Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P)
- Conditions
- Health Behavior, RiskyHealth-Related BehaviorHealth Knowledge, Attitudes, Practice
- Interventions
- Behavioral: SISTA-P Intervention
- Registration Number
- NCT06307028
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief Summary
In this project, the investigators will provide a new HIV prevention training and empowerment sessions to Black women in Washington D.C. 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.
- Detailed Description
Experienced facilitators will implement two 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- Black women are eligible if you:
- Have sex with men
- Are age 18+
- Live in Washington D.C.
- Are not HIV+
- HIV+
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SISTA-P Intervention 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 12- 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.
- Primary Outcome Measures
Name Time Method Acceptability of the Intervention Scale 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 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 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
- Secondary Outcome Measures
Name Time Method Participant Retention At the end of each cycle (each cycle is 42 days) Proportion of Session 1 participants who complete session 6. Benchmark: 80%
Post-Intervention Follow-up At the end of each cycle (each cycle is 42 days) Proportion of post-intervention surveys completed. Benchmark: 80%
Intervention Fidelity At the end of each cycle (each cycle is 42 days) Proportion of assigned materials distributed and assigned activities implemented (benchmark: 100%)
Feasibility of delivering 6 sessions in 6 weeks At the end of each cycle (each cycle is 42 days) Delivery of intervention sessions according to the planned timeline (6 weeks)
Recruitment At the end of each cycle (each cycle is 42 days) 12-15 participants enrolled
Intervention Fidelity- participant characteristics At the end of each cycle (each cycle is 42 days) proportion of participants are potentially PrEP eligible Black women (benchmark: 100%)
Acceptability of the intervention delivery At the end of each session 10-point scale assessment of facilitator performance. Benchmark: average acceptability rating of \>7.5/10
Participant Enrollment At the end of each cycle (each cycle is 42 days) Number of in-person participants in attendance at the first session. Benchmark: N = 12 - 15 in attendance at first session
Visual confirmation of self-reported PrEP uptake At the end of each cycle (each cycle is 42 days) Photo confirmation of self-reported PrEP use.
Trial Locations
- Locations (2)
Rutgers University
🇺🇸New Brunswick, New Jersey, United States
The Women's Collective
🇺🇸Washington, District of Columbia, United States