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

Sistas Informing Sistas on Topics About AIDS and PrEP

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.

Study Overview

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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20002
      • The Women's Collective
  • New Jersey
    • New Brunswick, New Jersey, United States, 08854
      • Rutgers University

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., Atlanta, GA, or New Orleans, LA
• 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 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.

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 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	At the time of post-test (after 6 sessions)
Acceptability of the Intervention Scale	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	At the time of post-test (after 6 sessions).
Appropriateness of the Intervention Scale	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	At the time of the post-test (after 6 sessions)
Behavioral Intentions (Post-test)	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	This occurred immediately before session 1 and again after session 6 (42 days after the first session was delivered; 42 days post baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Enrolled Out of All Eligible Participants	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).	At the end of each Session 1
Number of Participants Enrolled That Are Potentially PrEP Eligible Black Women	proportion of participants enrolled who are potentially PrEP eligible Black women (benchmark: 100%)	At the time of session 1
Acceptability of the Intervention Delivery (Acceptability)	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	At the time of post-test (after 6 sessions)
Participant Retention	Proportion of Session 1 participants who complete session 6. Benchmark: 80%	At the time of post-test (after 6 sessions).
Visual Confirmation of Self-reported PrEP Uptake	Photo confirmation of self-reported PrEP use.	At the time of post-test (after 6 sessions)
Number of Participants Who Completed Post-intervention Surveys	Proportion of post-intervention surveys completed. The researchers administered surveys and counted how many participants completed the surveys. Benchmark: 80%	At the time of post-test (after 6 sessions)

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 (Actual): November 13, 2024
• Study Completion (Actual): November 13, 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): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Black women
• Additional Relevant MeSH Terms: Health Behavior; Behavior; Health Risk Behaviors
• 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