Die OPENS-Studie: Frauen PrEP anbieten (Ziel 2)

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.

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.

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.

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.

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).

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)

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.

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").

Percentage of participants selecting the correct response to three questions. Response options for each item are different. Higher score represents higher knowledge.

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.

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.

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.

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].

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].

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].

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].

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.

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.

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.

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").

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.

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.

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

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.

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".

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".

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".

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"

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").

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".