An observational study in HIV Infections, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. Recruiting at 4 sites in 4 countries. Open to participants aged 14 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine · Observational
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.
Prospective observational cohort study of participants vulnerable to HIV, conducted in two 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. 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, then 12 weeks later, and lastly 24 weeks later, for a total of 48 weeks.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 200 across 781 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Henry M. Jackson Foundation for the Advancement of Military Medicine is the lead sponsor of 86 studies on the registry; 18 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
The enrolled study population in step 1 will consist of up to 3000 men and women between 14 and 55 years of age who are vulnerable to HIV and other sexually transmitted infections. The incidence of HIV will be evaluated across all study sites as a primary objective; the incidence of STIs and retention in the cohort will be evaluated as key secondary objectives. During the accrual period, additional volunteers may be screened to replace participants lost to follow-up or withdrawn from the study, but no additional participants will be screened once the accrual period has expired.
Step 1 Inclusion Criteria: Female or male aged 14-55 years; Documented negative test according to site-specific HIV testing procedures at entry/screening; Able and willing to provide ; 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:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Novel interventions to achieve HIV remission
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.
Behavioral: Novel interventions to achieve HIV remission
To establish a group of well-characterized people living with HIV who initiated ART during acute or early HIV transmission that can serve as a source population for future studies, including those designed to test novel interventions to achieve HIV remission.
Establish HIV Incidence at All Sites
For the analysis of the incidence rate, only individuals who are not living with HIV at the baseline exam will be included in the incidence rate analysis. People without HIV will contribute person-time beginning with the time they enter the study until the study concludes or they are either censored or an HIV transmission event occurs. The event time for each subject is set to the minimum of the HIV transmission event time or the censoring time caused by one of the following: a drop-out event, a death event, or study end event. If one of these censoring events occurs, the censoring time is set to the last time there is recorded data for the subject. If an individual tests positive for HIV during the study, the HIV transmission event time is set to the visit during which the HIV transmission occurred. Those individuals who are lost to follow-up after enrollment will be censored at the last visit.
Time frame: 10 Years
Establish Incidence and Prevalence of STIs Including Chlamydia, Gonorrhea, Syphilis, and Mycoplasma genitalium
For incident cases, the date of the positive test will be used as the date of infection. Specifically, for syphilis, a positive test can be determined by one of the following algorithms: 1. In the traditional algorithm, a non-treponemal test (e.g., rapid plasma reagin \[RPR\] or Venereal Disease Research Laboratory test \[VDRL\]) is used as the initial screen and reactive samples are confirmed with a treponemal test (e.g., fluorescent treponemal antibody absorption \[FTA-ABS\], T. pallidum particle agglutination \[TPPA\] test, Treponema pallidum particle agglutination assay \[TPHA\], or Syphilis IgG) or other tests that detect targets specific to T. pallidum. 2. The reverse algorithm uses a treponemal test for screening with reactive samples followed up with a non-treponemal test.
Time frame: 10 Years
Willingness to Participate and Other Calculations
Willingness to participate in an HIV vaccine trial and study retention rates and their respective 95% CIs will be estimated assuming a binomial distribution. Factors associated with willingness to participate in vaccine trial will be evaluated using logistic regression models. Self-reported risk behavior over time will be assessed by frequency tables and bar graphs. Changes in risk behavior over time will be evaluated using a Generalized Estimating Equation (GEE) model with clustering occurring within individuals (ex: multiple observations per person). Knowledge, attitudes, and practices regarding behaviors and preventive measures will be evaluated using descriptive statistics.
Time frame: 10 Years
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Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2021 (actual). Primary completion is estimated for Dec 2029, 97 months after the start.
Of 187 non-industry observational studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 97 months is above that.
Counting every sponsor, half of 201 studies reached it within 38 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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Henry M. Jackson Foundation for the Advancement of Military Medicine