SCOPE: Strategies to Combine PrEP With Prevention Efforts

• Status: Withdrawn
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This pilot, open-label, prospective study will determine the feasibility of integrating pre-exposure prophylaxis (PrEP) into existing HIV prevention programs for female sex workers and if women who are enrolled in those programs will adhere to the daily PrEP regimen of Truvada®. This study will enroll 500 HIV antibody negative female sex workers in Eldoret and Nairobi, Kenya.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FHI 360
• Collaborators: Family Health Options Kenya; Gilead Sciences; Institute of Tropical Medicine; Sex Workers Outreach Programme; University of North Carolina, Chapel Hill
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• At least 18 years of age

• Willing and able (i.e., successfully complete an open-ended comprehension assessment on key topics related to the study) to give written informed consent

• Expresses willingness at screening and enrollment to take PrEP daily

• Willing to provide contact information and be contacted by staff between visits (per participant-approved methods)

• Is sexually active, defined as having had at least one vaginal sex act in the last four weeks, and reports receiving money or goods in exchange for sex in the last 6 months as part of her source of income/livelihood

• Is HIV antibody negative on rapid test algorithm at the enrollment visit

• Does not have symptoms suggestive of acute HIV infection at the enrollment visit (i.e., fever (temperature above 38ºC), fatigue, sweating, night sweats, pain, rash, pharyngitis, headache, muscle and joint pain, adenopathy (cervical and inguinal), vomiting, diarrhea and coughing) combined with self-reported possibility of recent HIV exposure leading to clinical suspicion of acute HIV infection

• Has a negative urine pregnancy test at screening and enrollment

• Is not currently trying to become pregnant

• Is not breastfeeding

• Has a creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula) at screening

• Is Hepatitis B virus antigen (HBV Ag) negative at screening

• Is in general good health and does not have a medical or social condition which may make study participation unsafe or complicate data interpretation in the opinion of the site investigator

• Is not participating in another PrEP program or PrEP research study

• Is not taking HIV post-exposure prophylaxis at enrollment

Exclusion Criteria:

Pregnant HIV antibody positive Using HIV post-exposure prophylaxis at enrollment

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