Health Behavior, Risky, Health Knowledge, Attitudes, Practice, Health-Related Behavior
Conditions
Keywords
Black women, HIV
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.
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.
Interventions
BEHAVIORALSISTA-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.
Sponsors
Rutgers, The State University of New Jersey
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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+
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention Scale | 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 | 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 | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Enrolled Out of All Eligible Participants | At the end of each Session 1 | 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). |
| Number of Participants Enrolled That Are Potentially PrEP Eligible Black Women | At the time of session 1 | proportion of participants enrolled who are potentially PrEP eligible Black women (benchmark: 100%) |
| Acceptability of the Intervention Delivery (Acceptability) | 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 |
| Participant Retention | At the time of post-test (after 6 sessions). | Proportion of Session 1 participants who complete session 6. Benchmark: 80% |
| Visual Confirmation of Self-reported PrEP Uptake | At the time of post-test (after 6 sessions) | Photo confirmation of self-reported PrEP use. |
| Number of Participants Who Completed Post-intervention Surveys | 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% |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShawnika Hull, PhD
Rutgers University School of Communication and Information
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 43.48 years STANDARD_DEVIATION 12.11 |
| Pretest Behavioral Intentions | 2.96 units on a scale STANDARD_DEVIATION 1.33 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 23 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
None listed