HIVNCT05614492
Development and Evaluation of a PrEP Decision Aid for Women Seeking Domestic Violence Services in Baltimore
A study testing Individual PrEP Decision Aid, CDC PrEP Video and Shared PrEP Decision Aid in people with HIV and Violence, Gender-Based, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
This study is designed to develop and test an individual decision aid for pre-exposure prophylaxis (PrEP) tailored to Black women who have been exposed to intimate partner violence and are working with a domestic violence service provider. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Violence, Gender-Based, Pre-Exposure Prophylaxis
- What is being tested?
- Individual PrEP Decision Aid, CDC PrEP Video and Shared PrEP Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2023to 31 Jul 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older
- self-identification as cisgender female
- IPV-exposed (i.e., at least one physical, sexual, or psychological IPV victimization experience by a male partner) in the past 12 months
- self-reported HIV negative
- English- and/or Spanish-speaking
- self-identify as Black or African American
Who cannot join
- Currently using PrEP
- Unable to provide consent
- Participated in formative research for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Springboard Community Services - Baltimore City Office
Baltimore, Maryland, 21209
About this study
This study is designed to develop and test an individual decision aid for pre-exposure prophylaxis (PrEP) tailored to Black women who have been exposed to intimate partner violence and are working with a domestic violence service provider. three different ways of delivering the tailored decision aid are being tested: 1) as an individual tool; or 2) as a shared decision-making tool with a domestic violence advocate; as compared to generalized information. The goal of decision aid will be to address key cultural and structural factors affecting these women and can help them gain PrEP awareness and access.
Read the detailed description
Intimate partner violence (IPV)-exposed Black women are often forced to choose between relationship safety and HIV prevention; thus, trauma-, gender-, culturally-responsive HIV prevention interventions are needed for this key priority population. Pre-exposure prophylaxis (PrEP) may be a viable partner-independent option for IPV-exposed Black women, but no study has identified an evidence-based strategy to promote and increase PrEP uptake among this population, specifically IPV-exposed Black women in the South. Guided by the Consolidated Framework for Implementation Research (CFIR), the proposed research aims to adapt, implement and evaluate self- and advocate-administered versions of a PrEP decision aid in a domestic violence agency in Baltimore in order to increase PrEP uptake among Black women in Ending the HIV Epidemic (EtHE) priority areas, address trauma as a barrier to PrEP uptake, and ultimately combat racial disparities in women's HIV cases.
Therefore, this Type II hybrid effectiveness-implementation study seeks to adapt an existing PrEP decision aid to IPV-exposed Black women seeking domestic violence (DV) services in Baltimore, an EtHE priority state. Self- and advocate-administered versions of the PrEP decision aid will be implemented and the aid will be evaluated using a three-arm randomized trial. The Consolidated Framework for Implementation Research (CFIR) will guide this research. A formative evaluation using qualitative interviews with IPV-exposed Black women (N=10) and DV advocates (N=20) was conducted to adapt the PrEP decision aid. Next, the decision aid will be implemented in a DV agency and 90 IPV-exposed Black women will be randomized to either the self- or advocate-administered versions of the aid, or the control intervention, in order to compare feasibility, acceptability and preliminary effectiveness with baseline, 1-, 3-, and 6-month surveys. Focus groups with DV advocates and participants will assess for implementation process outcomes. This study will: provide support for a PrEP decision aid that addresses HIV prevention for IPV-exposed Black women; use implementation science to increase PrEP uptake; include DV agencies in intervention development and implementation; and improve understanding of PrEP scale-up by addressing implementation factors in settings that serve IPV-exposed Black women.
- Conditions
- HIV, Violence, Gender-Based, Pre-Exposure Prophylaxis
- Being tested
- Individual PrEP Decision Aid, CDC PrEP Video, Shared PrEP Decision Aid
- Keywords
- HIV Prevention, Tenofovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual PrEP Decision AidBehavioural
Also called IDM
Participant engages with the decision support tool designed to optimize PrEP uptake among Black cisgender women who have experienced IPV independently. They also enter data independently.
CDC PrEP VideoBehavioural
Also called Control
A video from the Centers for Disease Control and Prevention that provides basic, general information on PrEP
Shared PrEP Decision AidBehavioural
Also called SDM
Domestic violence service advocate (DVA) engages with the decision support tool designed to optimize PrEP uptake among Black cisgender women who have experienced IPV with the participant and enters data
| Study group | Role | What they receive |
|---|---|---|
| Individual Arm (IDM) | Experimental | Self-administration of the intervention Receives: Behavioral: Individual PrEP Decision Aid |
| Shared Arm (SDM) | Experimental | Advocate-administration of the intervention Receives: Behavioral: Shared PrEP Decision Aid |
| Control Arm (Time and Attention Matched Control) | Active comparator | Self-administration of standard PrEP information from Centers for Disease Control (CDC). Receives: Behavioral: CDC PrEP Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Risk Perception
Perceived HIV risk was assessed using an 8-item Perceived Risk of HIV Scale administered at the beginning and end of engagement with the decision aid. Responses were measured on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Individual item scores were summed to create a total score ranging from 8 to 40, with higher scores indicating greater perceived HIV risk.
Measured: Baseline and 6 months post intervention
Participant's Decisional Preference for PrEP
Single item screening question: "How interested are you in starting PrEP now?" repeated at the beginning and end of engagement with the decision aid, with responses measured on a 5- point Likert scale, with responders specify their level of agreement to the question in five points: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.
Measured: Pre-Decision Aid and Post-Decision Aid
Secondary outcomes (1)
Participant's With PrEP Uptake
defined as participant's having filled a PrEP prescription (by a composite of self-report and pharmacy refill data) and coded as a binary variable.
Measured: 6-Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start10 May 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 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.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Model description
- Parallel: Participants will be assigned to one of three groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Tiara Willie, PhD, MA, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614492
- Sponsor's protocol ID
- IRB00017152
- Other IDs
- R34MH127986-01
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2022
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a PrEP Decision Aid for Women Seeking Domestic Violence Services in Baltimore
- ClinicalTrials.gov ID
- NCT05614492
- Acronym / sponsor ID
- IRB00017152
- Conditions
- HIV, Violence, Gender-Based, Pre-Exposure Prophylaxis
- Keywords
- HIV Prevention, Tenofovir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Yale University, National Institute of Mental Health (NIMH)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Posted 30 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to develop and test an individual decision aid for pre-exposure prophylaxis (PrEP) tailored to Black women who have been exposed to intimate partner violence and are working with a domestic violence service provider. three different ways of delivering the tailored decision aid are being tested: 1) as an individual tool; or 2) as a shared decision-making tool with a domestic violence advocate; as compared to generalized information. The goal of decision aid will be to address key cultural and structural factors affecting these women and can help them gain PrEP awareness and access.
Detailed description
Intimate partner violence (IPV)-exposed Black women are often forced to choose between relationship safety and HIV prevention; thus, trauma-, gender-, culturally-responsive HIV prevention interventions are needed for this key priority population. Pre-exposure prophylaxis (PrEP) may be a viable partner-independent option for IPV-exposed Black women, but no study has identified an evidence-based strategy to promote and increase PrEP uptake among this population, specifically IPV-exposed Black women in the South. Guided by the Consolidated Framework for Implementation Research (CFIR), the proposed research aims to adapt, implement and evaluate self- and advocate-administered versions of a PrEP decision aid in a domestic violence agency in Baltimore in order to increase PrEP uptake among Black women in Ending the HIV Epidemic (EtHE) priority areas, address trauma as a barrier to PrEP uptake, and ultimately combat racial disparities in women's HIV cases.
Therefore, this Type II hybrid effectiveness-implementation study seeks to adapt an existing PrEP decision aid to IPV-exposed Black women seeking domestic violence (DV) services in Baltimore, an EtHE priority state. Self- and advocate-administered versions of the PrEP decision aid will be implemented and the aid will be evaluated using a three-arm randomized trial. The Consolidated Framework for Implementation Research (CFIR) will guide this research. A formative evaluation using qualitative interviews with IPV-exposed Black women (N=10) and DV advocates (N=20) was conducted to adapt the PrEP decision aid. Next, the decision aid will be implemented in a DV agency and 90 IPV-exposed Black women will be randomized to either the self- or advocate-administered versions of the aid, or the control intervention, in order to compare feasibility, acceptability and preliminary effectiveness with baseline, 1-, 3-, and 6-month surveys. Focus groups with DV advocates and participants will assess for implementation process outcomes. This study will: provide support for a PrEP decision aid that addresses HIV prevention for IPV-exposed Black women; use implementation science to increase PrEP uptake; include DV agencies in intervention development and implementation; and improve understanding of PrEP scale-up by addressing implementation factors in settings that serve IPV-exposed Black women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel: Participants will be assigned to one of three groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Individual Arm (IDM) | Experimental | Behavioral: Individual PrEP Decision AidSelf-administration of the intervention |
| Shared Arm (SDM) | Experimental | Behavioral: Shared PrEP Decision AidAdvocate-administration of the intervention |
| Control Arm (Time and Attention Matched Control) | Active comparator | Behavioral: CDC PrEP VideoSelf-administration of standard PrEP information from Centers for Disease Control (CDC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 years or older
- self-identification as cisgender female
- IPV-exposed (i.e., at least one physical, sexual, or psychological IPV victimization experience by a male partner) in the past 12 months
- self-reported HIV negative
- English- and/or Spanish-speaking
Key exclusion criteria (3 listed)
- Currently using PrEP
- Unable to provide consent
- Participated in formative research for this study
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 |
|---|---|---|
| Individual PrEP Decision AidAlso: IDMParticipant engages with the decision support tool designed to optimize PrEP uptake among Black cisgender women who have experienced IPV independently. They also enter data independently. | Behavioural | Individual Arm (IDM) |
| CDC PrEP VideoAlso: ControlA video from the Centers for Disease Control and Prevention that provides basic, general information on PrEP | Behavioural | Control Arm (Time and Attention Matched Control) |
| Shared PrEP Decision AidAlso: SDMDomestic violence service advocate (DVA) engages with the decision support tool designed to optimize PrEP uptake among Black cisgender women who have experienced IPV with the participant and enters data | Behavioural | Shared Arm (SDM) |
Primary outcome
HIV Risk Perception
Time frame: Baseline and 6 months post intervention
Perceived HIV risk was assessed using an 8-item Perceived Risk of HIV Scale administered at the beginning and end of engagement with the decision aid. Responses were measured on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Individual item scores were summed to create a total score ranging from 8 to 40, with higher scores indicating greater perceived HIV risk.
Participant's Decisional Preference for PrEP
Time frame: Pre-Decision Aid and Post-Decision Aid
Single item screening question: "How interested are you in starting PrEP now?" repeated at the beginning and end of engagement with the decision aid, with responses measured on a 5- point Likert scale, with responders specify their level of agreement to the question in five points: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.
1 secondary outcome
Participant's With PrEP Uptake
Time frame: 6-Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Tiara Willie, PhD, MA principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual PrEP Decision Aid, CDC PrEP Video and Shared PrEP Decision Aid in people with HIV and Violence, Gender-Based, run by Johns Hopkins Bloomberg School of Public Health 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 3 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 30 Oct 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?
Yes. Results are posted in the registry (first posted 30 Oct 2026). 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?
HIV Risk Perception (time frame: Baseline and 6 months post intervention). The study lists 2 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 30 Oct 2026.