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

NCT06307028 | Completed Results DMC

• 2 other identifiers: Pro2023002116K01DA050496
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Health Behavior, Risky; Health Knowledge, Attitudes, Practice; Health-Related Behavior

Keywords

Black women; HIV

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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)

Study Arms (1)

SISTA-P Intervention

EXPERIMENTAL

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

Interventions

SISTA-P Intervention BEHAVIORAL

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.

SISTA-P Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Black women are eligible for this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+

You may not qualify if:

• HIV+

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

The Women's Collective

Washington D.C., District of Columbia, 20002, United States

Location

Rutgers University

New Brunswick, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Health Risk Behaviors; Behavior; Health Behavior

Results Point of Contact

• Title: Dr. Shawnika J. Hull
• Organization: Rutgers University

shawnika.hull@rutgers.edu

848-932-7500

Study Officials

• Shawnika Hull, PhD

  Rutgers University School of Communication and Information

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Communication

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 12, 2024
• Study Start: January 8, 2024
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)