Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections
- Conditions
- HIV Infections
- Interventions
- Behavioral: Novel interventions to achieve HIV remission
- Registration Number
- NCT05147519
- Lead Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Step 2 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. Step 1 Novel interventions to achieve HIV remission 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). Step 3 Novel interventions to achieve HIV remission 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.
- Primary Outcome Measures
Name Time Method Establish HIV Incidence at All Sites 10 Years 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.
- Secondary Outcome Measures
Name Time Method Willingness to Participate and Other Calculations 10 Years 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.
Establish Incidence and Prevalence of STIs Including Chlamydia, Gonorrhea, Syphilis, and Mycoplasma genitalium 10 Years 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.
Trial Locations
- Locations (3)
Kenya Medical Research Institute/ USAMRD-A/Kenya (Kericho)
🇰🇪Kericho, Kenya
Makerere University Walter Reed Program
🇺🇬Makerere, Kampala, Uganda
Institute of Clinical Epidemiology, National Institutes of Health, University of the Philippines Manila
🇵ðŸ‡Manila, Philippines