Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections

NCT05147519 | Recruiting

• 2 other identifiers: RV 583WRAIR # 2877
• Study Type: observational
• Target: 2,500
• Locations: 3 countries
• Sites: 3

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.

Conditions

HIV Infections

Keywords

STI; Observational

Outcome Measures

Primary Outcomes (1)

• 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.

  10 Years

Secondary Outcomes (2)

• Establish Incidence and Prevalence of STIs Including Chlamydia, Gonorrhea, Syphilis, and Mycoplasma genitalium

  10 Years

• Willingness to Participate and Other Calculations

  10 Years

Study Arms (3)

Step 1

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

Step 2

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

Step 3

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.

Behavioral: Novel interventions to achieve HIV remission

Interventions

Novel interventions to achieve HIV remission BEHAVIORAL

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.

Step 1; Step 2; Step 3

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead

Study Sites (3)

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, P.O. Box 16524,, Uganda

COMPLETED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Trevor A. Crowell, MD, PhD

  US Military HIV Research Program

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trevor A. Crowell, MD, PhD

CONTACT

301-500-3990; tcrowell@hivresearch.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 7, 2021
• Study Start: November 5, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2032
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1); UG (1); KE (1)