HIV and AIDS Trial, Recruiting NCT05147519 Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine Condition: HIV and AIDS
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HIV and AIDS Trial, Recruiting

NCT05147519
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Step 1 (Initial enrolment):

  • People aged 14 to 55 years, of any gender
  • People who have tested negative for HIV at the start of the study, following the testing process used at the trial site
  • People who are able and willing to give their informed consent to participate
  • People willing to provide biometric identification (such as fingerprints or a photo)
  • People who can be available for follow-up visits for the full length of the study
  • People who understand English or another language approved for the study, including those who cannot read or write
  • People willing to share their own contact details and those of one person who would know their location during the study
  • People willing to answer questions about HIV risk behaviours and to be tested for HIV and other sexually transmitted infections (STIs)
  • People considered to be at risk of HIV or other STIs based on one or more of the following:
    • A newly diagnosed STI (such as syphilis, gonorrhoea, chlamydia, Mycoplasma genitalium, herpes simplex virus, or acute hepatitis C) in the 24 weeks before screening
    • Regularly exchanging sex for money in the 24 weeks before screening
    • Having condomless vaginal or anal sex with at least three different partners who are living with HIV or whose HIV status is unknown, in the 24 weeks before screening
    • Injecting drugs in the 24 weeks before screening
    • Having anal sex (either giving or receiving) with one or more male or transgender partners in the 24 weeks before screening

Step 2 (Follow-on phase, for people newly diagnosed with HIV during Step 1):

  • People who received a new HIV diagnosis within the last 90 days during Step 1, confirmed by the trial site's testing process
  • People who are able and willing to continue follow-up visits for the rest of the study

Who may not be able to join:

Step 1:

  • People with a significant medical, psychological, psychiatric, or social condition that the study doctor believes could interfere with participation
  • People with current or ongoing drug or alcohol use or dependence that the study doctor believes would make it difficult to follow study requirements
  • People who have previously taken part in a preventive or therapeutic HIV vaccine study, unless they are confirmed to have received a placebo (inactive) injection in that study
  • People who are pregnant, or who could be pregnant, based on a positive pregnancy test at screening — this also applies to people who have not had a menstrual period for fewer than 12 consecutive months

Step 2:

  • People with a significant medical, psychological, psychiatric, or social condition that the study doctor believes could interfere with participation
  • People with current or ongoing drug or alcohol use or dependence that the study doctor believes would make it difficult to follow study requirements

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 7 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Trevor A. Crowell, MD, PhD, US Military HIV Research Program

Phone: 301-500-3990

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Registry
ClinicalTrials.gov
Start date
5 November 2021
Est. completion
30 December 2029

Where this trial is recruiting

Kenya Nigeria 🇵🇭 Philippines Uganda

Primary endpoints

Establish HIV Incidence at All Sites

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov