HIV Prevention Study for Cisgender Women
Researchers at the University of Pennsylvania are conducting a study in healthy women to learn more about preventing HIV with investigational medication.
Fast Facts
Cisgender Women Ages 18+
Have been sexually active with a man (condomless) in the last 12 months
Do not have HIV
Compensation Provided
Conducted in Philadelphia
Study Background
Researchers at the University of Pennsylvania are investigating an experimental drug to prevent HIV.
This study is focused on finding answers to important questions about preventing HIV in cisgender women in the United States. Women have long been underrepresented in HIV prevention research, and this study aims to change that. This study focuses on lenacapavir (LEN), an investigational long-acting injectable PrEP option given every six months. The research is exploring whether cisgender women prefer getting injections of LEN or taking pills of F/TDF. By addressing these questions, this research aims to explore HIV prevention options that address the needs of women in the U.S.
Study Background
Researchers at the University of Pennsylvania are investigating an experimental drug to prevent HIV.
This study is focused on finding answers to important questions about preventing HIV in cisgender women in the United States. Women have long been underrepresented in HIV prevention research, and this study aims to change that. This study focuses on lenacapavir (LEN), an investigational long-acting injectable PrEP option given every six months. Researchers are studying how LEN works in women’s bodies and its safety compared to F/TDF (Truvada). By addressing these questions, this research aims to explore HIV prevention options that address the needs of women in the U.S.
Additional Information
This study wants to advance HIV prevention research for women in the US by checking how an investigational drug (Lenacapavir) works in their bodies, evaluating its safety, and finding out if they prefer taking Lenacapavir by injection or F/TDF (Truvada).
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Ages 18+
- Woman (assigned female at birth)
- Have been sexually active with a man (condomless) in the last 12 months
- Do not have HIV
- Not pregnant or breastfeeding
- Have not used long-acting PrEP in the past
If you participate in this study, you will participate in 13 various study visits across a 2.5 year span. Details of these visits are outlined below:
Screening Visit: Before starting the study, you’ll have a screening visit to check if you’re eligible. This visit isn’t counted in the 13 study visits.
First Phase (Randomized Phase): You will be randomly assigned to receive either injectable Lenacapavir or F/TDF (Truvada) for one year. You’ll visit the clinic at least 6 times during this phase, which lasts about a year. At each visit, you’ll provide updated medical history, get HIV risk-reduction counseling, have a brief physical exam, measure vital signs, and give blood and/or urine samples. If you’re in the LEN group, you may also receive phone calls after each injection visit.
Second Phase: After the Randomized Phase, you’ll have a choice of moving into:
- the Pharmacokinetic Tail Phase which will last about 1.5 years and consist of 7 visits,
OR - The Lenacapavir Open-label Extension Phase, which lasts until the study ends or injectable Lenacapavir is available, and consists of visits on Day 1, Week 4, Week 13, and every 13 weeks thereafter.
Conclusion of Study: When the study ends, you’ll be referred to local HIV prevention services for continued care and support. Throughout the entire study period, you’ll have a total of at least 13 clinic visits and regular check-ins with the study team to evaluate your safety and well-being.
You will receive compensation for your time and travel.
There is no cost for you to participate in our research study.