# Presentation: 404441

## Combined Pharmacological and Behavioral Therapy and HIV Risk Reduction

- Jennifer Schroeder, David Epstein, Katherine Belendiuk, Jessica Willner-Reid, John Schmittner, Kenzie L. Preston
- NIDA Intramural Research Program

- Supported by NIH NIDA Intramural funds

## Substance abuse is a significant vector for HIV transmission.

- Substance abuse is a significant vector for HIV transmission.
- Transmission can occur at multiple points:
- 	drug procurement
-  		exchanging (unprotected) sex for drugs 		act of self-administering drugs
- 		use of infected equipment
- 	effects of the drug
- 		unprotected sex during intoxication

**Notes:**
Use of infected equipment leads to the spread among drug users
Unprotected sex leads to the spread among drug users and to non-drug users
Substance abuse treatment has substantial potential for reducing behaviors associated with HIV transmission. 
Effective approaches to reducing HIV transmission may need to be multi-dimensional.
We have been investigating ways to decrease HIV risk behaviors in the context of substance abuse treatments that combine pharmacological and behavioral interventions.
We are also investigated whether there are characteristics that identify particular populations whom we might target with interventions.

## Objectives

- To investigate HIV risk behaviors in a subpopulation of heroin/cocaine users - individuals infected with hepatitis C.

## Treatment Population

- Race:	58% African American  40% White  2% Other
- Age:	38 years old
- Education: 11 years
- 10 years of Heroin Use; 100% opioid dependent
- 8 years of Cocaine Use; 65% DSM IV cocaine dependent
- <10% HIV positive

**Notes:**
67% employed 
54% never married

## Combination Treatment

- Target cocaine use -
- 	Contingency management - reinforced cocaine 			abstinence
- 	Cognitive Behavioral Therapy - four specific skills taught:
- 		Coping skills to deal with stress
- 		Relapse prevention skills to deal with craving
- 		Development of alternative (non-drug) reinforcers
- 		HIV Risk Reduction Education

- Combination

- Single

-  Single

- Control

- Cognitive
- Behavioral

- Social
- Support

- Contingency
- Management

- Noncontingent
- Control

**Notes:**
Our laboratory has been investigating improving treatment for poly-drug (heroin/cocaine) users through the combination of pharmacological and behavioral treatments.

## •

- Baseline

- Intervention

- Post Intervention
- Maintenance

- 5 weeks

- 12 weeks

- 8-12 weeks

- Study Time Line

- Informed consent
- and screening

- weekly individual

- Randomization

**•**

**•**

## HIV Risk Behavior Questionnaire

- Internally developed questionnaire modified from that used in the ALIVE study (Vlahov et al., 1991).
- Drug-related behaviors
- 	how often injected any kind of drug
- 	how frequently injected with shared needles
- Sexual behaviors
- 	how frequently had unprotected sex
- 	how frequently traded sex for money, drugs or gifts.
- Possible responses: none, less than 4 times per month, once per week, 2-6 times per week, daily, 2 or more times a day.
- Responses were dichotomized to none vs. some (i.e., any occurrence of the behavior).

## HIV Risk Behaviors

- 0

- 20

- 40

- 60

- 80

- 100

- Injection
- Drug Use

- Share
- Needles

- Unprotected
- Sex

- Trade Sex for
- Money or Drugs

- % Reporting Behavior

- Before Treatment

- 96%

- 57%

- 31%

- 29%

- N=81

## HIV Risk Behaviors

- 0

- 20

- 40

- 60

- 80

- 100

- Injection
- Drug Use

- Share
- Needles

- Unprotected
- Sex

- Trade Sex for
- Money or Drugs

- % Reporting Behavior

- Before Treatment

- After Treatment

- 96%

- 49%

- 57%

- 5%

- 31%

- 4%

- 29%

- 2%

- N=81

**Notes:**
All treatments significantly reduced HIV risk behaviors. 
Compared to Intake, at exit:
>50% of those injecting reported no injecting.
90% of those who shared needles reported no sharing.
88% of those reporting unprotected sex reported none.
91% of those reporting trading sex for drugs reported none.

## *

- 0

- 20

- 40

- 60

- 80

- 100

- CBT
- +CM

- CBT

- CM

- Control

- % Reporting Behavior

- 0

- 20

- 40

- 60

- 80

- 100

- CBT
- +CM

- CBT

- CM

- Control

- % Reporting Behavior

- Before

- After

- 0

- 20

- 40

- 60

- 80

- 100

- CBT
- +CM

- CBT

- CM

- Control

- % Reporting Behavior

- 0

- 20

- 40

- 60

- 80

- 100

- CBT
- +CM

- CBT

- CM

- Control

- % Reporting Behavior

- Frequencies of self-reported HIV risk behaviors by treatment group

- CBT - Cognitive Behavioral Therapy; CM - Contingency Management Therapy

- Injection Drug Use

- Share Needles

- Unprotected Sex

- Trade Sex for Money or Drugs

*****

*****

*****

*****

**Notes:**
There were only modest group differences.
Groups receiving CBT 3x more likely than controls to to stop sharing needles
CBT+CM 5x more likely than controls to to stop unprotected sex
Methadone maintenance augmented with behavioral interventions has broad beneficial effects in reducing HIV risk behaviors.
Cognitive behavior therapy enhanced with HIV Risk education had only limited benefits over standard treatment.

## Methadone maintenance augmented with behavioral interventions has broad beneficial effects in reducing risky behaviors.

- Cognitive behavior therapy enhanced with HIV Risk education had limited added benefit over standard treatment.
- Are treatment effects on risky behaviors different in infected and non-infected populations?

## Risky Behaviors in HCV-infected Polydrug Users

- Participants:
- 	647 polydrug (heroin/cocaine) users
- 	tested for HCV antibodies on admission
- 	55% HCV positive (n = 356); 45% HCV negative (n = 291)
- 		most were unaware of their HCV status at the time of testing
- Treatment:
- 	Methadone Maintenance
- 	Contingency management - reinforced cocaine/heroin abstinence.
- 	HIV risk reduction education was incorporated in individual counseling
- 		for all participants.
- HIV Risk-taking Behavior Scale (HRBS; Darke, et al., 1991)
- 	Two subscales: Drug-related risk behavior; Sexual risk behavior 	Completed every two weeks

- 0

- 2

- 4

- 6

- 8

- 10

- 12

- 0

- 4

- 8

- 12

- 16

- 20

- 24

- 28

- HIV Risk-taking Behavior Scale

- T

- ota

- l

- Score

- Treatment Week

- *

- HCV negative

- HCV positive

- Maximum possible score = 60; higher score = more risky behavior

- HIV Risk-taking Behaviors and Hepatitis C Infection

- Intake:
- F1, 645 = 86.6, *p*<.001

- 0

- 2

- 4

- 6

- 8

- 10

- 12

- 0

- 4

- 8

- 12

- 16

- 20

- 24

- 28

- HIV Risk-taking Behavior Scale

- T

- ota

- l

- Score

- Treatment Week

- *

- *

- *

- HCV negative

- HCV positive

- Maximum possible score = 60; higher score = more risky behavior

- HIV Risk-taking Behaviors and Hepatitis C Infection

- HCV status: F1, 645 = 10.3, *p< *.001
- HCV status X Time: F15, 6229 = 10.3, *p< *.0001

## HIV Risk-taking Behavior Scale

- Treatment Week

- 0

- 1

- 2

- 3

- 4

- 5

- 6

- 7

- 8

- 0

- 4

- 8

- 12

- 16

- 20

- 24

- 28

- Drug Risk Subscale

- Subscale

- Score

- *

- *

- *

- *

- *

- *

- Times Injected

- 0

- 1

- 2

- 3

- 4

- 0

- 5

- 10

- 15

- 20

- 25

- 30

- Did Not Clean Needles

- Week

- Representative Individual Items

- Maximum possible score: subscale = 30; individual items = 6; higher score = more risky behavior

- N = 647
- HCV status: F1, 645 = 552.5, *p< *.0001

- N = 418
- HCV status: F1, 412 = 11.3, *p< *.0008

- HCV status: F1, 645 =23.9, *p< *.001
- Time: F15, 6147 =76.9, *p< *.0001
-  HCV stat X Time: F15, 6147 =23.9, *p< *.0001

**Notes:**
HCV positive participants:
reported higher rates of HIV risk behaviors that were accounted for number of times injecting 
decreased their frequency of needle-use behavior overall
became more likely over time to clean them and avoid sharing them when needles were used 
- HCV- participants did not

## HIV Risk-taking Behavior Scale

- Week

- 0

- 1

- 2

- 3

- 4

- 5

- 6

- 7

- 8

- 0

- 4

- 8

- 12

- 16

- 20

- 24

- 28

- Sex Risk Subscale

- Subscale

- Score

- Sex with How Many Partners

- No Condoms with Casual Partners

- Week

- Representative Individual Items

- Treatment Week

- Maximum possible score: subscale = 30; individual items = 6; higher score = more risky behavior

- N = 647
- HCV status: NS

- N = 480
- HCV status: F1, 477= 19.9, *p< *.0001

- HIV status: F1, 645 = 9.8, *p< *.01
- Time: F15, 6144 = 18.9, *p< *.0001
- HIV status X Time: NS

**Notes:**
became more likely over time to avoid specific sex-risk behaviors when sex was reported
	- HCV- participants did not

## Conclusions

- HIV-risk behaviors decreased in polydrug users receiving combined pharmacological and behavioral treatments.
- Polydrug users who were already infected with hepatitis C reported a steeper decline in risky behaviors than non-infected patients.

## HIV Risk-taking Behavior Scale

- Week

- 0

- 1

- 2

- 3

- 4

- 5

- 6

- 7

- 8

- 0

- 4

- 8

- 12

- 16

- 20

- 24

- 28

- Sex Risk Subscale

- Subscale

- Score

- No Condoms with Regular Partners

- No Condoms with Casual Partners

- Week

- Representative Individual Items

- Treatment Week

- Maximum possible score: subscale = 30; individual items = 6; higher score = more risky behavior

- N = 480
- HCV status: F1, 477= 17.2, *p< *.0001

- N = 480
- HCV status: F1, 477= 19.9, *p< *.0001

- HIV status: F1, 645 = 9.8, *p< *.01
- Time: F15, 6144 = 18.9, *p< *.0001
- HIV status X Time: NS

**Notes:**
became more likely over time to avoid specific sex-risk behaviors when sex was reported
	- HCV- participants did not

## Cognitive Behavioral Therapy	

- Four specific skills taught:
- 	Coping skills to deal with stress
- 	Relapse prevention skills to deal with craving
- 	Development of alternative (non-drug) reinforcers
- 	HIV Risk Reduction Education
- Delivered by masters-level counselors in 12 manualized group sessions, monitored for adherence.