Supporting Tailored And Responsive PrEP in Rural North Carolina

Not Applicable

Recruiting

• Conditions: HIV Pre-Exposure Prophylaxis
• Interventions: Behavioral: HealthMpowerment Digital Health Intervention - Basic; Other: PrEP Navigation Services; Other: Telehealth PrEP Services Referral; Behavioral: HealthMpowerment Digital Health Intervention - Enhanced

• Registration Number: NCT05984030
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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 Timeline

• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-09
• Study Start: 2023-08-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 336

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STARR NC Intervention Condition	Telehealth PrEP Services Referral	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.
STARR NC Standard-of-Care Control Condition	HealthMpowerment Digital Health Intervention - Basic	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.
STARR NC Intervention Condition	HealthMpowerment Digital Health Intervention - Enhanced	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.
STARR NC Intervention Condition	PrEP Navigation Services	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants reporting PrEP initiation by 3 months	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

Name	Time	Method
Average number of days PrEP used among persons initiating daily oral PrEP in the 30 days prior to the 3-month visit.	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.
Proportion of participants reporting PrEP initiation by 6 months	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
Proportion of PrEP initiators adhering to chosen PrEP strategy over first 3 months	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
Average number of consecutive months PrEP used over first 3 months	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
Proportion of PrEP initiators adhering to chosen PrEP strategy over first 6 months	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
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.	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.
Average number of consecutive months PrEP used over first 6 months	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
Proportion of injectable PrEP initiators reporting PrEP use in the 90 days prior to the 3-month visit	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
Average number of days PrEP used among persons initiating daily oral PrEP in the 30 days prior to the 6-month visit.	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.
Proportion of injectable PrEP initiators reporting PrEP use in the 90 days prior to the 6-month visit	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
Proportion of oral PrEP initiators with detected PrEP concentrations in blood at 6 months	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
Proportion of participants who test positive for HIV among those tested at or prior to the 3-month visit	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
Proportion of participants who test positive for HIV among those tested at or prior to the 6-month visit	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
Proportion of participants who test positive for an STI other than HIV among those tested at or prior to the 3-month visit	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
Average self-reported score on the PrEP Stigma scale at 3 months	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).
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.	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.
Proportion of oral PrEP initiators with detected PrEP concentrations in blood at 3 months	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
Proportion of participants who test positive for an STI other than HIV among those tested at or prior to the 6-month visit	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.
Proportion of injectable PrEP initiators receiving all prescribed injections through 3 months	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
Proportion of injectable PrEP initiators receiving all prescribed injections through 6 months	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
Average self-reported score on the PrEP Stigma scale at 6 months	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).

Trial Locations

Locations (1)

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States