Health Behavior, RiskySISTA-PNCT06307028
Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P)
A study testing SISTA-P Intervention in people with Health Behavior, Risky and Health Knowledge, Attitudes, Practice, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Risky, Health Knowledge, Attitudes, Practice, Health-Related Behavior
- What is being tested?
- SISTA-P Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jan 2024to 13 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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+
Who cannot join
- HIV+
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rutgers University
New Brunswick, New Jersey, 08854
The Women's Collective
Washington D.C., District of Columbia, 20002
About this study
Official title: 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.
Read the 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.
- Being tested
- SISTA-P Intervention
- Keywords
- Black women, HIV
- Medical subject headings
- Health Risk Behaviors, Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SISTA-P InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SISTA-P Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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).
Measured: 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%)
Measured: 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
Measured: At the time of post-test (after 6 sessions)
Participant Retention
Proportion of Session 1 participants who complete session 6. Benchmark: 80%
Measured: At the time of post-test (after 6 sessions).
Visual Confirmation of Self-reported PrEP Uptake
Photo confirmation of self-reported PrEP use.
Measured: 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%
Measured: At the time of post-test (after 6 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start8 Jan 2024
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Health Behavior, RiskyStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Shawnika J. Hull, PhD, Rutgers, The State University of New Jersey
- Investigators
- Shawnika Hull, PhD, Principal investigator, Rutgers University School of Communication and Information
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307028
- Sponsor's protocol ID
- Pro2023002116
- Other IDs
- K01DA050496
- Acronym
- SISTA-P
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2024
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As of now, there are no plans to share the IPD.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sistas Informing Sistas on Topics About AIDS and PrEP
- ClinicalTrials.gov ID
- NCT06307028
- Acronym / sponsor ID
- SISTA-P / Pro2023002116
- Keywords
- Black women, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Posted 28 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SISTA-P Intervention | Experimental | Behavioral: SISTA-P InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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+
Key exclusion criteria (1 listed)
- HIV+
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SISTA-P InterventionThis 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. | Behavioural | SISTA-P Intervention |
Primary outcome
Feasibility of the Intervention Scale
Time frame: 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
Acceptability of the Intervention Scale
Time frame: 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
Appropriateness of the Intervention Scale
Time frame: 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
Behavioral Intentions (Post-test)
Time frame: 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
6 secondary outcomes
Number of Participants Enrolled Out of All Eligible Participants
Time frame: At the end of each Session 1
Number of Participants Enrolled That Are Potentially PrEP Eligible Black Women
Time frame: At the time of session 1
Acceptability of the Intervention Delivery (Acceptability)
Time frame: At the time of post-test (after 6 sessions)
Participant Retention
Time frame: At the time of post-test (after 6 sessions).
Visual Confirmation of Self-reported PrEP Uptake
Time frame: At the time of post-test (after 6 sessions)
Number of Participants Who Completed Post-intervention Surveys
Time frame: At the time of post-test (after 6 sessions)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. As of now, there are no plans to share the IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawnika Hull, PhD principal investigator
Rutgers University School of Communication and Information
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SISTA-P Intervention in people with Health Behavior, Risky and Health Knowledge, Attitudes, Practice, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention Scale (time frame: At the time of post-test (after 6 sessions)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.