: 3 months ]
   Among those who initiate daily oral PrEP, average number of days PrEP used, based on self-reported recall of doses taken in past 30 days.
7. Average number of condomless anal sex acts protected by PrEP among persons initiating event-driven oral PrEP in the 30 days prior to the 3-month visit. [ Time Frame: 3-months ]
   Among those who initiate event-driven oral PrEP, average proportion of condomless anal sex acts covered by PrEP, based on self-reported number of condomless anal sex episodes and frequency of complete event-driven PrEP use (before and after) condomless anal sex act.
8. Proportion of injectable PrEP initiators reporting PrEP use in the 90 days prior to the 3-month visit [ Time Frame: 3 months ]
   Number of participants who initiated injectable PrEP and reported using Injectable PrEP within an on-time injection interval, in the 90 days prior to the 3-month visit, divided by the number who initiated injectable PrEP
9. Average number of days PrEP used among persons initiating daily oral PrEP in the 30 days prior to the 6-month visit. [ Time Frame: 6 months ]
   Among those who initiate daily oral PrEP, average number of days PrEP used, based on self-reported recall of doses taken in past 30 days.
10. Average number of condomless anal sex acts protected by PrEP among persons initiating event-driven oral PrEP in the 30 days prior to the 6-month visit. [ Time Frame: 6 months ]
    Among those who initiate event-driven oral PrEP, average proportion of condomless anal sex acts covered by PrEP, based on self-reported number of condomless anal sex episodes and frequency of complete event-driven PrEP use (before and after) condomless anal sex act.
11. Proportion of injectable PrEP initiators reporting PrEP use in the 90 days prior to the 6-month visit [ Time Frame: 6 months ]
    Number of participants who initiated injectable PrEP and reported using Injectable PrEP within an on-time injection interval, in the 90 days prior to the 3-month visit, divided by the number who initiated injectable PrEP
12. Proportion of oral PrEP initiators with detected PrEP concentrations in blood at 3 months [ Time Frame: 3 months ]
    Number of PrEP initiators with PrEP concentrations detected at the 3-month study follow-up visit, based on intraerythrocytic Tenofovir diphosphate (TFV-DP) collected as Dried Blood Spot (DBS) divided by the number who initiated oral PrEP
13. Proportion of oral PrEP initiators with detected PrEP concentrations in blood at 6 months [ Time Frame: 6 months ]
    Number of PrEP initiators with PrEP concentrations detected at the 6-month study follow-up visit, based on intraerythrocytic TFV-DP collected as DBS divided by the number who initiated oral PrEP
14. Proportion of injectable PrEP initiators receiving all prescribed injections through 3 months [ Time Frame: 3 months ]
    Number of injectable PrEP initiators with injections recorded in the EHR at all prescribed timepoints prior to the 3-month follow up visit divided by the number who initiated injectable PrEP
15. Proportion of injectable PrEP initiators receiving all prescribed injections through 6 months [ Time Frame: 6 months ]
    Number of injectable PrEP initiators with injections recorded in the EHR at all prescribed timepoints prior to the 6-month follow up visit divided by the number who initiated injectable PrEP
16. Proportion of participants who test positive for HIV among those tested at or prior to the 3-month visit [ Time Frame: 3 months ]
    Number with a positive clinical test result for human immunodeficiency virus (HIV) obtained from state, clinic, or commercial lab results, or verified participant-uploaded results, divided by the number tested for HIV prior to the 3-month visit, as indicated by state, clinic, commercial, or self-uploaded indication of receiving a test
17. Proportion of participants who test positive for HIV among those tested at or prior to the 6-month visit [ Time Frame: 6 months ]
    Number with a positive clinical test result for HIV obtained from state, clinic, or commercial lab results, or verified participant-uploaded results, divided by the number tested for HIV prior to the 6-month visit, as indicated by state, clinic, commercial, or self-uploaded indication of receiving a test
18. Proportion of participants who test positive for an STI other than HIV among those tested at or prior to the 3-month visit [ Time Frame: 3 months ]
    Number with a positive clinical test result for an sexually transmitted infections (STI) other than HIV obtained from state, clinic, or commercial lab results, or verified participant-uploaded results, divided by the number tested for HIV prior to the 3 month visit, as indicated by state, clinic, commercial, or self-uploaded indication of receiving a test
19. Proportion of participants who test positive for an STI other than HIV among those tested at or prior to the 6-month visit [ Time Frame: 6 months ]
    Number with a positive clinical test result for an STI other than HIV obtained from state, clinic, or commercial lab results, or verified participant-uploaded results, divided by the number tested for HIV prior to the 6-month visit, as indicated by state, clinic, commercial, or self-uploaded indication of receiving a test.
20. Average self-reported score on the PrEP Stigma scale at 3 months [ Time Frame: 3 months ]

    Average self-reported score on the PrEP Anticipated Stigma Scale as reported on the computer-assisted self-interview (CASI) at 3 months

    The mean composite score is calculated from the PrEP Anticipated Stigma Scale (Calabrese et al., 2018), an 8-item validated scale measuring the sub-constructs of PrEP user stereotypes and PrEP disapproval by others. Item response options include: (1) Strongly Disagree, (2) Disagree, (3) Agree, (4) Strongly Agree. Mean scores are calculated, with higher scores indicating stronger perceived PrEP stigma. Total possible composite score ranges from 8 (lowest stigma, best outcome) to 32 (highest stigma, worst outcome).

21. Average self-reported score on the PrEP Stigma scale at 6 months [ Time Frame: 6 months ]

    Average self-reported score on the PrEP Anticipated Stigma Scale as reported on the CASI at 6 months

    The mean composite score is calculated from the PrEP Anticipated Stigma Scale (Calabrese et al., 2018), an 8-item validated scale measuring the sub-constructs of PrEP user stereotypes and PrEP disapproval by others. Item response options include: (1) Strongly Disagree, (2) Disagree, (3) Agree, (4) Strongly Agree. Mean scores are calculated, with higher scores indicating stronger perceived PrEP stigma. Total possible composite score ranges from 8 (lowest stigma, best outcome) to 32 (highest stigma, worst outcome).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 39 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Assigned male sex at birth
• Report sexual activity with a male in the past 12 months
• Received HIV testing within 90 days pre-enrollment and not known to be HIV-positive at screening/enrollment by self-report
• Age 18-39 years
• Have daily smartphone access
• Be English speaking
• Deny current PrEP use

Exclusion Criteria:

• Confirmed prior HIV-positive diagnosis
• Prior PrEP use (oral PrEP or injectable PrEP) within the last 3 months.

Contacts and Locations

Contacts

Contact: Sarah E Rutstein, MD, PhD; 919-966-2537; srutstein@unc.edu

Locations

United States, North Carolina

The University of North Carolina at Chapel Hill; Recruiting

Chapel Hill, North Carolina, United States, 27514

Contact: Sarah Rutstein, MD, PhD 919-843-5859 sarah_rutstein@med.unc.edu

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Sarah Rutstein, MD, PhD; University of North Carolina, Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT05984030
• Other Study ID Numbers: 22-3058; R61AI174285 ( U.S. NIH Grant/Contract )
• First Posted: August 9, 2023
• Last Update Posted: October 4, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: Beginning 9 months and ending 36 months following publication of primary study results.
• Access Criteria: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No