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UAB Launches Clinical Trial for On-Demand PrEP Rectal Douche

• The University of Alabama at Birmingham (UAB) is conducting a clinical trial to evaluate a novel on-demand PrEP rectal douche. • The trial seeks healthy, adult males who engage in receptive anal intercourse and regularly douche, but have not used oral or injectable PrEP for 8 weeks. • Participants will undergo medical evaluations, provide samples, and receive PrEP products, with compensation provided for their time and effort. • This research aims to develop an alternative PrEP method, potentially improving adherence and accessibility for at-risk populations.

The Alabama Vaccine Research Clinic (AVRC) at UAB is now enrolling participants in a clinical trial focused on developing an on-demand pre-exposure prophylaxis (PrEP) in the form of a rectal douche. This study aims to provide an alternative prevention method for individuals at risk of HIV infection, potentially improving adherence and expanding access to PrEP.

Trial Design and Eligibility

The clinical trial is actively recruiting participants who meet specific criteria: individuals assigned male at birth, aged 18 years or older, and in generally good health. A key requirement is a history of receptive anal intercourse (RAI) and regular douching before intercourse. Exclusion criteria include living with HIV or having used oral or injectable PrEP within the 8 weeks prior to screening.

Study Procedures and Compensation

Enrolled participants will undergo several procedures, including the collection of medical and sexual history, blood and urine sample testing, and a physical examination. Participants will also receive PrEP products in both oral pill and douche forms. Compensation will be provided to participants in recognition of their time and effort.

Potential Impact

This clinical trial represents a significant step towards diversifying PrEP options and addressing the needs of individuals who may prefer or benefit from an on-demand, topical formulation. The development of a rectal douche PrEP could offer a discreet and convenient alternative to daily oral PrEP, potentially increasing uptake and effectiveness in preventing HIV transmission among high-risk populations.
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Reference News

[1]
Are you over 18, generally healthy, and assigned male at birth? - The Reporter | UAB
uab.edu · Dec 17, 2024

Alabama Vaccine Research Clinic at UAB seeks participants assigned male at birth, 18+, no HIV, had RAI, and regularly do...

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