Human Immunodeficiency Virus Transmission, Sexually Transmitted Diseases
Conditions
Keywords
Pre-exposure prophylaxis (PrEP), HIV prevention behaviors, HIV prevention methods, HIV education, African American, Latina, women of color, Shared decision making, Decision making, shared, Patient decision support, Patient decision aid
Brief summary
To address the significant barriers to PrEP implementation for those who were assigned female at birth and self-identify as a woman 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 one part of a multi-component project and involves a patient-level intervention in one public health family planning clinic in Duval County Florida, where the majority of patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed a tablet-based decision support tool that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV. Participants will be randomized to use the HIV decision support tool before their visit or standard counseling (without the use of the tool) and will be surveyed about the use of the tool, experiences with HIV prevention counseling, and intentions about the use of HIV prevention. A subset of participants, all individuals who self-identify as a woman and as Black or Latina, will also complete a post-clinic visit interview. The investigators will follow-up with participants at three months following their initial visit to see if they have initiated the HIV prevention method(s) they chose at their 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. Hypotheses: 1. Women who use the HIV prevention decision support tool will be more likely to have initiated PrEP within 3 months compared to women who received standard counseling at the time of their initial appointment. 2. The HIV prevention decision support tool will increase women's knowledge of PrEP and other HIV prevention methods compared to women who received standard counseling at the time of their initial appointment. 3. The HIV prevention decision support tool will increase participants' decisional certainty in their choice of an HIV prevention method compared to women who received standard counseling at the time of their initial appointment.
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. 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 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 in order to facilitate deliberation with the provider. The DST takes approximately 10 minutes to complete. Approximately 200 women presenting to one reproductive health clinic in Duval County, Florida, will be randomized to standard counseling plus use of an HIV prevention DST, providing education about PrEP and encouraging self-assessment of HIV risk, or standard counseling alone. In addition to the experimental intervention, a subset of 40 participants (20 per arm) will be asked to allow audio-recording of their counseling sessions with a provider. A subset of up to 40 additional participants (20 per arm), 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.
Interventions
BEHAVIORALHIV Prevention Decision Support Tool (DST)
The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk.
BEHAVIORALStandard Counseling
Participants in this arm will receive usual care.
Sponsors
Florida Department of Health
National Institute on Minority Health and Health Disparities (NIMHD)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
HIV Prevention Decision Support Tool (DST) - An interactive, tablet-based decision support tool that is designed to help women consider options to reduce their risk of HIV, with emphasis on PrEP as an emerging HIV prevention tool for women.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Self-identify as a woman (regardless of pregnancy status) * Age 18 - 45 years * Not known to be living with HIV (based on self-report) * English-speaking * Interested in participating
Exclusion criteria
* 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 * Already participated in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Prescriptions (As Measured by Chart Review) | 3 months post baseline visit | The number of participants who received a PrEP prescription within 3 months of their baseline visit, obtained by chart extraction from the medical record. Outcome is dichotomous (Yes, received a PrEP prescription /No, did not receive a PrEP prescription). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Perceived HIV Risk | Baseline, pre-intervention compared to immediately post baseline visit | We will measure the change in HIV risk perception in the next 6 months from pre- to post-visit at baseline. Response options include 4-point scale: 1 (Not at all worried) to 4 (Extremely worried). |
| Patient-Perceived HIV Risk | Immediately post baseline visit | 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). |
| PrEP Knowledge | Immediately post baseline visit | Proportion of participants selecting the correct response to knowledge questions. Response options for each item are different. Higher score represents greater knowledge. |
| Decisional Conflict - Total Score | Immediately post baseline visit | Decisional Conflict scale: 16-item scale to measure decisional conflict. 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 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]. Higher scores represent high decisional conflict. |
| Decisional Conflict - Uncertainty Subscore | Immediately post baseline visit | 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. |
| Decisional Conflict - Informed Subscore | Immediately post baseline visit | 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. |
| Decisional Conflict - Values Clarity Subscore | Immediately post baseline visit | 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 \[feels extremely unclear about personal values\]. |
| Decisional Conflict - Support Subscore | Immediately post baseline visit | 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 \[feels extremely unsupported in decision making\]. |
| Decisional Conflict - Effective Decision Subscore | Immediately post baseline visit | 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 \[bad decision\]. |
| Interpersonal Quality of HIV Prevention Care | Immediately post baseline visit | Mean 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). Scores will be dichotomized between 20 \[excellent interpersonal quality of care\] and less than 20 \[poor interpersonal quality of care\]. |
| Intention to Use Any HIV Prevention Method | Immediately post baseline visit | A one-time, one-item measure of plan to use HIV prevention method after the initial visit. Participants can select from none, condoms, PrEP, post exposure prophylaxis (PEP), treatment as prevention, regular HIV testing (inclusive of partner), still thinking about my options, or other method. |
| Number of Patients Reporting PrEP Use | 3 months post baseline 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 initial visit or no, did not initiate PrEP within 3 months of initial visit). |
| Satisfaction With Information Received About HIV Prevention | Immediately post baseline visit | 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). |
| Perceived Quality of Information Received About HIV Prevention | Immediately post baseline visit | Participants will 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 their chances of getting HIV. Response options are 1 to 5 strongly disagree to strongly agree. Higher values indicate greater perceived quality. |
| Acceptability of HIV Prevention Methods | Immediately post baseline visit | Participants are asked to rate their preference for a method (even if they never used it). Participants can select from condoms, PrEP, PEP, partner HIV testing, regular STD testing, 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). |
| Acceptability of the Decision Support Tool | Immediately post baseline visit | Participants 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. |
| Perception of the Decision Support Tool | Immediately post baseline visit | Participants in the experimental arm 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 disliked it, I somewhat liked it, I really liked it. |
| Satisfaction With the Decision Support Tool | Immediately post baseline visit | Participants in the experimental arm will be asked about the degree to which they were satisfied with the information in the tool. Response options vary from 1-5: very unsatisfied to very satisfied. |
| Recommend the Decision Support Tool | Immediately post baseline visit | Participants in the experimental arm will be asked whether they would recommend the tool a friend. Response options are yes, no, unsure. |
| Willingness to Use the Decision Support Tool at Future Visits | Immediately post baseline visit | Participants in the experimental arm will be asked about whether they would use the tool again if they returned to the clinic. Response options are yes, no, unsure. |
| HIV Prevention Method Use (Any Method - Planned or New Method) | 3 months post baseline visit | 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. 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, other method. The outcome will be dichotomized to those who responded affirmatively vs other responses (no/unsure). |
| HIV Prevention Method Continuation | 3 months post baseline visit | A self-reported measure of HIV prevention method continuation. 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, other method. The outcome will be dichotomized to those who responded yes vs no. |
| Confidence in Decision to Use an HIV Prevention Method | Immediately post baseline visit | A one-time, one-item measure of certainty of plan to use HIV prevention after the initial visit. Participants can select from 4 options: 1 (completely unsure), 2 (mostly unsure), 3 (mostly sure, but not 100%), or 4 (100% sure). |
Countries
United States
Participant flow
Recruitment details
Individuals will be handed a flyer about the study and eligibility criteria when they present to the front desk for check in. Interested individuals are then brought back to a private clinic room for an eligibility screening. Eligible individuals will then be enrolled into the study and randomized to either the control or intervention.
Pre-assignment details
3 individuals did not meet inclusion criteria. 4 individuals did not want to participate after learning more about the study.
Participants by arm
| Arm | Count |
|---|---|
| HIV Prevention DST Intervention Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.
HIV Prevention Decision Support Tool (DST): The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk. | 95 |
| Standard Counseling Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care. | 94 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Standard Counseling | Total | HIV Prevention DST Intervention |
|---|---|---|---|
| Age, Customized Age 18-24 years old | 30 Participants | 57 Participants | 27 Participants |
| Age, Customized Age 25-29 years old | 18 Participants | 37 Participants | 19 Participants |
| Age, Customized Age 30-34 years old | 25 Participants | 55 Participants | 30 Participants |
| Age, Customized Age 35-44 years old | 16 Participants | 31 Participants | 15 Participants |
| Age, Customized Age Missing | 5 Participants | 9 Participants | 4 Participants |
| Birth History Missing | 4 Participants | 7 Participants | 3 Participants |
| Birth History Never | 24 Participants | 40 Participants | 16 Participants |
| Birth History Once | 16 Participants | 35 Participants | 19 Participants |
| Birth History Three or more times | 30 Participants | 65 Participants | 35 Participants |
| Birth History Twice | 20 Participants | 42 Participants | 22 Participants |
| Educational Attainment 4-yr college graduate or more | 7 Participants | 11 Participants | 4 Participants |
| Educational Attainment 8th grade or less | 1 Participants | 4 Participants | 3 Participants |
| Educational Attainment < high school diploma | 6 Participants | 19 Participants | 13 Participants |
| Educational Attainment High school graduate | 49 Participants | 93 Participants | 44 Participants |
| Educational Attainment Missing | 1 Participants | 3 Participants | 2 Participants |
| Educational Attainment Some college | 29 Participants | 56 Participants | 27 Participants |
| Educational Attainment Still in high school | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity Hispanic/Latine | 11 Participants | 24 Participants | 13 Participants |
| Ethnicity Missing | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity Not Hispanic/Latine | 82 Participants | 162 Participants | 80 Participants |
| Housing Status Housing insecure | 26 Participants | 47 Participants | 21 Participants |
| Housing Status Missing | 1 Participants | 3 Participants | 2 Participants |
| Housing Status Rent or own | 67 Participants | 139 Participants | 72 Participants |
| Language Spoken at Home English | 88 Participants | 177 Participants | 89 Participants |
| Language Spoken at Home Mandarin | 0 Participants | 1 Participants | 1 Participants |
| Language Spoken at Home Missing | 1 Participants | 3 Participants | 2 Participants |
| Language Spoken at Home Multiple | 5 Participants | 6 Participants | 1 Participants |
| Language Spoken at Home Other | 0 Participants | 1 Participants | 1 Participants |
| Language Spoken at Home Spanish | 0 Participants | 1 Participants | 1 Participants |
| Parental Education 8th grade or less | 4 Participants | 8 Participants | 4 Participants |
| Parental Education College graduate or greater | 11 Participants | 23 Participants | 12 Participants |
| Parental Education High school graduate | 32 Participants | 79 Participants | 47 Participants |
| Parental Education Missing | 1 Participants | 3 Participants | 2 Participants |
| Parental Education Some college | 23 Participants | 41 Participants | 18 Participants |
| Parental Education Some high school | 23 Participants | 35 Participants | 12 Participants |
| Percentage of monogamous participants | 53 Participants | 115 Participants | 62 Participants |
| Percentage of participants who are currently breastfeeding | 5 Participants | 7 Participants | 2 Participants |
| Percentage of participants who are currently pregnant | 13 Participants | 17 Participants | 4 Participants |
| Percentage of participants who are currently trying to get pregnant | 3 Participants | 8 Participants | 5 Participants |
| Percentage of participants who are currently using or plan to use condoms as contraception | 34 Participants | 70 Participants | 36 Participants |
| Percentage of participants who are using or plan to use most/moderately effectively contraception | 60 Participants | 130 Participants | 70 Participants |
| Percentage of participants who engaged in binge drinking weekly or more frequently, past 6 months | 9 Participants | 15 Participants | 6 Participants |
| Percentage of participants who had anal sex, past 6 months | 7 Participants | 15 Participants | 8 Participants |
| Percentage of participants who had condomless vaginal sex, past 6 months | 61 Participants | 125 Participants | 64 Participants |
| Percentage of participants who have been to jail or prison, ever | 23 Participants | 40 Participants | 17 Participants |
| Percentage of participants who have experienced domestic violence, ever | 7 Participants | 16 Participants | 9 Participants |
| Percentage of participants who have experienced hunger, past year | 10 Participants | 21 Participants | 11 Participants |
| Percentage of participants who have injected drugs, ever | 3 Participants | 4 Participants | 1 Participants |
| Percentage of participants who have used illicit substances, ever | 6 Participants | 7 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American/Black | 72 Participants | 143 Participants | 71 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Missing | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Mixed race or multiracial | 4 Participants | 9 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 14 Participants | 28 Participants | 14 Participants |
| Relationship Status In a relationship with more than one person | 2 Participants | 5 Participants | 3 Participants |
| Relationship Status In a relationship with one person | 54 Participants | 120 Participants | 66 Participants |
| Relationship Status Missing | 4 Participants | 7 Participants | 3 Participants |
| Relationship Status Not in a relationship | 34 Participants | 57 Participants | 23 Participants |
| Sex/Gender, Customized Gender Female | 91 Participants | 184 Participants | 93 Participants |
| Sex/Gender, Customized Gender Gender non-conforming or non-binary | 2 Participants | 2 Participants | 0 Participants |
| Sex/Gender, Customized Gender Missing | 1 Participants | 3 Participants | 2 Participants |
| STD Diagnosis History Ever Had Chlamydia | 34 Participants | 55 Participants | 21 Participants |
| STD Diagnosis History Ever Had Gonorrhea | 14 Participants | 25 Participants | 11 Participants |
| STD Diagnosis History Ever Had Hepatitis C | 1 Participants | 2 Participants | 1 Participants |
| STD Diagnosis History Ever Had Syphilis | 2 Participants | 2 Participants | 0 Participants |
| STD Diagnosis History Ever Had Trichomonas | 18 Participants | 32 Participants | 14 Participants |
| Yearly Income < $10,000 | 38 Participants | 79 Participants | 41 Participants |
| Yearly Income $10,000-$19,999 | 24 Participants | 48 Participants | 24 Participants |
| Yearly Income $20,000-$29,999 | 15 Participants | 30 Participants | 15 Participants |
| Yearly Income $30,000-$39,999 | 10 Participants | 15 Participants | 5 Participants |
| Yearly Income Missing | 1 Participants | 3 Participants | 2 Participants |
| Yearly Income Over $40,000 | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 94 |
| other Total, other adverse events | 0 / 95 | 0 / 94 |
| serious Total, serious adverse events | 0 / 95 | 0 / 94 |
Outcome results
Primary
PrEP Prescriptions (As Measured by Chart Review)
The number of participants who received a PrEP prescription within 3 months of their baseline visit, obtained by chart extraction from the medical record. Outcome is dichotomous (Yes, received a PrEP prescription /No, did not receive a PrEP prescription).
Time frame: 3 months post baseline visit
Population: All participants who completed study activities at T1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Prevention DST Intervention | PrEP Prescriptions (As Measured by Chart Review) | 1 Participants |
| Standard Counseling | PrEP Prescriptions (As Measured by Chart Review) | 0 Participants |
p-value: 0.51Fisher Exact
Secondary
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, partner HIV testing, regular STD testing, 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).
Time frame: Immediately post baseline visit
Population: participants who completed immediate post-visit survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Prevention DST Intervention | Acceptability of HIV Prevention Methods | PEP (great method for me) | 18 Participants |
| HIV Prevention DST Intervention | Acceptability of HIV Prevention Methods | HIV Testing (great method for me) | 48 Participants |
| HIV Prevention DST Intervention | Acceptability of HIV Prevention Methods | Condoms (great method for me) | 35 Participants |
| HIV Prevention DST Intervention | Acceptability of HIV Prevention Methods | STD Tesating (great method for me) | 47 Participants |
| HIV Prevention DST Intervention | Acceptability of HIV Prevention Methods | PrEP (great method for me) | 19 Participants |
| HIV Prevention DST Intervention | Acceptability of HIV Prevention Methods | Treatment as prevention (great method for me) | 24 Participants |
| HIV Prevention DST Intervention | Acceptability of HIV Prevention Methods | Abstinence (great method for me) | 27 Participants |
| Standard Counseling | Acceptability of HIV Prevention Methods | Treatment as prevention (great method for me) | 20 Participants |
| Standard Counseling | Acceptability of HIV Prevention Methods | Abstinence (great method for me) | 29 Participants |
| Standard Counseling | Acceptability of HIV Prevention Methods | Condoms (great method for me) | 40 Participants |
| Standard Counseling | Acceptability of HIV Prevention Methods | PEP (great method for me) | 14 Participants |
| Standard Counseling | Acceptability of HIV Prevention Methods | PrEP (great method for me) | 14 Participants |
| Standard Counseling | Acceptability of HIV Prevention Methods | HIV Testing (great method for me) | 48 Participants |
| Standard Counseling | Acceptability of HIV Prevention Methods | STD Tesating (great method for me) | 48 Participants |
Comparison: Testing proportion of acceptability of abstinence method (proportion that responded great for me)p-value: 0.74Chi-squared
Comparison: Testing proportion of acceptability of condoms method (proportion that responded great for me)p-value: 0.59Chi-squared
Comparison: Testing proportion of acceptability of PEP method (proportion that responded great for me)p-value: 0.66Chi-squared
Comparison: Testing proportion of acceptability of PrEP method (proportion that responded great for me)p-value: 0.49Chi-squared
Comparison: Testing proportion of acceptability of HIV testing method (proportion that responded great for me)p-value: 0.94Chi-squared
Comparison: Testing proportion of acceptability of STD testing method (proportion that responded great for me)p-value: 0.95Chi-squared
Comparison: Testing proportion of acceptability of Treatment as prevention method (proportion that responded great for me)p-value: 0.39Chi-squared
Secondary
Acceptability of the Decision Support Tool
Participants 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.
Time frame: Immediately post baseline visit
Population: group randomized to the DST
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Prevention DST Intervention | Acceptability of the Decision Support Tool | Got all of the information I need from the DST (strongly agree or agree) | 82 Participants |
| HIV Prevention DST Intervention | Acceptability of the Decision Support Tool | Information on the DST was easy to understand (strongly agree or agree) | 81 Participants |
| HIV Prevention DST Intervention | Acceptability of the Decision Support Tool | I trusted the information on the DST (strongly agree or agree) | 83 Participants |
| HIV Prevention DST Intervention | Acceptability of the Decision Support Tool | The information felt helpful to me (strongly agree or agree) | 71 Participants |
| Standard Counseling | Acceptability of the Decision Support Tool | The information felt helpful to me (strongly agree or agree) | 0 Participants |
| Standard Counseling | Acceptability of the Decision Support Tool | Got all of the information I need from the DST (strongly agree or agree) | 0 Participants |
| Standard Counseling | Acceptability of the Decision Support Tool | I trusted the information on the DST (strongly agree or agree) | 0 Participants |
| Standard Counseling | Acceptability of the Decision Support Tool | Information on the DST was easy to understand (strongly agree or agree) | 0 Participants |
Secondary
Change in Patient-Perceived HIV Risk
We will measure the change in HIV risk perception in the next 6 months from pre- to post-visit at baseline. Response options include 4-point scale: 1 (Not at all worried) to 4 (Extremely worried).
Time frame: Baseline, pre-intervention compared to immediately post baseline visit
Population: Participants who completed post-visit survey.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Prevention DST Intervention | Change in Patient-Perceived HIV Risk | No Change | 77 Participants |
| HIV Prevention DST Intervention | Change in Patient-Perceived HIV Risk | Increased Worry | 9 Participants |
| HIV Prevention DST Intervention | Change in Patient-Perceived HIV Risk | Decreased Worry | 6 Participants |
| Standard Counseling | Change in Patient-Perceived HIV Risk | No Change | 85 Participants |
| Standard Counseling | Change in Patient-Perceived HIV Risk | Increased Worry | 3 Participants |
| Standard Counseling | Change in Patient-Perceived HIV Risk | Decreased Worry | 2 Participants |
p-value: 0.207Fisher Exact
Secondary
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 4 options: 1 (completely unsure), 2 (mostly unsure), 3 (mostly sure, but not 100%), or 4 (100% sure).
Time frame: Immediately post baseline visit
Population: participants who completed immediate post-visit survey
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | PEP | I feel mostly sure | 3 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Abstinence | I feel completely unsure | 1 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | PEP | I feel 100% sure | 15 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Condoms | I feel completely unsure | 1 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Regular HIV testing | I feel completely unsure | 0 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | PrEP | I feel mostly unsure | 1 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Regular HIV testing | I feel mostly unsure | 2 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Condoms | I feel mostly unsure | 0 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Regular HIV testing | I feel mostly sure | 3 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Abstinence | I feel mostly unsure | 2 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Regular HIV testing | I feel 100% sure | 74 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Condoms | I feel mostly sure | 18 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Regular STD testing | I feel completely unsure | 0 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | PrEP | I feel 100% sure | 10 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Regular STD testing | I feel mostly unsure | 3 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Condoms | I feel 100% sure | 58 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Regular STD testing | I feel mostly sure | 7 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Abstinence | I feel mostly sure | 9 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Regular STD testing | I feel 100% sure | 72 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | PEP | I feel completely unsure | 1 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Treatment as prevention | I feel completely unsure | 1 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | PrEP | I feel mostly sure | 6 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Treatment as prevention | I feel mostly unsure | 1 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | PEP | I feel mostly unsure | 1 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Treatment as prevention | I feel mostly sure | 4 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Abstinence | I feel 100% sure | 26 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | Treatment as prevention | I feel 100% sure | 28 Participants |
| HIV Prevention DST Intervention | Confidence in Decision to Use an HIV Prevention Method | PrEP | I feel completely unsure | 2 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Treatment as prevention | I feel 100% sure | 19 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | PrEP | I feel completely unsure | 2 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | PrEP | I feel mostly unsure | 2 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | PrEP | I feel mostly sure | 4 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | PrEP | I feel 100% sure | 7 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Abstinence | I feel completely unsure | 1 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Abstinence | I feel mostly unsure | 4 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Abstinence | I feel mostly sure | 6 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Abstinence | I feel 100% sure | 28 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Condoms | I feel completely unsure | 2 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Condoms | I feel mostly unsure | 3 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Condoms | I feel mostly sure | 12 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Condoms | I feel 100% sure | 59 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | PEP | I feel completely unsure | 3 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | PEP | I feel mostly unsure | 1 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | PEP | I feel mostly sure | 5 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | PEP | I feel 100% sure | 8 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Regular HIV testing | I feel completely unsure | 3 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Regular HIV testing | I feel mostly unsure | 2 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Regular HIV testing | I feel mostly sure | 4 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Regular HIV testing | I feel 100% sure | 71 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Regular STD testing | I feel completely unsure | 2 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Regular STD testing | I feel mostly unsure | 2 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Regular STD testing | I feel mostly sure | 3 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Regular STD testing | I feel 100% sure | 75 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Treatment as prevention | I feel completely unsure | 1 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Treatment as prevention | I feel mostly unsure | 4 Participants |
| Standard Counseling | Confidence in Decision to Use an HIV Prevention Method | Treatment as prevention | I feel mostly sure | 0 Participants |
Comparison: Comparing confidence between treatment groups of those who said they intended to use PrEPp-value: 0.9Fisher Exact
Comparison: Comparing confidence between treatment groups of those who said they intended to use abstinencep-value: 0.75Fisher Exact
Comparison: Comparing confidence between treatment groups of those who said they intended to use PEPp-value: 0.32Fisher Exact
Comparison: Comparing confidence between treatment groups of those who said they intended to use HIV testingp-value: 0.4Fisher Exact
Comparison: Comparing confidence between treatment groups of those who said they intended to use STD testingp-value: 0.34Fisher Exact
Comparison: Comparing confidence between treatment groups of those who said they intended to use Treatment as Preventionp-value: 0.1Fisher Exact
Secondary
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 \[bad decision\].
Time frame: Immediately post baseline visit
Population: Participants who completed immediate post-visit survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HIV Prevention DST Intervention | Decisional Conflict - Effective Decision Subscore | 16.7 units on a scale |
| Standard Counseling | Decisional Conflict - Effective Decision Subscore | 0 units on a scale |
Comparison: Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.p-value: 0.1Chi-squared
Secondary
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.
Time frame: Immediately post baseline visit
Population: Participants who completed immediate post-visit survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HIV Prevention DST Intervention | Decisional Conflict - Informed Subscore | 0 units on a scale |
| Standard Counseling | Decisional Conflict - Informed Subscore | 0 units on a scale |
Comparison: Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.p-value: 0.05Chi-squared
Secondary
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 \[feels extremely unsupported in decision making\].
Time frame: Immediately post baseline visit
Population: Participants who completed immediate post-visit survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HIV Prevention DST Intervention | Decisional Conflict - Support Subscore | 6.3 units on a scale |
| Standard Counseling | Decisional Conflict - Support Subscore | 0 units on a scale |
Comparison: Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.p-value: 0.07Chi-squared
Secondary
Decisional Conflict - Total Score
Decisional Conflict scale: 16-item scale to measure decisional conflict. 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 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]. Higher scores represent high decisional conflict.
Time frame: Immediately post baseline visit
Population: Participants who completed post-visit survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HIV Prevention DST Intervention | Decisional Conflict - Total Score | 10 units on a scale |
| Standard Counseling | Decisional Conflict - Total Score | 0 units on a scale |
Comparison: Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.p-value: 0.04Chi-squared
Secondary
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.
Time frame: Immediately post baseline visit
Population: Participants who completed immediate post-visit survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HIV Prevention DST Intervention | Decisional Conflict - Uncertainty Subscore | 16.7 units on a scale |
| Standard Counseling | Decisional Conflict - Uncertainty Subscore | 0 units on a scale |
Comparison: Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.p-value: 0.02Chi-squared
Secondary
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 \[feels extremely unclear about personal values\].
Time frame: Immediately post baseline visit
Population: Participants who completed immediate post-visit survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HIV Prevention DST Intervention | Decisional Conflict - Values Clarity Subscore | 12.5 units on a scale |
| Standard Counseling | Decisional Conflict - Values Clarity Subscore | 0 units on a scale |
Comparison: Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.p-value: 0.03Chi-squared
Secondary
HIV Prevention Method Continuation
A self-reported measure of HIV prevention method continuation. 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, other method. The outcome will be dichotomized to those who responded yes vs no.
Time frame: 3 months post baseline visit
Population: participants who completed 3-month follow-up survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Prevention DST Intervention | HIV Prevention Method Continuation | 53 Participants |
| Standard Counseling | HIV Prevention Method Continuation | 48 Participants |
p-value: 0.08Fisher Exact
Secondary
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. 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, other method. The outcome will be dichotomized to those who responded affirmatively vs other responses (no/unsure).
Time frame: 3 months post baseline visit
Population: participants who completed 3-month follow-up survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Prevention DST Intervention | HIV Prevention Method Use (Any Method - Planned or New Method) | 53 Participants |
| Standard Counseling | HIV Prevention Method Use (Any Method - Planned or New Method) | 49 Participants |
p-value: 0.13Fisher Exact
Secondary
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, post exposure prophylaxis (PEP), treatment as prevention, regular HIV testing (inclusive of partner), still thinking about my options, or other method.
Time frame: Immediately post baseline visit
Population: participants who completed immediate post-visit survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Prevention DST Intervention | Intention to Use Any HIV Prevention Method | Any method | 88 Participants |
| HIV Prevention DST Intervention | Intention to Use Any HIV Prevention Method | Abstinence | 38 Participants |
| HIV Prevention DST Intervention | Intention to Use Any HIV Prevention Method | Condoms | 77 Participants |
| HIV Prevention DST Intervention | Intention to Use Any HIV Prevention Method | PEP | 20 Participants |
| HIV Prevention DST Intervention | Intention to Use Any HIV Prevention Method | PrEP | 19 Participants |
| HIV Prevention DST Intervention | Intention to Use Any HIV Prevention Method | Regular HIV testing | 79 Participants |
| HIV Prevention DST Intervention | Intention to Use Any HIV Prevention Method | Regular STD testing | 82 Participants |
| HIV Prevention DST Intervention | Intention to Use Any HIV Prevention Method | Treatment as prevention | 58 Participants |
| Standard Counseling | Intention to Use Any HIV Prevention Method | Treatment as prevention | 66 Participants |
| Standard Counseling | Intention to Use Any HIV Prevention Method | Any method | 87 Participants |
| Standard Counseling | Intention to Use Any HIV Prevention Method | PrEP | 15 Participants |
| Standard Counseling | Intention to Use Any HIV Prevention Method | Abstinence | 39 Participants |
| Standard Counseling | Intention to Use Any HIV Prevention Method | Regular STD testing | 82 Participants |
| Standard Counseling | Intention to Use Any HIV Prevention Method | Condoms | 77 Participants |
| Standard Counseling | Intention to Use Any HIV Prevention Method | Regular HIV testing | 80 Participants |
| Standard Counseling | Intention to Use Any HIV Prevention Method | PEP | 17 Participants |
p-value: 0.51Fisher Exact
Secondary
Interpersonal Quality of HIV Prevention Care
Mean 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). Scores will be dichotomized between 20 \[excellent interpersonal quality of care\] and less than 20 \[poor interpersonal quality of care\].
Time frame: Immediately post baseline visit
Population: Participants who completed immediate post-visit survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV Prevention DST Intervention | Interpersonal Quality of HIV Prevention Care | 17.2 units on a scale | Standard Deviation 4.9 |
| Standard Counseling | Interpersonal Quality of HIV Prevention Care | 16.9 units on a scale | Standard Deviation 5.3 |
Comparison: Given strong negative skew of responses, transformed into a binary variable comparing those with highest possible score versus higher score. Data then tested through tests of proportions.p-value: 0.22Chi-squared
Secondary
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 initial visit or no, did not initiate PrEP within 3 months of initial visit).
Time frame: 3 months post baseline visit
Population: Participants who completed one-month follow up survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Prevention DST Intervention | Number of Patients Reporting PrEP Use | 1 Participants |
| Standard Counseling | Number of Patients Reporting PrEP Use | 1 Participants |
p-value: 0.62Fisher Exact
Secondary
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).
Time frame: Immediately post baseline visit
Population: Participants who completed baseline survey.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Prevention DST Intervention | Patient-Perceived HIV Risk | Extremely worried | 2 Participants |
| HIV Prevention DST Intervention | Patient-Perceived HIV Risk | Very worried | 4 Participants |
| HIV Prevention DST Intervention | Patient-Perceived HIV Risk | A little worried | 11 Participants |
| HIV Prevention DST Intervention | Patient-Perceived HIV Risk | Not at all worried | 75 Participants |
| Standard Counseling | Patient-Perceived HIV Risk | Not at all worried | 72 Participants |
| Standard Counseling | Patient-Perceived HIV Risk | Extremely worried | 4 Participants |
| Standard Counseling | Patient-Perceived HIV Risk | A little worried | 13 Participants |
| Standard Counseling | Patient-Perceived HIV Risk | Very worried | 1 Participants |
p-value: 0.496Fisher Exact
Secondary
Perceived Quality of Information Received About HIV Prevention
Participants will 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 their chances of getting HIV. Response options are 1 to 5 strongly disagree to strongly agree. Higher values indicate greater perceived quality.
Time frame: Immediately post baseline visit
Population: participants who completed immediate post-visit survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Prevention DST Intervention | Perceived Quality of Information Received About HIV Prevention | I got all the information I needed (strongly agree) | 35 Participants |
| HIV Prevention DST Intervention | Perceived Quality of Information Received About HIV Prevention | Information was easy to understand (strongly agree) | 37 Participants |
| HIV Prevention DST Intervention | Perceived Quality of Information Received About HIV Prevention | Trusted the information given (strongly agree) | 35 Participants |
| HIV Prevention DST Intervention | Perceived Quality of Information Received About HIV Prevention | Found the information useful (strongly agree) | 33 Participants |
| Standard Counseling | Perceived Quality of Information Received About HIV Prevention | Found the information useful (strongly agree) | 31 Participants |
| Standard Counseling | Perceived Quality of Information Received About HIV Prevention | I got all the information I needed (strongly agree) | 31 Participants |
| Standard Counseling | Perceived Quality of Information Received About HIV Prevention | Trusted the information given (strongly agree) | 32 Participants |
| Standard Counseling | Perceived Quality of Information Received About HIV Prevention | Information was easy to understand (strongly agree) | 31 Participants |
Comparison: Comparing proportions in response to prompt The information was easy to understandp-value: 0.26Fisher Exact
Comparison: Comparing proportions in response to prompt: I got all of the information I neededp-value: 0.26Fisher Exact
p-value: 0.59Fisher Exact
Comparison: Comparing proportions in response to prompt: The information felt useful to mep-value: 0.17Fisher Exact
Secondary
Perception of the Decision Support Tool
Participants in the experimental arm 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 disliked it, I somewhat liked it, I really liked it.
Time frame: Immediately post baseline visit
Population: Group randomized to DST
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Prevention DST Intervention | Perception of the Decision Support Tool | I really liked it | 66 Participants |
| HIV Prevention DST Intervention | Perception of the Decision Support Tool | I somewhat liked it | 18 Participants |
| HIV Prevention DST Intervention | Perception of the Decision Support Tool | I somewhat disliked it | 1 Participants |
| Standard Counseling | Perception of the Decision Support Tool | I really liked it | 0 Participants |
Secondary
PrEP Knowledge
Proportion of participants selecting the correct response to knowledge questions. Response options for each item are different. Higher score represents greater knowledge.
Time frame: Immediately post baseline visit
Population: Participants who completed immediate post-visit survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Prevention DST Intervention | PrEP Knowledge | PrEP side effects do not last forever | 51 Participants |
| HIV Prevention DST Intervention | PrEP Knowledge | PrEP will not work if taken once a week | 30 Participants |
| HIV Prevention DST Intervention | PrEP Knowledge | A baby could be born to HIV discordant parents without transmitting HIV | 46 Participants |
| HIV Prevention DST Intervention | PrEP Knowledge | PrEP is a daily pill to prevent HIV | 54 Participants |
| HIV Prevention DST Intervention | PrEP Knowledge | There is medication that you can take after sex to prevent HIV (PEP) | 51 Participants |
| HIV Prevention DST Intervention | PrEP Knowledge | PrEP does not prevent STDs other than HIV | 51 Participants |
| HIV Prevention DST Intervention | PrEP Knowledge | PrEP efficacy is > 95% | 43 Participants |
| HIV Prevention DST Intervention | PrEP Knowledge | PrEP is for all adults | 75 Participants |
| Standard Counseling | PrEP Knowledge | PrEP efficacy is > 95% | 49 Participants |
| Standard Counseling | PrEP Knowledge | PrEP is a daily pill to prevent HIV | 37 Participants |
| Standard Counseling | PrEP Knowledge | PrEP will not work if taken once a week | 16 Participants |
| Standard Counseling | PrEP Knowledge | PrEP does not prevent STDs other than HIV | 32 Participants |
| Standard Counseling | PrEP Knowledge | PrEP side effects do not last forever | 23 Participants |
| Standard Counseling | PrEP Knowledge | A baby could be born to HIV discordant parents without transmitting HIV | 31 Participants |
| Standard Counseling | PrEP Knowledge | There is medication that you can take after sex to prevent HIV (PEP) | 21 Participants |
| Standard Counseling | PrEP Knowledge | PrEP is for all adults | 58 Participants |
Comparison: Test comparing proportion correctly identifying PrEP is a daily pill to prevent HIVp-value: 0.02Chi-squared
Comparison: Test comparing proportion correctly responding to prompt: PrEP is for all adultsp-value: 0.01Chi-squared
Comparison: Test comparing proportion who correctly identified: PrEP will not work if taken once a weekp-value: <0.01Chi-squared
Comparison: Test of proportion who correctly identified PrEP does not prevent STDs other than HIVp-value: <0.01Chi-squared
Comparison: Test comparing proportion who correctly identified, PrEP side effects do not last foreverp-value: <0.01Chi-squared
Comparison: Test comparing proportion who correctly identified, A baby could be norm to HIV discordant parents without transmitting HIVp-value: 0.03Chi-squared
Comparison: Test comparing proportion who correctly identified There is medication you can take after sex to prevent HIVp-value: <0.01Chi-squared
Comparison: Test for proportion who correctly identified PrEP efficacy is \> 95%p-value: 0.29Chi-squared
Secondary
Recommend the Decision Support Tool
Participants in the experimental arm will be asked whether they would recommend the tool a friend. Response options are yes, no, unsure.
Time frame: Immediately post baseline visit
Population: Group randomized to the DST
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Prevention DST Intervention | Recommend the Decision Support Tool | 81 Participants |
| Standard Counseling | Recommend the Decision Support Tool | 0 Participants |
Secondary
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).
Time frame: Immediately post baseline visit
Population: participants who completed immediate post-visit survey
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Prevention DST Intervention | Satisfaction With Information Received About HIV Prevention | Very satisfied | 77 Participants |
| HIV Prevention DST Intervention | Satisfaction With Information Received About HIV Prevention | Somewhat satisfied | 9 Participants |
| HIV Prevention DST Intervention | Satisfaction With Information Received About HIV Prevention | Neither satisfied nor unsatisfied | 3 Participants |
| HIV Prevention DST Intervention | Satisfaction With Information Received About HIV Prevention | Somewhat unsatisfied | 1 Participants |
| HIV Prevention DST Intervention | Satisfaction With Information Received About HIV Prevention | Very unsatisfied | 2 Participants |
| HIV Prevention DST Intervention | Satisfaction With Information Received About HIV Prevention | I was not given information about HIV prevention | 0 Participants |
| Standard Counseling | Satisfaction With Information Received About HIV Prevention | Very unsatisfied | 1 Participants |
| Standard Counseling | Satisfaction With Information Received About HIV Prevention | Very satisfied | 60 Participants |
| Standard Counseling | Satisfaction With Information Received About HIV Prevention | Somewhat unsatisfied | 1 Participants |
| Standard Counseling | Satisfaction With Information Received About HIV Prevention | Somewhat satisfied | 10 Participants |
| Standard Counseling | Satisfaction With Information Received About HIV Prevention | I was not given information about HIV prevention | 9 Participants |
| Standard Counseling | Satisfaction With Information Received About HIV Prevention | Neither satisfied nor unsatisfied | 9 Participants |
p-value: 0.01Chi-squared
Secondary
Satisfaction With the Decision Support Tool
Participants in the experimental arm will be asked about the degree to which they were satisfied with the information in the tool. Response options vary from 1-5: very unsatisfied to very satisfied.
Time frame: Immediately post baseline visit
Population: Group randomized to the DST
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Prevention DST Intervention | Satisfaction With the Decision Support Tool | Somewhat satisfied | 10 Participants |
| HIV Prevention DST Intervention | Satisfaction With the Decision Support Tool | Very satisfied | 69 Participants |
| HIV Prevention DST Intervention | Satisfaction With the Decision Support Tool | Neither satisfied nor unsatisfied | 5 Participants |
| HIV Prevention DST Intervention | Satisfaction With the Decision Support Tool | Very unsatisfied | 1 Participants |
| HIV Prevention DST Intervention | Satisfaction With the Decision Support Tool | Missing | 7 Participants |
| Standard Counseling | Satisfaction With the Decision Support Tool | Very satisfied | 0 Participants |
Secondary
Willingness to Use the Decision Support Tool at Future Visits
Participants in the experimental arm will be asked about whether they would use the tool again if they returned to the clinic. Response options are yes, no, unsure.
Time frame: Immediately post baseline visit
Population: Group randomized to the DST
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Prevention DST Intervention | Willingness to Use the Decision Support Tool at Future Visits | 63 Participants |
| Standard Counseling | Willingness to Use the Decision Support Tool at Future Visits | 0 Participants |