Effectiveness of online supportive counselling on quality of life in women with high-risk human papillomavirus in Iran: study protocol for a randomised controlled trial

Abstract

Introduction

Human papillomavirus (HPV) is one of the most common sexually transmitted diseases and affects the quality of life (QoL) of individuals, necessitating interventions beyond physical treatments. The aim of this study is to determine the effectiveness of individual supportive counselling on the QoL in women with high-risk HPV.

Methods and analysis

This randomised clinical trial will include 80 women with HPV who will be selected from 2025 to 2026 in Babol, Iran. Following selection based on inclusion criteria, samples will be randomly allocated to intervention and control groups. Then, they will complete demographic–social questionnaires, QoL in HPV patients and general health questionnaires. Individuals in the intervention group will receive 4 weekly online supportive counselling sessions in addition to routine care. The control group will receive routine care. Both groups will complete the questionnaires again at 6 weeks and 4 months postbaseline. Data will be analysed using SPSS V.26 software and statistical tests including χ², t-test and repeated measures analysis of variance, and regression models if necessary. A significance level of 5% will be used for the tests.

Ethics and dissemination

This study was approved by the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.HRI.REC.1404.082). The trial will adhere to the ethical principles of the Declaration of Helsinki. Findings will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences.

Trial registration number

IRCT20180218038783N11, 14 September 2025.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• Evaluates a non-pharmacological, low-cost and accessible intervention to improve quality of life in women with high-risk human papillomavirus (HPV).

• Employs a randomised controlled clinical trial design to ensure methodological rigour.

• Uses validated and standardised tools (HPV Impact Profile and General Health Questionnaire) to assess quality of life and general health.

• Online delivery of counselling sessions increases accessibility, though it may pose challenges with internet connectivity and participant engagement.

• The study does not include long-term follow-up, which limits the ability to evaluate sustained effects.

Introduction

Human papillomavirus (HPV) is a common sexually transmitted infection, affecting approximately 70% of sexually active individuals.¹ In the USA, around 40% of people aged 15–59 are infected with HPV, with a slightly higher prevalence among women (38.4%).² A meta-analysis in Iran found HPV infection rates of 9.4% in healthy women and 77.4% in women with cervical cancer.³ HPV infects basal epithelial cells, and over 200 types have been identified, categorised as either low-risk (non-oncogenic) or high-risk.¹ Low-risk types, most commonly types 6 and 11, typically cause genital warts.⁴

Most cervical cancer cases are associated with high-risk HPV types; the most common high-risk and oncogenic types are 16 and 18, but types 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82 with lower prevalence are also included in this category.⁵ Globally, primary prevention of HPV is implemented through prophylactic HPV vaccination, which has been widely incorporated into national immunisation schedules in many high-income and several middle-income countries. Secondary prevention relies on organised cervical cancer screening programmes using HPV testing or cytology (Pap smear) at regular intervals.⁶ In contrast, in Iran, HPV vaccination is not yet part of the national immunisation programme and remains available only in the private sector, leading to limited uptake. Cervical cancer screening is offered opportunistically rather than through an organised national programme, and population-level HPV testing is limited.⁷ These gaps highlight the need for complementary approaches to support women diagnosed with high-risk HPV.

Adolescent girls and young women are the most vulnerable groups for acquiring HPV due to early sexual debut, high partner turnover and low vaccination rates.⁶ While HPV infection alone does not appear to impair fertility, cervical abnormalities and subsequent treatments such as LEEP may slightly increase risks such as preterm birth. Moreover, concerns regarding reproductive potential often cause psychological distress among young women diagnosed with high-risk HPV.⁸ In addition to physical consequences such as genital warts, psychological outcomes cannot be ignored; psychological problems related to HPV, such as feelings of fear, guilt, shame and anxiety, may exist.⁹

The psychological distress of genital warts often dominates medical outcomes. Patients commonly suffer from low self-esteem, depression, sexual anxiety and decreased libido. Quality of life (QoL) is one of the basic indicators of health.¹⁰ HPV infection affects women’s QoL; QoL is of great importance as it includes multiple dimensions such as physical health, mental health, social relationships, family life and emotions. A large number of studies have reported the impact of psychological stress on the progression of cellular changes to cancer.11,13 One of the common problems that women with HPV face after diagnosis is sexual problems; HPV infection can have a negative impact on women’s sexual function.¹⁴ For this reason, it is necessary for all women to learn self-care skills.¹⁵

Individuals with HPV need to change some habits and modify their lifestyle to improve QoL, including: using condoms, reducing the number of sexual partners and longer periods of sexual abstinence.⁹ General health is a multidimensional concept that includes mental, social and physical health of individuals.¹⁶ A study on women with abnormal Pap smear results showed that although initial anxiety decreases after receiving results, concerns about sexual health and the possibility of developing cancer persist over time and can affect QoL.¹⁷ Improving general health requires a combination of comprehensive health education, access to services, management of psychological effects and health interventions.¹⁸ For this reason, counselling sessions are needed to improve QoL and enhance sexual self-care skills.^{19 20}

Counselling patients about any sexually transmitted disease is challenging for both the physician and the patient. However, the important goals of such counselling are to help make informed decisions about treatment, understand the relationship between viral infection, cervical cancer and reduce transmission risk; most importantly, emotional, psychological and social attention.²¹ Therefore, the support provided to individuals at the time of disease diagnosis is very important. This support should not only ensure that the individual can manage the physical effects of the disease, but should also cover the psychological and social challenges that the disease brings.²² Supportive counselling is a type of counselling to help individuals who are facing a crisis or temporary state of confusion. It aims to help people achieve better adaptation to stressful situations by strengthening their tools using reassurance, explanation, guidance and providing and creating a safe space for emotional aspects. The ultimate goal of supportive counselling is to increase clients’ self-confidence and independence in decision-making.²³

Recent evidence documents a substantial psychosocial burden following HPV diagnosis, including anxiety, stigma and reduced QoL. Psychosocial and digital interventions (eg, web-based education, motivational-interviewing frameworks and mHealth counselling) have shown promise in reducing psychological distress and improving QoL in HPV-affected populations.24,26 In Iran, most studies have focused on HPV awareness, vaccination acceptance or cervical screening uptake and are largely descriptive.^{10 15} To date, no randomised controlled trial has evaluated whether structured supportive counselling can improve the psychological well-being or QoL of women living with high-risk HPV. This gap underscores the need to develop and test context-specific counselling interventions. Given the sensitive and potentially stigmatising nature of high-risk HPV infection, delivering supportive counselling online can help protect privacy while reducing barriers such as travel, scheduling and concerns about disclosure. Prior evidence indicates that telecounselling is feasible and acceptable among reproductive-age women.²⁷

Given the challenges facing individuals with this virus and the contradictory results in the field of supportive counselling, we will study the effectiveness of individual supportive counselling on QoL in women with high-risk HPV in this study. QoL as the primary outcome and general health as a secondary outcome will be examined so that if this type of counselling is effective, it can lead to improved physical and mental health in women who are a vulnerable population.

Method and analysis

Study setting

This randomised parallel clinical trial will be conducted with women with high-risk HPV referring to the oncology subspecialty clinic of one of the gynaecologists in Babol, Iran. The results of this study will be published in databases to inform participants, healthcare professionals, interested individuals, the public and researchers.

Participant timeline

Time schedule of enrolment, interventions, assessments and visits for participants is shown in figure 1.

Figure 1. Schedule of enrolment, interventions, assessments, and visits for participants in the study.

Study design

This protocol describes an open-label randomised controlled clinical trial with random allocation of participants into two parallel groups: intervention and control. This manuscript has been reported in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines (online supplemental material 1). The study design also follows the consolidated standards of CONSORT (Consolidated Standards of Reporting Trials) clinical trial reports (figure 2). The trial was registered in the Iranian Clinical Trial Registry (Code: IRCT20180218038783N11) on 14 September 2025. The recruitment period for this study started in September/October 2025 and is expected to continue until September/October 2026.

Figure 2. Flow of participants through the study.

Eligibility criteria

Participants in the present study will include eligible women with high-risk HPV referring to the oncology subspecialty clinic. Eligible and interested women will be invited by telephone contact to participate in this clinical trial. Inclusion criteria include: age 18–54 years, willingness to participate in the study with informed consent, diagnosis of high-risk HPV infection by specialised tests (PCR), (This study focused on women with high-risk HPV infection because high-risk genotypes are oncogenic and therefore more strongly associated with psychological distress, cancer worry and reduced QoL), having at least literacy skills for reading and writing, access to mobile phone, absence of cervical cancer and other cancers, at least 3 months since diagnosis and a maximum of 2 years since high-risk HPV infection. Exclusion criteria will be cervical cancer or other cancers, known mental disorders, use of psychotropic/antianxiety/antidepressant medications and disease-related counselling within the past 6 months.

Intervention

The researcher (Master’s student in midwifery counselling) will visit the subspecialty clinic in Babol to invite eligible women to participate in the study. The researcher will obtain phone numbers from the medical records of patients who have visited the clinic and contact them by telephone. After introducing themselves and providing a complete explanation of the study objectives to the samples, they will be asked to visit the clinic if they wish to participate in the study. Then, written informed consent will be obtained from them. The samples will be randomly assigned to intervention and control groups after selection based on the study inclusion criteria. They will be assured that even if they are unwilling to cooperate, their medical interventions will not be affected and they can withdraw from the study at any stage.

Additionally, participants will be assured that their personal information will remain confidential and only overall and group results of the study will be published without mentioning names or individual details. Then, before the start of the study, samples from both intervention and control groups will complete demographic-social questionnaires, QoL for HPV patients and general health questionnaires. In the intervention group, individual supportive counselling will be provided in the form of 4 weekly non-face-to-face (online) sessions, each session lasting 30–45 min, by the researcher (Master’s student in midwifery counselling). Counselling sessions will be provided online weekly for 4 weeks. The relevant platform will be determined according to the accessibility and convenience of the clients, including Google Meet and WhatsApp. These platforms will be used solely for real-time counselling and scheduling; no clinical data, records or identifiable information will be exchanged or stored through the application and their use is approved by the institutional ethics committee. Between sessions, patients will be required to practise the provided training and raise their questions and concerns in subsequent sessions. The researcher will be trained by a psychiatrist specialist consisting of approximately 4–6 hours of instruction on supportive-counselling principles and two practice sessions before the start of the trial and will receive supervision of the psychiatrist.^{28 29} Throughout the study, the psychiatrist will provide regular supervision after every two counselling sessions, with additional consultation available as needed. These procedures will be implemented to maintain consistency and fidelity across all delivered sessions. The objectives of the sessions are included in table 1.

Table 1. Model of counselling sessions to improve the quality of life and health of people infected with human papillomavirus.

Sessions	Title of sessions	Content
Session 1	Orientation session effective communication, stating session objectives, expressing confidentiality, expressing feelings and correcting beliefs, relaxation techniques and answering questions, session summary	Establishing effective and empathetic communication with patients and using supportive techniques such as active listening, empathy and reassurance to resolve any misunderstandings or doubts. Brief introduction regarding the number of sessions, duration of each session and counselling approach. Explaining the objectives of each session and expectations at the end of sessions. Explaining confidentiality throughout the sessions. Expressing feelings and assurance that these feelings are natural and understandable. Dispelling misconceptions and correcting them. Relaxation techniques: breathing, meditation, exercise. Answering client questions about session content. Session summary.
Session 2	Effective communication, stating session objectives, information about human papillomavirus, importance, complications and consequences of human papillomavirus infection, tips for improving quality of life, introduction of treatment methods, answering questions, session summary	Establishing effective communication and stating session objectives. Importance, complications and consequences of human papillomavirus infection. Providing information about the disease, transmission methods, prevention and vaccination. Explaining tips for improving quality of life and enhancing sexual relationship quality. Explaining various treatment approaches. Planning for follow-up and continuation of the treatment process. Answering client questions about session content. Session summary.
Session 3	Establishing effective communication, stating session objectives, self-control skills and stress management, answering questions, session summary	Establishing effective communication and stating session objectives. Identifying sources of stress. Accepting and acknowledging current conditions. Finding appropriate solutions. Answering client questions about session content. Session summary.
Session 4	Establishing effective communication, stating session objectives, presenting health-related matters, client progress, encouragement techniques, answering questions, session summary and review of previous sessions, goal readjustment	Establishing effective communication and stating session objectives. Presenting health-related matters: sleep, nutrition, social support. Using encouragement and motivation techniques to continue the counselling and treatment process. Evaluating changes in feelings and effectiveness of taught skills. Answering client questions about session content. Reviewing sessions and readjusting goals. Summarising content. Referring to counselling services if needed.

Continuous communication with members through social messaging platforms for answering questions and reinforcing session content will also be considered. Additionally, periodic surveys will be conducted online to assess members’ satisfaction level with the content and delivery method, and to receive constructive suggestions and criticisms. If needed, online question and answer sessions (webinars) will also be arranged to clarify ambiguities and answer members’ specialised questions.

Because of the sensitive nature of HPV counselling, sessions were not audio/video recorded to protect participant confidentiality. Instead, the counsellor prepared brief structured session summaries that were periodically reviewed with the supervising psychiatrist to ensure fidelity.

Control group participants will receive only routine care (disease information and treatment follow-ups and vaccination if needed) during the research period and no structured psychosocial support is routinely available in these settings. Contact with the research team will be restricted to baseline and follow-up assessments to avoid differential attention between groups. At the end of the research, to observe ethical considerations, the educational content file of the counselling sessions will also be made available to this group.

Control-group participants will continue with routine clinic visits as clinically indicated.

Both groups will complete the demographic–social, QoL for HPV patients and general health questionnaires again 6 weeks and 4 months after the start of the study.

Outcomes

The primary outcome of the study is the mean QoL score of women with HPV, which will be assessed using the standard HPV Impact Profile (HIP).

The secondary outcome is the mean general health score, which will be calculated using the standard General Health Questionnaire (GHQ).

Sample size

The sample size was calculated for comparing the mean total score of the HIP between the intervention and control groups. The total HIP score is a continuous variable ranging from 25 to 100. The SD of the total HIP score was derived from the published Persian validation study of HIP, which reported SDs of approximately 14–15. For the sample size calculation, a conservative SD of 15 was assumed.³⁰ A minimum clinically meaningful difference of 10 points was considered. Using a two-sided significance level of 0.05 and 80% power, the required sample size was calculated as 36 participants per group. To account for potential attrition, the final sample size was increased to 40 participants per group.

Assignment of interventions: allocation

Sequence generation

Participants will be selected using convenience (available) sampling method based on inclusion criteria. Then, they will be randomly allocated in a 1:1 ratio using random allocation generated by an online random number generator software and divided into two intervention and control groups (A and B) in four blocks. To achieve a sample size of 80 participants, 20 blocks of 4 are required. The random allocation list will be prepared by a researcher who is not involved in the sampling process. This is to ensure that the researcher responsible for sampling (Master’s student in midwifery consulting) cannot predict which group the next participant will be assigned to.

Concealment mechanism

To prevent revealing the random sequence and compromising the randomisation, this study will use sealed opaque envelopes containing the random allocation. A total of 80 envelopes will be prepared according to the sample size. The random sequence will be written on individual cards, which will then be placed inside the envelopes in order. During participant enrolment, one envelope will be opened according to the order of entry, and the assigned group for that participant will be determined. Considering the study design, this research will be conducted as an open-label trial.

Implementation

Registration of samples and obtaining informed consent for their participation will be done by the researcher. After the qualified sample is determined, the researcher contacts the supervisor to determine the group for the sample and the supervisor determines the number assigned to sample A or B by opening the envelope.

Assignment of interventions: blinding

In this study, considering that the type of intervention is known after randomisation and the completion of the questionnaires is also self-reported, blinding cannot be done in the first stage for researchers and patients. Blinding will only be done for the data analyst. The dataset will be anonymised with dummy codes (Group A/B) before being sent to the statistician.

Data collection and management

The data collection instruments in this study will be the demographic–social information questionnaire, QoL questionnaire for women with HPV and GHQ.

Demographic–social

Information Questionnaire that includes questions such as: age, occupation, education, place of residence, duration of marriage, number of deliveries, number of pregnancies, number of miscarriages, economic status, source of information about the disease, time of disease awareness, treatments performed and vaccine receipt.

HPV quality of life questionnaire

HIP was first designed by Mast et al in 2009 and consists of 29 questions across seven dimensions: concerns, emotional impact, sexual impact, self-image, partner/transmission, interaction with healthcare providers and health control/life impact. Responses are scored on a Likert scale from 0 to 10, with higher scores indicating greater psychosocial impact of HPV. This questionnaire was validated in Iran by Nasiri-Amiri et al, where exploratory factor analysis reduced it to 25 questions, and three extracted factors explained 81.65% of the variance. Confirmatory factor analysis results confirmed good model fit, and high reliability was demonstrated with Cronbach’s alpha of 0.932 (α=0.932) and McDonald’s omega of 0.996 (ω=0.996).³⁰

General Health Questionnaire

The GHQ was designed and developed by Goldberg in 1972 to assess general health in students.³¹ In the study by Montazeri et al¹⁶, factor analysis showed that the questionnaire has a two-factor structure that explains 51% of the variance. These two factors included ‘psychological distress’ and ‘social dysfunction’. Question seven belongs to both factors.¹⁶ The Cronbach’s alpha coefficient for the entire sample was 0.87, indicating good reliability of the questionnaire. A significant negative correlation was observed between the scores of the 12-item GHQ and global QoL scores (r=−0.56, p<0.0001), indicating good convergent validity of the questionnaire. The score range of this questionnaire will be between 0 and 36. The higher the score obtained from this questionnaire, the lower the general health level and vice versa.

Statistics methods

The analysis method in this study will be intention-to-treat analysis in order to preserve the random allocation process. The missing data will be handled using multiple imputation methods based on available baseline and follow-up variables. Data will be analysed using SPSS software V.26 and statistical tests including χ², t-test and analysis of variance with repeated measurement analysis of variance, and if necessary, regression models.

Ethics and dissemination

This study was approved by the Research Ethics Committee of Babol University of Medical Sciences (Code: IR.MUBABOL.HRI.REC.1404.082). Prior to participation, all participants will receive detailed written information about the study’s objectives, procedures, potential risks and benefits. Written informed consent will be obtained from all participants before enrolment. Confidentiality of participants’ information will be ensured through the use of anonymous identifiers and secure storage of all personal data. Participants will be informed of their right to withdraw from the study at any time without any penalty. The results of this study will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences. This manuscript, or any related manuscript, is not currently under consideration, nor has it been accepted for publication elsewhere.