HIV Prevention Study for Women
Researchers at the University of North Carolina at Chapel Hill are seeking healthy female volunteers for a HIV prevention study (HPTN 102/PURPOSE 3).
Fast Facts
Healthy Females
Ages 18+
Compensation Provided
Conducted in Chapel Hill, NC
Study Background
Study Background
Everyone deserves to be able to protect themselves from HIV.
When it comes to HIV prevention, many cisgender women have not considered HIV PrEP (pre-exposure prophylaxis) as an option for themselves. Despite a decline in HIV incidence in women in the United States, approximately 18% of new HIV diagnoses in the US in 2021 were among women. We want to find more options for women to protect themselves against HIV. HPTN 102/PURPOSE 3 will help to understand if an investigational PrEP medicine, lenacapavir, can be used by cisgender women in the US to help prevent acquiring HIV through sex.
HPTN 102/PURPOSE 3 was designed to support cisgender women in the US in HIV prevention.
Additional Information
This clinical study is being conducted to evaluate the safety and efficacy of an investigational medicine, Lenacapavir, to reduce the chance of getting HIV through sex—also known as pre-exposure prophylaxis (PrEP).
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- Ages 18+
- Cisgender Woman (born female at birth)
- Report at least 1 episode of condomless vaginal or anal sex with a cisgender man in the 12 months before enrollment.
- Self-report one or more of the following in the past 12 months (except for incarceration, which could have occurred in the past 5 years):
- Non-injection recreational drug use (ecstasy, cocaine, crack cocaine, methamphetamine, ketamine, 3,4-methylenedioxy-methamphetamine, or prescription drugs apart from those
prescribed by a licensed provider)
- Alcohol dependence (defined as Cut Down, Annoyed, Guilty, and Eye Opener score of 2 ;binge-drinking, defined as 4 or more drinks at a time)
- History of STIs, such as gonorrhea, chlamydia, or syphilis
- Exchange of sex for commodities, such as drugs, money, or shelter
- Incarceration (jail or prison > 24 hours within the past 5 years)
- Two or more sexual partners who were assigned male at birth
during the course of his sexual relationship with the participant, or incarceration (jail or prison > 24 hours within the past 5 years)
- Non-injection recreational drug use (ecstasy, cocaine, crack cocaine, methamphetamine, ketamine, 3,4-methylenedioxy-methamphetamine, or prescription drugs apart from those
- Not living with HIV
This study will last about 2.5 years.
Participants will have three visits (screening, entry, and week 4) about 4 weeks apart, followed by visits every 13 weeks for the rest of the study.
During the Randomized Phase, participants will be randomly assigned to receive either LEN or F/TDF for 52 weeks, followed by up to 78 weeks of F/TDF for both groups. Participants in the LEN group will switch to F/TDF for the rest of the study. Study visits will include consent, vital signs, questionnaires, physical exams, blood draws, and receiving/dispensing study medication.
As a participant, you can receive up to $50 per visit for your time and travel.
There is no cost for you to participate in our research study.