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The OPENS Trial: Offering Women PrEP (Aim 1)
NA trial testing HIV Prevention Decision Support Tool (DST) in Human Immunodeficiency Virus Transmission in 189 participants. Completed in 4 November 2022.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 189 |
| Start date | 3 May 2021 |
| Primary completion | 24 October 2022 |
| Estimated completion | 4 November 2022 |
| Sites | 1 location across United States |
University of California, San Francisco
Adults 18 to 45, any sex, with Human Immunodeficiency Virus Transmission or Sexually Transmitted Diseases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 1 | |
| Standard Counseling | 0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 1 | |
| Standard Counseling | 1 |
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").
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 77 | |
| Standard Counseling | 85 | |
| HIV Prevention DST Intervention | 9 | |
| Standard Counseling | 3 | |
| HIV Prevention DST Intervention | 6 | |
| Standard Counseling | 2 |
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").
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 2 | |
| Standard Counseling | 4 | |
| HIV Prevention DST Intervention | 4 | |
| Standard Counseling | 1 | |
| HIV Prevention DST Intervention | 11 | |
| Standard Counseling | 13 | |
| HIV Prevention DST Intervention | 75 | |
| Standard Counseling | 72 |
Proportion of participants selecting the correct response to knowledge questions. Response options for each item are different. Higher score represents greater knowledge.
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 54 | |
| Standard Counseling | 37 |
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 75 | |
| Standard Counseling | 58 |
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 30 | |
| Standard Counseling | 16 |
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 51 | |
| Standard Counseling | 32 |
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 51 | |
| Standard Counseling | 23 |
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 46 | |
| Standard Counseling | 31 |
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 51 | |
| Standard Counseling | 21 |
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 43 | |
| Standard Counseling | 49 |
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.
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 10 | 0 – 25 |
| Standard Counseling | 0 | 0 – 25 |
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.
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 16.7 | 0 – 25 |
| Standard Counseling | 0 | 0 – 25 |
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.
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 0 | 0 – 25 |
| Standard Counseling | 0 | 0 – 25 |
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
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 12.5 | 0 – 25 |
| Standard Counseling | 0 | 0 – 25 |
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 \[feels extremely unsupported in decision making\].
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 6.3 | 0 – 25 |
| Standard Counseling | 0 | 0 – 25 |
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 \[bad decision\].
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 16.7 | 0 – 25 |
| Standard Counseling | 0 | 0 – 25 |
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 \[poor interpersonal quality of care\].
| Group | Value | 95% CI |
|---|---|---|
| HIV Prevention DST Intervention | 17.2 | ± 4.9 |
| Standard Counseling | 16.9 | ± 5.3 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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