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IRCT20170513033951N2 IRCT 2025-06-02 Shahroud University of Medical Sciences The effect of sexual self-care education on sexual health and marital satisfaction of women with HIV-infected partners. "Determining the Effect of a Sexual Self-Care Education Intervention on Sexual Health and Marital Satisfaction of Healthy Women with HIV-Positive Husbands: A Randomized Controlled Clinical Trial" 2025-05-31 anticipated 80 Complete https://irct.ir/trial/83610 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: The method of assigning the intervention to individuals will be random and using the random permutation block method with a block size of 4. The randomization list will be prepared in consultation with a statistician. In order to conceal the allocation, sealed and waxed opaque envelopes will be used. After randomization, a number of envelopes will be prepared based on the size of the research sample, and each of the random sequences created will be recorded on a card and the cards will be placed in the envelopes in order. In order to preserve the random sequence, numbering will be done in the same order on the outer surface of the envelopes. Finally, the envelopes will be sealed and placed in a box in order. At the start of participant registration, based on the order in which eligible participants entered the study, one of the envelopes will be opened in order and the assigned group of that participant will be determined. In this way, eligible individuals who wish to participate in the study will be randomly assigned to either the intervention or control groups, Blinding description: This study will be a randomized, controlled, single-blinded interventional study. Due to the educational nature of the intervention, blinding of participants is not possible, but the data analyst will be blinded to group allocation. N/A Sexual health and marital satisfaction of healthy women with HIV-positive partners. Intervention group: This study will be conducted as a randomized clinical trial with two experimental and control groups, after the necessary preparations, including approval by the Ethics Committee of Shahrood University of Medical Sciences and registration in the clinical trials registry, and with the participation and informed consent of individuals referring to behavioral disease counseling centers. Primary sampling will be conducted in a convenient manner, and in order to access the desired samples, the researcher will visit the selected center after obtaining the necessary permits, with a written letter of introduction, and after explaining the research objectives and methods to the center officials and obtaining their consent, will begin sampling in this center. The researcher will visit this center on weekdays according to a pre-determined schedule and, after explaining the research objectives and methods to individuals who refer to receive health and medical services, will take a history from the individuals. Individuals who meet the entry criteria for the study and are willing to participate in the study will enter the study after obtaining written informed consent. At the beginning of the study, participants will be explained whether they will be randomly assigned to one of the intervention or control groups. They will also be assured that if they do not wish to continue participating in the study during the study, they will be withdrawn from the study. The initial questionnaire will be completed before random assignment of individuals to the two groups, and the designed intervention will be provided to the test group. The number of sessions and hours required, based on a review of related studies and interventions, is 6 sessions of 60-90 minutes, twice a week, for three consecutive weeks. The control group will not receive any intervention other than usual care until the end of the study. The effectiveness of the intervention will be assessed by completing a questionnaire before and four weeks after the intervention. The assessment in the control group will be conducted in the same way as in the intervention group. Research population: Healthy women with HIV-positive partners in the reproductive age group of 18 to 49 years, referring to behavioral disease counseling centers affiliated with Mazandaran University of Medical Sciences and the Behavioral Disease Counseling Center at Imam Khomeini Hospital in Tehran. Research sample: Healthy women with HIV-positive partners in the reproductive age group of 18 to 49 years, referring to behavioral disease counseling centers affiliated with Mazandaran University of Medical Sciences and the Behavioral Disease Counseling Center at Imam Khomeini Hospital in Tehran, who are eligible for inclusion in the study.. Yes - There is a plan to make this available What will be shared: Yes, the Individualized Data File (IPD) will be made available to interested researchers in an anonymized form after the analyses are completed and the results are published. Data will be provided through direct request and after evaluation of the applicant's research proposal. Contact information for requests: Motahari.m11@gmail.com When: The data access period will begin 6 months after the publication of the final study results in scientific journals and will continue for 3 years. Data will only be provided to qualified researchers with a valid research purpose, after submitting a written request and approval by the research team. To whom: Access to data will be available to researchers working in academic institutions, research centers, and industry professionals who have a clear, justified, and ethically approved research project. Applications will be reviewed by the research team, and data will be provided on an anonymized basis and in strict confidentiality. Conditions: Non-identifiable personal data and documentation related to this study can only be used for research purposes. Researchers who wish to receive the data must submit their formal request to the research team, along with the research plan and the type of analysis desired. Only scientific and statistical analyses related to the topic of sexual health and marital satisfaction will be permitted. Use of the data for commercial, promotional, or non-research purposes is not permitted. Any access to the data will only be possible after approval by the Ethics Committee of Shahroud University of Medical Sciences and signing a confidentiality agreement. Where to obtain: Applicants for data or documentation from this study can submit their request via email to the researcher responsible for the study. The request should include a complete introduction of the applicant, organizational affiliation, purpose of data use, a summary of the research design, and the type of analyses intended. Name: Mohadese Motaharinezhad Email address: Motahari.m11@gmail.com How to obtain: After receiving the formal request from the applicant, the review process will be carried out as follows: Receipt of a written request including complete information about the applicant, proposed research plan, objectives, type of analysis desired, and organizational affiliation Initial review by the responsible researcher to assess the completeness of the documents and documentation (maximum 7 working days) Expert review by the research team to ensure that the purpose of the request is consistent with the nature of the data and compliance with research ethics principles (maximum 2 to 3 working weeks) If approved, the signing of a Data Use Agreement between the parties is necessary. After the agreement is finalized, the anonymized data will be provided to the applicant via encrypted email or secure link. The entire process from receipt of the request to delivery of the data usually takes between 3 to 4 working weeks. Comments:
public Mohadese Motaharinezhad
Hafte-Tir Square, Imam Hossein Boulevard, Shahroud, Semnan Province, Iran
Shahroud Iran (Islamic Republic of) 7395536147 +98 23 3239 5054 Motahari.m11@gmail.com Shahroud University of Medical Sciences scientific Mohadese Motaharinezhad
Hafte-Tir Square, Imam Hossein Boulevard, Shahroud, Semnan Province, Iran
Shahroud Iran (Islamic Republic of) 7395536147 +98 23 3239 5054 Motahari.m11@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Being a woman and having an HIV-positive spouse (confirmed by medical documents or medical records) Negative HIV test result in the woman (woman is HIV negative = incompatible couple) Women of reproductive age 18 to 49 years Having lived together with your current spouse for at least 6 months Ability to read and write Having sexual activity Informed consent to participate in the study Absence of psychiatric illnesses or cognitive disorders (based on self-report) Not using psychotropic or narcotic drugs Not pregnant at the time of intervention No participation in similar interventions within the past 6 months 18 years 49 years Female HIV infection in women during the study period Unwillingness to continue cooperation at any stage of the study Individuals not attending more than three sessions of the intervention program The occurrence of severe family or personal crises that disrupt the individual's participation process The woman became pregnant during the study Change in marital status during the study (divorce) Use of medications or treatments that have a serious impact on sexual or psychological functioning during the implementation of the intervention Development of a previously undiagnosed psychiatric or cognitive disorder during the study Behavior Intervention group: This study will be conducted as a randomized clinical trial with two experimental and control groups, after the necessary preparations, including approval by the Ethics Committee of Shahrood University of Medical Sciences and registration in the clinical trials registry, and with the participation and informed consent of individuals referring to behavioral disease counseling centers. Primary sampling will be conducted in a convenient manner, and in order to access the desired samples, the researcher will visit the selected center after obtaining the necessary permits, with a written letter of introduction, and after explaining the research objectives and methods to the center officials and obtaining their consent, will begin sampling in this center. The researcher will visit this center on weekdays according to a pre-determined schedule and, after explaining the research objectives and methods to individuals who refer to receive health and medical services, will take a history from the individuals. Individuals who meet the entry criteria for the study and are willing to participate in the study will enter the study after obtaining written informed consent. At the beginning of the study, participants will be explained whether they will be randomly assigned to one of the intervention or control groups. They will also be assured that if they do not wish to continue participating in the study during the study, they will be withdrawn from the study. The initial questionnaire will be completed before random assignment of individuals to the two groups, and the designed intervention will be provided to the test group. The number of sessions and hours required, based on a review of related studies and interventions, is 6 sessions of 60-90 minutes, twice a week, for three consecutive weeks. The control group will not receive any intervention other than usual care until the end of the study. The effectiveness of the intervention will be assessed by completing a questionnaire before and four weeks after the intervention. The assessment in the control group will be conducted in the same way as in the intervention group. Research population: Healthy women with HIV-positive partners in the reproductive age group of 18 to 49 years, referring to behavioral disease counseling centers affiliated with Mazandaran University of Medical Sciences and the Behavioral Disease Counseling Center at Imam Khomeini Hospital in Tehran. Research sample: Healthy women with HIV-positive partners in the reproductive age group of 18 to 49 years, referring to behavioral disease counseling centers affiliated with Mazandaran University of Medical Sciences and the Behavioral Disease Counseling Center at Imam Khomeini Hospital in Tehran, who are eligible for inclusion in the study. Sexual health score. Timepoint: At the beginning of the study (before the intervention), at the end of the intervention, and 4 weeks after the intervention. Method of measurement: Sexual Self-Care Questionnaire for Women of Reproductive Age (FSHS): Female Sexual Health Self-care. Marital satisfaction score. Timepoint: At the beginning of the study (before the intervention), at the end of the intervention, and 4 weeks after the intervention. Method of measurement: ENRICH Marital Satisfaction Questionnaire: Evaluation and Nurturing Relationship Issues, Communication and Happiness. Sexual health score. Timepoint: At the beginning of the study (before the intervention), at the end of the intervention, and 4 weeks after the intervention. Method of measurement: Sexual Self-Care Questionnaire for Women of Reproductive Age (FSHS): Female Sexual Health Self-care. Marital satisfaction score. Timepoint: At the beginning of the study (before the intervention), at the end of the intervention, and 4 weeks after the intervention. Method of measurement: ENRICH Marital Satisfaction Questionnaire: Evaluation and Nurturing Relationship Issues, Communication and Happiness. Shahroud University of Medical Sciences Approved 2021-08-15 Ethics committee of shahroud University of Medical Sciences Hafte-Tir Square, Imam Hossein Boulevard, Shahroud, Semnan Province, Iran Shahroud Semnan Iran (Islamic Republic of)