Trial Outcomes & Findings for Supporting Tailored And Responsive PrEP in Rural North Carolina (NCT NCT05984030)
NCT ID: NCT05984030
Last Updated: 2025-08-15
Results Overview
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
COMPLETED
NA
17 participants
3 months
2025-08-15
Participant Flow
Prospective participants deemed study-eligible are required to complete the following before being randomized and enrolled in the study: (1) informational video, (2) informed consent, (3) HIPAA authorization, (4) baseline survey. To continue study participation, participants must receive baseline HIV testing and be confirmed seronegative within 45 days of completing the pre-screening questionnaire. Participants who do not verify HIV-negative status within that 45-day window are study-stopped.
Participant milestones
| Measure |
STARR NC Intervention Condition
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
Intervention Arm participants will complete baseline and quarterly follow-up assessments, and two Dried Blood Spot self-collection kits at 3 and 6 months.
PrEP Navigation Services: 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. Navigation services will be available to participants for the first 6 months of participation.
Telehealth PrEP Services Referral: PrEP Navigators can link intervention arm participants to pre-existing telehealth PrEP services via self-referral. 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 - Enhanced: The Enhanced version includes all features from the Basic version, plus the following: Interactive skill-building health activities; social support newsfeed/group chat; Ask the Expert anonymous health question and answer; Medication Tracker; Health Behavior Tracker.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
|
Overall Study
COMPLETED
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Supporting Tailored And Responsive PrEP in Rural North Carolina
Baseline characteristics by cohort
| Measure |
STARR NC Intervention Condition
n=7 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
Intervention Arm participants will complete baseline and quarterly follow-up assessments, and two Dried Blood Spot self-collection kits at 3 and 6 months.
PrEP Navigation Services: 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. Navigation services will be available to participants for the first 6 months of participation.
Telehealth PrEP Services Referral: PrEP Navigators can link intervention arm participants to pre-existing telehealth PrEP services via self-referral. 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 - Enhanced: The Enhanced version includes all features from the Basic version, plus the following: Interactive skill-building health activities; social support newsfeed/group chat; Ask the Expert anonymous health question and answer; Medication Tracker; Health Behavior Tracker.
|
STARR NC Standard-of-Care Control Condition
n=10 Participants
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.
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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsProportion 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
Outcome measures
| Measure |
STARR NC Intervention Condition
n=6 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=10 Participants
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.
|
|---|---|---|
|
Proportion of Participants Reporting PrEP Initiation by 3 Months
|
0.33 proportion of participants
|
0.10 proportion of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 16 participants enrolled who were followed through study completion, 12 participants were enrolled before 10/01/2024 and eligible for 6 months of follow-up.
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
Outcome measures
| Measure |
STARR NC Intervention Condition
n=4 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=8 Participants
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.
|
|---|---|---|
|
Proportion of Participants Reporting PrEP Initiation by 6 Months
|
0.50 proportion of participants
|
0.13 proportion of participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All available data are reported. Of the 16 participants enrolled who were followed through study completion, only 3 participants initiated PrEP over the first 3 months. The 2 intervention PrEP initiators had available PrEP refill data, while the 1 control participant PrEP initiator did not.
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
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=1 Participants
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.
|
|---|---|---|
|
Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 3 Months
|
0.50 proportion of participants
|
0.00 proportion of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All available data are collected. Of the 12 participants who enrolled before 10/01/2024 and were eligible for 6 months of follow-up, only 3 initiated PrEP in the first 6 months. One of the two intervention participants had available PrEP refill data. The control participant PrEP initiator did not have available PrEP refill data.
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
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=1 Participants
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.
|
|---|---|---|
|
Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 6 Months
|
0.00 proportion of participants
|
0.00 proportion of participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Of the 16 participants enrolled who were followed through study completion, only 3 participants initiated PrEP in the 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.
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=1 Participants
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.
|
|---|---|---|
|
Average Number of Consecutive Months PrEP Used Over First 3 Months
|
1.76 months
Standard Deviation 0.21
|
3.29 months
Standard Deviation NA
No standard deviation can be calculated as only one participant is contributing data for this metric.
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 12 participants who enrolled before 10/01/2024 and were eligible for 6 months of follow-up, only 3 participants initiated PrEP.
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
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=1 Participants
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.
|
|---|---|---|
|
Average Number of Consecutive Months PrEP Used Over First 6 Months
|
1.34 months
Standard Deviation 0.79
|
3.29 months
Standard Deviation NA
No standard deviation can be calculated as only one participant is contributing data for this metric.
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Of the 16 participants enrolled who were followed through study completion, only 3 participants initiated PrEP over the first 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.
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=1 Participants
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.
|
|---|---|---|
|
Average Number of Days PrEP Used Among Persons Initiating Daily Oral PrEP in the 30 Days Prior to the 3-month Visit.
|
16.50 days
Standard Deviation 16.26
|
28.00 days
Standard Deviation NA
No standard deviation can be calculated as only one participant is contributing data for this metric
|
SECONDARY outcome
Timeframe: 3-monthsPopulation: Of the 16 participants enrolled who were followed through study completion, none of the participants initiated event-driven oral PrEP.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Of the 16 participants enrolled who were followed through study completion, none of the participants initiated injectable PrEP.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 12 participants who enrolled before 10/01/2024 and were eligible for 6 months of follow-up, 3 participants initiated PrEP, but only 2 of those participants initiated PrEP before 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.
Outcome measures
| Measure |
STARR NC Intervention Condition
n=1 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=1 Participants
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.
|
|---|---|---|
|
Average Number of Days PrEP Used Among Persons Initiating Daily Oral PrEP in the 30 Days Prior to the 6-month Visit.
|
0 Days
Standard Deviation NA
No standard deviation can be calculated as only one participant is contributing data for this metric.
|
0 Days
Standard Deviation NA
No standard deviation can be calculated as only one participant is contributing data for this metric.
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 12 participants enrolled who were enrolled before 10/01/2024 and followed for 6 months, none of the participants initiated event-driven oral PrEP.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 12 participants enrolled who were enrolled before 10/01/2024 and followed for 6 months, none of the participants initiated injectable PrEP.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Of the 16 participants enrolled who were followed through study completion, only 3 participants initiated PrEP over the first 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
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=1 Participants
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.
|
|---|---|---|
|
Proportion of Oral PrEP Initiators With Detected PrEP Concentrations in Blood at 3 Months
|
0.00 proportion of participants
|
0.00 proportion of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 12 participants who enrolled before 10/01/2024 and were eligible for 6 months of follow-up, only 3 participants initiated PrEP in the first 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
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=1 Participants
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.
|
|---|---|---|
|
Proportion of Oral PrEP Initiators With Detected PrEP Concentrations in Blood at 6 Months
|
0.00 proportion of participants
|
0.00 proportion of participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Of the 16 participants enrolled who were followed through study completion, none of the participants initiated injectable PrEP.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 12 participants who enrolled before 10/01/2024 and were eligible for 6 months of follow-up, none of the participants initiated injectable PrEP.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Of the 16 participants enrolled who were followed through study completion, only 2 participants received HIV testing 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
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
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.
|
|---|---|---|
|
Proportion of Participants Who Test Positive for HIV Among Those Tested at or Prior to the 3-month Visit
|
0.00 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 12 participants who enrolled before 10/01/2024 and were eligible for 6 months of follow-up, only 2 participants received HIV testing 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
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
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.
|
|---|---|---|
|
Proportion of Participants Who Test Positive for HIV Among Those Tested at or Prior to the 6-month Visit
|
0.00 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Of the 16 participants enrolled who were followed through study completion, only 2 participants received STI testing 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
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
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.
|
|---|---|---|
|
Proportion of Participants Who Test Positive for an STI Other Than HIV Among Those Tested at or Prior to the 3-month Visit
|
0.00 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 12 participants who enrolled before 10/01/2024 and were eligible for 6 months of follow-up, only 2 participants received STI testing 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.
Outcome measures
| Measure |
STARR NC Intervention Condition
n=2 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
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.
|
|---|---|---|
|
Proportion of Participants Who Test Positive for an STI Other Than HIV Among Those Tested at or Prior to the 6-month Visit
|
0.00 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Of the 16 participants enrolled who were followed through study completion, only 12 participants responded to the 3M PrEP Anticipated Stigma survey questions.
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).
Outcome measures
| Measure |
STARR NC Intervention Condition
n=5 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=7 Participants
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.
|
|---|---|---|
|
Average Self-reported Score on the PrEP Stigma Scale at 3 Months
|
15.80 score on PrEP Stigma Scale
Standard Deviation 3.35
|
16.71 score on PrEP Stigma Scale
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 12 participants enrolled before 10/01/2024 and eligible for 6 months of follow-up, only 8 participants responded to the 6M PrEP Anticipated Stigma survey questions.
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).
Outcome measures
| Measure |
STARR NC Intervention Condition
n=3 Participants
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator; an enhanced version of the Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
|
STARR NC Standard-of-Care Control Condition
n=5 Participants
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.
|
|---|---|---|
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Average Self-reported Score on the PrEP Stigma Scale at 6 Months
|
15.33 score on PrEP Stigma Scale
Standard Deviation 1.53
|
14.8 score on PrEP Stigma Scale
Standard Deviation 4.97
|
Adverse Events
STARR NC Intervention Condition
STARR NC Standard-of-Care Control Condition
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sarah Rutstein, MD, PhD
UNC Institute for Global Health and Infectious Diseases
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place