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 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT05708261
Eligibility Criteria:
INCLUSION CRITERIA:
Aim 1 MSM
1. 18 years of age or older
2. MSM by self-report
3. HIV-positive status confirmed by HIV self-test
4. Sub-optimal ART adherence confirmed by Visual Analog Scale
5. Live in Eastern Cape confirmed by map exercise
6. Mentally competent to provide voluntary informed consent
7. Prescribed ART
8. Own a smartphone for personal use
9. Comfortable talking about living with HIV and relationships in group settings
10. In a relationship with a man (defined as a boyfriend, partner, husband, lover) with whom they are emotionally and romantically connected to all others.
11. Have not disclosed HIV-positive status to partner
12. Partner status is unknown or HIV-negative
Health Professional and Technical Experts
1. Provide clinical care (medical or nursing) to MSM in Eastern Cape, South Africa (Health Professionals only)
2. Experience developing mobile technologies for HIV prevention and treatment in Eastern Cape, South Africa (Technical Experts only)
3. Live in Eastern Cape, South Africa
4. Mentally competent to provide voluntary informed consent
Community Advisory Board
1. Identifies as MSM
2. In a relationship with a man
3. Participates in HIV-related activities focused on MSM
4. 18-25 years of age (N=4) or 26 years of age and older (N=4)
5. Lives in Eastern Cape
Aim 2 MSM (only)
1. 18 years of age or older
2. MSM by self-report
3. HIV-positive status confirmed by HIV self-test
4. Sub-optimal ART adherence confirmed by Visual Analog Scale
5. Live in Eastern Cape confirmed by map exercise
6. Mentally competent to provide voluntary informed consent
7. Prescribed ART
8. Own a smartphone for personal use
9. Comfortable talking about living with HIV and relationships in group settings
10. In a relationship with a man (defined as a boyfriend, partner, husband, lover) with whom they are emotionally and romantically connected to all others and the relationship is more than 1 month old.
11. Have not disclosed HIV-positive status to partner
12. Partner HIV-status is unknown or HIV-negative
EXCLUSION CRITERIA:
Aim 1 MSM
1. Under 18 years of age
2. Is not MSM by self-report
3. Is not HIV-positive as confirmed by HIV self-test
4. Does not have sub-optimal ART adherence confirmed by Visual Analog Scale
5. Does not live in Eastern Cape confirmed by map exercise
6. Is not mentally competent to provide voluntary informed consent
7. Not prescribed ART
8. Does not own a smartphone for personal use
9. Is not comfortable talking about living with HIV and relationships in group settings
10. Not in a relationship with a man (defined as a boyfriend, partner, husband, lover) with whom they are emotionally and romantically connected to all others or in this defined relationship for less than a month.
11. Has disclosed their HIV-positive status to partner
12. Partner is HIV-positive
Health Professional and Technical Experts
1. Does not provide clinical care (medical or nursing) to MSM in Eastern Cape, South Africa (Health Professionals only)
2. No experience developing mobile technologies for HIV prevention and treatment in South Africa (Technical Experts only)
3. Does not live in Eastern Cape, South Africa
4. Not mentally competent to provide voluntary informed consent
Community Advisory Board
1. Does not identify as MSM
2. Is not in a relationship with a man
3. Does not participate in HIV-related activities focused on MSM
4. Is not 18-25 years of age (N=4) or 26 years of age and older (N=4)
5. Does not live in Eastern Cape
Aim 2 MSM (only)
1. Under 18 years of age
2. Is not MSM by self-report
3. Is not HIV-positive as confirmed by HIV self-test
4. Does not have sub-optimal ART adherence confirmed by Visual Analog Scale
5. Does not live in Eastern Cape confirmed by map exercise
6. Is not mentally competent to provide voluntary informed consent
7. Not prescribed ART
8. Does not own a smartphone for personal use
9. Is not comfortable talking about living with HIV and relationships in group settings
10. Not in a relationship with a man (defined as a boyfriend, partner, husband, lover) with whom they are emotionally and romantically connected to all others, or in this defined relationship for less than a month.
11. Has disclosed their HIV-positive status to partner
12. Partner is HIV-positive
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05708261
Study Brief:
Protocol Section:
NCT05708261