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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT04778527
Eligibility Criteria:
Inclusion Criteria:
1. Age 16 through 40 years old (inclusive) at Screening, verified per site-specific SOPs.
2. Able and willing to provide informed consent per site SOPs. (If under the legal age of consent \[18 years old\] be able to provide informed assent and obtain parental or guardian consent, to be screened for and to enroll in the study.)
3. Fluent in spoken Zulu and/or English.
4. Able and willing to provide adequate locator information, as defined in site SOPs.
5. Able and willing to comply with all study procedures, including being comfortable taking the study products as evident by nurse/clinician-observed swallowing at Screening of a large Vitamin capsule that is of similar size to the study products.
6. Post-menarche, per participant report at Screening.
7. Sexually active, defined as having had penile-vaginal sex with a male within the 3 months before Screening (per self-report).
8. At moderate to high risk of HIV infection based on clinician assessment.
9. Considers herself to be at moderate to high risk of HIV acquisition based on self-assessment.
10. Has been using COCs for contraception for at least 3 months prior to Screening as confirmed by contraceptive card and intends to continue using COCs for at least 12 months.
11. HIV-negative per rapid test at Screening and Enrolment per site-specific SOP.
12. Negative pregnancy test at Screening and Enrolment.
13. Negative for chlamydia, gonorrhea, trichomoniasis, and syphilis at Screening; women who test positive at Screening may be treated and enrolled.
14. Hepatitis B surface antigen (HBsAG) negative per blood test at Screening.
15. Normal estimated creatinine clearance (eCrCl) ≥ 60 ml/min per blood test at Screening.
Exclusion Criteria:
1. Intends to become pregnant within the next 12 months.
2. Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past.
3. Use of PEP within 3 months of Screening (per self-report).
4. Breastfeeding \< 6 months postpartum (per self-report).
5. Less than 6 weeks (≤42 days) postpartum and not breastfeeding (per self-report).
6. For women 35 and older, currently smokes cigarettes (self-report).
7. History of deep vein thrombosis / pulmonary embolism (self-report) or history of thrombophlebitis or thromboembolic disorders at Screening (per self-report or medical records).
8. Prolonged immobilization (self-report).
9. Known thrombogenic mutation/complicated valvular disease (per self-report).
10. Ischemic heart disease (per self-report).
11. Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies (per self-report).
12. Migraines with aura
13. For women over 35 years old, migraines without aura (per self-report).
14. Current breast cancer or within 5 years of past breast cancer (per self-report) or history of carcinoma of the breast or other estrogen-dependent neoplasia reported at Screening.
15. Diabetes with nephropathy, retinopathy, or neuropathy (per self-report).
16. Diabetes for \> 20 years (per self-report).
17. Symptomatic gall bladder disease (per self-report).
18. Severe cirrhosis (per self-report).
19. Liver tumor (per self-report).
20. Any other condition the clinician feels would jeopardize the health and wellbeing of the participant.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT04778527
Study Brief:
Protocol Section:
NCT04778527