Clinical trial NCT05147519: Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections
Official title: Multinational Observational Cohort of HIV and Other Infections (MOCHI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Keywords: STI
Observational
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 2500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The enrolled study population in step 1 will consist of up to 2500 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 During the accrual period, additional volunteers may be screened to replace participants lost to follow-up or withdrawn from the study, but no additional participants will be screened once the accrual period has expired.

Brief 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.

Detailed description: Prospective 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 criteria: 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

Primary outcomes:
measure: Establish HIV Incidence at All Sites
timeFrame: 10 Years
Secondary outcomes:
measure: Establish Incidence and Prevalence of STIs Including Chlamydia, Gonorrhea, Syphilis, and Mycoplasma genitalium
timeFrame: 10 Years
measure: Willingness to Participate and Other Calculations
timeFrame: 10 Years
Other outcomes:
Locations:
city: Kericho
country: Kenya
facility: Kenya Medical Research Institute/ USAMRD-A/Kenya (Kericho)
city: Manila
country: Philippines
facility: Institute of Clinical Epidemiology, National Institutes of Health, University of the Philippines Manila
city: Makerere
country: Uganda
facility: Makerere University Walter Reed Program
state: Kampala
Study officials:
affiliation: US Military HIV Research Program
name: Trevor A. Crowell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: