Start-Up Tasks/Logistics

Study Overview

Intervention Sessions

Transgender Women Intervention

Study Overview2011 – CDC identified transgender women (TW) as a group at significantly high risk for HIV infection due to several syndemic factors:

o experiences of discrimination and stigmao health care providers’ insufficient cultural competenceo 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:

o feasibilityo cultural acceptabilityo preliminary efficacy

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.

Study Overview

•Intervention goals–

– Reduce sexual risk, substance use

– Increase stigma-coping and risk-buffering skills

– Increase connection to and utilization of support services

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

Timeline

Study Overview

Study Overview

Who can 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

Who cannot participate?

Intervention ProceduresIntervention 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 isThe quality or state of being

mindful…Or being

Attentive, Heedful, ThoughtfulEarnest, Intentional”

Intervention ProceduresIntervention Sessions 1-4

Session Title Format Content

1. Exploring Health Goals

Individual MI

1 hour

Intervention overview; personalized risk behavior feedback (e.g., unprotected sex, unsafe silicone injection, history of HIV/STI testing, HIV medications and adherence for HIV+ TW); assessment of readiness to change; goal identification or development of discrepancy between ideal and actual behavior; pros and cons of status quo; pros and cons of change.

2. Creating an Action Plan

Individual MI

1 hour

Decisional balance; elicit commitment; action reflections or roll with resistance; readiness, confidence, commitment rulers; crystallize health goals and change plans; prepare for first group session.

3. Transgender Stress

Group MI + CBST2 hours

Group introductions and rules; focus on empowerment via healthy behaviors; emphasize personal responsibility; identify common group goals; introduce transgender stress; group examples of transgender stress; education on impact of stress on health; rationale for effective communication; effective communication education, role-plays, feedback; plan for ongoing implementation of skill.

4. Stigma and Health Risks

Group MI + CBST2 hours

Define stigma; generate group examples of stigma; education about multiple levels of stigma and multiple effects of stigma; group discussion of impact of stigma on self-worth with personal examples; impact of stigma + self-worth on health; rationale for thought and mood recording; group exercise and practice; impact of thoughts and mood on health behavior; plan for ongoing implementation of skill; representatives from CLCHC introduce available health and medical services.

Intervention Sessions 5-7

Session Title Format Content

5. Drugs and Alcohol

Group MI + CBST

2 hours

Discussion regarding relationship between stigma, stress, and substance use; education about impact of substance use on health; discussion of unique issues for HIV+ TW; group examples of stigma, stress, and substance use; rationale for problem-solving; review of problem-solving steps; group practice, role-play, and feedback of problem-solving; plan for ongoing implementation of skill.

6. Personal Growth and Social Support

Group MI + CBST

2 hours

Define social support; group members share examples of type of social support; identify current social support; generate plan for improved support for improving and maintaining health; review and practice asking for and offering social support; representatives from The Center introduce available social support services; participants will generate plan for accessing services; participants prepare for final, health navigation session.

7. Connection to Resources for Ongoing Care

Individual Health

Navigation1 hour

Review progress toward goals; review barriers to change; review and fine-tune skills implementation; generate plan for connection to ongoing care, including making appointments and reviewing community resources; discussions of need for routine HIV testing for HIV- TW, routine STI testing for HIV- and HIV+ testing, and ongoing health care for HIV+ TW; consolidate progress toward health goals.

IndividualCheck-in

Individual contact

Inquire about participants’ following through with her plan for action at the post-intervention follow-up, one-two weeks after Session 7.

Intervention Procedures

Study Procedures1) Recruitment

Phone ScreenerField Screener

2) Enrollment

Baseline

4-Month 8-Month 12-Month

Recruiter Recruiter/RA/Intern

RA

RA RA RA

3) Retention

Intervention

Wait List

Wait List Intervention

PHN/RA

PHN/RA

either

or

Study Procedures - Assessment

What happens during appointments?

Study Procedures - AssessmentBaseline 4-Month

8-Month 12-Month

1. Informed Consent process (20 minutes)2. MMSE and Psych SCID3. ACASI Survey (30 minutes)4. TLFB for sexual and drug use behavior

in the last 30 days (20 minutes)5. Recent drug use test (5 minutes)6. HIV and STI counseling and testing (20-

40 minutes)7. Randomization

1. ACASI Survey (30 minutes)2. TLFB for sexual and drug use behavior in

the last 30 days (20 minutes)3. Recent drug use test (5 minutes)4. STI testing5. 4-Month booster: Intervention – social

reunion; Education – education review

1. ACASI Survey (30 minutes)2. TLFB for sexual and drug use behavior in

the last 30 days (20 minutes)3. Recent drug use test (5 minutes)4. STI testing

1. ACASI Survey (30 minutes)2. TLFB for sexual and drug use behavior in

the last 30 days (20 minutes)3. Recent drug use test (5 minutes)4. HIV and STI counseling and testing (20-

40 minutes)

Study Procedures - Assessment

1. Informed Consent process (20 minutes)2. MMSE and Psych SCID3. ACASI Survey (30 minutes)4. TLFB for sexual and drug use behavior

in the last 30 days (20 minutes)5. Recent drug use test (5 minutes)6. HIV and STI counseling and testing (20-

40 minutes)7. Randomization

Consent Process

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

Study Procedures - Assessment

1. Informed Consent process (20 minutes)2. MMSE and Psych SCID3. ACASI Survey (30 minutes)4. TLFB for sexual and drug use behavior

in the last 30 days (20 minutes)5. Recent drug use test (5 minutes)6. HIV and STI counseling and testing (20-

40 minutes)7. Randomization

MMSE and Psych SCID

MMSE: Mini-Mental State Exam (MMSE) • Screen for cognitive impairment – ask participant to complete simple tasks, like drawing thisPsych SCID: Structured Clinical Interview for DSM-IV • Questionnaire to determine whether participants have any

psychiatric disorders that may prevent them from participating

Study Procedures - Assessment

1. Informed Consent process (20 minutes)2. MMSE and Psych SCID3. ACASI Survey (30 minutes)4. TLFB for sexual and drug use behavior

in the last 30 days (20 minutes)5. Recent drug use test (5 minutes)6. HIV and STI counseling and testing (20-

40 minutes)7. 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

Study Procedures - Assessment

1. Informed Consent process (20 minutes)2. MMSE and Psych SCID3. ACASI Survey (30 minutes)4. TLFB for sexual and drug use behavior

in the last 30 days (20 minutes)5. Recent drug use test (5 minutes)6. HIV and STI counseling and testing (20-

40 minutes)7. 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…

Study Procedures - Assessment

Study Procedures - Assessment

1. Informed Consent process (20 minutes)2. MMSE and Psych SCID3. ACASI Survey (30 minutes)4. TLFB for sexual and drug use behavior

in the last 30 days (20 minutes)5. Recent drug use test (5 minutes)6. HIV and STI counseling and testing (20-

40 minutes)7. 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

Study Procedures - Assessment

1. Informed Consent process (20 minutes)2. MMSE and Psych SCID3. ACASI Survey (30 minutes)4. TLFB for sexual and drug use behavior

in the last 30 days (20 minutes)5. Recent drug use test (5 minutes)6. HIV and STI counseling and testing (20-

40 minutes)7. Randomization

HIV/STI Testing

Callen-Lorde will be performing in-house HIV and STI counseling and testing

After the Baseline, participants are randomized to either the intervention or control (waitlist) condition.

Participants are randomized stratifying by:1) HIV Status2) Age

This way, there will be an even representation in both conditions

Intervention

Wait List

PHN/RAeither

or

Study Procedures

Baseline

1) Recruitment

Phone ScreenerField Screener

2) Enrollment

Baseline

4-Month 8-Month 12-Month

3) Retention

InterventionIf randomized to:

Study Procedures - Intervention

Study Procedures – Wait List1) Recruitment

Phone ScreenerField Screener

2) Enrollment

Baseline

4-Month 8-Month 12-Month

3) Retention

Wait List

Wait List Intervention

If randomized to:

16-Month 20-Month