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 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT01772992
Eligibility Criteria:
b. Inclusion Criteria i. Male sex at birth ii. Male gender iii. 18 or older iv. Living in Atlanta, Chicago, or Boston for at least three months v. Has a main Male Sexual Partner of relationship duration one month or longer vi. In a known or assumed serodiscordant relationship, that is, where one member of the couple is HIV-positive and one is either known to be or believed to be HIV-negative or of unknown HIV status vii. If HIV-positive, reporting of one or more of the following forms of suboptimal HIV medication adherence:
1. Never having seen a prescribing provider for HIV care
2. Not having a viral load test performed in the past six months, or not knowing if a viral load test has been performed in the past six months
3. Never having been prescribed anti-HIV medications
4. Never having begun taking anti-HIV medications
5. Adherence to 90% or less of anti-HIV medications in the past week viii. No recent (one-year) severe intimate partner violence reported within the couple (note: mutually agreed-upon BDSM practices are excluded and not analogous with experiences of IPV)
(1) In the past six months, has he: i. Punched, hit or slapped you? ii. Kicked you? iii. Pushed or shoved you? iv. Used force or threats of force to make you do something sexual that you didn't want to do? v. Raped you? ix. No coercion to test for HIV reported within the couple x. Willingness to be tested for HIV with one's male sexual partner xi. Willingness to be randomized to either study arm xii. Participant reports feeling safe in his relationship
c. Exclusion Criteria i. Sex at birth other than male ii. Gender other than male iii. Either partner aged 17 or younger iv. Either partner living outside the Atlanta, Chicago, or Boston areas, or having moved to these areas within the past three months v. Does not have a main male sex partner or has a main male sex partner of relationship duration less than one month vi. Both partners have known or assumed negative HIV status vii. Both partners have known or assumed positive HIV status viii. Either partner reports experiencing or perpetrating severe physical or sexual intimate partner violence within the couple within the past year (see above, note that consensual BDSM practices are not classified as IPV) ix. Either partner reports feeling unsafe in his relationship x. Either partner reports feeling coerced or pressured into testing for HIV xi. Either partner reports feeling coerced or pressured into joining the research study xii. Unwillingness to test for HIV together with one's sexual partner xiii. Unwillingness to be randomized
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01772992
Study Brief:
Protocol Section:
NCT01772992