Trial Outcomes & Findings for The OPENS Trial: Offering Women PrEP (Aim 1) (NCT NCT04621760)
NCT ID: NCT04621760
Last Updated: 2024-05-20
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
189 participants
Primary outcome timeframe
3 months post baseline visit
Results posted on
2024-05-20
Participant Flow
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.
3 individuals did not meet inclusion criteria. 4 individuals did not want to participate after learning more about the study.
Participant milestones
| Measure |
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.
|
Standard Counseling
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
94
|
|
Overall Study
COMPLETED
|
92
|
90
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
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.
|
Standard Counseling
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The OPENS Trial: Offering Women PrEP (Aim 1)
Baseline characteristics by cohort
| Measure |
HIV Prevention DST Intervention
n=95 Participants
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.
|
Standard Counseling
n=94 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 18-24 years old
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Customized
Age · 25-29 years old
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Customized
Age · 30-34 years old
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Customized
Age · 35-44 years old
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Customized
Age · Missing
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
93 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Gender non-conforming or non-binary
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American/Black
|
71 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Mixed race or multiracial
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Parental Education
8th grade or less
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Parental Education
Some high school
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Parental Education
High school graduate
|
47 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Parental Education
Some college
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Parental Education
College graduate or greater
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Parental Education
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Yearly Income
< $10,000
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Yearly Income
$10,000-$19,999
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Yearly Income
$20,000-$29,999
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Yearly Income
$30,000-$39,999
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Yearly Income
Over $40,000
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Yearly Income
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Educational Attainment
8th grade or less
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Educational Attainment
Still in high school
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Educational Attainment
< high school diploma
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Educational Attainment
High school graduate
|
44 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Educational Attainment
Some college
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Educational Attainment
4-yr college graduate or more
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Educational Attainment
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity
Hispanic/Latine
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity
Not Hispanic/Latine
|
80 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Ethnicity
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Housing Status
Rent or own
|
72 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Housing Status
Housing insecure
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Housing Status
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Language Spoken at Home
English
|
89 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Language Spoken at Home
Spanish
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Language Spoken at Home
Mandarin
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Language Spoken at Home
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Language Spoken at Home
Multiple
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Language Spoken at Home
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Relationship Status
Not in a relationship
|
23 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Relationship Status
In a relationship with one person
|
66 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Relationship Status
In a relationship with more than one person
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Relationship Status
Missing
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Percentage of monogamous participants
|
62 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Percentage of participants who had condomless vaginal sex, past 6 months
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Percentage of participants who had anal sex, past 6 months
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
STD Diagnosis History
Ever Had Chlamydia
|
21 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
STD Diagnosis History
Ever Had Gonorrhea
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
STD Diagnosis History
Ever Had Hepatitis C
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
STD Diagnosis History
Ever Had Syphilis
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
STD Diagnosis History
Ever Had Trichomonas
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Percentage of participants who have experienced domestic violence, ever
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Percentage of participants who engaged in binge drinking weekly or more frequently, past 6 months
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Percentage of participants who have injected drugs, ever
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Percentage of participants who have used illicit substances, ever
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Percentage of participants who have experienced hunger, past year
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Percentage of participants who have been to jail or prison, ever
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Birth History
Never
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Birth History
Once
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Birth History
Twice
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Birth History
Three or more times
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Birth History
Missing
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Percentage of participants who are currently breastfeeding
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Percentage of participants who are currently pregnant
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Percentage of participants who are currently trying to get pregnant
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Percentage of participants who are currently using or plan to use condoms as contraception
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Percentage of participants who are using or plan to use most/moderately effectively contraception
|
70 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post baseline visitPopulation: All participants who completed study activities at T1
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).
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
PrEP Prescriptions (As Measured by Chart Review)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months post baseline visitPopulation: Participants who completed one-month follow up survey
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).
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=57 Participants
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.
|
Standard Counseling
n=58 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Number of Patients Reporting PrEP Use
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, pre-intervention compared to immediately post baseline visitPopulation: Participants who completed post-visit survey.
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").
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Change in Patient-Perceived HIV Risk
No Change
|
77 Participants
|
85 Participants
|
|
Change in Patient-Perceived HIV Risk
Increased Worry
|
9 Participants
|
3 Participants
|
|
Change in Patient-Perceived HIV Risk
Decreased Worry
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Participants who completed baseline survey.
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").
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Patient-Perceived HIV Risk
Extremely worried
|
2 Participants
|
4 Participants
|
|
Patient-Perceived HIV Risk
Very worried
|
4 Participants
|
1 Participants
|
|
Patient-Perceived HIV Risk
A little worried
|
11 Participants
|
13 Participants
|
|
Patient-Perceived HIV Risk
Not at all worried
|
75 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Participants who completed immediate post-visit survey
Proportion of participants selecting the correct response to knowledge questions. Response options for each item are different. Higher score represents greater knowledge.
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
PrEP Knowledge
PrEP is a daily pill to prevent HIV
|
54 Participants
|
37 Participants
|
|
PrEP Knowledge
PrEP is for all adults
|
75 Participants
|
58 Participants
|
|
PrEP Knowledge
PrEP will not work if taken once a week
|
30 Participants
|
16 Participants
|
|
PrEP Knowledge
PrEP does not prevent STDs other than HIV
|
51 Participants
|
32 Participants
|
|
PrEP Knowledge
PrEP side effects do not last forever
|
51 Participants
|
23 Participants
|
|
PrEP Knowledge
A baby could be born to HIV discordant parents without transmitting HIV
|
46 Participants
|
31 Participants
|
|
PrEP Knowledge
There is medication that you can take after sex to prevent HIV (PEP)
|
51 Participants
|
21 Participants
|
|
PrEP Knowledge
PrEP efficacy is > 95%
|
43 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Participants who completed post-visit survey
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.
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Decisional Conflict - Total Score
|
10 units on a scale
Interval 0.0 to 25.0
|
0 units on a scale
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Participants who completed immediate post-visit survey
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.
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Decisional Conflict - Uncertainty Subscore
|
16.7 units on a scale
Interval 0.0 to 25.0
|
0 units on a scale
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Participants who completed immediate post-visit survey
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.
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Decisional Conflict - Informed Subscore
|
0 units on a scale
Interval 0.0 to 25.0
|
0 units on a scale
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Participants who completed immediate post-visit survey
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 \[feels extremely unclear about personal values\].
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Decisional Conflict - Values Clarity Subscore
|
12.5 units on a scale
Interval 0.0 to 25.0
|
0 units on a scale
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Participants who completed immediate post-visit survey
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 \[feels extremely unsupported in decision making\].
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Decisional Conflict - Support Subscore
|
6.3 units on a scale
Interval 0.0 to 25.0
|
0 units on a scale
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Participants who completed immediate post-visit survey
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 \[bad decision\].
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Decisional Conflict - Effective Decision Subscore
|
16.7 units on a scale
Interval 0.0 to 25.0
|
0 units on a scale
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Participants who completed immediate post-visit survey
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 \[poor interpersonal quality of care\].
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Interpersonal Quality of HIV Prevention Care
|
17.2 units on a scale
Standard Deviation 4.9
|
16.9 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: participants who completed immediate post-visit survey
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.
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Intention to Use Any HIV Prevention Method
Treatment as prevention
|
58 Participants
|
66 Participants
|
|
Intention to Use Any HIV Prevention Method
Any method
|
88 Participants
|
87 Participants
|
|
Intention to Use Any HIV Prevention Method
Abstinence
|
38 Participants
|
39 Participants
|
|
Intention to Use Any HIV Prevention Method
Condoms
|
77 Participants
|
77 Participants
|
|
Intention to Use Any HIV Prevention Method
PEP
|
20 Participants
|
17 Participants
|
|
Intention to Use Any HIV Prevention Method
PrEP
|
19 Participants
|
15 Participants
|
|
Intention to Use Any HIV Prevention Method
Regular HIV testing
|
79 Participants
|
80 Participants
|
|
Intention to Use Any HIV Prevention Method
Regular STD testing
|
82 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: participants who completed immediate post-visit survey
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").
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Confidence in Decision to Use an HIV Prevention Method
PrEP · I feel completely unsure
|
2 Participants
|
2 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
PrEP · I feel mostly unsure
|
1 Participants
|
2 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
PrEP · I feel mostly sure
|
6 Participants
|
4 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
PrEP · I feel 100% sure
|
10 Participants
|
7 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Abstinence · I feel completely unsure
|
1 Participants
|
1 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Abstinence · I feel mostly unsure
|
2 Participants
|
4 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Abstinence · I feel mostly sure
|
9 Participants
|
6 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Abstinence · I feel 100% sure
|
26 Participants
|
28 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Condoms · I feel completely unsure
|
1 Participants
|
2 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Condoms · I feel mostly unsure
|
0 Participants
|
3 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Condoms · I feel mostly sure
|
18 Participants
|
12 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Condoms · I feel 100% sure
|
58 Participants
|
59 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
PEP · I feel completely unsure
|
1 Participants
|
3 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
PEP · I feel mostly unsure
|
1 Participants
|
1 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
PEP · I feel mostly sure
|
3 Participants
|
5 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
PEP · I feel 100% sure
|
15 Participants
|
8 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Regular HIV testing · I feel completely unsure
|
0 Participants
|
3 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Regular HIV testing · I feel mostly unsure
|
2 Participants
|
2 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Regular HIV testing · I feel mostly sure
|
3 Participants
|
4 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Regular HIV testing · I feel 100% sure
|
74 Participants
|
71 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Regular STD testing · I feel completely unsure
|
0 Participants
|
2 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Regular STD testing · I feel mostly unsure
|
3 Participants
|
2 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Regular STD testing · I feel mostly sure
|
7 Participants
|
3 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Regular STD testing · I feel 100% sure
|
72 Participants
|
75 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Treatment as prevention · I feel completely unsure
|
1 Participants
|
1 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Treatment as prevention · I feel mostly unsure
|
1 Participants
|
4 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Treatment as prevention · I feel mostly sure
|
4 Participants
|
0 Participants
|
|
Confidence in Decision to Use an HIV Prevention Method
Treatment as prevention · I feel 100% sure
|
28 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: participants who completed immediate post-visit survey
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").
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Satisfaction With Information Received About HIV Prevention
Very unsatisfied
|
2 Participants
|
1 Participants
|
|
Satisfaction With Information Received About HIV Prevention
Very satisfied
|
77 Participants
|
60 Participants
|
|
Satisfaction With Information Received About HIV Prevention
Somewhat satisfied
|
9 Participants
|
10 Participants
|
|
Satisfaction With Information Received About HIV Prevention
Neither satisfied nor unsatisfied
|
3 Participants
|
9 Participants
|
|
Satisfaction With Information Received About HIV Prevention
Somewhat unsatisfied
|
1 Participants
|
1 Participants
|
|
Satisfaction With Information Received About HIV Prevention
I was not given information about HIV prevention
|
0 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: participants who completed immediate post-visit survey
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.
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Perceived Quality of Information Received About HIV Prevention
I got all the information I needed (strongly agree)
|
35 Participants
|
31 Participants
|
|
Perceived Quality of Information Received About HIV Prevention
Information was easy to understand (strongly agree)
|
37 Participants
|
31 Participants
|
|
Perceived Quality of Information Received About HIV Prevention
Trusted the information given (strongly agree)
|
35 Participants
|
32 Participants
|
|
Perceived Quality of Information Received About HIV Prevention
Found the information useful (strongly agree)
|
33 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: participants who completed immediate post-visit survey
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").
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
n=90 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Acceptability of HIV Prevention Methods
Abstinence (great method for me)
|
27 Participants
|
29 Participants
|
|
Acceptability of HIV Prevention Methods
Condoms (great method for me)
|
35 Participants
|
40 Participants
|
|
Acceptability of HIV Prevention Methods
PEP (great method for me)
|
18 Participants
|
14 Participants
|
|
Acceptability of HIV Prevention Methods
PrEP (great method for me)
|
19 Participants
|
14 Participants
|
|
Acceptability of HIV Prevention Methods
HIV Testing (great method for me)
|
48 Participants
|
48 Participants
|
|
Acceptability of HIV Prevention Methods
STD Tesating (great method for me)
|
47 Participants
|
48 Participants
|
|
Acceptability of HIV Prevention Methods
Treatment as prevention (great method for me)
|
24 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: group randomized to the DST
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.
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Acceptability of the Decision Support Tool
Got all of the information I need from the DST (strongly agree or agree)
|
82 Participants
|
0 Participants
|
|
Acceptability of the Decision Support Tool
Information on the DST was easy to understand (strongly agree or agree)
|
81 Participants
|
0 Participants
|
|
Acceptability of the Decision Support Tool
I trusted the information on the DST (strongly agree or agree)
|
83 Participants
|
0 Participants
|
|
Acceptability of the Decision Support Tool
The information felt helpful to me (strongly agree or agree)
|
71 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Group randomized to DST
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".
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Perception of the Decision Support Tool
I really liked it
|
66 Participants
|
0 Participants
|
|
Perception of the Decision Support Tool
I somewhat liked it
|
18 Participants
|
—
|
|
Perception of the Decision Support Tool
I somewhat disliked it
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Group randomized to the DST
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".
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Satisfaction With the Decision Support Tool
Very satisfied
|
69 Participants
|
0 Participants
|
|
Satisfaction With the Decision Support Tool
Somewhat satisfied
|
10 Participants
|
—
|
|
Satisfaction With the Decision Support Tool
Neither satisfied nor unsatisfied
|
5 Participants
|
—
|
|
Satisfaction With the Decision Support Tool
Very unsatisfied
|
1 Participants
|
—
|
|
Satisfaction With the Decision Support Tool
Missing
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Group randomized to the DST
Participants in the experimental arm will be asked whether they would recommend the tool a friend. Response options are "yes", "no", "unsure".
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Recommend the Decision Support Tool
|
81 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately post baseline visitPopulation: Group randomized to the DST
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".
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=92 Participants
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.
|
Standard Counseling
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
Willingness to Use the Decision Support Tool at Future Visits
|
63 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months post baseline visitPopulation: participants who completed 3-month follow-up survey
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").
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=57 Participants
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.
|
Standard Counseling
n=58 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
HIV Prevention Method Use (Any Method - Planned or New Method)
|
53 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 3 months post baseline visitPopulation: participants who completed 3-month follow-up survey
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".
Outcome measures
| Measure |
HIV Prevention DST Intervention
n=57 Participants
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.
|
Standard Counseling
n=58 Participants
Participants in this arm will receive usual care.
Standard Counseling: Participants in this arm will receive usual care.
|
|---|---|---|
|
HIV Prevention Method Continuation
|
53 Participants
|
48 Participants
|
Adverse Events
HIV Prevention DST Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Dominika Seidman
University of California, San-Francisco
Phone: (415) 353-2119
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place