HIV Prevention Research Study
Researchers at the Johns Hopkins School of Medicine are conducting a study on how a long-acting HIV prevention shot works in the body for people who do and do not take estrogen-based hormones.
Fast Facts
Willing to Provide Small Tissue Samples (Biopsies) & Swabs as Part of The Study Procedures
Not Using PrEP & HIV Negative
Compensation
Provided Up To $4000
Conducted in
Baltimore, MD
Study Background
This study explores how cabotegravir (Apretude), a long-acting HIV prevention injection, behaves in the body and how safe it is for different groups of people.
HIV prevention continues to advance, and long-acting injectable medications are emerging as a more convenient and potentially more effective alternative to daily oral pills. One such medication is CAB-LA (cabotegravir long-acting, brand name Apretude), an FDA-approved injectable for HIV pre-exposure prophylaxis (PrEP) that is administered once every two months. CAB-LA works by blocking HIV from establishing infection in the body and has been shown in clinical trials to be highly effective at preventing HIV infection. Unlike daily pills, CAB-LA provides protection over an extended period with fewer dosing requirements, which may help reduce missed doses and improve adherence.
The CHIPP-PrEP Study (Cabotegravir-Hormone Interrogation of Pharmacokinetics/Pharmacodynamics for HIV Prevention) is designed to study how CAB-LA travels and works in blood and tissues, how the body processes the medication, and how it maintains its effectiveness over time. Participants will take part in a series of in-person visits, which may include safety assessments, blood draws, rectal and/or vaginal swabs, and rectal and/or cervical tissue biopsies.
By participating, individuals help researchers gain important knowledge that will improve HIV prevention strategies for people of all genders, ensuring that long-acting PrEP options like CAB-LA are safe, effective, and accessible.
Study Background
This study explores how cabotegravir (Apretude), a long-acting HIV prevention injection, behaves in the body and how safe it is for different groups of people.
HIV prevention continues to advance, and long-acting injectable medications are emerging as a more convenient and potentially more effective alternative to daily oral pills. One such medication is CAB-LA (cabotegravir long-acting, brand name Apretude), an FDA-approved injectable for HIV pre-exposure prophylaxis (PrEP) that is administered once every two months. CAB-LA works by blocking HIV from establishing infection in the body and has been shown in clinical trials to be highly effective at preventing HIV infection. Unlike daily pills, CAB-LA provides protection over an extended period with fewer dosing requirements, which may help reduce missed doses and improve adherence.
The CHIPP-PrEP Study (Cabotegravir-Hormone Interrogation of Pharmacokinetics/Pharmacodynamics for HIV Prevention) is designed to study how CAB-LA travels and works in blood and tissues, how the body processes the medication, and how it maintains its effectiveness over time. Participants will take part in a series of in-person visits, which may include safety assessments, blood draws, rectal and/or vaginal swabs, and rectal and/or cervical tissue biopsies.
By participating, individuals help researchers gain important knowledge that will improve HIV prevention strategies for people of all genders, ensuring that long-acting PrEP options like CAB-LA are safe, effective, and accessible.
Additional Information
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.
Principal Investigator: Mark Marzinke, PhD
Application No.: IRB00494387