Human Immunodeficiency VirusNCT05619497
The OPENS Trial: Offering Women PrEP (Aim 2)
A study testing Clinic-wide Trainings and Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST) in people with Human Immunodeficiency Virus and Human Immunodeficiency Virus Transmission, run by University of California, San Francisco at 1 site in United States.
Trial summary
To address the significant barriers to pre-exposure prophylaxis (PrEP) implementation for cisgender women and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Human Immunodeficiency Virus Transmission, Sexually Transmitted Diseases
- What is being tested?
- Clinic-wide Trainings and Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 1 Nov 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identify as a woman (regardless of pregnancy status)
- Age 18 years - 45 years
- Not known to be living with HIV (based on self-report)
- English speaking
- Interested in participating in the study
Who cannot join
- Unable to consent
- Currently using PrEP
- Those who were assigned male at birth and self-identify as a man
- Unwilling to be contacted in 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Department of Health, Duval County
Jacksonville, Florida, 32211
About this study
Official title: Offering Women PrEP With Education and Shared Decision-making (Aim 2)
To address the significant barriers to pre-exposure prophylaxis (PrEP) implementation for cisgender women and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. This study is the second part (Aim 2) of a multi-component project and involves a patient- and clinic-level intervention in a public health reproductive health clinic and an STI clinic in Duval County Florida, where most patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed 1) a tablet-based decision support tool (DST) that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV, and 2) clinic-wide trainings regarding shared decision making and trauma informed care. In Aim 1 (previously completed), participants were randomized to viewing an HIV prevention DST in a clinic that had not received clinic-wide trainings. In Aim 2 (the present study), there will be two phases. In the first phase, participants will receive care at the clinics following training; the DST will not be used. In the second phase, in addition to being seen at a clinic-site that has experienced the training, participants will use the DST before their visit. Participants will be surveyed about experiences with HIV prevention counseling, intentions about using HIV prevention, and DST use (among those in the active arm in the second phase). A subset of participants, individuals who self-identify as Black or Latinx, will also complete a post-clinic visit interview. The investigators will assess whether participants initiated an HIV prevention method three months following their initial visit. The main outcomes will include a quantitative and qualitative assessment of PrEP or other HIV prevention use, decisional certainty, and satisfaction with information about HIV prevention options.
Read the detailed description
Although 13% of the U.S. female population is Black, 60% of new HIV diagnoses in U.S. women occur among Black women. The South is the epicenter of the U.S. HIV epidemic, including in women, and Black Southern women are disproportionately affected: Black women account for 69% of new HIV diagnoses in women in the South. As the first highly effective, discrete, woman-controlled HIV prevention method, oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine radically expands HIV prevention options for women. However, uptake of PrEP in U.S. women has lagged, particularly among groups most affected by HIV.
PrEP cascades outline the necessary steps for accessing PrEP, including screening and identifying eligible individuals, linkage to care, prescription, and initiation of PrEP. Data suggest there are multilevel barriers related to the process of screening for HIV risk in women and identifying potential PrEP candidates that may drive a significant drop off early in the PrEP cascade for women. Women report feeling judged by risk assessment questions and experience stigma around disclosing sexual practices. As a result, if screening is required to educate patients about PrEP - as is true in most clinical settings - many women for whom PrEP is appropriate may never learn about PrEP. Further, women have low levels of knowledge about HIV risk and HIV prevention options, and therefore will not seek out PrEP services themselves. Lastly, there is often limited time to educate patients in busy clinics. By offering education to all women about vulnerabilities to HIV as well as information about HIV prevention methods including PrEP, at-risk women can circumvent these multifactorial barriers and request PrEP. Electronic decision support tools (DST), which have been used with success in a range of healthcare contexts including contraception, provide an efficient and private mechanism for this information-sharing step.
The study team developed a tablet-based tool that is designed to provide universal PrEP education and facilitate women's agency to identify their own risks and interest in PrEP. It was refined with iterative feedback from patient and community stakeholders and finalized based on cognitive testing.
The DST provides information about vulnerabilities to HIV, and emphasizes the variable and individual nature of baseline risk. It provides information on the core characteristics of different HIV prevention methods, and then the opportunity to explore these characteristics in depth, including efficacy, safety and side effects. The user chooses the level of information that they wish to receive through the interactive interface, allowing for an individualized experience. Upon reaching the end of the tool, information on the tablet suggests that women ask their provider about HIV prevention methods they are interested in using, based on their preferences for method characteristics, and their questions to facilitate deliberation with the provider. The DST takes approximately 10 minutes to complete. A decision support tool was chosen as a key component of the study following its proven effectiveness in offering contraceptive options to patients. The HIV prevention DST was tested in Aim 1 of this study: participants were randomized to viewing the DST or not, prior to receiving usual care.
Additionally, the study team recognizes the importance of receiving health information from a trusted source, such as health care providers or health educators, when making important health decisions. Therefore, this study (Aim 2) will offer and assess the effects of a combined intervention of the DST following a clinic-wide training on shared decision making and trauma-informed care. Shared decision making is an effective strategy to offer information and services to patients as it allows the health care provider to share their clinical knowledge and expertise while partnering with the patient to elicit their experiential knowledge, needs and preferences. Through partnership between a patient and provider, the patient can make an informed decision about HIV prevention and other health needs that align with their values and desires and can result in greater adherence to the prevention or treatment options and satisfaction with care. The training will also include information about trauma-informed approaches to deliver health care in a person-centered and affirming manner. This training will highlight how many people, particularly those vulnerable to HIV due to intersecting oppressions, carry traumas that impact their exposure to health issues and the resources needed to mitigate these harms. It is critical that health care providers and health professionals are aware of intersecting forms of oppression that create trauma, including those that the medical profession create and perpetuate. A combined approach of shared decision making at the interpersonal level and trauma informed care at the clinic-level is an equity-oriented strategy to offering HIV prevention information to women in the Southeastern U.S. who are disproportionately impacted by HIV.
Approximately 366 individuals who self-identify as women presenting to a reproductive health clinic and an STI clinic in Duval County, Florida, will be recruited to the study in Aim 2, with 183 enrolled in each of the two phases. As the decision support tool is primarily focused on cisgender women, participants who do not identify as cisgender will be included in the study, but their study data will be analyzed separately. In the first phase of Aim 2 of the study, participants will receive care as usual at a clinic site after the trainings have been held for staff. In the second phase of Aim 2, participants will receive care at this same clinic that has been exposed to the training and will also view the HIV prevention DST. These participants will be compared to those recruited in Aim 1 of this study, in which participants accessed care from the same clinic prior to clinic-wide trainings, and half of participants viewed the HIV prevention DST.
In addition to these interventions, a subset of up to 80 participants (40 per phase) will be asked to allow audio-recording of their counseling sessions with a provider. A subset of up to 80 additional participants (40 per phase), all of whom self-identify as women of color, will be invited to complete one-hour, semi-structured interviews after their clinic visit about their experiences of using the DST, HIV prevention counseling, and decision making about PrEP. Those who participated in Aim 1, are not excluded from participating in Aim 2 however, they will not be eligible to participate in an interview.
Hypotheses:
- Women who receive care at a clinic following clinic-wide trainings on shared decision making and trauma informed care are more likely to initiate PrEP as compared to women who received care at the same clinic prior to training.
- In a clinic that received clinic-wide trainings in shared decision making and trauma informed care, women who use the HIV prevention decision support tool are more likely to initiate PrEP as compared to women who did not use the tool.
- Women who receive care at a clinic following clinic-wide training on shared decision making and trauma informed care and who also used the decision support tool are more likely to initiate PrEP as compared to women who receive care at the same clinic prior to training and did not use the tool.
- Women who receive care at a clinic following clinic-wide trainings on shared decision making and trauma informed care and who also used the decision support tool are more likely to initiate PrEP as compared to those who receive care at the same clinic prior to training and used the DST.
- Conditions
- Human Immunodeficiency Virus, Human Immunodeficiency Virus Transmission, Sexually Transmitted Diseases
- Being tested
- Clinic-wide Trainings, Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST)
- Keywords
- Pre-exposure prophylaxis (PrEP), HIV prevention behaviors, HIV prevention methods, HIV education, African American, Latina, women of color, Shared decision making, Shared decision-making, Decision making, shared, Trauma informed care, Trauma-informed care, Patient decision support, Patient decision aid, Public health clinic, Health department clinic, Southeastern U.S.
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-wide TrainingsOther
The clinic-wide trainings combine principles of shared decision-making and trauma informed care to inform providers and clinic staff of an equitable approach to offering HIV prevention information. These care delivery approaches have been used in health education and counseling in a range of contexts and are effective strategies for care provision. Participants in this arm will receive care from providers and staff who received training.
Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST)Other
The clinic-wide trainings combine principles of shared decision-making and trauma informed care to inform providers and clinic staff of an equitable approach to offering HIV prevention information. These care delivery approaches have been used in health education and counseling in a range of contexts and are effective strategies for care provision. Participants in this arm will receive care from providers and staff who received training.
The DST is founded on principles of decision-science and will address barriers to PrEP delivery. The DST will present HIV prevention information through a tablet in the clinical setting. The tool provides information about vulnerabilities to HIV and core characteristics of different HIV prevention methods, and the opportunity to explore these characteristics in depth, including efficacy, safety and side effects. The tool emphasizes the highly variable and individual nature of baseline risk.
| Study group | Role | What they receive |
|---|---|---|
| Care Post Clinic-Wide Trainings | Active comparator | Participants in this arm will receive care in a clinic where providers and staff have been trained in shared decision making and trauma-informed care. Participants in this arm will not view the decision support tool in this phase. Receives: Other: Clinic-wide Trainings |
| Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST) | Experimental | Participants in this arm will receive care in a clinic where providers and staff have been trained in shared decision making and trauma informed care, and receive the HIV prevention DST intervention immediately before their provider visit. Receives: Other: Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Prescriptions (As Measured by Chart Review)
The number of participants who received a PrEP prescription within 3 months of their index clinical visit, obtained by chart extraction from the medical record. Outcome is dichotomous (Yes, received a PrEP prescription at initial visit/No, did not receive a PrEP prescription at initial visit).
Measured: 3 months post clinical visit
Secondary outcomes (25)
Number of Patients Reporting PrEP Use
Patients will be contacted at follow-up and asked if they took PrEP in the past 3 months regardless of where it was obtained. Outcome is dichotomous ("Yes", initiated PrEP within 3 months of index visit/"No", did not initiate PrEP within 3 months of index visit)
Measured: 3 months post clinical visit
Change in Patient-Perceived HIV Risk
We will measure the change in HIV risk perception from pre- to post- index clinical visit. Response options include 4-point scale: 1 ("Not at all worried") to 4 ("Extremely worried"). Used to varify reports of change in worry over time. No independent estimates of effect performed.
Measured: Immediately preceding clinical visit compared to immediately following clinical visit
Patient-Perceived HIV Risk
Participants will be asked about how worried they are about getting HIV in the next 6 months. Response options include 4-point scale of 1 ("Not at all worried") to 4 ("Extremely worried").
Measured: Immediately post clinical visit
PrEP Knowledge
Percentage of participants selecting the correct response to three questions. Response options for each item are different. Higher score represents higher knowledge.
Measured: Immediately post clinical visit
Decisional Conflict - Total Score
16-item scale to measure decisional conflict. Response options range from 1-5 "strongly disagree" to "strongly agree". Mean score will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [no decisional conflict' to 100 [extremely high decisional conflict].Higher scores represent high decisional conflict.
Measured: Immediately post clinical visit
Decisional Conflict - Uncertainty Subscore
Three items from the Decisional Conflict scale will measure uncertainty: "I am clear about the best choice for me", "I feel sure about what to choose", and "the decision is easy for me to make". Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [feels extremely certain about best choice] to 100 [feels extremely uncertain about decision]. Higher scores represent greater decision uncertainty.
Measured: Immediately post clinical visit
Decisional Conflict - Informed Subscore
Three items from the Decisional Conflict scale will measure the informed subscale: "I know which options are available to me", "I know the benefits of each option", and "I know the risks and side effects of each option". Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [feels extremely informed] to 100 [feels extremely uninformed]. Higher scores represent a greater degree of feeling uninformed.
Measured: Immediately post clinical visit
Decisional Conflict - Values Clarity Subscore
Three items from the Decisional Conflict scale will measure values clarity: "I am clear about which benefits matter the most to me", "I am clear about which risks and side effects matter most to me", and "I am clear about which is more important to me (the benefits or the risks and side effects." Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [feels extremely clear about personal values for benefits and risks/side effects] to 100 [feels extremely unclear about personal values].
Measured: Immediately post clinical visit
Decisional Conflict - Support Subscore
Three items from the Decisional Conflict scale will measure support: "I have enough support from others to make a choice", "I am choosing without pressure from others", and "I have enough advice to make a choice". Response options range from 1-5 "strongly disagree" to "strongly agree". Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [feels extremely supported in decision making] to 100 [feels extremely unsupported in decision making].
Measured: Immediately post clinical visit
Decisional Conflict - Effective Decision Subscore
Four items from the Decisional Conflict scale will measure effective decision: "I feel I have made an informed choice", "my decision shows what is important to me", "I expect to stick with my decision", and "I am satisfied with my decision". Response options range from 1-5 strongly disagree to strongly agree. Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [good decision] to 100 [bad decision].
Measured: Immediately post clinical visit
Interpersonal Quality of HIV Prevention Care
Median score of 4-item scale. Derived from the Person-Centered Contraceptive Care measure developed by the PI. Response options consist of 5-point Likert scale: 1 ("strongly disagree") to 5 ("strongly agree"). Minimum possible score is 0 and maximum possible score is 20, with higher scores indicating better care. Scores will be dichotomized between 20 [excellent interpersonal quality of care] and less than 20 [poor interpersonal quality of care].
Measured: Immediately post clinical visit
Interpersonal Quality of Health Services
Median score of 4-item scale. Derived from the Person-Centered Contraceptive Counseling measure developed by the PI. Response options consist of 5-point Likert scale: 1 ("strongly disagree") to 5 ("strongly agree"). Minimum possible score is 0 and maximum possible score is 20, with higher scores indicating better care. Scores will be dichotomized between 20 [excellent interpersonal quality of care] and less than 20 [poor interpersonal quality of care]. This measure will exclude HIV prevention care and focus on other services offered.
Measured: Immediately post clinical visit
Intention to Use Any HIV Prevention Method
A one time, one item measure of plan to use HIV prevention method after the initial visit. Participants can select from "none", condoms, PrEP, PEP, treatment as prevention, regular HIV testing (inclusive of partner), "still thinking about my options", or other method.
Measured: Immediately post clinical visit
Confidence in Decision to Use an HIV Prevention Method
A one-time, one-item measure of certainty of plan to use HIV prevention after the initial visit. Participants can select from four options: 1 ("completely unsure"), 2 ("mostly unsure"), 3 ("mostly sure, but not 100%"), or 4 ("100% sure"). Presented as the percentage who reported being "fully sure" about HIV prevention method. Reporting here the percent who reported high confidence.
Measured: Immediately post clinical visit
Satisfaction With Information Received About HIV Prevention
Participants will be asked a one-time question regarding satisfaction with HIV prevention counseling. Response options include: 1 ("I was not given any information about HIV), 2 ("Very unsatisfied") 3 ("Somewhat unsatisfied), 4 ("Neither satisfied or unsatisfied"), 5 ("Somewhat satisfied") and 6 ("Very satisfied").
Measured: Immediately post clinical visit
Perceived Quality of Information Received About HIV Prevention
Participants will also be asked four questions about the perceived quality of the HIV prevention information patients received during their health care visit: 1) getting the information they needed, 2) the ease of understanding the information, 3) the trustworthiness of the information, and 4), the usefulness of the information. These questions will be asked of those who reported talking about HIV/HIV prevention during their visit with the healthcare provider or health educator OR those who talked to the healthcare provider or health educator about your chances of getting HIV. Response options are 1 to 5 "strongly disagree" to "strongly agree". Higher values indicate greater perceived quality. Recorded here are percentage of participants who "strongly agreed" with each statement.
Measured: Immediately post clinical visit
Perceived Quality of Health Information Received
Participants will also be asked four questions about the perceived quality of the health information patients received during their health care visit, excluding HIV prevention information: 1) getting the information they needed, 2) the ease of understanding the information, 3) the trustworthiness of the information, and 4), the usefulness of the information. These questions will be asked of those who reported talking about alcohol or drugs, intimate partner violence or abuse, pregnancy, contraception or birth control, STDs (not including HIV) or STD prevention, or other, during their visit with the healthcare provider or health educator. Response options are 1 to 5 "strongly disagree" to "strongly agree". Higher values indicate greater perceived quality.
Measured: Immediately post clinical visit
Acceptability of HIV Prevention Methods
Participants are asked to rate their preference for a method (even if they never used it). Participants can select from condoms, PrEP, PEP, treatment as prevention or other method. The option, "never heard of it" is also included. Options for this scale range from 0 ("Terrible method for me") to 10 ("Great method for me"). Recorded here is percent of participants who responded "great for me" to each item
Measured: Immediately post clinical visit
Acceptability of the Decision Support Tool
Participants who used the DST in the second phase of the study are asked four questions about their experiences using the DST (e.g., degree to which they got all the information they needed, found the information to be easy to understand, trust the information, and found information useful). Response items vary from strongly disagree to strongly agree. Reported here are the percentage of the participants who reported "strongly agree" to each item.
Measured: Immediately post clinical visit
Perception of the Decision Support Tool
Participants who used the DST in the second phase of the study will be asked about the degree to which they liked/disliked the tool. Response options vary: "I did not like it at all", "I somewhat liked it", "I somewhat liked it", or "I really liked it".
Measured: Immediately post clinical visit
Satisfaction With the Decision Support Tool
Participants who used the DST in the second phase of the study will be asked about the degree to which they are satisfied with the information in the tool. Response options vary from 1-5: "very unsatisfied" to "very satisfied".
Measured: Immediately post clinical visit
Recommend the Decision Support Tool
Participants who used the DST in the second phase of the study will be asked about whether they would recommend the decision support tool to a friend. Response options are "yes", "no", and "unsure".
Measured: Immediately post clinical visit
Willingness to Use the Decision Support Tool at Future Visits
Participants who used the DST in the second phase of the study will be asked about whether they would use the tool again if they returned to the clinic. Response options are "yes", "no", and "unsure"
Measured: Immediately post clinical visit
HIV Prevention Method Use (Any Method - Planned or New Method)
A self-reported measure of HIV prevention method use, including those who reported discontinuing the initial HIV prevention method(s) that were reported post-clinic visit. This item will be measured by a response of "yes" to any of the following questions: since your [baseline] visit, have you used....for HIV prevention - abstinence, condoms, PEP, PrEP, regular HIV testing, treatment as prevention, regular sexually transmitted disease (STD) testing, or other method. The outcome will be dichotomized to those who responded affirmatively vs other responses ("no"/"unsure").
Measured: 3 months post clinical visit
HIV Prevention Method Continuation
A self-reported measure of HIV prevention method continuation. This item will be measured by a response of "yes" to any of the following questions: are you still using - abstinence, condoms, PEP, PrEP, regular HIV testing, treatment as prevention, regular sexually transmitted disease (STD) testing, or other method. The outcome will be dichotomized to those who responded "yes" vs "no".
Measured: 3 months post clinical visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start2 Dec 2022
- Primary completion8 Oct 2024
- Study completion1 Nov 2024
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 Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Christine Dehlendorf, MD, MAS, Principal investigator, University of California, San FranciscoAkilah Pope, MD, Principal investigator, Florida Department of Health, Duval County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619497
- Sponsor's protocol ID
- IRB # 2020-014-FDOH
- Other IDs
- 3R01MD013565
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2022
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Offering Women PrEP With Education and Shared Decision-making (Aim 2)
- ClinicalTrials.gov ID
- NCT05619497
- Acronym / sponsor ID
- IRB # 2020-014-FDOH
- Conditions
- Human Immunodeficiency Virus, Human Immunodeficiency Virus Transmission, Sexually Transmitted Diseases
- Keywords
- Pre-exposure prophylaxis (PrEP), HIV prevention behaviors, HIV prevention methods, HIV education, African American, Latina, women of color, Shared decision making, Shared decision-making, Decision making, shared
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Florida Department of Health, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To address the significant barriers to pre-exposure prophylaxis (PrEP) implementation for cisgender women and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. This study is the second part (Aim 2) of a multi-component project and involves a patient- and clinic-level intervention in a public health reproductive health clinic and an STI clinic in Duval County Florida, where most patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed 1) a tablet-based decision support tool (DST) that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV, and 2) clinic-wide trainings regarding shared decision making and trauma informed care. In Aim 1 (previously completed), participants were randomized to viewing an HIV prevention DST in a clinic that had not received clinic-wide trainings. In Aim 2 (the present study), there will be two phases. In the first phase, participants will receive care at the clinics following training; the DST will not be used. In the second phase, in addition to being seen at a clinic-site that has experienced the training, participants will use the DST before their visit. Participants will be surveyed about experiences with HIV prevention counseling, intentions about using HIV prevention, and DST use (among those in the active arm in the second phase). A subset of participants, individuals who self-identify as Black or Latinx, will also complete a post-clinic visit interview. The investigators will assess whether participants initiated an HIV prevention method three months following their initial visit. The main outcomes will include a quantitative and qualitative assessment of PrEP or other HIV prevention use, decisional certainty, and satisfaction with information about HIV prevention options.
Detailed description
Although 13% of the U.S. female population is Black, 60% of new HIV diagnoses in U.S. women occur among Black women. The South is the epicenter of the U.S. HIV epidemic, including in women, and Black Southern women are disproportionately affected: Black women account for 69% of new HIV diagnoses in women in the South. As the first highly effective, discrete, woman-controlled HIV prevention method, oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine radically expands HIV prevention options for women. However, uptake of PrEP in U.S. women has lagged, particularly among groups most affected by HIV.
PrEP cascades outline the necessary steps for accessing PrEP, including screening and identifying eligible individuals, linkage to care, prescription, and initiation of PrEP. Data suggest there are multilevel barriers related to the process of screening for HIV risk in women and identifying potential PrEP candidates that may drive a significant drop off early in the PrEP cascade for women. Women report feeling judged by risk assessment questions and experience stigma around disclosing sexual practices. As a result, if screening is required to educate patients about PrEP - as is true in most clinical settings - many women for whom PrEP is appropriate may never learn about PrEP. Further, women have low levels of knowledge about HIV risk and HIV prevention options, and therefore will not seek out PrEP services themselves. Lastly, there is often limited time to educate patients in busy clinics. By offering education to all women about vulnerabilities to HIV as well as information about HIV prevention methods including PrEP, at-risk women can circumvent these multifactorial barriers and request PrEP. Electronic decision support tools (DST), which have been used with success in a range of healthcare contexts including contraception, provide an efficient and private mechanism for this information-sharing step.
The study team developed a tablet-based tool that is designed to provide universal PrEP education and facilitate women's agency to identify their own risks and interest in PrEP. It was refined with iterative feedback from patient and community stakeholders and finalized based on cognitive testing.
The DST provides information about vulnerabilities to HIV, and emphasizes the variable and individual nature of baseline risk. It provides information on the core characteristics of different HIV prevention methods, and then the opportunity to explore these characteristics in depth, including efficacy, safety and side effects. The user chooses the level of information that they wish to receive through the interactive interface, allowing for an individualized experience. Upon reaching the end of the tool, information on the tablet suggests that women ask their provider about HIV prevention methods they are interested in using, based on their preferences for method characteristics, and their questions to facilitate deliberation with the provider. The DST takes approximately 10 minutes to complete. A decision support tool was chosen as a key component of the study following its proven effectiveness in offering contraceptive options to patients. The HIV prevention DST was tested in Aim 1 of this study: participants were randomized to viewing the DST or not, prior to receiving usual care.
Additionally, the study team recognizes the importance of receiving health information from a trusted source, such as health care providers or health educators, when making important health decisions. Therefore, this study (Aim 2) will offer and assess the effects of a combined intervention of the DST following a clinic-wide training on shared decision making and trauma-informed care. Shared decision making is an effective strategy to offer information and services to patients as it allows the health care provider to share their clinical knowledge and expertise while partnering with the patient to elicit their experiential knowledge, needs and preferences. Through partnership between a patient and provider, the patient can make an informed decision about HIV prevention and other health needs that align with their values and desires and can result in greater adherence to the prevention or treatment options and satisfaction with care. The training will also include information about trauma-informed approaches to deliver health care in a person-centered and affirming manner. This training will highlight how many people, particularly those vulnerable to HIV due to intersecting oppressions, carry traumas that impact their exposure to health issues and the resources needed to mitigate these harms. It is critical that health care providers and health professionals are aware of intersecting forms of oppression that create trauma, including those that the medical profession create and perpetuate. A combined approach of shared decision making at the interpersonal level and trauma informed care at the clinic-level is an equity-oriented strategy to offering HIV prevention information to women in the Southeastern U.S. who are disproportionately impacted by HIV.
Approximately 366 individuals who self-identify as women presenting to a reproductive health clinic and an STI clinic in Duval County, Florida, will be recruited to the study in Aim 2, with 183 enrolled in each of the two phases. As the decision support tool is primarily focused on cisgender women, participants who do not identify as cisgender will be included in the study, but their study data will be analyzed separately. In the first phase of Aim 2 of the study, participants will receive care as usual at a clinic site after the trainings have been held for staff. In the second phase of Aim 2, participants will receive care at this same clinic that has been exposed to the training and will also view the HIV prevention DST. These participants will be compared to those recruited in Aim 1 of this study, in which participants accessed care from the same clinic prior to clinic-wide trainings, and half of participants viewed the HIV prevention DST.
In addition to these interventions, a subset of up to 80 participants (40 per phase) will be asked to allow audio-recording of their counseling sessions with a provider. A subset of up to 80 additional participants (40 per phase), all of whom self-identify as women of color, will be invited to complete one-hour, semi-structured interviews after their clinic visit about their experiences of using the DST, HIV prevention counseling, and decision making about PrEP. Those who participated in Aim 1, are not excluded from participating in Aim 2 however, they will not be eligible to participate in an interview.
Hypotheses:
- Women who receive care at a clinic following clinic-wide trainings on shared decision making and trauma informed care are more likely to initiate PrEP as compared to women who received care at the same clinic prior to training.
- In a clinic that received clinic-wide trainings in shared decision making and trauma informed care, women who use the HIV prevention decision support tool are more likely to initiate PrEP as compared to women who did not use the tool.
- Women who receive care at a clinic following clinic-wide training on shared decision making and trauma informed care and who also used the decision support tool are more likely to initiate PrEP as compared to women who receive care at the same clinic prior to training and did not use the tool.
- Women who receive care at a clinic following clinic-wide trainings on shared decision making and trauma informed care and who also used the decision support tool are more likely to initiate PrEP as compared to those who receive care at the same clinic prior to training and used the DST.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Post Clinic-Wide Trainings | Active comparator | Other: Clinic-wide TrainingsParticipants in this arm will receive care in a clinic where providers and staff have been trained in shared decision making and trauma-informed care. Participants in this arm will not view the decision support tool in this phase. |
| Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST) | Experimental | Other: Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST)Participants in this arm will receive care in a clinic where providers and staff have been trained in shared decision making and trauma informed care, and receive the HIV prevention DST intervention immediately before their provider visit. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Self-identify as a woman (regardless of pregnancy status)
- Age 18 years - 45 years
- Not known to be living with HIV (based on self-report)
- English speaking
- Interested in participating in the study
Key exclusion criteria (4 listed)
- Unable to consent
- Currently using PrEP
- Those who were assigned male at birth and self-identify as a man
- Unwilling to be contacted in 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 |
|---|---|---|
| Clinic-wide TrainingsThe clinic-wide trainings combine principles of shared decision-making and trauma informed care to inform providers and clinic staff of an equitable approach to offering HIV prevention information. These care delivery approaches have been used in health education and counseling in a range of contexts and are effective strategies for care provision. Participants in this arm will receive care from providers and staff who received training. | Other | Care Post Clinic-Wide Trainings |
| Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST)The clinic-wide trainings combine principles of shared decision-making and trauma informed care to inform providers and clinic staff of an equitable approach to offering HIV prevention information. These care delivery approaches have been used in health education and counseling in a range of contexts and are effective strategies for care provision. Participants in this arm will receive care from providers and staff who received training. The DST is founded on principles of decision-science and will address barriers to PrEP delivery. The DST will present HIV prevention information through a tablet in the clinical setting. The tool provides information about vulnerabilities to HIV and core characteristics of different HIV prevention methods, and the opportunity to explore these characteristics in depth, including efficacy, safety and side effects. The tool emphasizes the highly variable and individual nature of baseline risk. | Other | Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST) |
Primary outcome
PrEP Prescriptions (As Measured by Chart Review)
Time frame: 3 months post clinical visit
The number of participants who received a PrEP prescription within 3 months of their index clinical visit, obtained by chart extraction from the medical record. Outcome is dichotomous (Yes, received a PrEP prescription at initial visit/No, did not receive a PrEP prescription at initial visit).
25 secondary outcomes
Number of Patients Reporting PrEP Use
Time frame: 3 months post clinical visit
Change in Patient-Perceived HIV Risk
Time frame: Immediately preceding clinical visit compared to immediately following clinical visit
Patient-Perceived HIV Risk
Time frame: Immediately post clinical visit
PrEP Knowledge
Time frame: Immediately post clinical visit
Decisional Conflict - Total Score
Time frame: Immediately post clinical visit
Decisional Conflict - Uncertainty Subscore
Time frame: Immediately post clinical visit
Decisional Conflict - Informed Subscore
Time frame: Immediately post clinical visit
Decisional Conflict - Values Clarity Subscore
Time frame: Immediately post clinical visit
Decisional Conflict - Support Subscore
Time frame: Immediately post clinical visit
Decisional Conflict - Effective Decision Subscore
Time frame: Immediately post clinical visit
Interpersonal Quality of HIV Prevention Care
Time frame: Immediately post clinical visit
Interpersonal Quality of Health Services
Time frame: Immediately post clinical visit
Intention to Use Any HIV Prevention Method
Time frame: Immediately post clinical visit
Confidence in Decision to Use an HIV Prevention Method
Time frame: Immediately post clinical visit
Satisfaction With Information Received About HIV Prevention
Time frame: Immediately post clinical visit
Perceived Quality of Information Received About HIV Prevention
Time frame: Immediately post clinical visit
Perceived Quality of Health Information Received
Time frame: Immediately post clinical visit
Acceptability of HIV Prevention Methods
Time frame: Immediately post clinical visit
Acceptability of the Decision Support Tool
Time frame: Immediately post clinical visit
Perception of the Decision Support Tool
Time frame: Immediately post clinical visit
Satisfaction With the Decision Support Tool
Time frame: Immediately post clinical visit
Recommend the Decision Support Tool
Time frame: Immediately post clinical visit
Willingness to Use the Decision Support Tool at Future Visits
Time frame: Immediately post clinical visit
HIV Prevention Method Use (Any Method - Planned or New Method)
Time frame: 3 months post clinical visit
HIV Prevention Method Continuation
Time frame: 3 months post clinical visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
Christine Dehlendorf, MD, MAS principal investigator
University of California, San Francisco
Akilah Pope, MD principal investigator
Florida Department of Health, Duval County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic-wide Trainings and Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST) in people with Human Immunodeficiency Virus and Human Immunodeficiency Virus Transmission, run by University of California, San Francisco 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: finished, as of the sponsor's last update on 4 Nov 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 4 Nov 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?
PrEP Prescriptions (As Measured by Chart Review) (time frame: 3 months post clinical visit). 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 4 Nov 2026.