Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections (MOCHI)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2032
  • participants needed
    2500
  • sponsor
    Henry M. Jackson Foundation for the Advancement of Military Medicine
Updated on 25 March 2022
hiv test
hepatitis
HIV Vaccine
injection drug
herpes
gonorrhea

Summary

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

The study will be a multi-site prospective observational cohort of males and females who are vulnerable to HIV and other STIs. Step 1 of the study is the evaluation of participants without HIV with quarterly follow up visits up to 72 weeks. At each follow up visit, we will administer behavioral questionnaires, HIV testing, STI testing, and other laboratory testing per the schedule of evaluations. Participants will also perform home-based HIV testing between study visits per the schedule of evaluations. Step 2 is the incident HIV acquisition evaluation. Follow-up visits will be conducted every four weeks up to 12 weeks after initial HIV diagnosis and then quarterly up to 48 weeks. Individuals will be monitored for HIV disease outcomes, STIs, and surveys, and other lab collections will be administered per the schedule of evaluations. Participants who are virally-suppressed at the completion of Step 2 will transition to Step 3 for long-term follow-up semi-annually out to week 192. Evaluation will primarily be HIV monitoring, surveys for consideration of trial participation, and specimen storage per the schedule of evaluations.

Details
Condition HIV Infections
Treatment Novel interventions to achieve HIV remission
Clinical Study IdentifierNCT05147519
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female or male aged 15-55 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 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 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

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 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 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note