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:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT02702895
Eligibility Criteria:
Inclusion Criteria (Phase 1 - Former ASPIRE participants):
1. Participated in the ASPIRE protocol, randomized to active product and informed of their randomization assignment.
2. Able and willing to provide written informed consent in one of the study languages.
3. Able and willing to complete the required study procedures.
4. For participants who did not acquire an HIV infection while taking part in ASPIRE, evidence of study product dispensation at a minimum of three consecutive ASPIRE scheduled clinic visits. For participants who acquired an HIV infection while taking part in ASPIRE, evidence of study product dispensation in the month prior to the participant's acquisition of HIV infection.
5. For participants who did not acquire an HIV infection while taking part in ASPIRE, have a minimum of three ASPIRE PK data measurement points available. For participants who acquired HIV infection while taking part in ASPIRE, have a minimum of one ASPIRE PK data measurement available.
Inclusion Criteria (Phase 2 - HOPE participants):
1. Participated in the HOPE protocol.
2. Able and willing to provide written informed consent in one of the study languages.
3. Able and willing to complete the required study procedures.
4. For participants who did not acquire an HIV infection while taking part in HOPE, evidence of study product dispensation for a minimum of three consecutive months.
5. For participants who acquired an HIV infection while taking part in HOPE, evidence of study product dispensation in the month prior to the participant's acquisition of an HIV infection.
Inclusion Criteria (Phase 2 - Male partners of HOPE participants):
1. Identifies as a male sexual partner of a HOPE participant for whom the HOPE participant has given permission to contact.
2. Was a male sexual partner of a HOPE participant during her participation in HOPE (regardless of whether she used the ring or not).
3. Able and willing to provide written informed consent in one of the study languages.
4. Able and willing to complete the required study procedures.
5. Is above the age of 18 at the time of study participation.
Exclusion Criteria (Phase 1 and Phase 2):
1\. Has any significant medical condition or other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02702895
Study Brief:
Protocol Section:
NCT02702895