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Dr. Calsyn has no conflicts of interest to report for this workshop presentation. Gender Specific Sexual Risk Reduction Interventions for Men and Women Workshop at the 2009 Clinical Practices Research Symposium June 3, 2009 Portland, Oregon. Donald Calsyn, Ph.D., Washington Node of the CTN,

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slide2

Gender Specific Sexual Risk Reduction Interventions for Men and WomenWorkshop at the 2009 Clinical Practices Research SymposiumJune 3, 2009 Portland, Oregon

Donald Calsyn, Ph.D., Washington Node of the CTN,

Alcohol & Drug Abuse Inst., University of Washington

presentation plan
Presentation Plan
  • Rationale for men’s and women’s protocols
  • Study design
  • “Real Men Are Safe” description
  • “Safer Sexual Skills Building” description
  • Differences between the two interventions
  • Main findings “Real Men Are Safe”
  • Main findings “Safer Sexual Skills Building”
  • “Real Men Are Safe” demonstration
  • “Safer Sexual Skills Building” demonstration
background
Background

HIV Risk Behavior

  • Engagement is substance abuse treatment is associated with reduction in HIV risk behaviors.
  • However, many men and women in treatment continue to engage in high risk sexual behavior while in treatment.

HIV Prevention in SA Treatment

  • Most treatment programs provide a one hour HIV/AIDS prevention limited to providing information only.
  • Meta analyses indicate the more efficacious HIV prevention interventions utilize:

 Separate sessions for ♂/♀,  Condom demonstrations,

 Skills training exercises,  Peer group discussions,

 A variety of techniques

background women
Background-Women
  • Heterosexual women are among the fastest growing subgroups of people with AIDS in the US
  • While female AIDS cases due to injection drug use have declined (32%), cases due to heterosexual transmission have increased (66%)
  • Partner risk factors in heterosexual transmission: partner that is an IDU (19.8%)
  • Race/Ethnicity of AIDS cases: Black (59.5%); White (20.2%); Latina (19.1%)
purpose
Purpose
  • Assess the effectiveness of an HIV risk reduction intervention for women in substance abuse treatment in multiple community treatment programs that had been shown to be efficacious previously in a single site
  • Develop an HIV sexual risk reduction interventions for men to serves as a companion research protocol to the CTN approved protocol for women.
  • Incorporate into the interventions elements shown to be efficacious previously, and consistent with current theories on HIV risk reduction interventions.
  • Compare the effectiveness of the developed interventions (“Safer Sex Skills Building” and “Real Men Are Safe”) to a standard HIV prevention intervention typicallyprovided in substance abuse treatment settings.
treatment sites
Treatment Sites

Red=PsychosocialOutpatient

Black=Methadone Maintenance

.

Seattle

Norwalk (18)

Hartford

Staten Is.

.

Philadelphia (x2)

Toledo

.

Huntington

.

.

.

Raleigh (19)

San Francisco (18)

High Point

.

Raleigh

.

.

.

La Puente (19)

Santa Fe (18)

Columbia

Rancho Cucamonga (18)

inclusion exclusion criteria screening measures
Inclusion / Exclusion Criteria & Screening Measures

Inclusion Criteria:

  • 1.Adult men or women in treatment at a participating CTP
  • 2. Self report engaging in unprotected vaginal or anal intercourse during the past 6 months.
  • 3.Agreeable to random assignment.
  • 4.Agreeable to completing assessment battery at baseline, 2 wk., 3 mo., & 6 mo. post intervention.

Exclusion Criteria:

  • 1.Observable, gross mental status impairment – including severe distractibility, incoherence or retardation
  • 2.Observable psychotic symptoms or severe psychiatric distress
  • 3. Having a primary partner planning to become pregnant.

Screening Measures:

  • 1.Demographic Form
  • 2.RiskBehavior Survey
  • 3. Mini Mental Status Exam < 25
primary and secondary outcomes
Primary and Secondary Outcomes

Primary Outcome Variable

Number of unprotected vaginal & anal sex events

Secondary Outcome Variables

Attitude towards condoms

Possessing condoms

Intent to use condoms

Sex under the influence of drugs or alcohol

Number of sexual partners

study design rct
Study Design - RCT

Baseline Assessment Eligibility

Cohort Randomization

Health/HIV Education(1 Session)

Safer Sex Skills BuildingorReal Men Are Safe(5 Session)

Post Treatment

3 Month FU

6 Month FU

real men are safe description

Real Men Are Safe Description

Donald Calsyn, Ph.D. and the CTN0018 protocol team

intervention source materials for real men are safe
Intervention Source Materials for “Real Men Are Safe”
  • Time Out! For Men: A communication skills and sexuality workshop for men

Bartholomew, N.G., & Simpson, D.D. (1996).

  • Approaches to HIV/AIDS education in drug treatment

Bartholomew, N.G. & Simpson, D.D. (1992).

Available at www.tcu.ibr

Institute for Behavioral Research, Texas Christian Univ.

  • Project Light Intervention Manual

The NIMH Multisite HIV Prevention Trial Group

sex under the influence of drugs or alcohol
Sex under the influence of drugs or alcohol

Sex Under the Influence

100

90

Baseline

80

3 Months

70

6 Months

60

Percent

50

40

30

20

10

0

Last 90 Days

Last Sexual Event

hiv education control group
HIV Education (Control Group)

I. Group Introductions. Goals and Guidelines 5 Min

II. HIV/AIDS Update 10 Min

III. HIV Risky Behaviors, injection practices 5 Min

IV. HIV Risky Behaviors, sexual practices 10 Min V. Healthy Options 10 Min

VI. Condom demonstrations 10 Min

VII. Overcoming Barriers to Condom Use 10 Min

techniques utilized in the hiv education group
Techniques Utilized in the HIV Education Group

Lecture

Information on Flipcharts

Condom Demonstrations

remas real men are safe
REMAS: Real Men are Safe

1. HIV/AIDS Update: Identifying Risks

2. HIV/AIDS Update: Planning Prevention

3. Sex without drugs. Can it happen? Is it pleasurable?

4. Beyond the pick up line, communicating about sex

5. Communicating about Safe Sex II. Workshop Summary

techniques utilized in the remas group
Techniques Utilized in the REMAS Group

Lecture & Discussion

Information on Flipcharts

Condom Demonstrations& Practice

Brainstorming & Discussion

Self Assessment Exercises

Role Plays

remas real men are safe session 1
REMAS: Real Men are SafeSession 1

HIV/AIDS Update: Identifying Risks

I. Group Introductions. Goals and Guidelines10 Min

II. Getting Started 10 Min III. HIV Risky Behaviors Exercise 15 MinIV. HIV/AIDS Update15 Min

V. HIV Risky Behaviors, injection practices10 MinVI. HIV Risky Behaviors, sexual practices10 MinVII. Condom demonstration10 Min

VIII. Revisit Risky Behaviors Exercise 10 Min

remas real men are safe session 2
REMAS: Real Men are SafeSession 2

HIV/AIDS Update: Planning Prevention

I. Welcome, redo introductions 5 Min

II. Healthy options10 Min

III. Barriers to Condom Use20 Min

IV. Condom Practice 25 Min

V. Identifying Triggers 15 Min

VI. Risk Reduction Problem Solving 15 Min

male condom skill list
Male condom skill list
  • Chose a latex condom
  • Chose a water-based lubricant
  • Expiration date on package is checked
  • Package is opened carefully
  • Condom checked for damage
  • Determined direction in which condom rolls
  • Condom rolled correctly downward
  • Condom rolled to base of penis
  • Air removed from condom
  • Space left at tip of condom
  • Lubricant added to inside tip of condom or penis
  • Turned to the side and withdrew condom
  • Took care to avoid spilling
  • Tied off condom and disposed of in trash
female condom skill list
Female condom skill list
  • Expiration date on package is checked
  • Package is opened carefully
  • Condom checked for damage
  • Condom unrolled and the two rings separated
  • Condom rubbed gently to evenly spread the lubricant
  • Inner ring squeezed between fingers
  • Inner ring pushed into vaginal canal while squeezed
  • Inner ring placed against cervix so that it is completely covered
  • Outer ring covers outside of vagina
  • End of condom is twisted and removed by pulling, with care taken not to spill its contents
  • Condom disposed of in a trash can
remas real men are safe session 3
REMAS: Real Men are SafeSession 3

Sex without drugs. Can it happen? Is it

Pleasurable?

I. Welcome, redo introductions 5 Min

II. Personalizing Commitment to Sexual

Safety 15 Min

III. Experience with combining sex & drugs

Enhancements/Impairments 35 Min

IV. Enhancing sex without drugs 20 Min

V. Coping with sexual impairment

without drugs 15 Min

remas real men are safe session 4
REMAS: Real Men are SafeSession 4

Beyond the pick up line, talking about

sex with partners

I.Welcome, redo introductions 5 Min

II. Challenging Stereotypes 20 Min

III. Unwritten rules 10 Min

IV. Responsibility in sexual relationships 20 Min

V. Communication about Safe Sex I 35 Min

remas real men are safe session 5
REMAS: Real Men are SafeSession 5

Talking about sexII

I. Welcome, redo introductions 5 Min

II. Practice Talk with Coaching and

Feedback 25 Min

III. Turning Around What They Say 25 Min

IV. Workshop Summary 25 Min

V. Workshop Closure 10 Min

safer sex skills building description

Safer Sex Skills Building Description

Susan Tross, Ph.D. and the CTN0019 protocol team

features of effective hiv preventive interventions for women
Features of Effective HIV Preventive Interventions For Women

Gender specific

Comprehensive skills building

> 4 sessions

skills underlying safer sex
Skills Underlying Safer Sex

Sense of self-efficacy about trying safer sex

(Marin et al., 1998)

Problem-solving skills

Negotiation and refusal skills – in as much as male condoms are controlled by men

Skills for using female condoms

Eroticizing safer sex skills

Partner abuse risk assessment and safety planning

theory
Theory

Social Cognitive Learning Theory:

Behavior is learned through the social processes of observation, modeling, skill rehearsal, and feedback, especially with one’s peer group

Empowerment Theory:

Individuals are empowered to action by the processes of: skill mastery; peer support; and ability to impact on one’s world

health education overview
Health Education Overview

HIV Information

STD Information

HIV Testing and Counseling

Living With HIV (Including HIV Treatment Information)

safer sex skill building overview
Safer Sex Skill Building Overview

HIV/STD education, testing & counseling

HIV/STD risk assessment

HIV/STD safer sex obstacle problem-solving

Condom use skill-building

Negotiation skill-building

Assertiveness training

Partner risk assessment and safety planning

sssb introduction and hiv std education session 1
SSSB: Introduction and HIV/STD Education (Session 1)

WORTH (Women On The Road To Health)

Introduction

Purpose

Counselor and Participant roles and rules

Warm-up: Why I Want to Take Care of Myself

HIV Information

STD Information

HIV Testing and Counseling

Living With HIV (Including HIV Treatment Information)

Closing: Homework and WORTH Affirmation

sssb making it real hiv stds in our lives session 2
SSSB: Making it Real: HIV/STDs in Our Lives (Session 2)

Check-in

HIV in Our Lives

HIV Risk Rationalizations

Challenging Rationalizations: Story of Jesse & Mathilde

Challenging Rationalizations: Our Own

Triggers for HIV/STD Risk Behavior: People, Places, Things

Identifying Our Supports For Taking Care Of

Ourselves

Closing: Homework and WORTH Affirmation

sssb making it real tuning up our hiv std safer sex skills session 3
SSSB: Making It Real, Tuning Up Our HIV/STD Safer Sex Skills (Session 3)

Check-in

Getting Smart about HIV/STD Risk: Stop Light Behaviors

Condom Use Practice and Feedback – Male

Condom Use Practice and Feedback – Female

Eroticizing safer sex

Self-Talk in Tough Risk Situations

Problem-Solving the SODAS Way

Closing: Homework and WORTH Affirmation

sssb making it real making safer sex happen session 4
SSSB: Making It Real, Making Safer Sex Happen(Session 4)

Check-In

Identifying Barriers to Safer Sex

Safer Sex Negotiation and Refusal: The Basics

Safer Sex Negotiation: Demonstration and Discussion

Safer Sex Negotiation: Pairing Up

Assessing Risk of Partner Abuse and Making Safety Plans

Closing: Homework and WORTH Affirmation

ssb keeping it going session 5
SSB: Keeping It Going (Session 5)

Check-in

Where We’ve Been Together: Review

Getting Ready: Common Slip Situations (Especially Involving Drugs & Alcohol)

Slip Plans: The SODAS Way

Program Evaluation and Feedback

Graduation

the sodas model
The SODAS Model

The letter S

STOP. DEFINE THE PROBLEM AND THE GOAL

The letter O

OPTIONS AND OUTCOMES

The letter D

DECIDE

The letter A

ACTION

The letter S

SELF - PRAISE

partner abuse and safer sex
Partner Abuse and Safer Sex

Knowing What Abuse Is

Identifying Your Risk For Abuse

Making A Safety Plan

Safety Plan Worksheet

similarities differences between remas safer sexual skills building

Similarities & Differences between REMAS & Safer Sexual Skills Building

Prepared originally by

Carol Davidson, M.S.W.

Evergreen Treatment Services Seattle, WA

similarities
Similarities
  • Basic information about HIV & STDs
  • Condom demonstration & practice
  • Identifying triggers for unsafe sex
  • Eroticizing safe sex
  • Communication skills training related to sexual situations
differences remas
Differences REMAS
  • Larger focus on the interplay between sex & drugs
  • Focus on recognizing partner needs and the role played by society’s “gender roles”
  • Stress importance of accepting responsibility for one’s own behavior
  • Use of assertive communication skills & “I” statements in safe sex negotiations
differences sssb
Differences SSSB
  • Large focus on increasing a sense of self worth and self efficacy
  • Problem solving skills training for risky sexual situations and relapse prevention
  • Identification and enhancement of positive social support systems
  • Communication skills which stress need to include physical risk assessment and personal safety plan
  • Communication skills training which includes both direct & indirect negotiation and refusal skills
slide51
HIV/STD SAFER SEX SKILLS GROUPS FOR MEN IN METHADONE MAINTENANCE OR DRUG-FREE OUTPATIENT TREATMENT PROGRAMS (CTN 0018)
  • Lead Investigator: Donald Calsyn, Ph.D.

Pacific Northwest Node

  • Co-lead Investigator: Susan Tross, Ph.D.

Long Island Node

  • Project Managers: Sara Berns, Ph.D./

Mary Hatch-Maillette, Ph.D.

  • Lead Statistician: Suzanne Doyle, Ph.D.
  • Supported by NIDA (1 U10DA13714-01, Dennis Donovan, PI)
baseline socio demographic characteristics
Baseline Socio-demographic Characteristics*

*No significant differences between REMAS and HIV Ed on any characteristic

model based mean predicted values for primary outcome variable itt
Model Based Mean Predicted Values for Primary Outcome Variable (ITT)

Number of unprotected sexual events at baseline, 3 & 6 months

as a function of time and intervention group (n=422)

30

25

ES=0.098

ES=0.167

20

Unprotected Sexual Acts

15

10

5

0

Baseline

3 Month

6 Month

Assessment Time Point

HIV ED

REMAS

model based mean predicted values for primary outcome variable
Model Based Mean Predicted Values for Primary Outcome Variable

Number of unprotected sexual events at baseline, 3 & 6 months

as a function of intervention group and completion status

(n=417)

30

Completed

Not Completed

25

ES=0.213

ES=0.337

ES-0.017

20

ES=0.037

Unprotected Sexual Acts

15

10

5

0

Baseline

3 Month

6 Month

Baseline

3 Month

6 Month

Assessment Time Point

HIV ED

REMAS

slide56
Change in Percentage of Men Engaging in Sex under the Influence during Last Sexual Event as a Function of Intervention Condition

Intervention x Time, t=2.18, p=0.03

50

45

HIV ED

REMAS

*

40

35

30

Percents

25

20

15

10

5

0

Baseline

3 Month

6 Month

*p=.0065

Assessment Time Point

slide57
Percentage of Men Engaging in Sex under the Influence during Last Sexual Event as a Function of Partner Risk

Partner Risk, t=3.50, p<.001

70

65

Regular

Casual

60

55

50

45

40

Percents

35

30

25

20

15

10

5

0

Baseline

3 Month

6 Month

Assessment Time Point

slide58
Percentage of Men Engaging in Sex under the Influence during Last Sexual Event as a Function of Treatment Modality

Treatment Modality,t=3.36, p=0.001

70

65

Methadone

60

Outpt. Psy-Soc

55

50

45

40

Percents

35

30

25

20

15

10

5

0

Baseline

3 Month

6 Month

Assessment Time Point

sexual satisfaction as a function of sex under the influence baseline to 3 months
Sexual Satisfaction as a Function of Sex under the Influence, Baseline to 3 Months

9

8

*

Sexual Satisfaction

7

SUI Both

6

SUI 3 Mo. Only

SUI Base Only

SUI Neither

5

Baseline

3 months

Assessment Time Point

sexual satisfaction as a function of sex under the influence baseline to 6 months
Sexual Satisfaction as a Function of Sex under the Influence, Baseline to 6 Months

9

8

*

Sexual Satisfaction

7

SUI Both

6

SUI 6 Mo. Only

SUI Base Only

SUI Neither

5

Baseline

6 Months

Assessment Time Point

findings from women s protocol

Findings from Women’s Protocol

From Susan Tross, Ph.D., and the CTN 0019 Protocol Team

slide62
HIV/STD SAFER SEX SKILLS GROUPS FOR WOMEN IN METHADONE MAINTENANCE OR DRUG-FREE OUTPATIENT TREATMENT PROGRAMS (CTN 0019)
  • Lead Investigator: Susan Tross, Ph.D.

Long Island Node

  • Co-lead Investigator: Donald Calsyn, Ph.D.

Pacific Northwest Node

  • Project Managers: Aimee Campbell, Ph.D.
  • Lead Statistician:, Ph.D.
  • Supported by NIDA (1 U10DA-01, Edward Nunes, PI)
baseline socio demographic characteristics64
Baseline Socio-demographic Characteristics*

*No significant differences between SSB and HE on any characteristic

effect sizes
Effect Sizes

3-Month Follow-Up:

SSB and HE both had similar effects (no significant difference)

6-Month Follow-Up:

USO decreased by 28% in the SSB condition, as compared to the HE condition – reflecting an effect size of .42

predictors of unprotected sexual occasions hanner tross campbell cohen and nunes
Predictors of Unprotected Sexual Occasions: Hanner, Tross, Campbell, Cohen and Nunes

Lower Age (<40) (p<.0001)

Monogamy X Perceived HIV Partner Status: Among those perceiving their partners to be HIV negative, monogamous > non-monogamous women (p<.0001)

Sex-with-drug occasions (p<.0001)

No methadone versus psychosocial treatment differences

analysis of uso summary
Analysis of USO: Summary

There was a significant difference in effect of SSB treatment over time (p<.0001), as compared to HE – at 6-month follow-up. This was enhanced by treatment completion.

Further, as expected, Monogamy status was a significant predictor of USO (p < .0001), such that:

Monogamous women exhibited significantly more (33% more) USO than non-monogamous women.

real world implications
Real World Implications

‘When extrapolated to high-risk populations . . . Modest changes have the potential to improve public health’

Copenhaver et al., 2006

real world implications73
Real World Implications

‘Increase the comprehensiveness of HIV-prevention interventions’

‘Advance female-controlled methods’

‘Change social and cultural norms regarding sexual behavior’

‘Combine substance abuse treatment with HIV prevention intervention’

Logan, Cole and Leukefeld, 2002

real men are safe demonstration

Real Men Are Safe Demonstration

Flipcharts for “Sex & Drugs” brainstorming exercise

putting sodas into action
Putting SODAS into Action

S: What's the problem? What’s the goal?

O: What are your options?

D: What would you decide?

A: What will you do – to act on your decision?

S: Once we decide and act, we deserve a pat on the back for taking care of ourselves!

example using sodas s
Example Using SODAS (S)

Latricia just met this guy James at this party. She kind of knew James before. Latricia and James go back to James's house. Latricia is feeling a little uncomfortable, but she is horny, and James is coming on to her, and he is looking real good. She wants to have sex with him, but she will only have safer sex, because she doesn't want to get anything.

S: What is Latricia’s problem and goal?

She wants to have sex with him, but she will only have safer sex and she is feeling unsure of herself and uncomfortable with James.

example using sodas o
Example Using SODAS (O)

What are Latricia’s Options?

She can negotiate with him to use a condom

She can slip the condom on when she gives him “head”

She can have an alternative to intercourse that is safer, like giving him a hand job

She can refuse to have any sex: directly (saying no) or indirectly (make an excuse)

What are the consequences or Outcomes of each Option?

She is feeling unsure of herself and she might not be able to hold up her "bottom line" of having safer sex and using a condom (he might be able to talk her out of it).

This might work best. She can avoid having to ask him directly. He may find this sexy, and he won't be able to talk her out of it.

She can avoid having to ask him directly. He may find this sexy. She may not be as sexually satisfied as she had hoped.

This would protect her, but her goal of having sex would not be achieved.

example using sodas d a s
Example Using SODAS (D, A, S)

What did Latricia’s Decide?

1)She chooses #2 “Slip the condom on when she gives him head.”

2) She also has an alternative to intercourse, giving him a “hand job” if he strongly objects to a condom.

Latricia Acts on her decision.

Latricia gives herself Self Praise,

“You go girl”

special thanks
Special Thanks!

590Men who participated in the CTN 0018 study

515 Women who participated in the CTN 0019 study

24 Regional Research Training Center Staff and CTP Principal Investigators

16 Site Coordinators

22 Research Assistants

70 Clinicians and Clinical Supervisors

32 Data Managers and Quality Assurance Monitors

clinical trials network dissemination library

NationalDrugAbuseTreatment

Clinical Trials Network ∙ Dissemination Library

Find it in the

CTN Dissemination Library!

http://ctndisseminationlibrary.org