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| ID | Type | Description | Link |
|---|---|---|---|
| WRAIR # 2877 | Other Identifier | WRAIR |
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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.
Prospective observational cohort study of participants vulnerable to HIV, conducted in two 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. 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, then 12 weeks later, and lastly 24 weeks later, for a total of 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Establish Incidence and Prevalence of STIs Including Chlamydia, Gonorrhea, Syphilis, and Mycoplasma genitalium | 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. |
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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:
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
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The enrolled study population in step 1 will consist of up to 3000 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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trevor A. Crowell, MD, PhD | Contact | 301-500-3990 | tcrowell@hivresearch.org |
| Name | Affiliation | Role |
|---|---|---|
| Trevor A. Crowell, MD, PhD | US Military HIV Research Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute/ USAMRD-A/Kenya (Kericho) | Completed | Kericho | Kericho County | Kenya | ||
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| 10 Years |
| Willingness to Participate and Other Calculations | 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. | 10 Years |
| Clinical Research Centre, Walter Reed Army Institute of Research -Africa/Nigeria (WRAIR-A/Nigeria) |
| Recruiting |
| Abuja |
| Nigeria |
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| Institute of Clinical Epidemiology, National Institutes of Health, University of the Philippines Manila | Recruiting | Manila | Philippines |
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| Makerere University Walter Reed Program | Completed | Makerere | Kampala | P.O. Box 16524, | Uganda |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |