FAQs
The SACRED WOMB study aims to understand how daily experiences of stress might influence the risk of progression, regression, or stability of high-grade cervical lesions through potential changes in the vaginal microbiome and cortisol levels.
Eligible participants are women diagnosed with high-grade cervical lesions who are willing to provide daily feedback and biological samples over a specified period.
We expect that you will be in this research study for at least 15 days and until the completion of your follow-up colposcopy visit. During this time, you will complete a 1-hour orientation session and provide daily feedback as well as biological samples.
You will be asked to complete daily surveys about their stress levels and daily experiences. Additionally, you will provide biological samples such as vaginal swabs (only once during your required follow-up visit), saliva (twice a day, upon waking and before bedtime, for 14 days), and urine (only twice).
Your privacy is of utmost importance to us. All data collected will be de-identified and stored securely. Only authorized research personnel will have access to the data.
Yes, you will receive compensation for your time and contribution to the study. Specific details about the compensation will be provided during the enrollment process.
You will receive two daily surveys—one in the morning and one in the evening—over a 14-day study period.
We understand that life can be unpredictable. If you miss a survey or sample collection, please complete it as soon as you can. Consistency is important, but occasional misses will not disqualify you from the study.
You will collect your own samples using kits provided by the study team. Samples will be stored in provided containers and kept at specified temperatures until they can be picked up by the study team.
Yes, participation in the study is entirely voluntary. You can withdraw at any time without any penalty or loss of benefits to which you are otherwise entitled.
The data will be analyzed to study the relationship between stress, vaginal microbiome changes, and cervical lesion outcomes. Findings may be published in scientific journals, but no personal identifying information will be included.
Participants may receive a summary of the study findings. However, individual results will not be provided, as the study is designed to understand population-level trends rather than individual diagnoses.
You can contact the study team via email provided during the enrollment process. We are here to support you and answer any questions you may have.
While there may not be direct benefits to you, your participation will contribute valuable information that can help improve understanding of cervical health and potentially lead to better prevention and treatment strategies.
The study involves minimal risk. There may be some discomfort associated with sample collection, but these procedures are non-invasive. All precautions are taken to ensure your safety and well-being.
The results will be used to advance scientific knowledge about the impact of stress on cervical health, potentially influencing future healthcare practices and policies.
Eligibility criteria will be explained during the screening process. If you meet the criteria, you will be invited to participate.
If you experience any adverse effects, please contact the study team immediately. Your health and safety are our top priority.
Please contact the study team for any technical issues. We will assist you in resolving the problem as quickly as possible.
Yes, if you know someone who might be eligible and interested in participating, please refer them to the study team for screening.
The study is funded by The V Foundation and the National Institutes of Health.
You are expected to complete two surveys each day and collect biological samples as instructed. Your consistent participation is crucial for the study's success.
We welcome your feedback and will provide a platform for you to share your thoughts and suggestions throughout the study.
All personal information is handled in accordance with strict confidentiality protocols. Data will be anonymized and securely stored.
You will not have access to your personal data during the study. However, a summary of the study's overall findings will be shared with participants.
The person in charge of the research study or the sponsor can remove you from the research study without any approval. Possible reasons for removal include nonadherence to the protocol, safety concerns, emotional distress, discovered ineligibility, or administrative request.
If you have questions please contact us.
Our team is available
Monday - Friday
8:00AM - 5:00PM
Sign up for the Sacred Womb Initiative today!