Juyani et al.

Trials (2022) 23:724

https://doi.org/10.1186/s13063-022-06663-5

STUDY PROTOCOL Open Access

Educational interventions to improve

women’s preventive behavior of sexually
transmitted infections (STIs): study protocol
for a randomized controlled trial
Afsaneh Karami Juyani1, Fatemeh Zarei1* , Shamsodin Niknami1, Alireza Haydarni1 and Raziyeh Maasoumi2

Abstract
Background: Sexually active women aged 18 to 48 are within the population at risk for acquiring sexually transmit-
ted infections. Some STIs can cause serious complications in women’s reproductive health. Accordingly, this practical
randomized trial aims to evaluate the effect of an interventional education based on the ISD model on improving
preventive behaviors for Iranian women.
Methods: Women aged 18–48 years that refer to Tehran Municipality Health Houses will be invited to join the study.
Recruitment will continue until a sample of 150 women participants. The study will be conducted using a mixed-
methods protocol in three phases. In the first phase, women’s educational and learning needs about STIs will be
identified using a qualitative approach. In the second phase, the results from the qualitative approach will be used
to design a training program based on an ISD model. The educational intervention will be performed in the third
phase. Participants will be randomly allocated into two groups: (1) the intervention group and (2) the control group.
Data will be collected using STI Four-Scale of Preventive Behaviors at baseline, immediately, 1-month, and 3-month
follow-up assessments. The impact of the intervention on the promotion of preventive behaviors from STIs will then
be evaluated.
Discussion: This study provides an educational program for empowering and promoting behaviors that prevent STIs.
If the designed interventions in the present study are effective, it has practical potential to be generalized for Iranian
women at risk of STIs.
Trial registration: ClinicalTrials.gov IRCT2​02006​02047​638N1. Registered on 22 May 2021 with the IRCTID, V1.0.
Keywords: Educational: https://www.ncbi.nlm.nih.gov/mesh/?term=Educational+intervention, Primary prevention:
https://www.ncbi.nlm.nih.gov/mesh/68011322, Sexually transmitted diseases: https://www.ncbi.nlm.nih.gov/mes
h/?term=Sexually+Transmitted+Infections, Women: https://www.ncbi.nlm.nih.gov/mesh/68014930, Instructional
System Design (ISD) model

Background
In both developed and developing countries, sexually
transmitted infections (STIs) are regarded as one of the
*Correspondence: [email protected] most serious public health issues [1] More than a mil-
1
Department of Health Education and Health Promotion, Tarbiat Modares lion people are infected with STIs every day around
University, P.O. Box: 14115‑331, Tehran, Iran the world, and 50 million are infected with one of four
Full list of author information is available at the end of the article

© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the
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to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory
regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this
licence, visit http://​creat​iveco​mmons.​org/​licen​ses/​by/4.​0/. The Creative Commons Public Domain Dedication waiver (http://​creat​iveco​
mmons.​org/​publi​cdoma​in/​zero/1.​0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Juyani et al. Trials (2022) 23:724 Page 2 of 11

curable sexually transmitted bacterial infections, namely some call “a health crisis behind the veil.” [13–15]. Fur-
chlamydia, gonorrhea, syphilis, and trichomoniasis [2]. thermore, individuals’ access to effective resources has
The World Health Organization (WHO) estimated in been hampered in many developing countries due to neg-
2008 that the total incidence of four preventable STIs ative attitudes toward sexual health education, ineffective
in the Eastern Mediterranean region was 26.4 million communication skills, insufficient educational materials,
[3]. Although the risk of HIV infection and death has and a lack of knowledge [16].
decreased in most areas of the Middle East and North Despite being prohibited in the religion of Islam, pre-
Africa, the virus’s prevalence is increasing. The actual marital and extramarital sexual relationships are by no
prevalence of STIs in Iran is much higher than official means non-existent, and the scarce literature dedicated
data and records indicate [1, 4]. to sexual practice in Iran confirms this [16]. Moreover,
The Ministry of Health and Medical Education in Iran the incidence of premarital sex has increased over the
presented alarming statistics on the rate of STIs (such years [17, 18]. Iranians’ sexual health may be jeopardized
as AIDS) and their rate of transmission through sexual as a result of receiving incorrect sexual information from
contact. According to reports, sexual transmission has the internet and other sources [19, 20]. Furthermore, dis-
increased from 10 to 21%, and 38.9% of the 28,000 cases cussing STIs is a cultural constraint and taboo [21].
registered in 2013 acquired it through unsafe sex [5]. From 2010 to 2013, the third national program on
Furthermore, 1700 cases of gonorrhea and 5500 cases AIDS and STIs in Iran included four STI strategies such
of chlamydia have been reported in Iranian men and as education, sexual transmission prevention, treatment,
women. These infections were found to be slightly more and strengthening of the epidemiological care system
common in women than in men [6]. with data management [22]. Educational intervention is
Some STIs can cause serious complications, includ- one of the most effective strategies for behavior change
ing pelvic inflammatory disease, infertility, ectopic preg- [23]. The educational approach’s goal is to provide people
nancy, cervical cancer, neonatal death, or congenital with the knowledge, information, and skills they need to
anomalies. Meanwhile, these infections can facilitate the adopt healthy behaviors. Also, behavioral approaches use
spread of bloodborne diseases such as the human immu- preventive strategies to encourage individuals to adhere
nodeficiency virus (HIV) and hepatitis B virus via sexual healthy behaviors [24]. Globally, the prevention of high-
contact [7]. In addition to the sexual route, blood prod- risk behavior and unprotected sex, as well as the promo-
uct transfusion, mother-to-child breastfeeding, intrau- tion of healthy behavior, has been identified as the most
terine, and delivery are all known ways for some STIs to effective solutions for STI prevention [25]. The timely
be acquired [8]. STI complications have a disproportion- and rapid diagnosis of disease, complete and effective
ate impact on people of all ages, with significant conse- treatment, education on prevention and risk reduction,
quences for women of reproductive age. Women are and encouraging the use of condoms are some of the
biologically more vulnerable to such STIs than men, and principles that can control and cure STIs [26].
they are more likely to experience problems as a result In general, health-related behavior and its determi-
[9]. Women who engage in sexual activity are at risk for nants are defined as “personal attributes such as beliefs,
STIs [10, 11]. expectations, motivations, values, perceptions, and other
Current efforts to prevent the spread of STIs are insuf- cognitive factors.”; personality traits, including affective
ficient and despite significant efforts to identify simple and emotional states and characteristics; and manifest
interventions for reducing high-risk behaviors, chang- behaviors, actions and habits related to the maintenance
ing behavior remains a complex challenge [3]. Several of health, the restoration of health and the promotion of
reasons highlight challenges in sexual health education health” [23]. A growing body of literature specifies that
in particular STIs. The results of a review study show behavioral interventions with clear conceptual frame-
that, in general, Muslim women have poor knowledge works or theories are more effective than those without
about the signs and symptoms of STIs, how to prevent, [27]. Measuring the use of behavioral theories/models is
diagnose, and treat them, in addition to many concerns. a key step in supporting theory/model-based behavio-
wrong concept. Negative attitudes towards people liv- ral interventions [28, 29]. In line with this, several stud-
ing with HIV/AIDS are widespread, and this attitude is ies have shown that theory-based training programs are
strongly influenced by misconceptions and inadequate effective in improving sexually transmitted disease pre-
knowledge. Infected women tend to face more blame and vention behaviors in Iranian women [30–32]. Given the
judgment than men [12]. The fact that the mere existence above, it seems that educational interventions based on
of sexually transmitted infections (STIs) in Iran and other theories that consider the learning needs of the target
Muslim countries is considered taboo by the government group will be effective in promoting preventive behav-
and the public has created a state of denial, which is what iors of sexually transmitted infections in at-risk women.
Juyani et al. Trials (2022) 23:724 Page 3 of 11

Therefore, this study mixes methods will be used to behaviors among Iranian women?”. To answer this main
design and evaluate an educational program to pro- question following primary outcomes are expected:
mote preventive behaviors of STIs among at-risk Iranian
women. 1. Determining and comparing the effects of an educa-
tional intervention designed based on the ISD model
Hypothesis in STI knowledge among women in the target and
The main aim is to assess the impact of an educational control groups before, immediately one month, and
program based on the ISD model on improving pre- three months after the interventions.
ventive behaviors for STIs Iranian women. Interven- 2. Determining and comparing the effects of an educa-
tion effects will be examined at 4 months. The research tional intervention designed based on the ISD model
hypotheses are as follows: in STI vulnerability among women in the target and
control groups before, immediately, one month, and
1. The intervention group will show higher preventive three months after the interventions.
behaviors for STIs than the control group measured 3. Determining and comparing the effects of an educa-
by mean scores. tional intervention designed based on the ISD model
2. The intervention group will show STI knowledge in STI prevention self-efficacy among women in the
more than the control group measured by mean target and control groups before, immediately, one
scores. month, and three months after the interventions.
3. The intervention group will show STI vulnerability 4. Determining and comparing the effects of an educa-
than the control group measured by mean scores. tional intervention designed based on the ISD model
4. The intervention group will show STI prevention in STI prevention intentions among the target and
self-efficacy more than the control group measured control groups before, immediately, 1 month, and 3
by mean scores. months after the interventions.
5. The intervention group will show STI prevention
intentions more than the control group measured by Consequently, we expect the effect of our educational
mean scores. intervention on preventive action regarding STIs among
women. To assess the expected secondary outcomes a
self-reported assessment addressing preventive actions
Trial design (using a condom, doing pap-test and genital examina-
The evaluation design is a parallel, randomized con- tion) will be conducted.
trolled trial, with two arms and with a 1:1 allocation ratio.
The intervention arm will receive the training program Ethical approval
starting in June 2022, and the control arm will receive This protocol and the template informed consent forms
the training program after the final research data collec- will be reviewed and approved by the sponsor and Medi-
tion, with training from June 2023. If the trial is not able cal Ethics Research Center of Tarbiat Modares University
to recruit 63 women within the recruitment period, then (reference: IR.MODARES.REC.1399.039). with respect
the research team will consider an unequal allocation to scientific content and compliance with applicable
ratio with a smaller number of participants in the control research and human subjects regulations. The protocol,
group or extending data gathering time. The impact of site-specific informed consent forms (Persian language),
this is discussed in the section on sample size. participant education and recruitment materials, and
other requested documents—and any subsequent modi-
Methods fications—also will be reviewed and approved by the eth-
Aim, design, and outcomes ical review bodies. Subsequent to the initial review and
This practical randomized trial aims to evaluate the approval, Ethical Committees (TMU) will review the pro-
impact of an educational program based on the ISD tocol at least annually. The Investigator will make safety
model on improving preventive behaviors of STI Ira- and progress reports to the TMU at least annually and
nian women. An exploratory sequential mixed-methods within six months of study termination. These reports
design will be used in the study. will include the total number of participants enrolled . . .
and summaries of each stage of intervention [33].
Outcome measures
The initial research questions addressed in this study are Consent or assent
“Does the educational intervention based on Instruc- A trained research health educator will introduce the
tional System Design (ISD) model affect STI preventive trial to participants who will receive a pdf file regarding
Juyani et al. Trials (2022) 23:724 Page 4 of 11

the main aspects of the trial. participants will also receive reported in accordance with the Consolidated Standards
information sheets. Trained Research will discuss the of Reporting Trials (CONSORT). A visual diagram of the
trial with participants in light of the information pro- study process is shown in Fig. 1.
vided in the pdf file and information sheets. participants
will then be able to have an informed discussion with the Phase 1: the qualitative exploration
participating consultant. Trained Research will obtain The qualitative study will take 5 months to complete.
written consent from participants willing to participate To explore the educational and learning needs of at-risk
in the trial. Information sheets and consent forms are women, semi-structured interviews with open-ended
provided for all involved in the trial however these have questions and conventional qualitative content analy-
been amended accordingly in order to provide separate sis methods will be used. The interviews will take place
information sheets and consent form. All information face-to-face in a mutually convenient quiet environment.
sheets, consent forms, and the pdf file are in the Persian In accordance with the study’s goals and objectives, an
language There are also separate information sheets and interview guide has been created. The first question is a
consent forms for the control group. wide, open-ended question about the participant’s feel-
ings about STIs, to which they will be asked to respond
Participants in detail. Then, based on this response, further probing
The research population will include women aged 18–48 questions are asked. The goal is to gain a comprehen-
years who are sexually active. To meet these inclusion sive understanding of women’s attitudes toward STIs.
criteria, recruitment will be from women who refer to Each interview will be transcribed word by word imme-
Tehran Municipality Health House Participants will be diately after each interview. The transcript will then
recruited from Tehran Municipality Health House affili- be sent to each woman, along with a summary of key
ated by the Women Empowerment Headquarters of points extracted from each interview, to ensure that the
Tehran Municipality. The list of introduced eligible par- interviewer has correctly interpreted their declarations
ticipants will be initially contacted via phone and given (member checking), and any vague discrepancies will be
an in-depth description of the study, those interested will resolved. In addition, we will use the literature review to
be followed up with an inclusion listing. Once Tehran identify the educational and learning needs of women
Municipality Health House has received a briefing about about STIs in order to gain an understanding of their
the project and understands the randomized controlled needs. Finally, an educational intervention that best fits
trial design and data collection elements of the study, it the qualitative study results will be developed using the
will be asked to sign the consent form and allocate one two approaches mentioned above (interview and litera-
room for the research project. Invitations to partici- ture review) and the ISD model.
pate in the study will be stretched to all eligible women
until we reach a sample size of 150 women who provide Phase 2: designing the intervention program
informed consent to participate. Table 1 contains a com- The second phase of the study begins after the required
plete list of the inclusion and exclusion criteria. data has been collected through qualitative research. The
purpose of this step is to develop an effective educational
Study design program based on the ISD model to promote preventive
This exploratory sequential mixed-methods study will behavior from STIs among Iranian women.
be divided into three phases, which are described below.
Table 2 shows the enrollment, interview, intervention, Conceptual framework of content development based
and assessment schedule. This protocol was developed on ISD model
and reported in accordance with the Standard Proto- Dick and Carey’s (2014) Instructional System Design
col Items: Recommendations for Interventional Trials (ISD) model provided the framework for this program.
(SPIRIT), and the clinical trial will be carried out and The ISD model depicts the processes and steps we

Table 1 Inclusion and exclusion criteria

Inclusion criteria Exclusion criteria

• Women aged 18–48 years • Absence of more than two sessions in training sessions
• Women without cervical cancer • The participant has a special illness that is not able to participate in
• Women without mental disorders, drug dependence, and addiction training sessions
• Tend to participate with informed consent to share information, and
participate
Juyani et al. Trials (2022) 23:724 Page 5 of 11

Table 2 Schedule of enrolment, interviews, intervention, and assessment of the Educational Intervention trial, following the Standard
Protocol Items Recommended for Clinical Trials (SPIRIT) guidelines

take to effectively organize all components in order to These objectives are the result of need assessments.
achieve our objectives [34]. This model is a systematic Need assessments are analyses of the gap between
and structured process that establishes a strong connec- one’s current status and one’s desired status.
tion between stimulus (learning materials) and response 2. Conduct instructional analysis
(learning) [35]. The role of the environment in learning When learners have achieved their instructional goals,
is highlighted in this systematic approach. According to what they should do is determined by stages in a
this model, it is necessary to first identify the sub-skills hierarchy.
that learners should master before selecting the stimulus 3. Analyze learners and contexts
and strategy that are appropriate for each sub-skill [36]. In this stage, we will analyze learners’ STI learning expe-
rience, preferences, traits, and learning situations.
4. Write performance objectives
Instructional System Design (ISD) model steps When students complete the education program, they
The ISD includes 10 steps develop a detailed action plan based on the knowl-
edge they have gained, which is aligned with per-
1. Identify instructional goals formance objectives.
5. Develop assessment instruments
The first stage determined what learners could accom- Assessment tools determine whether or not students
plish after completing the educational process [37]. met their objectives.
Juyani et al. Trials (2022) 23:724 Page 6 of 11

Fig. 1 Study visual diagram

6. Develop instructional strategy and 3 months after the end of the educational
The researcher determines the educational method that intervention.
learners will use to achieve their ultimate learning
goals during the educational strategy phase. Phase 3: the randomized controlled trial
7. Develop instructional materials Randomized controlled trials (RCTs) are the most effec-
The researcher will choose educational materials at this tive way to assess public health interventions. RCT
stage based on the instructional strategy. reduces the impact of confounding bias because each
8. Design and conduct formative evaluation study participant is assigned to an intervention or con-
At this stage, the educational content will be made trol group solely by chance [38]. Figure 2 depicts the flow
available to at least 5 to 10 women outside of the chart of the randomized controlled protocol.
research team, and the content’s validity will be
evaluated in terms of applicability, comprehensibil- The intervention programs
ity, simplicity, and attractiveness. The intervention will be created using the qualitative
9. Design and conduct a summative evaluation study’s phase 1 findings. Women who meet the inclusion
Following the evaluators’ comments in Step 8, any pos- criteria will be recruited indefinitely until the required
sible and necessary corrections to the educational sample size is reached. At this point, all participants will
content will be made. be coded and blindly allocated into one of the interven-
10. Final evaluation tion and control groups by the researchers using a per-
The effect of the intervention will be evaluated at this muted block randomization program: (1) intervention (2)
stage in three time periods: immediately, 1 month, control.
Juyani et al. Trials (2022) 23:724 Page 7 of 11

Fig. 2 The flow chart of the randomized controlled protocol

Based on the design of the randomized controlled trial Instruments

intervention, the impact of the intervention program on The instrument that will be used to collect the data is the
promoting women’s STI prevention behaviors will be STI Four-Scale of Preventive Behaviors in females [2].
assessed. Measurements will be taken at baseline, after This scale was finalized by applying 40 five-point Likert
one month, and after three months of following their response items where the items ranged from completely
respective program, as shown in Fig. 1. In accordance agree to completely disagree; the higher the score the
with ethical principles, the participants in the control greater the preventive STI behaviors. The calculated
group will also receive the most effective intervention Content Validity Rate (CVR) and Content Validity Index
after the final evaluation and comparisons of the three (CVI) of the four-scale items ranged between 0.56–1.00
intervention groups. and 0.83–1.00, respectively. The impact score of all items
was above 1.5. Cronbach’s alpha for each scale was as fol-
Strategies to improve adherence to interventions lows: STI knowledge (0.81), STI vulnerability (0.66), STI
Women are required to be present at the study site in prevention self-efficacy (0.83), and STI prevention inten-
person to receive the intervention, and any missed ses- tions (0.85). Cronbach’s alpha and intra-class correlation
sions are recorded to check adherence. To improve coefficient were calculated for the reliability of the four-
adherence, training program times are flexible between scale items and ranged between 0.66–0.85 and 0.846–
9am and 5pm each day (room availability permitting), are 0.977, respectively.
not required to be at the same time of day, and are not
required on weekends. Participants will be arranged for Sample size and power calculations
a free visit with a trained midwife for genital examination The sample size we require in the quantitative phase to
and health counseling. provide sufficient power was calculated as 63 persons for
Juyani et al. Trials (2022) 23:724 Page 8 of 11

each group. This sample size was calculated to be ade- and attentive to the individual’s needs, and frequent
quate at an alpha of 0.05 and a power of .80, to test for a opportunities for questions and feedback. In addition,
difference between the groups. we considered a potential for a free visit, a trained midwifery will coordinate for a
dropout rate of 30%. According to the formula below, we genital examination, and the names of the intervention
should start with a recruitment target of 75 participants group will be announced to the specialist.
in each group:

In accordance with this approach, a total of 150 Data analysis

women at risk, aged 18 to 48, from the Tehran Munici- Phase 1 (qualitative analysis)
pality Health House, will be recruited using the inclu- To carry out the qualitative content analysis process, each
sion and exclusion criteria listed in Table 1. interview’s audio file will be listened to carefully several
times on the same day and transcribed verbatim. In order
to keep the data from the interviews private, each tran-
Randomization and blinding script will be assigned a code. To come up with the overall
After informed consent and baseline data collection, impression of the interviews and become fully immersed
participants in the randomized controlled trial will be in the data, the audio files and transcripts will be reviewed
randomly assigned to the intervention and control arms several times, and any ambiguities and inconsistencies
in a restricted randomized block design. A research will be removed by comparing the audio files and the tran-
identification number will be given to each woman. scripts. The interviews will be audiotaped and a summary
Then, the identified individuals who volunteered to of the key points of each interview will be then sent to
participate in the study were randomly assigned to each participant to ensure that the interviewer will have
the experimental and control groups using a blocking interpreted that participant’s comments accurately [39].
method. Following simple randomization procedures, The process of data analysis will be performed continu-
participants will be assigned to one of two trial arms ously and simultaneously with the data gathering process.
in a 1:1 ratio based on a computerized randomization All words, statements, and paragraphs that are relevant to
program via https://​w ww.​seale​denve​lope.​com/​simple-​ the analysis process will be considered as a single seman-
rando​miser/​v1. The letter A will be considered for the tic unit. After merging the semantic units, the codes will
intervention group1 and the letter B for the control be extracted. The codes are combined to form subcatego-
group. The process of random allocation will be contin- ries, which are then combined to form the main catego-
ued continuously until the sample size will be reached. ries. Finally, after the categories have been abstracted, the
Masking of participants and study staff is not possible relevant themes will be identified [40]. The data will be
due to the nature of the intervention (educational) and managed using MAX.QDA-ver2020.
allocation ratio. The first researcher (AKJ) will enroll
participants in the study and allocate them a unique
ID number. A statistic expert out of the research team Phase 3 (quantitative analysis)
(SHH) will generate the allocation sequence using the The collected data will be analyzed using descriptive sta-
women’s numbers. The first researcher (AKJ) will then tistics (such as frequency, frequency percentage, mean,
inform women which group they have been allocated to. and standard deviation) and inferential statistics in SPSS
ver16. Generalized mixed models of analysis of variance
for repeated measures will be used to compare the differ-
Engagement and retention ences between the values obtained before the interven-
As this is a group of participants that can be particu- tion and 1 and 3 months after the intervention in each
larly difficult to participate and maintain in a study, group. We will also calculate the differences in means
given the sensitive nature of STIs, several steps will be between the independent groups, as well as their respec-
taken to optimize retention. These include schedul- tive 95% confidence intervals. All tests will be run with a
ing training at maximally convenient times for partic- 0.05 significance level (p 0.05). The Kolmogorov-Smirnov
ipants, hiring a trained midwifery that will be flexible test will be used to determine the data’s normality.
Juyani et al. Trials (2022) 23:724 Page 9 of 11

Interim analysis intervention based on ISD to promote preventive behav-

Intervention allocation will remain hidden for any iors from STIs in at-risk Iranian women. Women in Iran
interim analysis performed. Furturemore, As this is a account for a high percentage of the population. Despite
minimal risk experiment, there will be no interim analy- the high prevalence of sexually transmitted infections
sis or stopping instructions. affecting this community, low educational interventions
have been made to enable them to preventive behaviors.
Methods for additional analyses (non‑adherence
Therefore, this study aims to identify the educational
and missing data)
and learning needs of at-risk women and implement a
Missing data will be reported and links between results purposeful intervention program as an effective step to
reviewed. depending on the extent of data missing an promote preventive behaviors regarding STIs of Iranian
appropriate sensitivity analysis will be performed. women aged 18–48 years. This study has several robust
design features detailed as follows:

Auditing 1. Performing a randomized controlled trial based on the

The auditors will follow a monitoring plan to verify that ISD model: This study is the first randomized controlled
the clinical trial is conducted and that data are generated, trial performed on women at risk of STIs to evaluate the
documented, and reported in compliance with the pro- effectiveness of the educational intervention.
tocol and the applicable regulatory requirements. Due 2. Theory-based intervention: The gap in the majority
to the nature of the educational intervention, there is no of intervention studies is that they are designed based
adverse event and no harm in this study. To our knowl- on educational needs. The present study explores
edge, the present study will not have any negative con- the effectiveness of the training intervention over an
sequences. Every 6 months, we will send a report to the educational framework called the Instructional sys-
auditor. We will share the results of this study with keys tem design (ISD) model.
Representative of the ethics committee and reviewers via
presenting in related seminars. We do recognize that this study will have some limi-
tations in so far as we must limit the randomized con-
Protocol amendment trolled trial to women residing in one region of Iran.
Any changes to the study protocol, including modifications This, however, will enable us to maintain good control
in study objectives, study design, participants population, of the test procedure. There is a possibility of not hav-
sample size, study procedure, or significant administrative ing enough access to the questionnaire link and reduc-
aspects that may affect the conduct of the study, potential ing the Response-Rate. To reduce this limitation, the
participants’ benefit, or participants’ safety will require link of the online questionnaire will be provided to
protocol modification. Such amendments will be agreed the target group with maximum variance in different
upon by the Department of Health Education and Health ways. Another limitation of this study is the possibility
Promotion, Faculty of Medical Sciences, Tarbiat Modares of samples falling in the final intervals of the study; It
University, and will be approved by the Ethics Committee seems that considering the financial cost in exchange for
of Tarbiat Modares University prior to implementation. completing the questionnaire in four stages (pre-test,
Administrative changes of the protocol are minor correc- one month later, and three months after the interven-
tions and/or clarifications that have no effects on the way tion) is a good solution. Last but not least, performing
the study is to be conducted. These administrative changes educational interventions in the field of sexual health
will be agreed upon by Tarbiat Modares University. The among Iranian women always faces cultural problems.
Ethics Committee of the Faculty of Medical Sciences, Tar- Accordingly, the issue of sexually transmitted diseases is
biat Modares University may be notified of the administra- no exception to this rule. Hence, it may be difficult to
tive changes at the discretion of the Department of Health accept participants to enter the study at first.
Education and Health Promotion, Faculty of Medical Sci-
ences, Tarbiat Modares University. Conclusion
This study provides an educational program for edu-
Discussion cating, empowering, and promoting behaviors that
This paper describes the clinical trial protocol which prevent sexually transmitted infections. If the inter-
will examine intervention programs to promote preven- ventions designed in the present study are effective, It
tive behaviors in at-risk women. This will be the first has a high practical potential for generalization for all
study to examine the impact of an educational program women aged 18-48 at risk of STIs.
Juyani et al. Trials (2022) 23:724 Page 10 of 11

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