Empowering sexual self-care in HPV-positive women: A randomized trial of health belief model-Based education.

The human papillomavirus (HPV) is the most common sexually transmitted infection worldwide [ 1 ]. HPV strains are classified into low-risk and high-risk types based on their association with cancer [ 2 ]. The global prevalence of HPV is estimated to be 11.7%, with the highest rates observed in Southern Africa (17.4%), Eastern Africa (33.6%), Eastern Europe (21.4%), and Western Europe (9.0%) [ 3 ]. HPV transmission occurs through direct skin-to-skin or mucosal contact during vaginal, anal, or oral sex. Both asymptomatic and symptomatic individuals infected with HPV can transmit the virus [ 4 ]. However, most anogenital HPV infections resolve on their own; for example, over 90% of cervical infections clear within 1–3 years [ 5 ]. High-risk sexual behaviors, including a young age at first vaginal or oral intercourse and having more sexual partners, are the main risk factors associated with the acquisition and persistence of HPV infection and the development of related cancers. These sexual risk factors vary based on socioeconomic status, age, race, and education level [ 6 , 7 ]. It is estimated that around 2.8% of Iranian women in the general population have HPV16/18 infection. Iran has a population of about 33.5 million women aged 15 years and older at risk of developing cervical cancer, with 1,056 women diagnosed with cervical cancer and 644 deaths annually [ 8 ]. Most HPV-related diseases are preventable through education, screening programs, and vaccination [ 1 ]. HPV infection and genital warts have significant physical and psychological effects on women [ 9 ]. The more severe the disease, the greater the impact on mental health, which also imposes financial costs on healthcare systems [ 10 ]. A lack of awareness about safe sexual practices, the protective benefits of HPV vaccination, and the need for a range of tests could be the primary reasons for these issues [ 11 ]. Self-care refers to the ability of individuals, families, and communities to take intentional and purposeful actions to promote and maintain their health, prevent illness, and manage disease and disability, with or without the support of healthcare providers [ 12 ]. Effective techniques for enhancing self-care behaviors in women are organized into three categories: lifestyle modification, preventive behaviors and screening, and disease and treatment management behaviors. Self-care behaviors that help prevent HPV infection include undergoing Pap smears, vaccination, consistent and correct use of condoms during sexual intercourse, and limiting sexual partners to one [ 11 , 12 ]. Self-care interventions are among the most important and promising approaches to improving universal health coverage and well-being, both for health systems and individuals. As accessible, cost-effective, and acceptable interventions, they promote self-efficacy, independence, and participation in health [ 13 ], yet nearly four billion women of reproductive age worldwide lack access to such services [ 14 ]. One of the most widely used theories in health behavior is the Health Belief Model (HBM), which has extensive applications in health education for various health-related issues. The HBM posits that six constructs predict health behavior: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action [ 15 ]. A study by Bayrami et al. (2019) aimed to assess the constructs of the HBM in relation to the willingness to receive HPV vaccination among female students at Urmia University of Medical Sciences. According to the results, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action were all significantly associated with the acceptance of the HPV vaccine [ 16 ]. According to the results of a qualitative study conducted in Iran (2023), most women infected with HPV lacked sufficient knowledge about the virus, including its causes, symptoms, complications, prevention, and screening methods. Education, counseling, support, and healthcare services were identified as the main needs and challenges in reproductive and sexual health [ 17 ]. Based on the literature review, most studies have focused on the prevention of HPV infection. However, individuals who are already affected by this condition face numerous challenges, highlighting the need for further research into self-care practices for this group of patients. Given the Iranian and Islamic cultural context, HPV infection may be associated with negative psychological effects and significant challenges for Iranian women due to its sexual nature and the stigma attached to it, complicating efforts to educate, support, and address their needs [ 18 , 19 ]. Therefore, the present study aimed to examine the impact of an educational intervention based on the Health Belief Model (HBM) on sexual self-care among married women of reproductive-age infected with HPV.

This randomized clinical trial was conducted from April to December 2024 at Arash Women’s Comprehensive Hospital and Imam Khomeini Hospital, two referral centers in Tehran, Iran. The study population consisted of women with a confirmed HPV-DNA test who attended gynecology clinics at these hospitals. The trial adhered to the CONSORT guidelines ( Fig 1 ) [ 20 ]. Participants were eligible if they were Iranian, married, between 15 and 49 years of age, literate (able to read and write), and had no history of chronic psychiatric disorders, malignant diseases, or previous participation in educational or counseling sessions related to sexually transmitted infections (STIs). Women were excluded if they were absent from more than two educational sessions, submitted incomplete or incorrect questionnaires, or expressed unwillingness to continue participation. After obtaining approval from the Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.FNM.REC.1402.186) on 2023/12/19 and registering the trial (IRCT20231223060503N1) on 2024/01/01, eligible participants were recruited through convenience sampling. Written informed consent was obtained from all women, and those who met the criteria were randomly allocated to either the intervention or control group using block randomization (block size = 4) with a computer-generated sequence. Allocation concealment was maintained using opaque, sequentially numbered envelopes, and outcome assessors were blinded to group assignments. Although blinding of researchers and participants was not feasible due to the nature of the intervention, the outcome evaluator remained blinded by having a separate colleague handle data collection. The intervention group attended four weekly, face-to-face educational sessions (45–60 minutes each) based on the constructs of the Health Belief Model (HBM). Sessions were delivered in groups of 10–15 participants by the researcher and employed interactive methods including lectures, group discussions, Q&A, PowerPoint presentations, pamphlets, videos, and role-playing ( Table 1 ). The control group received routine care during the study period. Questionnaires were administered to both groups at baseline, immediately after the intervention, and eight weeks post-intervention. Participants in the control group received routine care as provided by the hospitals’ gynecology clinics, which typically included standard counseling on reproductive health, general advice on hygiene, and routine check-ups. Participants continued to receive care as they normally would, without additional structured education. The educational content delivered to the intervention group did not overlap with routine care topics, ensuring that observed effects could be attributed to the HBM-based educational sessions. To uphold ethical considerations, control group participants were offered educational pamphlets and CDs after the study concluded if they expressed interest. 1) Introduction of the facilitator and participants, study objectives (10 min) 2) Information on HPV, its global and local prevalence, and the importance of sexual self-care (40 min) 3) Q&A session (10 min) 1) Review of the previous session (5 min) 2) Explanation of the consequences of not having a Pap smear test, non-vaccination against non-infecting strains, effects on marital life and quality of life, issues with having multiple sexual partners (45 min) 3) Q&A session to address perceived benefits (10 min) 1) Review of previous sessions (5 min) 2) Request women with HPV to share their issues since the onset of symptoms or diagnosis, discuss the concept of sexual self-care and its connection to self-efficacy (40 min) 3) Share common experiences and solutions with each other, summarize the taught materials using the educational video (15 min) 4) Q&A session (10 min) 1) Review of previous sessions (5 min) 2) Teach various sources of information about HPV (15 min) 3) Ask women to express their fears about symptoms and provide self-care recommendations, advise appropriate behaviors, and communicate problems and needs to healthcare providers (30 min) 4) Role-playing, educational video, and summarization of the taught materials (10 min) 5) Q&A session (10 min) The required sample size was calculated using a confidence level of 95%, 80% power, and an expected effect size (Cohen’s d = 0.7) based on previous studies reporting medium to large effects of theory-based sexual health interventions [ 21 , 22 ]. This calculation yielded 32 participants per group; accounting for a 10% dropout rate, 35 participants were enrolled in each group. The primary outcome of the study was sexual self-care, measured using the Sexual Self-Care in Women of Reproductive Age (FSHS) questionnaire. The secondary outcomes included participants’ perceived susceptibility, severity, benefits, barriers, and self-efficacy regarding sexual self-care, which were assessed using a researcher-designed questionnaire based on the Health Belief Model (HBM). The three study instruments are described below: Demographic and obstetric information questionnaire : This questionnaire consists of 15 questions, including: age, education level, employment status, income level, duration of marriage, number of pregnancies, number of deliveries, type of delivery, number of abortions, contraceptive method, history of Pap smear, history of HPV vaccination, smoking history, genital warts, and duration of HPV infection based on diagnostic tests. Sexual Self-Care in Women of Reproductive Age (FSHS) questionnaire : This questionnaire consists of 40 items scored on a 5-point Likert scale ranging from “Never” (1) to “Always” (5). It covers four domains: prevention of sexually transmitted infections (STIs), prevention of gynecological cancers, prevention of unintended pregnancies, and promotion of sexual health. Developed using a deductive approach based on the Waltz model in 2021 by Yazdani and colleagues in Iran, the tool has demonstrated strong psychometric properties. It has a content validity index (CVI) of 0.93, a content validity ratio (CVR) of 0.96, and high internal consistency reliability with a Cronbach’s alpha of 0.94. The instrument’s stability, measured by intra-cluster correlation, was 0.97 (confidence interval: 0.94–0.98), indicating strong validity and reliability in the Iranian population. These properties make it a suitable measure of sexual self-care [ 23 ]. Researcher-Designed Questionnaire Based on the Health Belief Model : This questionnaire was designed by the researchers based on the study objectives and relevant literature. The questions are presented in Table 2 . To confirm the qualitative content validity of the questionnaire, it was reviewed by 10 faculty members in midwifery and reproductive health at Tehran University of Medical Sciences, and their feedback was incorporated. For the CVR, experts were asked to evaluate each item on a 3-point scale (“essential,” “useful but not essential,” or “not essential”). After calculating the CVR and making necessary revisions, experts also assessed the CVI by rating each item on a scale from 1 to 4 based on relevance (4 = very relevant, 3 = relevant, 2 = somewhat relevant, 1 = not relevant). Face validity was assessed by asking 10 women of reproductive age to provide feedback on the clarity of the questionnaire, and necessary clarifications were made based on their input. Internal consistency was evaluated using Cronbach’s alpha to determine the reliability of the instrument. I am at risk of complications from HPV. I am at risk of cervical cancer. I am at risk of high-risk HPV strains. My partner is at risk of the disease. The disease causes problems in sexual relations. Thinking about the complications of HPV scares me. Thinking about the problems caused by HPV infection makes me anxious and worried. If I experience HPV complications, my spouse and family will blame me. The cost of treatment is high. Quality of life decreases after contracting the disease. Women who engage in sexual self-care experience fewer physical and emotional crises. Sexual self-care reduces the costs associated with cervical cancer. Sexual self-care prevents my partner from contracting the disease. Sexual self-care allows me to enjoy sexual relations more. Sexual self-care helps prevent high-risk HPV strains. I don’t have enough time to get the HPV vaccine. I don’t have enough time to visit a doctor or midwife. I can’t afford the HPV vaccine. I don’t have access to accurate information about sexual self-care. My partner agrees to use condoms during sexual relations. I feel embarrassed about vaginal exams and Pap smears. I am afraid of vaginal exams and Pap smears. Fear of side effects from the HPV vaccine prevents me from getting it. Reading brochures and using educational videos are effective for sexual self-care. Media (TV and social media) are effective for sexual self-care. My doctor and midwife assist me with sexual self-care. I can do sexual self-care. Analyses were conducted using linear mixed-effects regression models to account for repeated measures and assess intervention effects over time. Effect estimates (mean differences) with 95% confidence intervals (CI) were reported alongside Cohen’s d for standardized effect sizes. Between-group comparisons at each time point used independent t-tests, and within-group changes over time were assessed using repeated-measures ANOVA. Missing data were minimal (<5%) and handled using complete-case analysis. Statistical significance for secondary outcomes was interpreted conservatively, considering multiple testing and risk of Type I error, with emphasis on primary outcomes.

The results indicated no significant differences between the control and intervention groups in terms of demographic and obstetric variables. Independent-sample t-test results revealed no significant differences between the intervention and control groups regarding the mean age and duration of marriage (P > 0.05). Fisher’s Exact Test also showed no significant differences between the two groups in terms of education level, employment status, number of abortions, and contraceptive method (P > 0.05). Additionally, chi-square tests demonstrated no significant differences between the groups in economic status, smoking history, number of pregnancies, number of deliveries, type of delivery, history of HPV vaccination, duration of HPV infection, and presence of genital warts (P > 0.05) ( Table 3 ). p-values are based on t, Chi-squared, and Fisher’s exact tests. At baseline, no significant differences were observed between groups (p > 0.05). The intervention group demonstrated significant improvements across all sexual self-care domains compared to the control group (p < 0.05) ( Table 4 ). Within-group changes over time were analyzed using Repeated Measures ANOVA, and between-group comparisons at each time point were performed using Independent t-tests. The intervention group showed significant improvements in perceived susceptibility, perceived benefits, cues to action, and self-efficacy, while perceived barriers decreased (p  0.05). Interpretation of secondary outcomes considers potential Type I error due to multiple testing ( Table 5 ). Within-group changes over time were analyzed using Repeated Measures ANOVA, and between-group comparisons at each time point were performed using Independent t-tests. Effect estimates were calculated using linear mixed-effects models; missing data (<5%) were handled with complete-case analysis; secondary outcomes are interpreted cautiously in light of multiple testing.

This study confirms that HBM-based educational interventions can significantly improve sexual self-care behaviors among HPV-positive women. Improvements in perceived susceptibility, perceived benefits, self-efficacy, and cues to action indicate the utility of HBM in designing effective preventive interventions. By reducing barriers and empowering women with knowledge and confidence, such interventions can mitigate adverse HPV outcomes and strengthen reproductive health. HBM-based educational programs should be integrated into public health policy and clinical practice, especially for vulnerable populations.

(DOCX)