Sistas Informing Sistas on Topics About AIDS and PrEP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Acceptability of the Intervention Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Black women are eligible if you:
- •Have sex with men
- •Are age 18+
- •Live in Washington D.C., Atlanta, GA, or New Orleans, LA
- •Are not HIV+
排除标准
- 未提供
研究组 & 干预措施
SISTA-P Intervention
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.
干预措施: SISTA-P Intervention (Behavioral)
结局指标
主要结局
Acceptability of the Intervention Scale
时间窗: At the end of each cycle (each cycle is 42 days)
5-item scale, range 1 (strongly disagree) to (strongly agree). 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
Feasibility of the Intervention Scale
时间窗: At the end of each cycle (each cycle is 42 days)
5-item scale, range 1 (strongly disagree) to (strongly agree). 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
Appropriateness of the Intervention Scale
时间窗: At the end of each cycle (each cycle is 42 days)
5-item scale, range 1 (strongly disagree) to (strongly agree). 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
Feasibility of the Intervention Scale
时间窗: 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
Acceptability of the Intervention Scale
时间窗: 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
Appropriateness of the Intervention Scale
时间窗: 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
Behavioral Intentions (Post-test)
时间窗: 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
次要结局
- Recruitment(At the end of each cycle (each cycle is 42 days))
- Participant Retention(At the end of each cycle (each cycle is 42 days))
- Post-Intervention Follow-up(At the end of each cycle (each cycle is 42 days))
- Intervention Fidelity(At the end of each cycle (each cycle is 42 days))
- Feasibility of delivering 6 sessions in 6 weeks(At the end of each cycle (each cycle is 42 days))
- Intervention Fidelity- participant characteristics(At the end of each cycle (each cycle is 42 days))
- Acceptability of the intervention delivery(At the end of each session)
- Participant Enrollment(At the end of each cycle (each cycle is 42 days))
- Visual confirmation of self-reported PrEP uptake(At the end of each cycle (each cycle is 42 days))
- Number of Participants Enrolled Out of All Eligible Participants(At the end of each Session 1)
- Number of Participants Enrolled That Are Potentially PrEP Eligible Black Women(At the time of session 1)
- Acceptability of the Intervention Delivery (Acceptability)(At the time of post-test (after 6 sessions))
- Participant Retention(At the time of post-test (after 6 sessions).)
- Visual Confirmation of Self-reported PrEP Uptake(At the time of post-test (after 6 sessions))
- Number of Participants Who Completed Post-intervention Surveys(At the time of post-test (after 6 sessions))
研究者
Shawnika J. Hull, PhD
Associate Professor, Department of Communication
Rutgers, The State University of New Jersey