Start-Up Tasks/Logistics

1. Transgender Women Intervention Study Overview Intervention Sessions Start-Up Tasks/Logistics

2. Study Overview 2011 – CDC identified transgender women (TW) as a group at significantly high risk for HIV infection due to several syndemic factors: • experiences of discrimination and stigma • health care providers’ insufficient cultural competence • elevated rates of sexual risk and substance use. • In response to the needs of this vulnerable and • overlooked group, we will expand a small-group, • peer-led HIV risk reduction intervention (Girlfriends) that showed evidence about its: • feasibility • cultural acceptability • preliminary efficacy

3. Study Overview • Together with our community partners, we intend to expand, refine and implement the original group-based intervention as a 7-session individual- and group-based program that may be scalable for community settings.

4. Study Overview • Intervention goals– • Reduce sexual risk, substance use • Increase stigma-coping and risk-buffering skills • Increase connection to and utilization of support services

5. Study Overview Timeline The study spans 5 years, and has 3 phases: • Phase 1: Identify and train peer health navigators; refine conditions with community partners • Phase 2: Pilot both conditions with 20 TW and modify conditions based on findings • Phase 3: Enroll 240 TW; evaluate intervention’s efficacy

6. Study Overview Who can participate? Who cannot participate? Eligibility Criteria Exclusion Criteria • AGE: 18 years of age or older • GENDER ID: Identify as transwoman • SEX BEHAVIOR: Report at least 3 acts of unprotected anal or vaginal sex in the past 90 days and at least 1 in the last 30 days • SUBSTANCE USE: Report at least 5 days of illicit drug use in the past 90 days and at least 2 in the last 30 • Provide contact information • Reside in the NYC metropolitan area • Able to complete a survey in English (Spanish-language assistance can be provided by bilingual staff). • Unstable, serious psychiatric symptoms; • Current suicidal/homicidal ideation • Evidence of gross cognitive impairment; or • Currently enrolled in a drug abuse treatment or enrolled in an HIV risk or drug use intervention study • Unable to communicate in English

7. InterventionProcedures Intervention Condition • Based in Motivational Interviewing (MI) “You can see that there are some problems here, but quitting altogether may not be what you want to do right now.” • And Cognitive-Behavioral Skills Training (CBST) “Mindfulness is The quality or state of being mindful… Or being Attentive, Heedful, Thoughtful Earnest, Intentional”

8. InterventionProcedures Intervention Sessions 1-4

9. InterventionProcedures Intervention Sessions 5-7

10. Study Procedures 1) Recruitment Field Screener Phone Screener Recruiter Recruiter/RA/Intern 2) Enrollment Intervention either PHN/RA Baseline or RA Wait List 3) Retention Wait List Intervention 4-Month 8-Month 12-Month RA RA RA PHN/RA

11. Study Procedures - Assessment What happens during appointments?

12. Study Procedures - Assessment 4-Month Baseline • ACASI Survey (30 minutes) • TLFB for sexual and drug use behavior in the last 30 days (20 minutes) • Recent drugusetest (5 minutes) • STI testing • 4-Month booster:Intervention – social reunion;Education – education review • Informed Consent process (20 minutes) • MMSE and Psych SCID • ACASI Survey (30 minutes) • TLFB for sexual and drug use behavior in the last 30 days (20 minutes) • Recent drugusetest (5 minutes) • HIV and STI counseling and testing (20-40 minutes) • Randomization 8-Month 12-Month • ACASI Survey (30 minutes) • TLFB for sexual and drug use behavior in the last 30 days (20 minutes) • Recent druguse test (5 minutes) • HIV and STI counseling and testing (20-40 minutes) • ACASI Survey (30 minutes) • TLFB for sexual and drug use behavior in the last 30 days (20 minutes) • Recent drugusetest (5 minutes) • STI testing

13. Study Procedures - Assessment Consent Process • Informed Consent process (20 minutes) • MMSE and Psych SCID • ACASI Survey (30 minutes) • TLFB for sexual and drug use behavior in the last 30 days (20 minutes) • Recent drug use test (5 minutes) • HIV and STI counseling and testing (20-40 minutes) • Randomization During the Consent process: • Explain the procedures and confidentiality to participant • Define responsibilities of the researcher • and the participant • Participant and researcher sign two • copies

14. Study Procedures - Assessment • Informed Consent process (20 minutes) • MMSE and Psych SCID • ACASI Survey (30 minutes) • TLFB for sexual and drug use behavior in the last 30 days (20 minutes) • Recent drug use test (5 minutes) • HIV and STI counseling and testing (20-40 minutes) • Randomization MMSE and Psych SCID MMSE: Mini-Mental State Exam (MMSE) • Screen for cognitive impairment – ask participant • to complete simple tasks, like drawing this Psych SCID: Structured Clinical Interview for DSM-IV • Questionnaire to determine whether participants have any psychiatric disorders that may prevent them from participating

15. Study Procedures - Assessment • Informed Consent process (20 minutes) • MMSE and Psych SCID • ACASI Survey (30 minutes) • TLFB for sexual and drug use behavior in the last 30 days (20 minutes) • Recent drug use test (5 minutes) • HIV and STI counseling and testing (20-40 minutes) • Randomization ACASI Survey Participants answer a bunch of questions about their experiences: mental health, sexual health, behavior, emotions, access to health care, etc… • This is all done online with audio assistance

16. Study Procedures - Assessment • Informed Consent process (20 minutes) • MMSE and Psych SCID • ACASI Survey (30 minutes) • TLFB for sexual and drug use behavior in the last 30 days (20 minutes) • Recent drug use test (5 minutes) • HIV and STI counseling and testing (20-40 minutes) • Randomization Timeline Follow-Back During the Timeline Follow-Back (TLFB), we collect information about our participants’ behavior: sex, drugs, and alcohol • We look at an actual digital calendar and enter this information live • For example…

17. Study Procedures - Assessment

18. Study Procedures - Assessment • Informed Consent process (20 minutes) • MMSE and Psych SCID • ACASI Survey (30 minutes) • TLFB for sexual and drug use behavior in the last 30 days (20 minutes) • Recent drug use test (5 minutes) • HIV and STI counseling and testing (20-40 minutes) • Randomization Drug Use Test Through a urine sample, we collect a test of recent drug use. This tests for: amphetamine, methamphetamine, marijuana, and cocaine/crack, and opiates • This is done to confirm what was reported on the TLFB

19. Study Procedures - Assessment • Informed Consent process (20 minutes) • MMSE and Psych SCID • ACASI Survey (30 minutes) • TLFB for sexual and drug use behavior in the last 30 days (20 minutes) • Recent drug use test (5 minutes) • HIV and STI counseling and testing (20-40 minutes) • Randomization HIV/STI Testing Callen-Lorde will be performing in-house HIV and STI counseling and testing

20. Study Procedures After the Baseline, participants are randomized to either the intervention or control (waitlist) condition. Participants are randomized stratifying by: • HIV Status • Age This way, there will be an even representation in both conditions Intervention either PHN/RA Baseline or Wait List

21. Study Procedures - Intervention 1) Recruitment Field Screener Phone Screener If randomized to: 2) Enrollment Intervention Baseline 3) Retention 4-Month 8-Month 12-Month

22. Study Procedures – Wait List 1) Recruitment Field Screener Phone Screener 2) Enrollment Baseline Wait List If randomized to: 3) Retention Wait List Intervention 4-Month 8-Month 12-Month 16-Month 20-Month