Observational cohort study of HIV and other infections

Multinational Observational Cohort of HIV and Other Infections (MOCHI)

This study is looking to see how many new HIV infections happen among people aged 14-55 who are at risk, while also checking for other STIs and helping those diagnosed with HIV get the right treatment.

Quick facts

• Study type: Observational
• Enrollment: 2500 (estimated)
• Ages: 14 Years to 55 Years
• Sex: All
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine (Academic / other)
• Locations: 3 sites (Kericho and 2 other locations)
• Trial ID: NCT05147519 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather data on the incidence of new HIV infections among individuals at risk across multiple international sites. Participants aged 14-55 who are vulnerable to HIV will be enrolled and evaluated every 12 weeks for HIV and other sexually transmitted infections (STIs). Those diagnosed with HIV will undergo further assessments to monitor viral load and treatment efficacy, with a focus on maintaining viral suppression. The study also aims to facilitate future recruitment into interventional studies targeting HIV remission.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 14-55 who are at risk of contracting HIV and willing to participate in regular testing and follow-up.

Not a fit: Patients who are not at risk for HIV or those who are already diagnosed with HIV and not willing to engage in the study's follow-up may not benefit.

Why it matters

Potential benefit: If successful, this study could enhance understanding of HIV transmission dynamics and improve strategies for prevention and treatment.

How similar studies have performed: Other observational studies have shown success in understanding HIV transmission, making this approach both relevant and potentially impactful.

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

Where this trial is running

Kericho and 2 other locations

• Kenya Medical Research Institute/ USAMRD-A/Kenya (Kericho) — Kericho, Kenya (Completed)
• Institute of Clinical Epidemiology, National Institutes of Health, University of the Philippines Manila — Manila, Philippines (Recruiting)
• Makerere University Walter Reed Program — Makerere, Kampala, Uganda (Completed)

Study contacts

• Principal investigator: Trevor A. Crowell, MD, PhD — US Military HIV Research Program
• Study coordinator: Trevor A. Crowell, MD, PhD

Conditions HIV Infections; STI; Observational