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| ID | Type | Description | Link |
|---|---|---|---|
| K01DA050496 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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In this project, the investigators will provide a new HIV prevention training and empowerment sessions to Black women in Washington D.C., Atlanta and New Orleans, who are at high risk for getting HIV. This training is tailored to the experience of Black women and seeks to reduce the high HIV transmission rates in the Black community.
Experienced facilitators will implement three cycles of six 3-hour sessions with up to 15 participants per cycle while expert panelists observe. After each session, participants and subject matter expert observers will complete brief surveys. Surveys following each session include closed and open-ended measures: six items rating how well the session conveyed core information (e.g., I am confident I can communicate more effectively [Session 3]; I have a better understanding of the effects of alcohol on making sexual choices, [Session 4]) and single-item scales to evaluate the facilitator's performance and the session overall. In open-ended measures, respondents will be prompted to elaborate on their survey responses to identify ways the session could be improved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SISTA-P Intervention | Experimental | Participants will complete four sessions lasting up to three hours each over the course of one week. The sessions will be conducted by two facilitators with a technical monitor and the PI observing. Core elements of SISTA-P are: (1) small group discussions, modeling and role-play that facilitate repetition, reinforcement and sequential approximation; (2) skilled facilitators; (3) gender and culturally specific materials to enhance pride and self-worth; (4) teaching negotiation, self-advocacy; and (5) HIV prevention relevant skills; (6) discussing gender and culture-specific barriers and facilitators to prevention; and (7) enhancing HIV prevention norms and self-efficacy. Each discussion group will consist of up to 15 participants and each cycle will consist of one group. Participants will be asked to complete a follow up survey and two booster sessions. They will also be asked to submit photo-confirmation of PrEP prescription to the research team. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SISTA-P Intervention | Behavioral | This intervention is a small group discussion designed specifically for Black women. The sessions cover topics including: self pride and self-care; HIV & PrEP education; assertiveness skills training; coping skills; skills practice; and barriers and facilitators to HIV prevention and PrEP. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Intervention Scale | 5-item scale, range 1 (strongly disagree) to 5 (strongly agree). Lower values indicate less feasibility and higher values indicate more feasibility; adapted from Weiner, B.J., Lewis, C.C., Stanick, C. et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci 12, 108 (2017). https://doi.org/10.1186/s13012-017-0635-3 | At the time of post-test (after 6 sessions) |
| Acceptability of the Intervention Scale | 5-item scale, range 1 (strongly disagree) to 5 (strongly agree). Lower scores indicate less acceptability, and higher scores indicate more acceptability. adapted from Weiner, B.J., Lewis, C.C., Stanick, C. et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci 12, 108 (2017). https://doi.org/10.1186/s13012-017-0635-3 | At the time of post-test (after 6 sessions). |
| Appropriateness of the Intervention Scale | 5-item scale, range 1 (strongly disagree) to 5 (strongly agree). Lower scores indicate lower appropriateness, and higher scores indicate higher appropriateness. adapted from Weiner, B.J., Lewis, C.C., Stanick, C. et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci 12, 108 (2017). https://doi.org/10.1186/s13012-017-0635-3 | At the time of the post-test (after 6 sessions) |
| Behavioral Intentions (Post-test) | Participants' intentions to use PrEP within the next 12 months. range 1 (strongly disagree) to 5 (strongly agree). Lower scores indicate lower behavioral intentions and higher scores indicate higher behavioral intentions. adapted from Scott RK, Hull SJ, Huang JC, et al. Factors Associated with Intention to Initiate Pre-exposure Prophylaxis in Cisgender Women at High Behavioral Risk for HIV in Washington, D.C. Arch Sex Behav. 2022;51(5):2613-2624. doi:10.1007/s10508-021-02274-4 | This occurred immediately before session 1 and again after session 6 (42 days after the first session was delivered; 42 days post baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled Out of All Eligible Participants | Initial outcome was 8-12 participants enrolled per cycle (3). The research team revised to accommodate smaller groups of 5-8 participants. Each participant was counted by the researchers if they attended Session 1 in each cycle (city). | At the end of each Session 1 |
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Inclusion Criteria:
Exclusion Criteria:
Black women are eligible for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Shawnika Hull, PhD | Rutgers University School of Communication and Information | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Women's Collective | Washington D.C. | District of Columbia | 20002 | United States | ||
| Rutgers University |
As of now, there are no plans to share the IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | SISTA-P Intervention | Participants will complete four sessions lasting up to three hours each over the course of one week. The sessions will be overseen by two facilitators and a technical monitor. Core elements of SISTA-P are: (1) small group discussions, modeling and role-play that facilitate repetition, reinforcement and sequential approximation; (2) skilled facilitators; (3) gender and culturally specific materials to enhance pride and self-worth; (4) teaching negotiation, self-advocacy; and (5) HIV prevention relevant skills; (6) discussing gender and culture-specific barriers and facilitators to prevention; and (7) enhancing HIV prevention norms and self-efficacy. Each discussion group will consist of up to 15 participants and each cycle will consist of one group. Participants will be asked to complete a follow up survey and two booster sessions. They will also be asked to submit photo-confirmation of PrEP prescription to the research team. SISTA-P Intervention: This intervention is a small group discussion designed specifically for Black women. The sessions cover topics including: self pride and self-care; HIV & PrEP education; assertiveness skills training; coping skills; skills practice; and barriers and facilitators to HIV prevention and PrEP. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SISTA-P Intervention | Participants will complete four sessions lasting up to three hours each over the course of one week. The sessions will be overseen by two facilitators and a technical monitor. Core elements of SISTA-P are: (1) small group discussions, modeling and role-play that facilitate repetition, reinforcement and sequential approximation; (2) skilled facilitators; (3) gender and culturally specific materials to enhance pride and self-worth; (4) teaching negotiation, self-advocacy; and (5) HIV prevention relevant skills; (6) discussing gender and culture-specific barriers and facilitators to prevention; and (7) enhancing HIV prevention norms and self-efficacy. Each discussion group will consist of up to 15 participants and each cycle will consist of one group. Participants will be asked to complete a follow up survey and two booster sessions. They will also be asked to submit photo-confirmation of PrEP prescription to the research team. SISTA-P Intervention: This intervention is a small group discussion designed specifically for Black women. The sessions cover topics including: self pride and self-care; HIV & PrEP education; assertiveness skills training; coping skills; skills practice; and barriers and facilitators to HIV prevention and PrEP. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Intervention Scale | 5-item scale, range 1 (strongly disagree) to 5 (strongly agree). Lower values indicate less feasibility and higher values indicate more feasibility; adapted from Weiner, B.J., Lewis, C.C., Stanick, C. et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci 12, 108 (2017). https://doi.org/10.1186/s13012-017-0635-3 | Posted | Mean | Standard Deviation | units on a scale | At the time of post-test (after 6 sessions) |
|
During the period from baseline to post-test (approximately 42 days)
The number of participants at risk for Serious Adverse Events and All-Cause Mortality are zero because this behavioral intervention does not pose threats to physical health or serious threats to mental health.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SISTA-P Intervention | Participants will complete four sessions lasting up to three hours each over the course of one week. The sessions will be overseen by two facilitators and a technical monitor. Core elements of SISTA-P are: (1) small group discussions, modeling and role-play that facilitate repetition, reinforcement and sequential approximation; (2) skilled facilitators; (3) gender and culturally specific materials to enhance pride and self-worth; (4) teaching negotiation, self-advocacy; and (5) HIV prevention relevant skills; (6) discussing gender and culture-specific barriers and facilitators to prevention; and (7) enhancing HIV prevention norms and self-efficacy. Each discussion group will consist of up to 15 participants and each cycle will consist of one group. Participants will be asked to complete a follow up survey and two booster sessions. They will also be asked to submit photo-confirmation of PrEP prescription to the research team. SISTA-P Intervention: This intervention is a small group discussion designed specifically for Black women. The sessions cover topics including: self pride and self-care; HIV & PrEP education; assertiveness skills training; coping skills; skills practice; and barriers and facilitators to HIV prevention and PrEP. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shawnika J. Hull | Rutgers University | 848-932-7500 | shawnika.hull@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2024 | Sep 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 11, 2026 | Feb 11, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2024 | Sep 18, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000073599 | Health Risk Behaviors |
| D001519 | Behavior |
| D015438 | Health Behavior |
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|
| Number of Participants Enrolled That Are Potentially PrEP Eligible Black Women |
proportion of participants enrolled who are potentially PrEP eligible Black women (benchmark: 100%) |
| At the time of session 1 |
| Acceptability of the Intervention Delivery (Acceptability) | 10-point scale assessment of facilitator performance, with 1 indicating "poor" and 10 indicating "excellent" performance. Higher scores indicated greater acceptability of the intervention delivery, and lower scores indicated lower acceptability. Benchmark: average acceptability rating of >7.5/10 | At the time of post-test (after 6 sessions) |
| Participant Retention | Proportion of Session 1 participants who complete session 6. Benchmark: 80% | At the time of post-test (after 6 sessions). |
| Visual Confirmation of Self-reported PrEP Uptake | Photo confirmation of self-reported PrEP use. | At the time of post-test (after 6 sessions) |
| Number of Participants Who Completed Post-intervention Surveys | Proportion of post-intervention surveys completed. The researchers administered surveys and counted how many participants completed the surveys. Benchmark: 80% | At the time of post-test (after 6 sessions) |
| New Brunswick |
| New Jersey |
| 08854 |
| United States |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Pretest Behavioral Intentions | Intentions to uptake PrEP in the next 12 months, as measured on the pretest. Single item measure. Range: 1 (definitely not) to 5 (definitely yes), with higher intentions indicated by higher scores. | Mean | Standard Deviation | units on a scale |
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| Primary | Acceptability of the Intervention Scale | 5-item scale, range 1 (strongly disagree) to 5 (strongly agree). Lower scores indicate less acceptability, and higher scores indicate more acceptability. adapted from Weiner, B.J., Lewis, C.C., Stanick, C. et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci 12, 108 (2017). https://doi.org/10.1186/s13012-017-0635-3 | Posted | Mean | Standard Deviation | units on a scale | At the time of post-test (after 6 sessions). |
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| Primary | Appropriateness of the Intervention Scale | 5-item scale, range 1 (strongly disagree) to 5 (strongly agree). Lower scores indicate lower appropriateness, and higher scores indicate higher appropriateness. adapted from Weiner, B.J., Lewis, C.C., Stanick, C. et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci 12, 108 (2017). https://doi.org/10.1186/s13012-017-0635-3 | Posted | Mean | Standard Deviation | units on a scale | At the time of the post-test (after 6 sessions) |
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| Primary | Behavioral Intentions (Post-test) | Participants' intentions to use PrEP within the next 12 months. range 1 (strongly disagree) to 5 (strongly agree). Lower scores indicate lower behavioral intentions and higher scores indicate higher behavioral intentions. adapted from Scott RK, Hull SJ, Huang JC, et al. Factors Associated with Intention to Initiate Pre-exposure Prophylaxis in Cisgender Women at High Behavioral Risk for HIV in Washington, D.C. Arch Sex Behav. 2022;51(5):2613-2624. doi:10.1007/s10508-021-02274-4 | Posted | Mean | Standard Deviation | units on a scale | This occurred immediately before session 1 and again after session 6 (42 days after the first session was delivered; 42 days post baseline) |
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| Secondary | Number of Participants Enrolled Out of All Eligible Participants | Initial outcome was 8-12 participants enrolled per cycle (3). The research team revised to accommodate smaller groups of 5-8 participants. Each participant was counted by the researchers if they attended Session 1 in each cycle (city). | Posted | Count of Participants | Participants | At the end of each Session 1 |
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| Secondary | Number of Participants Enrolled That Are Potentially PrEP Eligible Black Women | proportion of participants enrolled who are potentially PrEP eligible Black women (benchmark: 100%) | Posted | Count of Participants | Participants | At the time of session 1 |
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| Secondary | Acceptability of the Intervention Delivery (Acceptability) | 10-point scale assessment of facilitator performance, with 1 indicating "poor" and 10 indicating "excellent" performance. Higher scores indicated greater acceptability of the intervention delivery, and lower scores indicated lower acceptability. Benchmark: average acceptability rating of >7.5/10 | Posted | Mean | Standard Error | units on a scale | At the time of post-test (after 6 sessions) |
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| Secondary | Participant Retention | Proportion of Session 1 participants who complete session 6. Benchmark: 80% | Posted | Count of Participants | Participants | At the time of post-test (after 6 sessions). |
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| Secondary | Visual Confirmation of Self-reported PrEP Uptake | Photo confirmation of self-reported PrEP use. | Posted | Count of Participants | Participants | At the time of post-test (after 6 sessions) |
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| Secondary | Number of Participants Who Completed Post-intervention Surveys | Proportion of post-intervention surveys completed. The researchers administered surveys and counted how many participants completed the surveys. Benchmark: 80% | Posted | Count of Participants | Participants | At the time of post-test (after 6 sessions) |
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| 23 |
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