Jessica Cruz Whitley Protocol Assignment #1

Jessica Cruz Whitley Protocol Assignment #1

by Jessica -
Number of replies: 2

Sorry for the late post. 

A. What evidence are you proposing to translate into practice?

An educational tool about HIV vaccine research to engage populations at high risk for HIV infection in San Francisco and Oakland, with a focus on young Black and Latino MSM and trans women.

1. Justify that this evidence is “ready for translation.”

HIV vaccine research studies have acknowledged that recruitment should first focus on building awareness of HIV vaccine research through effective information dissemination along with facilitation of learning opportunities in order to foster support for HIV vaccines among minority populations.1-2 The Internet, and its growing population of users, particularly among Black and Latino young adults 3-4, provides a less resource intensive means of recruiting diverse participants in HIV clinical trials. To date, internet-based tools have been focused on HIV education and prevention through chat discussions, message board forums, individual outreach and educational websites, but there is limited data on video educational tools in recruiting Black and Latino MSM in HIV vaccine research.5 Educational videos, in particular, can deliver content with a balanced presentation of information in order to provide standardized education, and if delivered through video-sharing websites can even reach a broader audience via social media.

 As an example, one randomized, controlled trial of an education video intervention to consent to organ donation showed that those in the video intervention arm consented to organ donation more than the control group, and this was particularly effective among black participants, with fewer participants citing insufficient information about donation.6

2. Identify a single, key behavior change target for your translational activity. 

Interest in participation in HIV clinical research

 3. Conduct a “gap analysis” of your target behavior.  Look to diverse sources for “best guess” estimates if specific measures are not available.

 Misconceptions regarding HIV vaccines are common and differ by race/ethnicity with minority participants reporting concerns about safety of the vaccine and mistrust of the government and government-sponsored HIV/AIDS research.1,7 One of the most commonly reported reasons for not participating in clinical research by minorities has been lack of information communication about the research.8

B.  What is the quality (performance) gap?

Lack of appropriate recruitment and educational tools about HIV vaccine research

C.  What is the outcome gap?

In the U.S., substantial racial/ethnic and sexual risk behavior disparities exist in HIV infections. HIV disproportionately affects Latinos, Blacks, and transgender people. The epidemic is particularly intense among young Black MSM who has a rapidly increasing incidence of HIV.9-10 Despite this, Latinos and Blacks have been disproportionally underrepresented in HIV vaccine clinical trials. In the phase IIb STEP Study, 37% of eligible minorities were interested in participating after pre-screening, but only 25% were enrolled, highlighting the need to sustain participation among eligible minorities.11 Most recently, the HVTN conducted a phase IIb efficacy trial of a vaccine regimen in at-risk populations in the U.S. with the study population comprised of only 16% Blacks and 8% Latinos.12

 D.  Is there evidence that changing performance will improve health (clinical outcomes)? 

Engagement in HIV vaccine research from the most affected communities is important for trial conduct and the generalizability of study findings; therefore, it is important to increase recruitment of minority trial participants in HIV vaccine research.

 

 

1. Sobieszczyk, M., Xu, G., Goodman, K., Lucy, D., & Koblin, B. (2009). Engaging members of african american and latino communities in preventive HIV vaccine trials. JAIDS Journal of Acquired Immune Deficiency Syndromes:, 51(2), 194-201.

2. Frew, P., Rio, C., Clifton, S., Archibald, M., Hormes, J., & Mulligan, M. (2008). Factors influencing HIV vaccine community engagement in the urban south. Journal of Community Health, 33(4), 259-269.

3. Smith, A. (2010). Mobile access 2010: Pew internet and the american life project. Retrieved 2/19, 2014, from http://www.pewinternet.org/Reports/2010/Mobile-Access-2010.aspx

4. Purcell, K. (2010). The state of online video. Retrieved 2/19, 2014, from http://www.pewinternet.org/2010/06/03/the-state-of-online-video/

5. Thornton, J., Alejandro-Rodriguez, M., León, J., Albert, J., Baldeon, E., De Jesus, L., et al. (2012). Effect of an ipod intervention on consent to donate organs. Annals of Internal Medicine, 156(7), 483-490.

6. Hightow-Weidman, L., Fowler, B., Kibe, J., McCoy, R., Pike, E., Calabria, M., et al. (2011). Healthmpowerment.org: Development of A theory-based HIV/STI website for young black MSM. AIDS Education Prevention, 23(1), 1-12.

7. Priddy, F. H., Cheng, A. C., Salazar, L. F., & Frew, P. M. (2006). Racial and ethnic differences in knowledge and willingness to participate in HIV vaccine trials in an urban population in the southeastern US. International Journal of STD & AIDS, 17(2), 99-102.

8. Sullivan, P.S., McNagten, A.D., Begley, E., Hutchinson, A., Cargill, V.A. (2007). Enrollment of racial/ethnic minorities and women with HIV in clinical research studies of HIV medicines. J Natl Med Assoc. 99(3), 242-50.

9. CDC, . (2013). HIV among transgender people. Retrieved 2/19, 2013, from http://www.cdc.gov/hiv/risk/transgender/index.html

10. CDC, . (2013). HIV in the united states: At A glance, by risk group. Retrieved 2/19, 2014, from http://www.cdc.gov/hiv/statistics/basics/ataglance.html

11. Frew, P. (2009). Understanding differences in enrollment outcomes among high-risk populations recruited to a phase IIb HIV vaccine trial. Journal of Acquired Immune Deficiency Syndromes, 50(3), 314-319.

12. Hammer, S. M., Sobieszczyk, M. E., Janes, H., Karuna, S. T., Mulligan, M. J., Grove, D., et al. (2013). Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med, 369(22), 2083-2092.

 

In reply to Jessica

Re: Jessica Cruz Whitley Protocol Assignment #1

by Lisa Thompson -

Hi Jessica, This is an interesting approach, and very important to increase recruitment of a hard to reach population. You did an excellent job of documenting the gap. In addition to using the video for recruitment, would you also be using it for consenting? Current consent forms are long and unwieldy and a video explaining the consent process might be a friendlier format (organ transplant example).

I thought you would be interested in an old article....

Fureman I, Meyers K, McLellan AT, et al. Evaluation of a video-supplement to informed consent: injection drug users and preventive HIV vaccine efficacy trials. AIDS Educ Prev 1997;9:330–41.

....and a new SR/MA that includes studies using videos for recruiting African Americans into cancer trials (see Du et al.):

Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan FM, Wilson S, Jackson C, Jones R, Mitchell ED.Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013 Feb 7;3(2).  PMID:23396504

See you  in class on Thursday, Lisa Thompson
In reply to Jessica

Re: Jessica Cruz Whitley Protocol Assignment #1

by Matt Hickey -

Thanks for sharing Jessica.  Agreed - excellent job defining the outcome gap.

For the 'evidence you are proposing to translate', I wonder if this evidence might be the need for participation by key populations in HIV vaccine research?  This seems to be what your outcome gap is defining.  There also seems to be clear literature demonstrating that this is important, but not actually realized in practice.  If this is the case, then your approach for translating this evidence into practice would be the educational tool you are developing.

I found this difficult with my protocol as well - I initially thought that the translation intervention I was evaluating was the thing that needed translating.  As I have gained more clarity on the distinction though, it seems like the evidence we want to translate is the particular outcome that has been shown to be important but has a 'gap' in its actualization.  Would love to hear what you and others think.