Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT07194902
Eligibility Criteria:
Female Inclusion Criteria:
* woman
* Age ≥18
* ≥30 weeks pregnant per medical record due date
* non-reactive third trimester HIV test (verified from their antenatal care chart)
* reporting at least one unknown-serostatus partner
* fluent in English or isiZulu
* willing to give researchers permission to contact them for repeated assessments
* able to provide informed consent
Male Inclusion Criteria: partners meeting the inclusion criteria as described above, and who complete verification questions to confirm their identity and status as the partners of the enrolled female participants. Additional inclusion criteria for men include:
* man
* Age ≥18
* partner of enrolled women, confirmed via couples verification tool
* fluent in English or isiZulu
* willing to give researchers permission to contact them
* able to provide informed consent.
Exclusion Criteria: Individuals with significant psychiatric illness that could interfere with participation or the ability to provide informed consent will be excluded at the discretion of the study team.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07194902
Study Brief:
Protocol Section:
NCT07194902