Trial Outcomes & Findings for Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P) (NCT NCT06307028)
NCT ID: NCT06307028
Last Updated: 2026-04-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
At the time of post-test (after 6 sessions)
Results posted on
2026-04-28
Participant Flow
Participant milestones
| Measure |
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 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.
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.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P)
Baseline characteristics by cohort
| Measure |
SISTA-P Intervention
n=23 Participants
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 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.
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
43.48 years
STANDARD_DEVIATION 12.11 • n=9 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=9 Participants
|
|
Pretest Behavioral Intentions
|
2.96 units on a scale
STANDARD_DEVIATION 1.33 • n=9 Participants
|
PRIMARY outcome
Timeframe: At the time of post-test (after 6 sessions)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
Outcome measures
| Measure |
SISTA-P Intervention
n=20 Participants
Participants will complete four sessions sessions lasting up to three hours each over the course of one week, followed by two boosters which are delivered four and six weeks later, respectively. 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 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.
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.
|
|---|---|
|
Feasibility of the Intervention Scale
|
4.78 units on a scale
Standard Deviation .73
|
PRIMARY outcome
Timeframe: At the time of post-test (after 6 sessions).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
Outcome measures
| Measure |
SISTA-P Intervention
n=20 Participants
Participants will complete four sessions sessions lasting up to three hours each over the course of one week, followed by two boosters which are delivered four and six weeks later, respectively. 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 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.
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.
|
|---|---|
|
Acceptability of the Intervention Scale
|
4.72 units on a scale
Standard Deviation .89
|
PRIMARY outcome
Timeframe: At the time of the post-test (after 6 sessions)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
Outcome measures
| Measure |
SISTA-P Intervention
n=20 Participants
Participants will complete four sessions sessions lasting up to three hours each over the course of one week, followed by two boosters which are delivered four and six weeks later, respectively. 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 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.
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.
|
|---|---|
|
Appropriateness of the Intervention Scale
|
4.83 units on a scale
Standard Deviation .59
|
PRIMARY outcome
Timeframe: This occurred immediately before session 1 and again after session 6 (42 days after the first session was delivered; 42 days post baseline)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
Outcome measures
| Measure |
SISTA-P Intervention
n=20 Participants
Participants will complete four sessions sessions lasting up to three hours each over the course of one week, followed by two boosters which are delivered four and six weeks later, respectively. 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 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.
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.
|
|---|---|
|
Behavioral Intentions (Post-test)
|
3.85 units on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: At the end of each Session 1Initial 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).
Outcome measures
| Measure |
SISTA-P Intervention
n=23 Participants
Participants will complete four sessions sessions lasting up to three hours each over the course of one week, followed by two boosters which are delivered four and six weeks later, respectively. 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 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.
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.
|
|---|---|
|
Number of Participants Enrolled Out of All Eligible Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: At the time of session 1proportion of participants enrolled who are potentially PrEP eligible Black women (benchmark: 100%)
Outcome measures
| Measure |
SISTA-P Intervention
n=23 Participants
Participants will complete four sessions sessions lasting up to three hours each over the course of one week, followed by two boosters which are delivered four and six weeks later, respectively. 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 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.
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.
|
|---|---|
|
Number of Participants Enrolled That Are Potentially PrEP Eligible Black Women
|
23 Participants
|
SECONDARY outcome
Timeframe: At the time of post-test (after 6 sessions)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
Outcome measures
| Measure |
SISTA-P Intervention
n=23 Participants
Participants will complete four sessions sessions lasting up to three hours each over the course of one week, followed by two boosters which are delivered four and six weeks later, respectively. 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 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.
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.
|
|---|---|
|
Acceptability of the Intervention Delivery (Acceptability)
|
9.90 units on a scale
Standard Error 0.035
|
SECONDARY outcome
Timeframe: At the time of post-test (after 6 sessions).Proportion of Session 1 participants who complete session 6. Benchmark: 80%
Outcome measures
| Measure |
SISTA-P Intervention
n=23 Participants
Participants will complete four sessions sessions lasting up to three hours each over the course of one week, followed by two boosters which are delivered four and six weeks later, respectively. 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 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.
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.
|
|---|---|
|
Participant Retention
|
20 Participants
|
SECONDARY outcome
Timeframe: At the time of post-test (after 6 sessions)Photo confirmation of self-reported PrEP use.
Outcome measures
| Measure |
SISTA-P Intervention
n=23 Participants
Participants will complete four sessions sessions lasting up to three hours each over the course of one week, followed by two boosters which are delivered four and six weeks later, respectively. 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 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.
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.
|
|---|---|
|
Visual Confirmation of Self-reported PrEP Uptake
|
3 Participants
|
SECONDARY outcome
Timeframe: At the time of post-test (after 6 sessions)Proportion of post-intervention surveys completed. The researchers administered surveys and counted how many participants completed the surveys. Benchmark: 80%
Outcome measures
| Measure |
SISTA-P Intervention
n=23 Participants
Participants will complete four sessions sessions lasting up to three hours each over the course of one week, followed by two boosters which are delivered four and six weeks later, respectively. 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 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.
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.
|
|---|---|
|
Number of Participants Who Completed Post-intervention Surveys
|
20 Participants
|
Adverse Events
SISTA-P Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place