HIV Pre-Exposure ProphylaxisSTARR-NCNCT05984030
Supporting Tailored And Responsive PrEP in Rural North Carolina
A study testing PrEP Navigation Services, Telehealth PrEP Services Referral and HealthMpowerment Digital Health Intervention - Enhanced in people with HIV Pre-Exposure Prophylaxis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Pre-Exposure Prophylaxis
- What is being tested?
- PrEP Navigation Services, Telehealth PrEP Services Referral and HealthMpowerment Digital Health Intervention - Enhanced
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Confirmed prior HIV-positive diagnosis
- Prior PrEP use (oral PrEP or injectable PrEP) within the last 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Meet me Where I am: A Multilevel Strategy to Increase PrEP Uptake and Persistence in Rural NC
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.
Read the 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.
- Conditions
- HIV Pre-Exposure Prophylaxis
- Being tested
- PrEP Navigation Services, Telehealth PrEP Services Referral, HealthMpowerment Digital Health Intervention - Enhanced, HealthMpowerment Digital Health Intervention - Basic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP Navigation ServicesOther
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
Telehealth PrEP Services ReferralOther
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.
HealthMpowerment Digital Health Intervention - EnhancedBehavioural
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.
HealthMpowerment Digital Health Intervention - BasicBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| STARR NC Intervention Condition | Experimental | 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. Receives: Other: PrEP Navigation Services; Other: Telehealth PrEP Services Referral; Behavioral: HealthMpowerment Digital Health Intervention - Enhanced |
| STARR NC Standard-of-Care Control Condition | Active comparator | 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. Receives: Behavioral: HealthMpowerment Digital Health Intervention - Basic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Reporting PrEP Initiation by 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
Measured: 3 months
Secondary outcomes (21)
Proportion of Participants Reporting PrEP Initiation by 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
Measured: 6 months
Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 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
Measured: 3 months
Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 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
Measured: 6 months
Average Number of Consecutive Months PrEP Used Over First 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.
Measured: 3 months
Average Number of Consecutive Months PrEP Used Over First 6 Months
Among those who initiate PrEP, average number of consecutive months PrEP used, based on date of first and last dose over first 6 months of follow-up, as indicated through survey self-report and visits/prescriptions noted in the EHR
Measured: 6 months
Average Number of Days PrEP Used Among Persons Initiating Daily Oral PrEP in the 30 Days Prior to the 3-month Visit.
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.
Measured: 3 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.
Among those who initiate event-driven oral PrEP, average number 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.
Measured: 3-months
Proportion of Injectable PrEP Initiators Reporting PrEP Use in the 90 Days Prior to the 3-month Visit
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.
Measured: 3 months
Average Number of Days PrEP Used Among Persons Initiating Daily Oral PrEP in the 30 Days Prior to the 6-month Visit.
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.
Measured: 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 6-month Visit.
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.
Measured: 6 months
Proportion of Injectable PrEP Initiators Reporting PrEP Use in the 90 Days Prior to the 6-month Visit
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
Measured: 6 months
Proportion of Oral PrEP Initiators With Detected PrEP Concentrations in Blood at 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
Measured: 3 months
Proportion of Oral PrEP Initiators With Detected PrEP Concentrations in Blood at 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
Measured: 6 months
Proportion of Injectable PrEP Initiators Receiving All Prescribed Injections Through 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
Measured: 3 months
Proportion of Injectable PrEP Initiators Receiving All Prescribed Injections Through 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
Measured: 6 months
Proportion of Participants Who Test Positive for HIV Among Those Tested at or Prior to the 3-month Visit
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
Measured: 3 months
Proportion of Participants Who Test Positive for HIV Among Those Tested at or Prior to the 6-month Visit
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
Measured: 6 months
Proportion of Participants Who Test Positive for an STI Other Than HIV Among Those Tested at or Prior to the 3-month Visit
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 STIs other than HIV prior to the 3 month visit, as indicated by state, clinic, commercial, or self-uploaded indication of receiving a test
Measured: 3 months
Proportion of Participants Who Test Positive for an STI Other Than HIV Among Those Tested at or Prior to the 6-month Visit
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 STIs other than HIV prior to the 6-month visit, as indicated by state, clinic, commercial, or self-uploaded indication of receiving a test.
Measured: 6 months
Average Self-reported Score on the PrEP Stigma Scale at 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).
Measured: 3 months
Average Self-reported Score on the PrEP Stigma Scale at 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start31 Aug 2023
- Primary completion2 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to Intervention Condition or Control Condition. The study will use blocked randomization stratified by county, with randomly ordered blocks of sizes 4 and 6. Depending on their date of enrollment, participants will be asked to complete baseline and quarterly assessments at 3, 6, and 12-month follow-ups. Primary outcome measures are assessed at month 3. Secondary outcome measures are assessed at months 3 and 6.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Rutstein, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984030
- Sponsor's protocol ID
- 22-3058
- Other IDs
- R61AI174285
- Acronym
- STARR-NC
- Status last verified
- Jun 2025
- First submitted
- 1 Aug 2023
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Rutstein SE, Ferguson E, Mansour O, Brown N, Stocks JB, Washington A, Mobley V, Dowler S, Edwards J, Hightow-Weidman LB, Hurt CB, Pence B, Muessig KE. Multilevel Intervention to Support Tailored and Responsive HIV Pre-Exposure Prophylaxis Care in Rural North Carolina: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 21;14:e68085. doi: 10.2196/68085.
PubMed 40117579
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meet me Where I am: A Multilevel Strategy to Increase PrEP Uptake and Persistence in Rural NC
- ClinicalTrials.gov ID
- NCT05984030
- Acronym / sponsor ID
- STARR-NC / 22-3058
- Conditions
- HIV Pre-Exposure Prophylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Posted 15 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to Intervention Condition or Control Condition. The study will use blocked randomization stratified by county, with randomly ordered blocks of sizes 4 and 6. Depending on their date of enrollment, participants will be asked to complete baseline and quarterly assessments at 3, 6, and 12-month follow-ups. Primary outcome measures are assessed at month 3. Secondary outcome measures are assessed at months 3 and 6.
| Arm | Type | Receives |
|---|---|---|
| STARR NC Intervention Condition | Experimental | Other: PrEP Navigation Services, Other: Telehealth PrEP Services Referral, Behavioral: HealthMpowerment Digital Health Intervention - EnhancedIntervention 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 | Active comparator | Behavioral: HealthMpowerment Digital Health Intervention - BasicStandard-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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Confirmed prior HIV-positive diagnosis
- Prior PrEP use (oral PrEP or injectable PrEP) within the last 3 months.
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 |
|---|---|---|
| PrEP Navigation ServicesTrained 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 | STARR NC Intervention Condition |
| Telehealth PrEP Services ReferralPrEP 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. | Other | STARR NC Intervention Condition |
| HealthMpowerment Digital Health Intervention - EnhancedThe 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. | Behavioural | STARR NC Intervention Condition |
| HealthMpowerment Digital Health Intervention - BasicThe 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. | Behavioural | STARR NC Standard-of-Care Control Condition |
Primary outcome
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
21 secondary outcomes
Proportion of Participants Reporting PrEP Initiation by 6 Months
Time frame: 6 months
Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 3 Months
Time frame: 3 months
Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 6 Months
Time frame: 6 months
Average Number of Consecutive Months PrEP Used Over First 3 Months
Time frame: 3 months
Average Number of Consecutive Months PrEP Used Over First 6 Months
Time frame: 6 months
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
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
Proportion of Injectable PrEP Initiators Reporting PrEP Use in the 90 Days Prior to the 3-month Visit
Time frame: 3 months
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
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
Proportion of Injectable PrEP Initiators Reporting PrEP Use in the 90 Days Prior to the 6-month Visit
Time frame: 6 months
Proportion of Oral PrEP Initiators With Detected PrEP Concentrations in Blood at 3 Months
Time frame: 3 months
Proportion of Oral PrEP Initiators With Detected PrEP Concentrations in Blood at 6 Months
Time frame: 6 months
Proportion of Injectable PrEP Initiators Receiving All Prescribed Injections Through 3 Months
Time frame: 3 months
Proportion of Injectable PrEP Initiators Receiving All Prescribed Injections Through 6 Months
Time frame: 6 months
Proportion of Participants Who Test Positive for HIV Among Those Tested at or Prior to the 3-month Visit
Time frame: 3 months
Proportion of Participants Who Test Positive for HIV Among Those Tested at or Prior to the 6-month Visit
Time frame: 6 months
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
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
Average Self-reported Score on the PrEP Stigma Scale at 3 Months
Time frame: 3 months
Average Self-reported Score on the PrEP Stigma Scale at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40117579Rutstein SE, Ferguson E, Mansour O, Brown N, Stocks JB, Washington A, Mobley V, Dowler S, Edwards J, Hightow-Weidman LB, Hurt CB, Pence B, Muessig KE. Multilevel Intervention to Support Tailored and Responsive HIV Pre-Exposure Prophylaxis Care in Rural North Carolina: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 21;14:e68085. doi: 10.2196/68085.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Sarah Rutstein, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP Navigation Services, Telehealth PrEP Services Referral and HealthMpowerment Digital Health Intervention - Enhanced in people with HIV Pre-Exposure Prophylaxis, run by University of North Carolina, Chapel Hill 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 6 inclusion and 2 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 15 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants Reporting PrEP Initiation by 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05984030, which also lists 1 linked publication.
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 15 Aug 2025.