Observational cohort study of HIV and other infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 in the 24 weeks prior to screening
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 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

Where it's running

• Clinical Research Centre, Walter Reed Army Institute of Research -Africa/Nigeria (WRAIR-A/Nigeria)
  Abuja, Nigeria Recruiting
• Institute of Clinical Epidemiology, National Institutes of Health, University of the Philippines Manila
  Manila, Philippines Recruiting
• Kenya Medical Research Institute/ USAMRD-A/Kenya (Kericho)
  Kericho, Kericho County, Kenya Completed
• 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
• Email: tcrowell@hivresearch.org
• Phone: 301-500-3990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.