This study aims to understand the safety, drug levels, and HIV-blocking activity of a long-acting HIV prevention shot, and to compare these results between people who use estrogen-based hormones and those who do not.

You may be eligible for this study if you meet the following criteria.

Inclusion Criteria:

• Willing to provide small tissue samples (biopsies) and swabs as part of the study procedures
• Not using PrEP
• HIV negative
• If using hormones, must be on a stable regimen for ≥6 months and remain on that regimen throughout study conduct, and must be prescribed and managed under the care of a healthcare professional
• Willing to abstain from antiretroviral agents (including PrEP agents, F/TAF and F/TDF) during the duration of the study
• No History of previous long-acting antiretroviral use, including CAB-LA and long-acting lenacapavir
• No tattoo or other dermatological condition which may interfere with product administration or interpretation of injection site reactions
• Not pregnant or breastfeeding
• Willing to undergo rectal and/or cervical biopsy and swabs collection
• Ages 19+

If eligible after a screening visit, you will complete 11 total in-person study visits over at least 14 weeks. These visits may include:

• Blood collection (via single needlestick, peripheral IV, or finger-prick)

• Rectal and/or vaginal swabs

• Rectal and/or cervical biopsies (at several visits)

• A single intramuscular injection of cabotegravir (Apretude) shortly after enrollment
  You will also be asked to maintain a diary of medications you take throughout the study.

Participants are compensated at each visit. Women participants may receive up to $4,000, and other participants may receive up to $3,000 for completing the study.
Participants may also receive parking passes, Lyft transportation (when appropriate), and meal cards on long blood-draw or biopsy days.

There is no cost for you to participate in our research study.