Overview
Multinational Observational Cohort of HIV and other Infections (MOCHI). This observational study is to gain information regarding the number of new HIV infections among people who engage in behaviors that make them vulnerable to acquiring HIV across multiple international sites.
Description
ective observational cohort study of participants vulnerable to HIV, conducted in three Steps. Step 1 will enroll participants aged 14-55 years who are vulnerable to contracting HIV. They will be evaluated every 12 weeks for HIV and other sexually transmitted infections (STIs). Participants who are diagnosed with HIV will proceed to Step 2, with evaluation of viral load and other HIV-related tests every four weeks for 12 weeks and then every 12 weeks for a total of 48 weeks. Participants who achieve and maintain viral suppression in Step 2 will proceed to Step 3 for continued HIV monitoring every 24 weeks to document maintenance of viral suppression and maintain engagement with the study site for potential future recruitment into interventional studies, including clinical trials of novel strategies to achieve HIV remission.
Eligibility
Step 1 Inclusion Criteria Female or male aged 14-55 years Documented negative HIV test
according to site-specific HIV testing procedures at entry/screening Able and willing to
provide informed consent Willing to provide biometric identification Available for
follow-up for the planned study duration Understands English or the local language as
approved by the IRB, including people who are illiterate Willing to provide contact
information for themselves and one personal contact who would know their whereabouts during
the study period Willing to provide information regarding HIV risk behaviors and to undergo
testing for HIV and other STIs
Considered to be vulnerable to HIV and other STIs based on any one or more of the following
test results and/or self-reported behaviors:
1. Documented history of newly diagnosed syphilis, gonorrhea, chlamydia, Mycoplasma
genitalium, herpes simplex virus, or acute hepatitis C virus infection in the 24 weeks
prior to screening
2. Self-reported vaginal, oral, or anal intercourse in exchange for money as a regular
source of income
3. Self-reported condomless vaginal or anal intercourse with at least three different
partners living with HIV or of unknown status in the 24 weeks prior to screening
4. Self- reported injection drug use (IDU) in the 24 weeks prior to screening
5. Self-reported insertive or receptive anal or neovaginal intercourse with one or more
different male or transgender partners in the 24 weeks prior to screening Step 1
Exclusion Criteria Any significant condition (medical, psychologic/psychiatric or
social) that, in the judgment of the study investigator, might interfere with the
conduct of the study Active drug or alcohol use or dependence that, in the judgement
of the study investigator, would interfere with adherence to study requirements
Current or past participation in a preventive or therapeutic HIV vaccine study, unless
known placebo recipient Positive β-HCG (human chorionic gonadotropin) pregnancy test
(urine or serum) at screening for people of child-bearing potential and people who are
amenorrheic for less than 12 consecutive months.
Step 2 Inclusion Criteria New diagnosis of HIV in the last 90 days during Step 1 as
determined by site-specific HIV testing procedures Able and willing to continue follow-up
for the planned study duration Step 2 Exclusion Criteria Any significant condition
(medical, psychologic/psychiatric or social) that, in the judgment of the study
investigator, might interfere with the conduct of the study Active drug or alcohol use or
dependence that, in the opinion of the investigator, would interfere with adherence to
study requirements Step 3 Inclusion Criteria Virally-suppressed at the completion of Step 2
Adherent to ART Able and willing to continue follow-up for the planned study duration Step
3 Exclusion Criteria Any significant condition (medical, psychologic/psychiatric or social)
that, in the judgment of the study investigator, might interfere with the conduct of the
study Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with adherence to study requirements