1. Willingness to participate in clinical trials among HIV+ adults in Puerto Rico
ORTIZ AP1,2, Miranda S4, Girona G, Roman L, Díaz-Santana MV2, Frontera W, Díaz-Miranda OL2, Colon V1,6.
1 Cancer Control and Population Sciences Program, Comprehensive Cancer Center, University of Puerto Rico, San Juan, Puerto Rico, 2Department of Biostatistics and Epidemiology, Graduate School of Public Health, Medical Sciences Campus; 3UPR/MDACC Partnership for Excellence in Cancer Research Program, School of Medicine, Medical Sciences Campus; 4Puerto Rico Department of Health, HIV Surveillance Program, San Juan, Puerto Rico; Center, University of Puerto Rico, San Juan, Puerto Rico, 5 Division of Infectious Diseases, University of California, San Francisco, USA, 6Department of Health Services Administration, Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.
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Puerto Rico (PR) has a disproportionate burden of HIV/AIDS. In 2010, PR was one of the top ten US states/ territories in terms of the number of cumulative AIDS cases (33,597 reported through 2010), AIDS incidence rate (14.9 per 100,000) and prevalence (329.1 per 100,000)1. A high risk of cancer among people living with HIV/AIDS has been documented.
One of the greatest opportunities for reducing the cancer burden in this population is through increasing their participation in clinical trials (CT). However, minority populations, including Hispanics, tend to be underrepresented in such trials, including those related to HIV and cancer. This underrepresentation of minority populations in clinical trials, is a source for health disparities.
A bigger involvement of minority population in clinical trials is needed to secure that they can benefit in the long run from the new treatments and technologies developed by these trials2. Results from the 2009 Health Information National Trends Survey (HINTS) conducted in PR show that only 51% of persons in PR were aware of clinical trials. Results from the Elimination Disparities in Clinical Trials (EDICT) Project3,4 have documented the following barriers for clinical trial execution in PR: 1) limited emphasis to patient benefit, 2) mistrust and 3) lack of a centralized system for persons in the community to identify trials.
This study aims to describe willingness to participate in CT, and its determinants, among HIV+ persons in Puerto Rico (PR).
Study Design: Cross-sectional study
Study Population: Random sample of HIV+ adults (≥18 years) who received care for HIV infection and participated in the PR HIV/AIDS Surveillance System Medical Monitoring Project (MMP) survey, and answered a local module on CT (n=153).
Statistical Analysis. Descriptive statistics were used to describe the study population. Contingency table analysis, chi-square statistics, Fisher’s exact test and logistic regression models were used to describe factors associated to willingness to participate in CT.
INTRODUCTION
RESULTS
CONCLUSIONS
Although previous experience with CT is low in this group, there is an interest for participation in the future. Sociodemographic factors did not influence willingness to CT participation.
Concerns about potential side effects and about the use of private information are major reasons for patients not to participate in a CT. Meanwhile, physician recommendation, as well as personal and community-level benefits were reported as factors that would influence CT participation.
Educational initiatives should be developed in PR in order to increase participation of HIV+ individuals in CT. These interventions should include education for patients, physicians and researchers about the purpose and benefits of CT.
Opportunities for CT participation across the island should be expanded and promoted, including collaboration with the AIDS Malignancy Clinical Trials Consortium (AMC)5.
The project described was supported by the UPR Comprehensive Cancer Center (UPRCCC) and the University of Texas MD Anderson cancer center (MDACC) partnership for excellence in cancer research grant 5U54CA The content is solely the responsibility of the authors and does not necessarily represent the official views of the NCI.
1. Centers for Disease Control and Prevention. HIV Surveillance Report.2010; vol. 22. Available from: Url: Published March Accessed May 2012.
2. Stark N. Paskett E, Bell R, Cooper MR, Walker E, Wilson A, Tatum C. (2002). Increasing participation of minorities in cancer clinical trials: summary of the “Moving Beyond the Barriers” Conference in North Carolina . J Natl Med Assoc, 94(1):
3. Intercultural Cancer Council. Eliminationg Disparities in Clinical Trials (EDICT) Project. Executive Summary Report from Eight Community Dialogue Meetings. Retreived from
4. Spiker CA, Weinberg AD. (2009). Policies to address disparities in clinical trials: the EDICT Project. J Cancer Educ, 24 Suppl 2: S36-49
5. Ortiz AP, Colón-López V, Girona-Lozada G, Botello-Harbaum MT, Sheon N, Guiot HM, Román-Torres L, Díaz-Santana MV, Miranda-De LS, Palefsky JM. Report of the 2012 capacity building for HIV-HPV clinical trials recruitment among minority underserved populations of Hispanic origin in Puerto Rico. P R Health Sci J Sep;31(3): No
OVERVIEW
The mean age of study participants is 50.3 ± 10.0 years, 58.2% are men and 7.2% have had a cancer diagnosis % consider themselves to be Hispanic.
Overall, 60.8% of participants have ever heard about CT, but only 28.1% have been invited to participate in a CT.
The majority of persons interviewed (83%) would like to receive more information about CT and 66% report to be interested in participating in a CT in the future.
Among, those not interested in participating in CT (n=52), the main reason was concern about possible side effects (67.3%).
Also, 60.1% reported that physician recommendation would influence the willingness of HIV+ individuals to participate in CT.
None of the sociod-emographic factors evaluated was associated to willingness to participate in CT.
Table 1. Sociodemographic variables and willingness to participate in CT among a sample of HIV+ adults in PR (n=143).
Characteristics
Total
N (%)
Willingness
No Willingness
P-value
Gender 
Male
87(60.8)
66(65.3)
21(50.0)
0.09
Female
56(39.2)
35(34.6)
Age (years)
<40
25(17.5)
19(18.8)
6(14.3)
0.66
40-54
77(53.8)
52(51.5)
25(59.5)
>55
41(28.7)
30(29.7)
11(26.2)
Level of Education
< High-school
60(42.0)
39(38.6)
0.15
High-school
graduate
27(18.9)
23(22.8)
4(9.5)
> High-school
17(40.5)
In the last 12 months, did you had health coverage?
Yes
141(98.6)
99(98.0)
42(100.0)
1.00 No
2(1.4)
2(2.0)
FUNDING SOURCE
PRIMARY AIM
REFERENCES
METHODS