NCT Number: NCT06307028
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
The Women's Collective, Washington D.C., District of Columbia, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At the time of post-test (after 6 sessions)
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
Time frame: At the time of post-test (after 6 sessions).
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
Time frame: At the time of the post-test (after 6 sessions)
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
Time frame: This occurred immediately before session 1 and again after session 6 (42 days after the first session was delivered; 42 days post baseline)
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
Time frame: At the end of each Session 1
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).
Time frame: At the time of session 1
proportion of participants enrolled who are potentially PrEP eligible Black women (benchmark: 100%)
Time frame: At the time of post-test (after 6 sessions)
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
Time frame: At the time of post-test (after 6 sessions).
Proportion of Session 1 participants who complete session 6. Benchmark: 80%
Time frame: At the time of post-test (after 6 sessions)
Photo confirmation of self-reported PrEP use.
Time frame: At the time of post-test (after 6 sessions)
Proportion of post-intervention surveys completed. The researchers administered surveys and counted how many participants completed the surveys. Benchmark: 80%
Rutgers, The State University of New Jersey
Other
Sistas Informing Sistas on Topics About AIDS and PrEP
Acronym: SISTA-P
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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