1. Special Diabetes Program for Indians: Cardiovascular Disease Prevention Group Planning Meeting 2 Recruitment and Retention Issues and Strategies January 11, 2005 Jeffrey A. Henderson, M.D., M.P.H. President and CEO Black Hills Center for American Indian Health

3. Community-based 501 (c)(3) organization Founded in 1998 To conduct activities that will lead to the enhanced wellness of American Indian peoples, communities, and tribes Research, Service, Education, and Philanthropy

4. Black Hills Center for American Indian Health Research Portfolio Six DHHS/NIH peer-reviewed health research grants totaling $8.8 million 1.Education and Research Towards Health (EARTH Study) – NIH/NCI 2.Native American Research Centers for Health: Lakota Center for Health Research – NIH/NIGMS/IHS 3.Stop Atherosclerosis Among Natives with Diabetes (SANDS Study) – NIH/NHLBI

5. Black Hills Center for American Indian Health Research Portfolio 4.Project Export – NIH/NCMHHD 5.Minority Research Infrastructure for MT/WY Tribes – DHHS/AHRQ 6.Environmental Justice on Cheyenne River – NIH/NIEHS

6. Black Hills Center for American Indian Health Research Portfolio Grants currently under development: Health Careers Opportunity Program (HCOP) The experience of chest pain in a Lakota community Knowledge, attitudes, and behaviors about prostate and colorectal cancer screening among Lakota men Ethical, legal, and social implications of genetic testing/studies for environmental pollutants Mold, tribal housing, and adverse health effects

7. Black Hills Center for American Indian Health Research Portfolio BHCAIH has consented more than 4,000 American Indians into its various studies in the past 18 months We expect to recruit another 3,000 in the next 18 months Some examples…

9. A baseline feasibility study for a longitudinal study of risk factors for cancer and other chronic diseases Three linked RO-1s: BHCAIH, Alaska Native Tribal Health Consortium (Lanier), and the University of Utah (Slattery) Total recruitment goal at baseline ~ 16,000 American Indians/Alaska Natives Black Hills Center for American Indian Health The EARTH Study

10. Tribal Communities Participating in EARTH Plains/AZ Center has received tribal approval from the following tribesPlains/AZ Center has received tribal approval from the following tribes –Cheyenne River Sioux Tribe –Oglala Sioux Tribe –Gila River Indian Community

11. Plains/AZ Center EARTH Specifics Plains/AZ Center plans to recruit a total of 5,000 participants in three years –4000 between Cheyenne River and Pine Ridge –1000 Gila River An age-stratified sampling scheme on Cheyenne River and Pine Ridge, and a systematic, household- based sampling scheme on Gila River ~ 650 examinations in first 3 months Sahara heel ultrasound for bone density determination, biological samples, environmental health module, depression, eyesight/hearing, etc.

13. Black Hills Center for American Indian Health The SANDS Study A multicenter, randomized clinical trial to prevent CVD among American Indians with DM through LDL- and SBP-lowering. Sioux San is the only site on the Northern Plains. Two groups with goals of 100/70 (LDL) and 130/115 (SBP), respectively.

14. Black Hills Center for American Indian Health The SANDS Study The primary endpoint is carotid intimal-medial thickness and plaque progression. Secondary endpoints include cardiac function measures by echocardiography, lipoproteins, albuminuria, and C-reactive protein. American Indians 40 yrs. and older with type 2 DM and without signs of CVD. Recruitment began in May 2003 and ended July 2004, with three years of follow-up.

15. The Good Red Road: Tribal Collaborations in Health Research The BHCAIH Experience

16. The Good Red Road: Tribal Collaborations in Health Research American Indians and Alaska Natives, too, have historical situations that have fostered mistrust –Thyroid (I 131 ) studies in Alaska in the 1950s –Barrow alcohol study, 1970s –Coerced sterilization of American Indian/Alaska Native women, 1970s –Early pre-approval use of Depo-Provera and Norplant, 1980s –Present situation involving Havasupai, 2004

17. The Good Red Road: Tribal Collaborations in Health Research American Indian and Alaska Native Tribes are unique in many ways –Domestic, dependent nations with sovereignty –Unique types and levels of approval, which vary by tribe, PLUS group consent in most cases –Very different demographics –DHHS/PHS/Indian Health Service beneficiaries

18. The Good Red Road: Tribal Collaborations in Health Research American Indian and Alaska Native Tribes are unique in many ways –Frequently lack typical supportive and easily accessible community resources (e.g., colleges and universities, social service agencies, grant-making bodies, etc.) –Have such pressing needs that often health research, including health promotion, falls far down the list of priorities

19. The Good Red Road: Tribal Collaborations in Health Research So What Can We do? –Be there –Involve tribal and other grassroots collaborators early and often –Solicit broad input and feedback

20. The Good Red Road: Tribal Collaborations in Health Research So What Can We do? –Add value back to the community in explicit ways This can take many different forms Durable medical equipment Diagnostic and therapeutic services Enhanced skills –Build training and employment opportunities into every grant –Show that you are willing to think outside the box and go the extra mile!

21. The Good Red Road: Tribal Collaborations in Health Research Recruitment and retention issues and strategies: 1.You’d like to maximize community resources in order to: a.Avoid duplication of efforts b.Encourage wider participation in your project c.Help participants to be more comfortable with their participation d.Make it easier for people to participate Strategies: a.Partner with the local health center (and other interested parties) b.Hire staff from the community

22. The Good Red Road: Tribal Collaborations in Health Research Recruitment and retention issues and strategies: 1.You’d like to maximize community resources for recruitment (con’t) c.Market the project to physicians and other providers, staff, and patients Consider providing transportation and child care d.Use a staged recruitment strategy e.Provide an appropriate incentive f.Engender a sense of community, belonging, and ownership

23. The Good Red Road: Tribal Collaborations in Health Research Recruitment and retention issues and strategies: 2.You’d like to try to ensure that participants are committed to seeing the project through to the end. a.Use a staged recruitment process consisting of: –A medical record review –A personalized letter –A pre-screening telephone call –Two screening visits –Randomization or consenting visit

24. The Good Red Road: Tribal Collaborations in Health Research Recruitment and retention issues and strategies: 2.You’d like to try to ensure that participants are committed to seeing the project through to the end. b.Use a staged incentive system: –Payment after the 1 st screening visit and after randomization or study entry –Payments to accompany each follow-up visit c.Build rapport with personal contact d.Maximize privacy and confidentiality within the limits of your project

25. The Good Red Road: Tribal Collaborations in Health Research So What Can We do? –Communicate openly, honestly, clearly, and often, and NEVER make promises that cannot be kept –Disseminate findings clearly and in terms understandable to all –Offer to package research results in a manner useful to the tribe for other purposes –Always be building

26. CONTACT INFORMATION Jeff Henderson President and CEO Black Hills Center for American Indian Health 701 St. Joseph St., Suite 204 Rapid City, SD 57701 (605) 348-6100 (605) 348-6990 fax E-mail: jhenderson@bhcaih.org