Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P)

Health Knowledge, Attitudes, Practice Clinical Trial

— SISTA-P  

Official title:

Sistas Informing Sistas on Topics About AIDS and Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307028
• Other study ID #: Pro2023002116
• Secondary ID: K01DA050496
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Shawnika Hull, PhD
• Phone: 520-661-3300
• Email: sh1449[@]comminfo.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Black women are eligible if you:
• Have sex with men
• Are age 18+
• Live in Washington D.C.
• Are not HIV+

Exclusion Criteria:

• HIV+

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Rutgers University	New Brunswick	New Jersey
United States	The Women's Collective	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the Intervention Scale	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	At the end of each cycle (each cycle is 42 days)
Primary	Acceptability of the Intervention Scale	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	At the end of each cycle (each cycle is 42 days)
Primary	Appropriateness of the Intervention Scale	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	At the end of each cycle (each cycle is 42 days)
Secondary	Recruitment	12-15 participants enrolled	At the end of each cycle (each cycle is 42 days)
Secondary	Intervention Fidelity- participant characteristics	proportion of participants are potentially PrEP eligible Black women (benchmark: 100%)	At the end of each cycle (each cycle is 42 days)
Secondary	Intervention Fidelity	Proportion of assigned materials distributed and assigned activities implemented (benchmark: 100%)	At the end of each cycle (each cycle is 42 days)
Secondary	Acceptability of the intervention delivery	10-point scale assessment of facilitator performance. Benchmark: average acceptability rating of >7.5/10	At the end of each session
Secondary	Participant Enrollment	Number of in-person participants in attendance at the first session. Benchmark: N = 12 - 15 in attendance at first session	At the end of each cycle (each cycle is 42 days)
Secondary	Participant Retention	Proportion of Session 1 participants who complete session 6. Benchmark: 80%	At the end of each cycle (each cycle is 42 days)
Secondary	Feasibility of delivering 6 sessions in 6 weeks	Delivery of intervention sessions according to the planned timeline (6 weeks)	At the end of each cycle (each cycle is 42 days)
Secondary	Visual confirmation of self-reported PrEP uptake	Photo confirmation of self-reported PrEP use.	At the end of each cycle (each cycle is 42 days)
Secondary	Post-Intervention Follow-up	Proportion of post-intervention surveys completed. Benchmark: 80%	At the end of each cycle (each cycle is 42 days)