"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"

Determining the effect of sexual self-care education intervention on sexual health and marital satisfaction of healthy women with HIV-infected partners

A randomized, controlled, single-blind clinical trial with a control group on 80 subjects. The method of assigning the intervention to subjects was random and using a permutation block method with a block size of 4.

Individuals who meet the inclusion criteria will be included in the study after obtaining written informed consent. The initial questionnaire will be completed before random assignment to two groups, and the designed intervention will be provided to the experimental group. The effectiveness of the intervention will be assessed by completing the 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. Location: Sari County Behavioral Diseases Counseling Center and Imam Khomeini Hospital, Tehran

Inclusion criteria: Inclusion: Being a woman and having an HIV-positive partner, people of reproductive age 18 to 49 years, having lived with their current partner for at least 6 months, being sexually active, not suffering from psychiatric illnesses or cognitive disorders, not using psychotropic or narcotic drugs. Exclusion criteria: Women becoming infected with HIV during the study, not attending more than three sessions of the intervention program, changing marital status during the study.

The intervention group will receive 6 health promotion counseling sessions on sexual health, twice a week for 90 minutes. The control group will not receive any intervention other than usual care until the end of the study.

Sexual health score and marital satisfaction score

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.

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.

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

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.

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.

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.

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

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.