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

Not Applicable
Recruiting
Conditions
Health Behavior, Risky
Health-Related Behavior
Health 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
Inclusion Criteria
  • Black women are eligible if you:
  • Have sex with men
  • Are age 18+
  • Live in Washington D.C.
  • Are not HIV+
Read More
Exclusion Criteria
  • HIV+
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
SISTA-P InterventionSISTA-P InterventionParticipants 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
NameTimeMethod
Acceptability of the Intervention ScaleAt 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 ScaleAt 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 ScaleAt 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
NameTimeMethod
Participant RetentionAt the end of each cycle (each cycle is 42 days)

Proportion of Session 1 participants who complete session 6. Benchmark: 80%

Post-Intervention Follow-upAt the end of each cycle (each cycle is 42 days)

Proportion of post-intervention surveys completed. Benchmark: 80%

Intervention FidelityAt 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 weeksAt the end of each cycle (each cycle is 42 days)

Delivery of intervention sessions according to the planned timeline (6 weeks)

RecruitmentAt the end of each cycle (each cycle is 42 days)

12-15 participants enrolled

Intervention Fidelity- participant characteristicsAt 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 deliveryAt the end of each session

10-point scale assessment of facilitator performance. Benchmark: average acceptability rating of \>7.5/10

Participant EnrollmentAt 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 uptakeAt 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

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