The University of Pennsylvania institutional review board (IRB) approved the experimental protocol. The current study followed the principles of community-based participatory research, involving the South Philadelphia Hispanic community throughout65
. An advisory board was established at the outset, consisting of representatives from the following organizations that serve the target community: the Mexican Consulate, the Catholic Archdiocese, a primary-care clinic, and a social service organization. These organizations guided the research through regular feedback provided in both formal and informal settings. This group—composed of individuals from the target population and advocates who were not community members—met quarterly and participated actively in the conceptualization, development, implementation, evaluation, and dissemination of the study.
120 Hispanic women aged 18-65 were recruited and enrolled in the community by 4 female promotoras. Exclusion criteria included age older than 65 or younger than 18, current pregnancy, prior history of cervical cancer, and prior history of hysterectomy. Recruitment and enrollment efforts took place in local faith-based and community-based organizations, the Philadelphia Mexican Consulate, and participants’ homes. This sampling approach was chosen to more accurately reflect the target population, rather than recruiting subjects in healthcare institutions where baseline health knowledge and behaviors may be greater. Eligible women were invited to participate in the study, and received two $20 gift cards as an incentive.
All participants took a baseline questionnaire, which was administered in Spanish by the promotoras and lasted approximately 30 minutes. The promotoras’ training in research methods has been reported elsewhere49
. The personal and professional backgrounds of our promotoras are also described elsewhere66
. The baseline questionnaire—previously piloted in the community—included 55 questions measuring the following constructs: health status, history of Pap smear screening and general health care use, and risk profile for cervical cancer. Sociodemographic characteristics measured in the baseline questionnaire included age, marital status, educational attainment, employment, insurance status, country of origin, length of residence in the U.S., and acculturation. Our primary outcome was receipt of cervical cancer screening following the intervention; our secondary outcomes were knowledge about cervical cancer and self-efficacy to undergo Pap smear screening. All outcome measures were assessed in the baseline questionnaire and in a 28-question follow-up questionnaire, which was also administered in Spanish by the promotoras in approximately 15 minutes.
Self-reported health status was measured with a single question using a five-point Likert scale from 1 (“Excellent”) to 5 (“Poor”). Previous Pap smear screening history was assessed by asking the month and year of the participants’ last Pap smear. This question was dichotomized as having received a Pap within 1 year (i.e. up-to-date) or not. Knowledge about cervical cancer was measured using a 6-item questionnaire developed by the research team. (See Online Appendix
). These six questions covered the pathogenic role of HPV, methods for prevention, screening recommendations, the meaning of a positive Pap smear, the relevant epidemiology of cervical cancer in Hispanics, and anatomy of the cervix. Self-efficacy was measured using a previously validated scale that contains 19 close-ended questions with a 5-point Likert scale describing the participants’ likelihood of undergoing Pap smear screening under different scenarios67
. Responses range from 1 (“I would definitely not have a Pap smear”) to 5 (“I would definitely have a Pap smear”). Acculturation was measured using the Short Acculturation Scale for Hispanics developed by Marin et al, and is represented as a numeric average of the responses to the five questions, which range from 1 (least acculturated) to 5 (most acculturated)68
All 120 participants were randomized to receive a promotora-led cervical cancer educational intervention or usual care. At the suggestion of community members involved in the design of the study, control-group participants crossed over to receive the experimental intervention after completion of the follow-up evaluation. A random number sequence was generated by the PI to guide group assignment. Subjects were allocated to either the intervention or control group by the promotoras based on whether their study number was odd or even. We determined a priori that 60 participants in each group were necessary to detect a 25% difference in the percentage of women who received Pap screening between the two groups, assuming a baseline screening level of 50%, an α of 0.05, and 80% power.
The intervention consisted of two 3-hour workshops—including between 4 and 10 women in each group—which were led by a pair of promotoras. These workshops followed a previously-studied curriculum, which was modified by the study team for the purposes of the current study62
. The curriculum employs an interactive format and includes information about female genital anatomy, risk factors for cervical cancer, common myths about cervical cancer, screening procedures and recommendations, the implications of screening, and the epidemiology of cervical cancer in Hispanic women. All participants were given a copy of this curriculum, in addition to other program materials including informational pamphlets from the American Cancer Society and U.S. Department of Health and Human Services.
The intervention was delivered in several rounds over a 4-month period. We used multiple process measures to ensure that the intervention was implemented uniformly. A basic set of questions was filled out by the promotoras at the end every workshop documenting the number of participants, the length of time spent on each portion of the curriculum, and the total time for each session. The principal investigator and study coordinator randomly observed 20% of the workshop sessions to confirm adherence to the curriculum and to verify the promotoras’ responses to the process measures outlined above. Follow-up of all study participants occurred approximately 6 months following the delivery of the educational intervention, consisting of a second questionnaire that included a question about whether the participants underwent Pap smear screening during the follow-up period, and if so, where they received it. Self-reported data on Pap smear receipt were verified by chart review for 83% of participants who reported undergoing screening at three local health centers.
Baseline characteristics were compared between the two study groups using chi-square tests for dichotomous variables and t-tests for continuous variables. The Mann–Whitney test was used to compare continuous variables with non-normal distributions, which was assessed using the Shapiro–Wilk test. Receipt of Pap smear screening during the follow-up period was expressed as the percentage of women in each group that underwent Pap screening. This outcome was compared between the two groups using the chi-square test. The secondary outcome of a cervical cancer knowledge score was calculated using the number of questions answered correctly; and a self-efficacy score was expressed as the numerical average of participants’ answers to the 19 self-efficacy questions. Post-intervention knowledge and self-efficacy were expressed both as t-test comparisons of these scores between the groups, and as a difference in differences from baseline scores using t-tests. We used multivariate logistic regression to estimate the influence of the following predictors on receiving a Pap smear among the follow-up cohort: age, education, having a usual source of care, parity, acculturation, self-efficacy, cervical cancer knowledge, and group assignment.