# Presentation: 760415

## Remnants of the Tuskegee Syphilis Study Effects on University Freshmen: Yet a Possible Barrier to Research Participation?

**Crystal B. Spivey, MPH, DrPH**
**March 9, 2004**
**Supported by: R24MD00151 NCMHD**

**Notes:**
The title of my presentation is......... The study is sponsored by a grant from the National Center on Minority Health and Health Disparites.

EXPORT Project REAP
(Reproductive Health Disparity Awareness and Prevention)

## Co- Authors

- Tina Simpson, MD1
- Tina Vazin, PhD2
- M. Kim Oh, MD1
- Karyn Gunn, PhD2
- 1University of Alabama at Birmingham, AL
- 2 AL State University, Montgomery, AL

**Notes:**
I would like to acknowledge and Thank my co-authors..... 
Dr. Simpson is and Dr. Vazin are both project investigators.  Dr. Kim Oh and Dr. Karyn Gunn are the PIs.

## Introduction

- African Americans lag behind the overall population on virtually all health status indicators
- African Americans’ decision to participate in research is  a difficult one
- Tuskegee Syphilis Study (1932-1972)?

**Notes:**
African Americans lag behind the overall population on virtually all health status indicators, underlining the need for continued focus on health research to lessen and eventually eliminate racial and ethnic disparities.  Unfortunately, the decision to participate in basically any type of medical research is a difficult one for A.A.

The Tuskegee Study still remains as one of the pervading factors, singled out by both professionals and popular press, as being the major source of distrust among  A. A. toward medical  and public health authorities.  This in turn has led to critical low A. A. participation in clinical trials.  Especially, in respect to HIV/AIDS prevention and treatment programs.

## Purpose of the Study

- Identify clinical research interest of young college students
- Identify perceived barriers to research participation

**Notes:**
In this particular study we had the unique opportunity to gather information from young women and men on what they considered to be barriers to their participation in clinical research.

## Methods: Setting

- Historically Black College University in the Southeastern U.S.

**Notes:**
The study took place at a Historically Black College University in the Southeastern U.S.

## Methods	

-  Cross-sectional survey
- Conducted Fall 2003 (Sept-Oct)
- Chi-square method of analysis

**Notes:**
A cross –sectional survey was administered during freshmen orientation.  The survey was conducted Sept-October 2003.

Approximately 22 classes with approximately 30 students per  classroom were surveyed.  There were 2 surveyors assigned per classroom.

## Survey Instrument

- Participant Demographics (race, gender, and age)
- Level of interest in STD/HIV and pregnancy prevention clinical trials
- Perception of barriers

**Notes:**
 Survey instrument was developed by project staff. The survey gathered information on participant demographics.    In the survey we assessed interest in participating in clinical trials.  We asked students about their interest in participating in clinical trials that tested the effectiveness of new products for  STD/HIV prevention as well as for pregnancy prevention.   And also asked them about their perception of some selected barriers.

## Study Population Characteristics

-  N = 691
- 95% African Americans (less than 1% White, 3% more than one race, and 1% did not categorize )
- 57%  Females
- 16-24 years of age
- Mean age 18

**Notes:**
A total of 691 individuals participated in this survey.  95% of study participants were AA and less than 1% were White.  Females had a higher representation among study participants.  The age range of participants was 16-24.  Mean age of respondents was 18.

## Interest in participation in clinical trials

- Level of Interest

**Notes:**
We asked participants about their interest in STD/HIV and Pregnancy Prevention clinical trials.   When asked the question “If you are compensated (paid by cash) for your time and efforts, would you be interested in being in a study that tests safety and effectiveness of new products for STD/HIV prevention.    20% responded they would be very interested, about 30% somewhat interested, 32  % responded they would not be interested at all and approx. 18% were not sure at the time.     What is unusual about this finding is when you look at the % of those very or somewhat interested in clinical research, nearly 50% would be very/or somewhat interested in participating in STD/HIV clinical trials.  While Similar, the findings for Pregnancy Prevention were not as high.   When asked of their interest in participating in studies that tests the effectiveness of new products for  Temporary (a short term) pregnancy prevention 19% expressed they would be very interested , around 24% somewhat, and 37% indicated they would not be interested at all and again 18% were not sure.

## Perceived Barriers

**Notes:**
Participants were given a list of possible reasons why one may not want to volunteer for clinical trials and asked their perception of importance for each factor.

## Lack of Interest

**Notes:**
When it came to Lack of Interest
35% responded it was very important 
33% Somewhat important
21% A little important
11% Not important

## Confidentiality Issues

**Notes:**
When asked about Confidentiality Issues
62% responded that it was very important
28% somewhat important
5% A little important\
3% Not important

## Mistrust

**Notes:**
When asked about Mistrust i.e. cannot trust the researchers
47% responded it was very important
33% Somewhat important
15% A little important
5% Not important

## Impact of the Unethical Aspects of the Tuskegee Syphilis Study

**Notes:**
When asked about the impact of the Tuskegee Syphilis study as a possible deterrent to participation in  research.  35% stated it was very important, 33% somewhat important, 14% not important, and 17% reportedly didn’t know what the Tuskegee Study was about.

## Impact of the Tuskegee Syphilis Study 

- P-value = .020

- Level of Impact

**Notes:**
Next we looked at the association between the TSS barriers with place of residence.   Alabama students or in state students were significantly more likely to report the study as being very important to their participation in research. 39% vs. 32% and Non Alabama students were more likely to not know what the study was 21%. 13.20%. 

## Gender Differences

- P-value < .001

- Level of Impact

**Notes:**
We looked at gender differences as well....  Females were morel likely to report the Tuskegee Syphilis Study as being very important to their participation than males.38% vs. 32%  Males were more inclined to report the study as not being important.  20% vs. 9.3%

## Association between Tuskegee Syphilis Study and other study barriers

- Lack of Interest	p-value < .001
- Confidentiality 		p-value< .001
- Mistrust 			p-value< .001

**Notes:**
Students citing lack of interest  as a very important barrier were more likely to report the Tuskegee Syphilis Study as being very important (Chi-square = 51.65).

Students citing confidentiality as not being important was were less likely to have heard of the Tuskegee Syphilis Study.

By far, students citing mistrust of researchers as being very important were more likely to report the Tuskegee Syphilis Study as being very important in their decision to participate in research. (49%).  Trusting researchers were less of an issue among students unfamiliar with the Tuskegee Study. (42%).

## Conclusions

- Tuskegee Syphilis Study continues to influence African Americans willingness to participate in clinical research
- Confidentiality Issues very important
- Must build a foundation to develop trust

**Notes:**
In conclusion, much consideration has been given to the Tuskegee SS, regarding AA participation in clinical trials.  Based on the empiric evidence, we were able to determine first hand, barriers that potentially influence AA willingness to participate in clinical research.  
Yes the TSS still casts a shadow, however, in our study the young women and men perceived confidence issues as the greatest barrier to their volunteering in clinical research.  90% stated that it was very/somewhat important .  
Nearly 50% of participants cited mistrust as a possible barrier.  We must build a foundation to develop trust.  Researchers must secure AA trust, which will be a gradual process, simply because it takes time to develop trust.  Long term commitment, community involvement as well as a two way dialogue provides a strong foundation for the development of trust.

The Tuskegee Syphilis Study still continues to be one of the pervading factors within the African American community influencing individual interest in participation in biomedical research.  It is of great importance that more AA participate in clinical research if we are to reach biological and culturally appropriate conclusions.  Researchers must secure AA trust.  Which will be a gradual process, because it takes time to build trust.  Long term commitment, community involvement, Honesty, full disclosure, and a  two way dialogue provides a strong foundation for the development of trust.

## Confidentiality Issues

- P-value < .001

- I

- Impact of the Tuskegee Study

- Importance of Confidentiality

- Level of Impact

**Notes:**
Students citing confidentiality as being somewhat important were significantly more likely to report the Tuskegee Syphilis Study as being somewhat important in their decision to participate in research. (45%)  Likewise, students in which confidentiality was not of concern were less likely to have heard of the Tuskegee Syphilis Study. (39%)

## Mistrust- Cannot trust the researchers

- P-value <.001

- Impact of the Tuskegee Study

- Mistrust of researchers

- Level of Impact

**Notes:**
By far, students citing mistrust of researchers as being very important were more likely to report the Tuskegee Syphilis Study as being very important in their decision to participate in research.(49%)  Trusting researchers were less of an issue among students unfamiliar with the Tuskegee Study.(42%)

## Just not interested in being in a research study

- P-value < .001

- Lack of interest

- Impact of the Tuskegee Study

- Level of Impact

**Notes:**
Students citing lack of interest as a very important barrier were more likely to report the Tuskegee Syphilis Study as being very important (Chi-square = 51.65). (50%)  Those citing research interest as not being important, 30% was not familiar with the study.