Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05619497
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2022-11-03
Brief Title:
The OPENS Trial Offering Women PrEP Aim 2
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Offering Women PrEP With Education and Shared Decision-making Aim 2
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 family planning 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 clinic 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 US female population is Black 60 of new HIV diagnoses in US women occur among Black women The South is the epicenter of the US 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 fumarateemtricitabine radically expands HIV prevention options for women However uptake of PrEP in US 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 womens 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 US who are disproportionately impacted by HIV
Approximately 366 individuals who self-identify as women presenting to one reproductive health 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 40 participants 20 per phase will be asked to allow audio-recording of their counseling sessions with a provider A subset of up to 40 additional participants 20 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
1 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
2 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
3 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
4 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
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 womens 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 US who are disproportionately impacted by HIV
Approximately 366 individuals who self-identify as women presenting to one reproductive health 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 40 participants 20 per phase will be asked to allow audio-recording of their counseling sessions with a provider A subset of up to 40 additional participants 20 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
1 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
2 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
3 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
4 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3R01MD013565 | NIH | None | httpsreporternihgovquickSearch3R01MD013565 |