Actively Recruiting
Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections
Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2025-03-06
2500
Participants Needed
3
Research Sites
555 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
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:
- 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
- Self-reported vaginal, oral, or anal intercourse in exchange for money as a regular source of income
- 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
- Self- reported injection drug use (IDU) in the 24 weeks prior to screening
- 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
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Kenya Medical Research Institute/ USAMRD-A/Kenya (Kericho)
Kericho, Kenya
Completed
2
Institute of Clinical Epidemiology, National Institutes of Health, University of the Philippines Manila
Manila, Philippines
Actively Recruiting
3
Makerere University Walter Reed Program
Makerere, Kampala, Uganda, P.O. Box 16524,
Completed
Research Team
T
Trevor A. Crowell, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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