HIV InfectionsPrEPwiseNCT07398482
PrEPwise Pilot Among Black Women in Eastern Virginia
A study testing PrEPwise in people with HIV Infections and Sexually Transmitted Infection, run by Boston University at 1 site in United States.
Trial summary
HIV is a virus that affects many people, but Black women in the U.S. are a population at a much higher risk of getting it compared to white women-about 18 times higher. Pre-exposure prophylaxis (PrEP), a medicine if taken as recommended by a clinician can prevent HIV almost completely (99% effective). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections, Sexually Transmitted Infection
- What is being tested?
- PrEPwise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2027to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black women seeking HIV testing services at the community HIV testing clinic
- Eligible for PrEP according to CDC guidelines
- Willing to be followed for 3 months
- Able to provide contact information
- Able to provide informed consent
Who cannot join
- Participated in the development of the intervention (provided input in the adaptation of PrEP decision aid)
- Unable to provide informed consent
- Unable to provide contact information
- Currently using PrEP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
LGBT Life Center (5360 Robin Hood Road, Norfolk, VA 23513
Norfolk, Virginia, 23513
Sylvia Shangani, PhD, 617-358-1347, sylvia65@bu.edu
About this study
Official title: Feasibility and Preliminary Effectiveness of PrEPwise Intervention on PrEP Initiation Among Black Women in Eastern Virginia
HIV is a virus that affects many people, but Black women in the U.S. are a population at a much higher risk of getting it compared to white women-about 18 times higher. Pre-exposure prophylaxis (PrEP), a medicine if taken as recommended by a clinician can prevent HIV almost completely (99% effective). The problem is that many Black women, especially those living in the Southern U.S., don't know about this medicine called PrEP or find it hard to access it. To address this, healthcare providers sometimes use "decision aids" which are tools, like brochures or videos, designed to help people understand their medical options and make informed choices based on what's important to them. While these tools have worked well for other health issues, they haven't been widely used for preventing HIV. The challenges are doctors do not have enough time to explain PrEP fully to patients during clinic visits and also some Black women do not trust the healthcare system because of a long history of unfair treatment toward Black communities.
Community health workers (CHWs) are trained health workers from the same communities as their patients and can facilitate their ability to provide culturally appropriate health education and information consistent with patients' values and needs. Because of this, patients are often more comfortable talking to them. This project aims to test the acceptability and effectiveness of a decision tool to be integrated into HIV testing services to help Black women decide if PrEP is right for them. The investigators are calling this intervention PrEPwise. A tool originally designed for women dealing with opioid addiction will be adapted to fit the needs of Black women living in the South. The long-term goal of this project is to make it easier for Black women to learn about PrEP and decide whether to use it, ultimately helping lower the number of new HIV cases in Black women.
Read the detailed description
The study will follow a type-1 effectiveness-implementation hybrid design as a single-site, single-blinded randomized controlled trial. The following procedures detail the study conduct and masking approach:
Baseline Visit:
- Informed consent process
- Collection of demographic information
- Administration of baseline survey assessing: Perceived HIV risk, PrEP knowledge, PrEP attitudes, PrEP stigma, Discrimination/racism experiences, PrEP norms, Decisional conflict, and Self-efficacy
Randomization and Intervention Delivery:
- Random assignment will be conducted at the individual level with 1:1 allocation using random block sizes of 2
- Randomization assignments will be generated through REDCap's randomization module by the study data analyst
- Only participants will be blinded to their study arm assignment. Study staff delivering the intervention cannot be blinded due to the nature of the behavioral intervention
- Participants will be informed they will receive either enhanced or standard HIV prevention information, without specifying their assigned arm
- The research assistant conducting outcome assessments will be different from the staff delivering the intervention
- Immediate post-intervention survey assessing implementation outcomes
- Intervention acceptability
- Intervention feasibility
- Intervention fidelity 3-Month Follow-up Visit:
- Assessment of effectiveness outcomes:
- PrEP initiation status
- PrEP persistence
- Changes in baseline measures
- Collection of pharmacy fill data. At the 3-month follow-up visit, participants will be asked to self-report whether they initiated PrEP and if they obtained refills.
Additional Procedures:
- Qualitative interviews with a subsample (n=20) of participants to explore perspectives about intervention acceptability, fidelity, barriers, and recommendations for adaptations
The research hypothesis is:
Compared to the control arm, the intervention arm will have (1) a higher percentage of Black women initiate PrEP at 3-months, (2) increased PrEP and HIV risk awareness at 3-month follow-up, (3) reduced HIV PrEP stigma, (4) increased trust in healthcare, and (5) Increased decisional certainty in the choice and intention to use PrEP at 3-month follow-up.
- Conditions
- HIV Infections, Sexually Transmitted Infection
- Being tested
- PrEPwise, Usual care
- Keywords
- Pre-Exposure Prophylaxis (PrEP), Community Health Worker (CHW)
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPwiseBehavioural
PrEPwise intervention is a tablet-based PrEP decision aid delivered by community health workers (CHW) to Black women in the context of their regular HIV testing visits. The intervention includes: Tailored PrEP decision aid providing information on HIV risks, PrEP choices, PrEP costs, how to use PrEP, Adherence guidance, side effects, and access points for obtaining PrEP.
Usual careOther
Usual care includes providing general HIV prevention information, basic PrEP information, and information about other available clinic services.
| Study group | Role | What they receive |
|---|---|---|
| PrEPwise (PrEPdecision aid) | Experimental | Participants randomized to this arm who are HIV negative will receive the behavioral intervention PrEPwise at the HIV testing clinic. Receives: Behavioral: PrEPwise |
| Usual care | Active comparator | Participants randomized to this arm will receive usual care including standard HIV testing, general HIV information, prep information and information about other available services. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability to Participants of PrEPwise Intervention
Acceptability will be assessed using the client satisfaction survey (CSQ-8), an 8-item instrument with 4 possible responses for each item (1-4). Total scores range from 8 to 32; higher scores indicating greater satisfaction.
Measured: 3 months
Acceptability to Community Health Workers (CHWs) of PrEPwise Intervention
Acceptability will be assessed using the client satisfaction survey (CSQ-8), an 8-item instrument with 4 possible responses for each item (1-4). Total scores range from 8 to 32; higher scores indicating greater satisfaction.
Measured: 3 months
PrEPwise intervention Feasibility
Feasibility will be assessed though process measures including number of participants contacted, number screened for eligibility, number enrolled, and number lost to follow-up.
Measured: 3 months
PrEPwise Intervention Fidelity
Fidelity will be assessed measured using a 10-item fidelity checklist, completed by participants after intervention delivery. Each item on the checklist indicates whether a specific component was delivered as expected (e.g., "The CHW discussed PrEP side effects with me") Items are scores as "yes=1" or "no=0". Total scores range from 0-10, with higher scores indicating higher fidelity to the intervention protocol.
Measured: 3 months
Secondary outcomes (8)
PrEP initiation
PrEP initiation is defined as having at least one PrEP prescription fill during the 3-month period of the study using pharmacy fill data.
Measured: 3 months
PrEP persistence
PrEP persistence is defined as the length of time that a person continued to refill PrEP prescription without an interruption of more than 30 days. PrEP persistence will be assessed using pharmacy refill data obtained at 3-month follow-up. Participants will be categorized as either PrEP-persistence (refilled prescription within 30 days of the previous fill running out) or PrEP non-persistent (gap of >30 days between refills). This binary outcome indicates whether participants maintained continuous PrEP coverage throughout the 3-month study period
Measured: 3 months
Perceived HIV risk
Perceived HIV risk will be measured using the Centers for Disease Control (CDC) 5-item screening tool to determine PrEP eligibility for heterosexual women. Questions assess behavioral risk factors. These questions are: having a sexual partner who is HIV positive, having condomless sex with partners of unknown status, having a bacterial sexually transmitted infection (STI) in the past 6 months, exchanging sex for money or drugs, and injecting drugs. A "yes" response to any of these questions indicates a risk factor. Participants who respond to one or more items are considered at high HIV risk and meet CDC criteria for PrEP eligibility. Higher numbers indicate greater perceived HIV risk.
Measured: 3 months
PrEP knowledge
PrEP knowledge will be assessed using 13-item knowledge scale developed by Walsh et al. (2019). This scale measures knowledge about PrEP through true/false items covering topics including: what PrEP is, how it works, its effectiveness in preventing HIV, who should use, side effects, and how to access it. Items are scored as correct=1 or incorrect/don't know=0. Total scores range from 0 to 13, with higher scores indicating greater knowledge about PrEP.
Measured: 3 months
PrEP attitude
PrEP attitudes will be assessed using 5-item attitudes scale developed by Walsh et al. (2019). This scale measures attitudes toward PrEP use including perceptions of effectiveness, safety, responsibility, adherence burden, and government safety assurance. Responses are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores re calculated by summing item responses, with higher scores indicating more positive attitudes toward PrEP.
Measured: 3 months
PrEP stigma
PrEP stigma will be assessed using 5-item HIV PrEP Stigma scale developed by Walsh et al. (2020). This scale measures perceptions of stigma associated with PrEP use, including judgments about PrEP users, embarrassment about obtaining PrEP, and concerns about disclosure to friends, family, and sexual partners. Responses are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5(strongly agree). Total scores range from 5-25, with higher scores indicating greater perceived PrEP stigma.
Measured: 3 months
Decisional conflict
Decisional conflict will be assessed using the 16-item Decisional Conflict Scale (DCS) developed by O'Connor (1995). The scale measures uncertainty in decision-making across five subscales: uncertainty, feeling uninformed, unclear values, unsupported in decision-making, and ineffective decision-making. Items are rated on a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree). Items are summed, divided by 16 then multiplied by 25. Score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Measured: 3 months
Intersectional discrimination experiences
Intersectional discrimination experiences. Intersectional discrimination will be assessed using the validated 31-item Intersectional Discrimination Index (InDI) developed by Scheim and Bauer (2019). The index consists of three subscales measuring: 1) anticipated discrimination (9 items), 2) day-to-day discrimination (9 items), and 3) major discrimination experiences (13 items). Participants rate frequency of discrimination experiences, with higher scores indicting greater experiences of discrimination.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startApr 2027 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sylvia Shangani, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398482
- Sponsor's protocol ID
- H-45671
- Other IDs
- 1K01MH136935-01A1
- Acronym
- PrEPwise
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of PrEPwise Intervention on PrEP Initiation Among Black Women in Eastern Virginia
- ClinicalTrials.gov ID
- NCT07398482
- Acronym / sponsor ID
- PrEPwise / H-45671
- Conditions
- HIV Infections, Sexually Transmitted Infection
- Keywords
- Pre-Exposure Prophylaxis (PrEP), Community Health Worker (CHW)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2027 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HIV is a virus that affects many people, but Black women in the U.S. are a population at a much higher risk of getting it compared to white women-about 18 times higher. Pre-exposure prophylaxis (PrEP), a medicine if taken as recommended by a clinician can prevent HIV almost completely (99% effective). The problem is that many Black women, especially those living in the Southern U.S., don't know about this medicine called PrEP or find it hard to access it. To address this, healthcare providers sometimes use "decision aids" which are tools, like brochures or videos, designed to help people understand their medical options and make informed choices based on what's important to them. While these tools have worked well for other health issues, they haven't been widely used for preventing HIV. The challenges are doctors do not have enough time to explain PrEP fully to patients during clinic visits and also some Black women do not trust the healthcare system because of a long history of unfair treatment toward Black communities.
Community health workers (CHWs) are trained health workers from the same communities as their patients and can facilitate their ability to provide culturally appropriate health education and information consistent with patients' values and needs. Because of this, patients are often more comfortable talking to them. This project aims to test the acceptability and effectiveness of a decision tool to be integrated into HIV testing services to help Black women decide if PrEP is right for them. The investigators are calling this intervention PrEPwise. A tool originally designed for women dealing with opioid addiction will be adapted to fit the needs of Black women living in the South. The long-term goal of this project is to make it easier for Black women to learn about PrEP and decide whether to use it, ultimately helping lower the number of new HIV cases in Black women.
Detailed description
The study will follow a type-1 effectiveness-implementation hybrid design as a single-site, single-blinded randomized controlled trial. The following procedures detail the study conduct and masking approach:
Baseline Visit:
- Informed consent process
- Collection of demographic information
- Administration of baseline survey assessing: Perceived HIV risk, PrEP knowledge, PrEP attitudes, PrEP stigma, Discrimination/racism experiences, PrEP norms, Decisional conflict, and Self-efficacy
Randomization and Intervention Delivery:
- Random assignment will be conducted at the individual level with 1:1 allocation using random block sizes of 2
- Randomization assignments will be generated through REDCap's randomization module by the study data analyst
- Only participants will be blinded to their study arm assignment. Study staff delivering the intervention cannot be blinded due to the nature of the behavioral intervention
- Participants will be informed they will receive either enhanced or standard HIV prevention information, without specifying their assigned arm
- The research assistant conducting outcome assessments will be different from the staff delivering the intervention
- Immediate post-intervention survey assessing implementation outcomes
- Intervention acceptability
- Intervention feasibility
- Intervention fidelity 3-Month Follow-up Visit:
- Assessment of effectiveness outcomes:
- PrEP initiation status
- PrEP persistence
- Changes in baseline measures
- Collection of pharmacy fill data. At the 3-month follow-up visit, participants will be asked to self-report whether they initiated PrEP and if they obtained refills.
Additional Procedures:
- Qualitative interviews with a subsample (n=20) of participants to explore perspectives about intervention acceptability, fidelity, barriers, and recommendations for adaptations
The research hypothesis is:
Compared to the control arm, the intervention arm will have (1) a higher percentage of Black women initiate PrEP at 3-months, (2) increased PrEP and HIV risk awareness at 3-month follow-up, (3) reduced HIV PrEP stigma, (4) increased trust in healthcare, and (5) Increased decisional certainty in the choice and intention to use PrEP at 3-month follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEPwise (PrEPdecision aid) | Experimental | Behavioral: PrEPwiseParticipants randomized to this arm who are HIV negative will receive the behavioral intervention PrEPwise at the HIV testing clinic. |
| Usual care | Active comparator | Other: Usual careParticipants randomized to this arm will receive usual care including standard HIV testing, general HIV information, prep information and information about other available services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Black women seeking HIV testing services at the community HIV testing clinic
- Eligible for PrEP according to CDC guidelines
- Willing to be followed for 3 months
- Able to provide contact information
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Participated in the development of the intervention (provided input in the adaptation of PrEP decision aid)
- Unable to provide informed consent
- Unable to provide contact information
- Currently using PrEP
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 |
|---|---|---|
| PrEPwisePrEPwise intervention is a tablet-based PrEP decision aid delivered by community health workers (CHW) to Black women in the context of their regular HIV testing visits. The intervention includes: Tailored PrEP decision aid providing information on HIV risks, PrEP choices, PrEP costs, how to use PrEP, Adherence guidance, side effects, and access points for obtaining PrEP. | Behavioural | PrEPwise (PrEPdecision aid) |
| Usual careUsual care includes providing general HIV prevention information, basic PrEP information, and information about other available clinic services. | Other | Usual care |
Primary outcome
Acceptability to Participants of PrEPwise Intervention
Time frame: 3 months
Acceptability will be assessed using the client satisfaction survey (CSQ-8), an 8-item instrument with 4 possible responses for each item (1-4). Total scores range from 8 to 32; higher scores indicating greater satisfaction.
Acceptability to Community Health Workers (CHWs) of PrEPwise Intervention
Time frame: 3 months
Acceptability will be assessed using the client satisfaction survey (CSQ-8), an 8-item instrument with 4 possible responses for each item (1-4). Total scores range from 8 to 32; higher scores indicating greater satisfaction.
PrEPwise intervention Feasibility
Time frame: 3 months
Feasibility will be assessed though process measures including number of participants contacted, number screened for eligibility, number enrolled, and number lost to follow-up.
PrEPwise Intervention Fidelity
Time frame: 3 months
Fidelity will be assessed measured using a 10-item fidelity checklist, completed by participants after intervention delivery. Each item on the checklist indicates whether a specific component was delivered as expected (e.g., "The CHW discussed PrEP side effects with me") Items are scores as "yes=1" or "no=0". Total scores range from 0-10, with higher scores indicating higher fidelity to the intervention protocol.
8 secondary outcomes
PrEP initiation
Time frame: 3 months
PrEP persistence
Time frame: 3 months
Perceived HIV risk
Time frame: 3 months
PrEP knowledge
Time frame: 3 months
PrEP attitude
Time frame: 3 months
PrEP stigma
Time frame: 3 months
Decisional conflict
Time frame: 3 months
Intersectional discrimination experiences
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvia Shangani, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEPwise in people with HIV Infections and Sexually Transmitted Infection, run by Boston University 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvia Shangani, PhD (617 358 1347, sylvia65@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability to Participants of PrEPwise Intervention (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.