Design, Implementation, and Evaluation of an Electronic Course of Sexual Health Education for Young Adults (18–35 Years): An Exploratory Sequential Mixed-Methods Study Protocol
ABSTRACT
Background and Aims
Sexual health education is crucial for young adults well-being, yet effective interventions are lacking in Iran. E-learning offers a promising avenue to deliver comprehensive sexual health education, tailored to the cultural context and diverse needs of Iranian young adults. This mixed-methods study with an exploratory sequential design aims to design, implement, and evaluate an electronic sexual health education course for Iranian young adults (18–35 years). The study has two phases: 1. needs assessment and course design, and 2. course implementation and evaluation.
Methods and Analysis
Phase one involves a systematic review of e-learning interventions and national/international guidelines, followed by qualitative research to explore young adults and key informants' perspectives on sexual health educational needs. These findings will inform the design and development of the e-course. Phase two will be a randomized controlled trial (RCT) involving nonmedical science students at Guilan University. The intervention group will receive the e-course, while the control group will not. Outcomes will be assessed using validated questionnaires, focusing on sexual health.
Ethics and Dissemination
This protocol has been approved by the Ethics Committee of the Shahroud University of Medical Sciences, Semnan, Iran (code number: IR.SHMU.REC.1403.085). All the steps/methods will be performed in accordance with the relevant guidelines and regulations.
Ethical Code
IR.SHMU.REC.1403.085. URL: https://ethics.research.ac.ir/EthicsProposalView.php?id=494573.
PROSPERO Registration Number
CRD42024573968, CRD42024578450.
Trial Registration
Iranian Registry of Clinical Trials (IRCT): IRCT20210313050689N1. URL: https://irct.behdasht.gov.ir/trial/79322.
Summary
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The mixed-methods design and the involvement of young adults and experts can contribute to a strong e-course design.
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The electronic nature of the course facilitates accessibility and wide dissemination.
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The e-course is tailored to the age and cultural context of the target population.
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Potential attrition of participants during the study is an inherent limitation.
Abbreviations
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- COREQ
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- consolidated criteria for reporting qualitative research
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- IRCT
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- Iranian Registry of Clinical Trials
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- MMAT
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- mixed methods appraisal tool
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- NGT
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- nominal group technique
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- PRISMA
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- preferred reporting items for systematic reviews and meta-analyses
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- RCT
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- randomized controlled trial
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- SRE
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- sexual and reproductive empowerment
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- UNESCO
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- United Nations Educational, Scientific and Cultural Organization
1 Background
Sexual health is a prerequisite for achieving reproductive health [1]. According to experts, sexual health in adult men and women means the satisfactory and proper fulfillment of sexual needs through a healthy and defined social relationship with a person of the opposite sex [2]. Universal access to health and the fulfillment of sexual and reproductive rights is a fundamental pillar of sustainable development [3].
Achieving sexual health necessitates the upholding, respecting, and implementing of the sexual rights of all individuals [4]. Given the youthful demographic structure of our country, where approximately 20% of the population comprises young people, and considering the growing trend of environmental risk factors threatening the health of young people, a review and integration of goals, policies, strategies, and programs in the field of young adults health, particularly for the age group of 18–29 years, is essential. This should be done by adopting an intersectoral and holistic approach to health. Therefore, in the Youth Health Document of the Youth Health Department of the Ministry of Health and Medical Education, improving the reproductive health of young people has been identified as a major goal by 2025 [5].
Studies focusing on young adults sexual health in Iran have increased considerably since 2011. In particular, studies focusing on sexual health interventions, policies, and challenges have increased significantly since 2016. Few studies have reported the prevalence of premarital sexual activity by age and gender. According to studies, the rate of premarital sex among young men in Iran ranged from 18% to 35%. However, lower rates of premarital sex have been reported among women in Iran (3.4%–14%) [6]. According to the World Health Organization report in 2021, the number of new HIV infections among Iranian women and men aged 15–24 is less than 200 and less than 500, respectively, and the rate of accurate knowledge about HIV prevention among Iranian women and men aged 15–24 is 16.2% and 20.6%, respectively [7]. There are no accurate reports on the rate of sexually transmitted infections among Iranian youth, but the awareness of youth about sexually transmitted diseases is poor [6]. According to research evidence [6, 8], some Iranian youth are at risk of high-risk sexual behaviors and therefore need sexual health services.
Iran's prevention of unwanted pregnancies has heavily depended on contraception, with usage peaking at 77.4% in 2022 [9]. Yet, recent limitations impacting access might increase the population's dependence on less reliable family planning methods [10]. Studies indicate that unwanted pregnancies and abortions, despite a relative decrease in more recent studies, remain significant public health issues in Iran, with about 30.7% of pregnancies being unwanted [11], and an abortion rate ranging from 70 to 148 cases per 1000 pregnancies [12]. Awareness regarding intrauterine devices (IUDs) was linked to a 57% decrease in the occurrence of unwanted pregnancies [13].
One of the challenges of sexual health in Iran is the taboo nature of sexual issues and the lack of awareness among the general public about sexual matters and healthy sexual behaviors. To address this challenge and empower citizens with healthy sexual behaviors, the development of standard educational packages is effective. In other words, education is the key to sexual health [1].
Developing comprehensive, culturally-sensitive sexual and reproductive health education for Iranian adolescents and young adults remains a significant challenge [6]. Studies have shown that education is one of the most effective methods for preventing high-risk behaviors [14].
Today, more than ever, young people are turning to digital spaces to gain information about their bodies, relationships, and sexual desires, while valuing privacy and confidentiality online. The digital space is the primary source of sexual information for young people. United Nations Educational, Scientific and Cultural Organization found that in 1 year, 71% of young people aged 15–24 sought sexual education and information online [15]. With the rapid advancement of technology and easy access to information globally, young people today are at risk of exposure to misinformation, especially regarding sexual matters [16-18]. The landscape of sex education is changing with the rapid expansion of online information and digital learning. Children and young people are increasingly exposed to a wide range of online content, some of which may be incomplete, poorly informed, or harmful [19]. Online media do not necessarily provide evidence-based facts tailored to the age groups of all users. Sometimes the media contains biased and distorted messages, while it is difficult for young people to distinguish between accurate and inaccurate information [20]. Proper sex education in Iran is of great importance; because according to the statistics of 2019 on the age and gender of users of information technology in Iran, the age group of 15–24 years - the group in which young people are located - has the highest penetration rate of computers and the Internet in the country. In this year, the penetration rate of mobile, computer and internet in the age group of 15–24 years was 89.6%, 68.3%, and 85%, respectively [21].
Given the limited access to healthcare professionals [22], the time-consuming and costly nature of in-person visits, and the fear of disclosing private matters [23, 24], few individuals seek face-to-face consultations to address their questions [25, 26]. On the other hand, considering that interventions based on information technologies eliminate unnecessary visits, reduce travel expenses, and provide comprehensive access to information [27], allowing users to access information tailored to their needs, e-learning courses can be both engaging and beneficial for young users. In light of the aforementioned points and the role of digital health in overcoming barriers to access and providing sexual and reproductive health services [28], as well as the lack of education tailored to the specific culture and needs of young people, the design of information technology-based interventions for this age group is imperative.
Furthermore, a search of scientific resources and databases reveals that studies on e-learning courses for sexual health education among young people are very limited, and no mixed-methods study that addresses the design, implementation, and evaluation of such a course for young people was found. Most existing studies on sexual health have focused on in-person interventions [29]. Current research has often focused on the sexual health of children and adolescents [30, 31], with studies focusing on young adults being rare, indicating a lack of sufficient attention to the educational needs of young people in the area of sexual health. The few qualitative studies that exist mainly focus on limited topics such as young people's awareness and attitudes, neglecting important aspects such as sexual skills and behaviors [32-34]. Therefore, the research team intends to design, implement, and evaluate an electronic course of sexual health education for young adults in this multiphase study. It is hoped that if this intervention proves effective, its results can be a step towards improving the sexual health of young adults.
2 Study Aim
Design, implementation, and evaluation of an electronic course of sexual health education for young adults (18–35 years).
2.1 Specific Objectives
Specific objectives can be seen in Table 1, categorized by phases and stages of the study. The objectives for Phase Two (second stage) will be finalized following consultation with the research team after the end of phase one and updated in the Iranian Registry of Clinical Trials (IRCT) before Phase Two commences.
| Phase one: Needs assessment and design of an electronic course for young adults (18–35 years) | ||
| Stage one | Systematic review |
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| Stage two | Qualitative research |
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| Stage three | Electronic course design |
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| Phase two: Implementation, and evaluation of an electronic course of sexual health education for young adults (18–35 years) | ||
| Stage one | Implementation |
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| Stage two | Evaluation |
|
3 Methods/Design
This study employs a mixed-method, exploratory sequential design, conducted in two phases. The first phase will be carried out in three stages, and the second phase in two stages. Figure 1 illustrates the stages of the study.
3.1 Patient and Public Involvement
This study is committed to incorporating the perspectives of both young adults and experts in the design and evaluation of the sexual health education e-course. A detailed account of the methodologies employed to elicit and integrate the views of these stakeholders is provided in the associated qualitative study. These findings, in conjunction with a comprehensive systematic review of the relevant literature, will inform the development of a preliminary framework for the e-course. Subsequently, a combination of the nominal group technique (NGT) and the Delphi technique will be employed to engage experts in the refinement and finalization of the e-course curriculum and platform. Following the implementation of the e-course, young adults feedback will be instrumental in assessing the impact of the e-course.
4 Study Phases
4.1 Phase One
The first phase, aimed at assessing needs and designing an electronic course for young adults, will be conducted in three stages. The first stage will involve a systematic review, the second stage will involve qualitative research, and the third stage will involve designing an e-learning course.
4.1.1 Stage One: Systematic Review (Aligned With Specific Objectives One and Two)
The systematic review will adhere to the reporting standards outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [35].
Specific Objectives One. To identify the dimensions and characteristics of various e-learning interventions in the field of sexual health education for young adults.
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Step 1. Formulate the research question: The research question is: What are the dimensions and characteristics of various electronic educational interventions in the field of young adults sexual health? Considering the objective of this review, various types of electronic sexual health educational interventions will be selected.
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Step 2. Defining inclusion and exclusion criteria: The PICOS framework [38, 39] will be used to determine the eligibility criteria for study selection as follows (Table 2).
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Step 3. Search Strategy Development and Study Identification: A combination of structured and unstructured methods will be used to identify keywords and phrases. These include thesauri (MeSH, EMTREE, ERIC, Thesaurus, IRANDOC thesauri) and free-text methods (related articles, specialized books, expert opinion). There will be no language restrictions. Since this is the first phase of a mixed-methods study to design, implement, and evaluate an e-course on sexual health education for Iranian young adults, we will also be searching for local (Persian) resources with Persian equivalents. The search strategy involved categorizing terms into key concepts (Population AND Intervention AND Outcome) to retrieve all relevant literature. The search strategy will be finalized by connecting keywords within each concept using the Boolean operator “OR” and linking concepts using the operator “AND.” The search strategy will be tailored to each database or search engine. The detailed search syntax used for each database will be provided in Supplementary File.
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The researcher (S.B.) will search for relevant studies using databases such as Web of Science (ISI), PubMed, Scopus, EMBASE, and Cochrane Library, as well as search engines like Google Scholar and Elmnet.
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Step 4. Screening and Study Selection: All identified records will be managed using the HubMeta platform, which will identify and remove duplicate entries [40]. Subsequently, the study selection process will be conducted in two stages. In the first stage, titles and abstracts will be screened by two independent reviewer (S.B. and T.N.), and records for which full text is unavailable after three attempts to contact the authors and journal editor will be excluded. In the second stage, the full texts of the remaining records will be independently reviewed by two reviewers based on predetermined inclusion and exclusion criteria. Any discrepancies between the reviewers will be resolved through consensus or, if necessary, by involving a third party for adjudication.
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A PRISMA flowchart [35] will be prepared to document all reviewed records, along with the reasons for their inclusion or exclusion. Additionally, contacting study authors to obtain missing information required for data synthesis may be necessary at this stage.
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Step 5. Data Extraction: Two researchers will independently and meticulously review the full text of each selected study to extract relevant information using a standardized data extraction form created by research team. This form will include details such as authors, year of publication, country of study, participant characteristics, study design, sample size, intervention and control groups, type of intervention, intervention duration, measurement tools, scales, and results. The extracted information will then be categorized. If necessary, study authors may be contacted to obtain missing information required for data pooling.
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The researchers will ensure that all intellectual property rights are respected throughout the research process. Ethical considerations and general publication standards (plagiarism, data fabrication and/or falsification, simultaneous submission, redundancy, etc.) will be strictly adhered to by the research team. Researchers will maintain objectivity and will not influence the selection of articles.
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Step 6. Assessment of Study Quality: In this step, the quality of the studies will be assessed independently by two assessors. The RevMan software will be used to assess the risk of bias [41]. The quality of the selected randomized controlled trials (RCTs) will be evaluated using the Cochrane RoB 2.0 tool, which is designed to assess the risk of bias in RCTs and considers five key domains [42]: selection bias, reporting bias, performance bias, detection bias, and attrition bias. The Consolidated criteria for reporting qualitative research (COREQ) [43] will be used to assess the reporting quality of qualitative studies. For assessing the quality of review studies, the MOOSE [44] or AMSTAR [45] tool will be used. Additionally, the Mixed Methods Appraisal Tool (MMAT) [46] will be used to assess the risk of bias in studies with a mixed-methods approach. Other valid and relevant tools can also be used as alternatives to the aforementioned tools. Any discrepancies in assessment will be mediated by a third researcher. Any remaining disagreements will be duly noted.
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Step 7. Analysis and Interpretation of Results: Based on the findings from the studies and the assessment of bias using appropriate tools, a comparative table will be created to match the dimensions and characteristics of electronic sexual health education interventions in young adults in a review study. Finally, the relevant results will be reported based on relevant checklists. If meta-analysis is feasible based on the obtained results, various statistical programs will be used, such as the Review Manager (RevMan) program endorsed by Cochrane.
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Step 8. Dissemination: After completing the study, necessary steps will be taken to publish the study in relevant scientific journals.
| Property | Inclusion criteria | Exclusion criteria | |
|---|---|---|---|
| P | Population | Young adults | Studies that include groups of women, men, and girls and boys who are not categorized as young adults. |
| I | Intervention | E-learning interventions for sexual health education. | Studies with other interventions. |
| C | Comparison | No intervention or other types of interventions or usual care. | Not applicable. |
| O | Outcome | Health outcomes related to sexual health. | Studies with other outcomes. |
| S | Study design | Systematic review, meta-analysis, randomized controlled trials, non-RCT, quasi-experimental, qualitative studies, studies with a mixed-methods approach. | Letter to the editor, conference papers, case report and case series studies, protocols, unpublished articles, commentary, gray literature, meeting or conference abstract. |
| Language | English, Persian | Studies that are not available in English and Persian. |
Specific Objectives Two. Identify the dimensions and characteristics of national and international guidelines related to sexual health education for young adults.
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Step one. Formulating the research question: What are the dimensions and characteristics of national and international guidelines for young adults sexual health education? Considering the aim of this review study, relevant national and international guidelines will be selected.
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Step two. Defining inclusion and exclusion criteria: The PIPOH [47] framework, which stands for Population, Intervention, Professionals, Outcomes, and Health care setting/context, will be used to determine the eligibility criteria for selecting the guidelines as follows (Table 3).
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Step 3. Search Strategy Development and Study Identification: A comprehensive keyword and phrase identification strategy will be employed, combining structured and unstructured methods. This approach will leverage thesauri (MeSH, EMTREE, ERIC, Thesaurus, IRANDOC thesauri) for controlled vocabulary and free-text techniques (related articles, specialized books, expert opinion) for broader keyword discovery. To ensure a comprehensive search, no language restrictions will be imposed. As this is the initial phase of a mixed-methods study aimed at designing, implementing, and evaluating an e-course on sexual health education for Iranian young adults, local (Persian) resources will also be extensively explored with Persian equivalents. To retrieve all relevant literature, a comprehensive search strategy will be designed by categorizing terms into key concepts (Population AND Intervention AND Outcome) and using relevant keywords. Keywords within each concept will be connected using the Boolean operator “OR” to capture variations, while concepts will be linked using the operator “AND” to specify relationships. The search strategy will be customized to each database or search engine. The specific search syntax used for each database will be detailed in Supplementary File.
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The researcher (SB) will search for national and international guidelines on sexual health education programs for young adults/students in PubMed, Cochrane Library, Google Scholar, TRIP database, Elmnet, and Google, as well as websites of relevant associations or organizations, such as the National Guideline Clearinghouse, World Health Organization, and The National Institute for Health and Care Excellence.
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Step 4. Screening and Guideline Selection: HubMeta will be used to manage all identified records, including the identification and removal of duplicates [40]. Subsequently, the study selection process will be conducted in two stages. In the first stage, titles and abstracts of the records will be screened by two independent reviewer (S.B. and T.N.). Irrelevant records will be excluded following the initial screening based on inclusion criteria. In the next stage, the full texts of the remaining records will be independently reviewed by two reviewers based on predetermined inclusion and exclusion criteria. Any discrepancies between the reviewers will be resolved through consensus or, if necessary, by involving a third party for adjudication. The final number of guidelines will then be determined.
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A report of all reviewed records, along with the reasons for their inclusion or exclusion, will be prepared in the form of a PRISMA flowchart [35].
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Step 5. Data Extraction: Two researchers will independently and meticulously examine the full text of each selected guideline, extracting relevant information using a standardized data extraction form developed by the research team. The data extraction form will include items such as the guideline title, publishing organization, year of publication, target audience, topics covered, teaching methods, and more. Subsequently, the extracted information will be categorized.
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The authors will ensure that all intellectual property rights are respected throughout the research process. Ethical considerations and general publication standards (plagiarism, data fabrication and/or falsification, concurrent submission or publication, redundancy, etc.) will be strictly adhered to by the research team. The researchers will maintain objectivity and will not influence the selection of articles.
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Step 6. Assessment of guideline Quality: In this step, two assessors will independently evaluate the quality of national and international guidelines related to young adults sexual health education. The AGREE II instrument will be used for guideline appraisal [48]. A third researcher will resolve any disagreements. Any unresolved disagreements will be reported.
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Step 7. Analysis and Interpretation of Results: A comparative table will be used to compare the dimensions and features of national and international guidelines related to sexual health education for young adults. The results will be reported based on relevant checklists.
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Step 8. Dissemination: After completing the study, necessary steps will be taken to publish the study in relevant scientific journals.
| Property | Inclusion criteria | Exclusion criteria | |
|---|---|---|---|
| P | Population | young adults | National and international guidelines that include groups of women, men, and girls and boys who are not categorized as young adults. |
| I | Intervention | Sexual health education interventions. | National and international guidelines with other interventions. |
| P | Professionals | Midwives, physicians, sex education instructors, healthcare providers, parents and caregivers, policymakers | — |
| O | Outcome | Health outcomes related to sexual health. | National and international guidelines with other outcomes. |
| H | Health care setting/context | Universities, healthcare centers, sexual health clinics, the community | — |
| Language | English, Persian | National and international guidelines that are not available in English and Persian. |
In the initial phase, a review of studies identifies the educational framework (training content, number of sessions, training methods, study design, etc.) required by young adults. This framework is then utilized in the development of an electronic course.
4.1.2 Stage Two: Qualitative Research (Aligned With Specific Objectives Three and Four)
Study design: In this study, we will employ a basic qualitative study strategy and inductive content analysis to gain a deeper understanding of young people's perspectives on sexual health educational needs. This approach allows us to identify key themes and prioritize the most important aspects that should be emphasized in the e-course, ensuring that it aligns with the real needs and views of the target audience. By incorporating these findings, we can develop relevant and engaging content, ultimately improving the quality and effectiveness of the electronic course.
The study population will comprise young adults and key informants, including midwives, reproductive health specialists, gynecologists, urologists, sex therapists, psychologists, psychiatrists, sociologists, experts in young adults sexual health, and parents of young adults. The researcher will serve as the primary data collection instrument. Data will be collected through in-depth, semi-structured individual interviews and observations, employing open-ended questions and an interview guide focused on young adults sexual health.
Inclusion criteria:
Participants: Young adults aged 18-35 years old, Female or male gender, Single or married, Willingness to participate in research, Ability to understand and respond to questions in Persian, Personal experience or awareness of the sexual health educational needs of young adults.
Key informants: Midwives and reproductive health specialists, gynecologists, psychologists, psychiatrists, sociologists, experts active in the field of young adults sexual health, Willingness to participate in research.
Exclusion criteria (Participants and Key informants): The presence of medical or psychiatric conditions that would affect the ability to participate in the study, Inability to attend the interview at the specified time and location, Lack of experience or expertise related to young adults sexual health, Lack of access to electronic devices (e.g., computer, smartphone, tablet).
Sampling: After obtaining approval from the university ethics committee and selecting participants based on research criteria, those willing to participate in the study will be informed about the objectives of the study, the reason for their selection, their role in the study, the benefits of their participation, the confidentiality of their information, their right to participate or not participate in the research, the interview process, and how to contact the researcher. Written informed consent will be obtained from participants.
Participants will be recruited through online advertisements on social media platforms relevant to young adults, universities and snowball sampling, where initial participants will be asked to refer other eligible individuals.
Data will be collected using individual, in-depth, semi-structured interviews with open and general questions using an interview guide related to sexual health. The questions will be formulated and designed through the research team's experience and the results of studies. Additional questions will be posed based on participants' responses. This method better and more deeply reveals individuals' perceptions and experiences.
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What issues and problems do you think young adults face in the area of sexual health?
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What are the most important sexual health needs of young adults?
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What solutions do you recommend to meet the sexual health needs of young adults?
Interviews will be conducted in a manner that respects the participants' preferences and privacy. The research setting will be determined based on the participant's preference and request, including possibilities such as the participant's home, community health centers, workplaces, and so forth. Furthermore, if an in-person interview is not feasible for any reason, videoconferencing platforms such as Skype, WhatsApp, and so forth may be used, with the participant's agreement. Interviews may be conducted in one or multiple sessions depending on the participant's time and patience, the information obtained, and the participant's willingness. The duration of each interview is expected to be 45–90 min and may vary depending on the circumstances and the participant's patience.
To ensure the de-identification of verbatim responses, participants will be assigned unique identification codes, and all directly identifying information (names, locations, specific dates) will be removed from the interview transcripts. Audio recordings will be stored securely and destroyed after transcription.
The sampling method used in this study is purposive sampling [49] with the help of the “maximum variation sampling” method. This approach is appropriate for qualitative research as it allows for the selection of participants who can provide rich and diverse perspectives on the phenomenon of interest [50].
Sampling will continue until data saturation is reached. Data saturation is defined as the point at which no new relevant information emerges from subsequent interviews, indicating that the data collected is sufficiently comprehensive [50]. While the exact number of participants needed to reach saturation is difficult to predict [50], based on similar studies with comparable scope and complexity [51-53], we estimate that saturation will likely be achieved with approximately 30 participants. This estimate is also informed by guidance on qualitative sample size, which suggests that saturation in interview-based studies can often be reached within a range of 10 to 30 participants [50].
Accordingly, diverse participants among young adults will be selected based on age, gender, marital status, social class, economic and cultural level, considering their neighborhood, different fields of study, engagement in high-risk behaviors, and so forth, which will enhance the credibility of the data. Purposive sampling with maximum variation will also be conducted among participants who have rich experience in this subject, including midwives and reproductive health specialists, gynecologists, psychologists, psychiatrists, sociologists, experts active in the field of young adults sexual health, and others.
Data analysis: The qualitative content analysis in this study follows an inductive approach [54], adhering to the steps outlined by Granheim and Landman (2004) [55]. Data analysis will involve: data implementation, identifying the unit of analysis, immersing in the data, identifying semantic units, coding, classification, and theme formation.
MAXQDA Ver.2020 software will be used for data analysis, facilitating in-depth analysis of interview transcripts. To ensure the rigor of the findings, Lincoln and Guba's criteria will be applied: credibility (internal validity), dependability (reliability), confirmability (objectivity), and transferability (external validity) [56]. The present qualitative study will be conducted and reported in accordance with the Standards for Reporting Qualitative Research (SRQR) guidelines [57].
4.1.3 Stage Three: Electronic Course Design (Aligned With Specific Objectives Five, Six and Seven)
In this phase, information from the systematic review and qualitative findings will be synthesized to examine existing electronic interventions for young adults sexual health education. Based on this analysis, an electronic course on young adults sexual health education will be designed and developed. The course content will be tailored to the culture and structure of Iran. In designing the electronic course, an attempt will be made, based on the opinions of the research team, to ensure that the course content takes into account the diversity of young adult's conditions and needs. The course content will be prepared by the principal investigator (S.B.) in collaboration with the research team.
To achieve the fifth objective, this study will utilize a combination of the NGT and the Delphi technique. In this study, the group's opinion is derived from the aggregation of the opinions of individual experts. A panel of eight to twelve experts will be purposefully selected. This panel will comprise a mix of internal stakeholders (such as key members of the research team familiar with the qualitative data) and external experts. External experts will be chosen based on their recognized expertise in areas including sexual health education, e-learning development, young adult psychology, and Iranian socio-cultural contexts. Opinions will be obtained in three stages. In the first stage, group members will be asked to submit their written opinions on the initial version of the electronic sexual health education course for young adults. The researcher will collect all viewpoints. In the second stage, a structured questionnaire will be prepared, encompassing all the topics raised and a combination thereof. Group members will be asked to individually rate their agreement with each item on a Likert scale. The collected opinions, reflecting the distribution of group members' views, will be shared with the participants again to discuss areas of disagreement and conflict. Following the group discussion, members will once again indicate their level of group agreement. Finally, an analysis will be conducted, and the group's agreement or disagreement on the final version of the electronic sexual health education course for young adults will be determined.
The decision regarding the technical development of the course (i.e., whether it will be handled by the research team or outsourced to a specialized provider) and the selection of any software for course design will be determined during the Delphi phase, following consultation with experts. This decision will depend on factors such as technical requirements, available resources, and the suitability of the software for the cultural and educational context of Iran.
To achieve the sixth objective, based on the results of the previous stages, the final version of the electronic sexual health education course for young adults will be designed.
4.2 Phase Two
4.2.1 Stage One: Implement the Electronic Course (Aligned With Specific Objectives Eight)
Study design: In this phase of the research, an electronic sexual health education course for young adults will be implemented as a parallel randomized controlled clinical trial. This methodological choice is justified by the RCT's capacity to provide strong evidence of causality. Randomization will minimize selection bias, ensuring that participant characteristics are evenly distributed between the intervention and control groups. The presence of a control group will allow us to isolate the impact of the online course, distinguishing its effects from those of other factors. By comparing outcomes between the two groups, the RCT design enables us to determine whether the online course causes significant changes in young adults' sexual health knowledge and behavior. The research population will comprise onmedical science students at the University of Guilan-Iran who meet the inclusion criteria (N = 140). Due to the electronic nature of the course, the research can be conducted in any location with internet access (e.g., home, university).
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Age 18–35 years
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Nonmedical science students at the University of Guilan
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Access to the internet
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Experience using the internet
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Possession of an email address
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Possession of a phone number for follow-up
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Provision of informed consent to participate in the study
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Willingness to be assigned to either the intervention or control group
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Completion of pretest questionnaires
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Presence of medical or psychological conditions that may affect participation in the study
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Participation in any other course or study on sexual health education within the past 6 months
The maximum desired sample size is 58. Due to intra-cluster correlation, this is multiplied by 1.2, resulting in 70 samples per group.
Sampling. Having obtained the IRCT code (IRCT20210313050689N1) and after receiving approval from the Ethics Committee of Shahroud University of Medical Sciences (IR.SHMU.REC.1403.085), and acquiring the necessary permissions, the researcher will proceed with sampling and conducting the research. The IRCT will be updated upon completion of phase one of the study. This will be done by explaining the study's objectives, obtaining the consent of the young adults, and acquiring their written informed consent. Figure 2 presents the flowchart for the CONSORT statement.
To prevent contamination, the intervention group will be thoroughly briefed on the importance of not sharing the intervention content or discussing study details until authorized by the researcher. Additionally, to prevent contamination, sampling will likely be conducted using a cluster randomized trial within the framework of a pragmatic clinical trial [60]. Thirteen nonmedical science faculties at Guilan University will be randomly allocated to either the intervention group (six faculties) or the control group (six faculties). Seventy students will be selected from each group. The number of students selected from each faculty will be determined based on the total number of students enrolled in that faculty. For this purpose, random numbers will be generated using the website www.random.org. Students will be selected to participate in the study and assessed against the study's inclusion criteria. After explaining the study's objectives and obtaining informed consent, they will be enrolled in the study. The intervention group will receive the electronic course, while the control group will not receive any intervention.
If the research results indicate that the electronic course is effective in improving the sexual health of the young adults, the control group will also receive the intervention due to ethical considerations.
Table 4 presents the SPIRIT schedule for the electronic sexual health education course for young adults.
| Study period | ||||
|---|---|---|---|---|
| Enrollment | Allocation | Postallocation | Close-out | |
| TIMEPOINT** | -t1 (Eligibility screening) | 0 (Baseline) | t1 (End of intervention) | 1-Month follow-up |
| ENROLLMENT: | ||||
| University Eligibility Screen | X | |||
| University Permission to Conduct Research | X | |||
| Student Informed Consent | X | |||
| Allocation | X | |||
| INTERVENTIONS: | ||||
| Electronic course |  |
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| Without intervention | |
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| ASSESSMENTS: | ||||
| Demographic Questionnaire | X | |||
| Sexual Knowledge and Attitude Scale | X | X | X | |
| MSSCQ Questionnaire | X | X | X | |
| Kirkpatrick Questionnaire | X | X | ||
| SRE Scale | X | X | X | |
- Note: The colors are used for readability.
4.2.2 Stage Two: Evaluation the Electronic Course (Aligned With Specific Objectives Nine, Ten, Eleven, and Twelve)
In the present study, a checklist of eligibility criteria, a demographic questionnaire, and relevant questionnaires in this field will be used based on the research team's opinions after the completion of the first phase of the study. Evaluation will also be conducted based on the Kirkpatrick educational evaluation model (level one). The Multidimensional Sexual Self-Concept Questionnaire [61], the Persian version of the Illustrated Sexual and Reproductive Health Questionnaire [62], and the Sexual and Reproductive Empowerment (SRE) Scale for Adolescents and Youth [63] are examples of these questionnaires. The objectives of this stage of the research may change after the content of the course is determined due to the uncertainty of the questionnaires, in consultation with the research team.
Data collection tools. Currently, the following questionnaires have been selected in accordance with the stated study objectives:
Demographic Questionnaire. A demographic questionnaire will be developed based on relevant literature and existing instruments. Face and content validity will be assessed via expert consultation with approximately 7-10 subject matter experts.
Sexual Knowledge and Attitude Scale. The Sexual Knowledge and Attitude Scale (SKAS), developed by Besharat and Ranjbar Kelagari (2013), is a 20-item self-report instrument assessing sexual knowledge and sexual attitude via two distinct subscales. Items are rated on a 5-point Likert scale (1-5), with subscale scores ranging from 10 to 50 and a total score from 20 to 100. Besharat and Ranjbar Kelagari demonstrated good psychometric properties, including strong internal consistency (Cronbach's α: 0.84-0.94) and good test-retest reliability (r: 0.76-0.87) [64].
Multidimensional Sexual Self-Concept Questionnaire (MSSCQ). Developed by Snell (1995), the Multidimensional Sexual Self-Concept Questionnaire (MSSCQ) evaluates sexual self-concept through 100 items across 20 dimensions. These dimensions include sexual anxiety, sexual self-efficacy, sexual consciousness, motivation to avoid risky sex, chance/luck sexual control, sexual preoccupation, sexual assertiveness, sexual optimism, sexual problem self-blame, sexual monitoring, sexual motivation, sexual problem management, sexual esteem, sexual satisfaction, power-other sexual control, sexual self-schemata, fear of sex, sexual problem prevention, sexual depression, and internal sexual control. The instrument utilizes a Likert scale format [61]. The validity (content, face, and criterion) and reliability (Cronbach's alpha > 0.7) of this questionnaire were established as adequate in the study by Ramezani et al. [65].
Kirkpatrick questionnaire. Based on the Kirkpatrick model, four levels will be assessed: Reaction, Learning, Behavior, and Result [66]. A Level 1 Kirkpatrick evaluation questionnaire will be utilized following its design and validation after the course completion.
Sexual And Reproductive Empowerment (SRE) Scale For Adolescents And Young Adults. The SRE Scale for Adolescents and Youth is a 23-item instrument measuring SRE via seven subscales: comfort talking with partner, choice of partners, marriage, and children, parental support, sexual safety, self-love, sense of future, and sexual pleasure [63].
We will report the findings according to the CONSORT statement [67].
5 Discussion
This mixed-methods study holds significant promise in the realm of sexual health education for young adults. The integration of systematic reviews, qualitative research, and a randomized controlled trial (RCT) enables a comprehensive approach, ensuring the electronic course aligns with both evidence-based practices and the specific needs of Iranian young adults.
The systematic review phase is instrumental in identifying the strengths and weaknesses of existing e-learning interventions and national/international guidelines. This comprehensive analysis establishes a solid foundation upon which the course content can be developed, ensuring it is both informative and culturally relevant.
The qualitative research phase is pivotal in capturing the nuanced perspectives and needs of young adults and key informants. By employing in-depth interviews and inductive content analysis, the study can uncover critical themes that might be overlooked in quantitative approaches. This data-driven approach ensures that the course content is tailored to address the actual concerns and questions young people have about sexual health.
The RCT phase is the cornerstone of the study, providing a robust evaluation of the electronic course's effectiveness. By comparing outcomes between the intervention and control groups, the study can confidently assess the course's impact on sexual and reproductive health knowledge, sexual self-concept, and overall sexual well-being. Additionally, using the Kirkpatrick model allows for a multi-faceted evaluation, considering not only knowledge acquisition but also learner satisfaction, behavior change, and long-term impact.
Due to significant constraints on funding and the project timeline, a pilot test of the electronic course could not be conducted within the scope of this study. While we acknowledge that a pilot study could provide valuable feedback on course navigation, content clarity, and technical functionality, these limitations necessitated a more streamlined approach.
The study's rigorous methodology, including the use of PRISMA guidelines, the PICOS framework, and the PIPOH framework, bolsters the credibility and generalizability of the findings. The adherence to ethical considerations and publication standards further strengthens the study's scientific integrity.
However, like any research endeavor, this study has limitations. The reliance on self-reported data in the qualitative phase and the potential for social desirability bias in responses are inherent challenges. Despite these limitations, this study has the potential to make a significant contribution to the field of sexual health education. The development of an evidence-based and culturally sensitive electronic course can empower young people with the knowledge and skills needed to make informed decisions about their sexual health. Future research could build upon this study by exploring the long-term impact of the e-course, investigating its effectiveness in diverse populations, and assessing the feasibility of scaling up the intervention to reach a broader audience.
Author Contributions
Sanam Borji-Navan: conceptualization, data curation, formal analysis, visualization, writing-original draft, methodology, investigation, project administration, writing-review and editing, software, validation.
Shahrbanoo Salehin: conceptualization, data curation, methodology, supervision, investigation, writing-review and editing, validation.
Tahereh Naseri-BooriAbadi: conceptualization, data curation, writing-review and editing, supervision, methodology, investigation, validation.
Shahrbanoo Goli: conceptualization, data curation, writing-review and editing, validation, supervision, methodology, formal analysis, investigation, software.
Mojgan Mirghafourvand: conceptualization, data curation, formal analysis, visualization, methodology, investigation, supervision, writing-review nd editing, project administration, software, validation.
Acknowledgments
The authors would like to acknowledge that this study was conducted as part of a PhD thesis in Reproductive Health at Shahroud University of Medical Sciences. The thesis code is 1699. The authors acknowledge the use of an AI language model for assistance with translating, writing and editing this manuscript. The authors maintained full oversight and responsibility for the final content.
Ethics Statement
Findings from this mixed-methods study may be disseminated via multiple publications, each addressing specific research questions or objectives. Any protocol amendments will be documented in the relevant publication(s). This protocol has been approved by the Ethics Committee of the Shahroud University of Medical Sciences, Semnan, Iran (code number: IR.SHMU.REC.1403.085). Before participation, written informed consent will be obtained from each individual enrolled in the study. All the steps/methods will be performed in accordance with the relevant guidelines and regulations. Amendments to the systematic review protocol will be updated in Prospero. Trial protocol modifications will be registered in the IRCT. All amendments will be detailed in the final publication. Deidentified data will be made available to other researchers upon reasonable request.
Conflicts of Interest
The authors declare no conflicts of interest.
Transparency Statement
The lead author Shahrbanoo Salehin affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any anticipated deviations from the protocol will be documented and explained. Shahrbanoo Salehin had full access to all of the data in this study and takes complete responsibility for the integrity of the data and the accuracy of the data analysis.
Open Research
Data Availability Statement
Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
