This two-group randomized controlled trial was conducted in 2017.
Setting and participants
Study setting was the STD Clinic of Tehran University of Medical Sciences which is located in Razi dermatology hospital, Tehran, Iran. Established in 1934, Razi hospital is one of the oldest teaching healthcare centers in Iran.
This study adheres to CONSORT guidelines(Fig. 2). Participants were 110 patients with HPV infection diagnosed by an infectious disease specialist. Inclusion criteria were an age of more than eighteen, basic literacy skills, and no affliction by physical or mental disabilities. Participants were excluded if they received HRSB-related education from other sources, developed acute physical or mental problems, had one absence from the educational sessions of the study intervention, did not answer our follow-up telephone contacts, did not refer to the study setting for follow-up HRSB assessment, or voluntarily withdraw from the study. They were recruited to the study through consecutive sampling and were allocated to a control and an intervention group through permuted block randomization with block size of 4. Allocation sequence was generated by the statistical advisor of the study, while sampling, data collection, and intervention were performed by the first author. Sampling and data collection were performed in eight months from November 2017 to June 2018.
Sample size was calculated based on the mean and standard deviation of HRSBs reported in a former study and with a confidence level of 0.95 and a power of 0.80. Accordingly, the sample size calculation formula showed that 45 patients were needed for each group (Fig. 3). Yet, considering the probability of participants’ withdrawal from the study and to increase the power of the study, sample size was increased to 55.
Data collection instruments were a demographic questionnaire and the Sexual Risk Scale. The demographic questionnaire had items on age, gender, marital and employment status, educational level, income, insurance, residence, hospitalization history, living arrangement, religion, cigarette smoking, drug abuse, alcohol consumption, and number of sexual partners. The Sexual Risk Scale is a 38-item for HRSB assessment(39). Each of its items is responded as either “Agree”, “I have no idea”, or “Disagree”. At the beginning, a total score of 80 is assigned to each respondent. Then, one point is subtracted for each item that is answered by “I have no idea”. Moreover, if the respondent provides the “Agree” response to odd items and item 38, two points per item are subtracted; otherwise, no point is subtracted. For even items except for item 38, two points per item are subtracted if the respondent responds with the “Disagree” answer, while no point is subtracted if he/she responds these items using the “Agree” answer. Consequently, the lowest and the highest possible scores for the scale are 4 and 80, respectively. The total score of the scale is interpreted as the following: scores less than 15: low risk of HRSBs; scores 15–37: moderate risk of HRSBs; and scores more than 38: high risk of HRSBs(39). In the present study, content validity assessment was performed for the cross-cultural adaptation of the scale. Accordingly, ten instructors of the Faculty of Nursing and Midwifery of Tehran University of Medical Sciences, Tehran, Iran, assessed and confirmed the content validity of the scale. The reliability of the scale was also confirmed with a Cronbach’s alpha of 0.763 and a test-retest correlation coefficient of 0.849. Data for reliability assessment were collected from fifteen patients who twice completed the scale with a one-week interval.
The study intervention was a TRA-based HRSB-related educational program. Primarily, a survey was conducted in the study population in order to identify the most important concepts of TRA among the study population and to design the TRA-based educational program of the study. Accordingly, one hundred patients with HPV infection were consecutively recruited to complete a researcher-made TRA-based HRSB-related questionnaire. The collected data were analyzed and the most important factors affecting HRSBs were identified. Survey findings revealed subjective norms as the most important factor contributing to HRSBs. Therefore, the educational program was designed mostly based on this concept as well as participants’ conditions.
After primary HRSB assessment, the TRA-based HRSB-related educational program was implemented for participants in the intervention group. Educations were provided to participants in two sixty-minute face-to-face sessions with a one-month interval. The instructor for male patients was the first author, while the instructor for female patients was a female nurse trained and supervised by the first author. Besides face-to-face education, an educational booklet containing HRSB-related materials was prepared and provided to patients to review educational materials during the study. After the first educational session, follow-up telephone contacts were made with participants every two weeks for three months to review educations, remind them of reviewing educations using the booklet, answer their probable questions, and assess their conditions. Participants in the control group received routine care services which included no TRA-based HRSB-related education. Three months after the first educational session, participants’ HRSBs were reassessed.
The Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran, approved the study (code: IR.TUMS.FNM.REC.1396.2095) and the study was registered in the Iranian Registry of Clinical Trials (code: IRCT2016121831453N1). Verbal and written informed consents were obtained from all participants and they were ensured that the data would be reported anonymously.
Data were analyzed via the SPSS software (v. 21.0) and were described via the measures of descriptive statistics (including frequency, percentage, mean, and standard deviation). Within- and between-group comparisons were made at a significance level of less than 0.05 using the paired-sample t, independent-sample t, Chi-square, and Fisher’s exact tests.