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

Sistas Informing Sistas on Topics About AIDS and Prevention

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.

Study Overview

• Status: Recruiting
• Conditions: Health Knowledge, Attitudes, Practice; Health-Related Behavior; Health Behavior, Risky
• Intervention / Treatment: Behavioral: SISTA-P Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shawnika Hull, PhD; Phone Number: 520-661-3300; Email: sh1449@comminfo.rutgers.edu
• Study Contact Backup: Name: Amanda Jones, BA; Email: acj54@cinj.rutgers.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20002
      • Active, not recruiting
      • The Women's Collective
  • New Jersey
    • New Brunswick, New Jersey, United States, 08854
      • Recruiting
      • Rutgers University
      • Contact: Shawnika Hull, PhD; Phone Number: 520-661-3300; Email: shawnika.hull@rutgers.edu
      • Principal Investigator: Shawnika Hull, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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+

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	12-15 participants enrolled	At the end of each cycle (each cycle is 42 days)
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)
Intervention Fidelity	Proportion of assigned materials distributed and assigned activities implemented (benchmark: 100%)	At the end of each cycle (each cycle is 42 days)
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
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)
Participant Retention	Proportion of Session 1 participants who complete session 6. Benchmark: 80%	At the end of each cycle (each cycle is 42 days)
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)
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)
Post-Intervention Follow-up	Proportion of post-intervention surveys completed. Benchmark: 80%	At the end of each cycle (each cycle is 42 days)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Shawnika Hull, PhD, Rutgers University School of Communication and Information

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: HIV; Black women
• Other Study ID Numbers: Pro2023002116; K01DA050496 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As of now, there are no plans to share the IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No