SCOPE: Strategies to Combine PrEP With Prevention Efforts

NCT01832571 | Withdrawn

• 1 other identifier: 391449
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV

Keywords

HIV; PrEP; Female Sex Workers; Kenya

Outcome Measures

Primary Outcomes (2)

• Drug Adherence

  Describe the patterns of adherence to a regimen of daily oral Truvada® among female sex workers currently or newly enrolled in established HIV prevention programs

  11 months

• PrEP Integration

  Assess the feasibility of integrating PrEP into existing HIV prevention programs for female sex workers

  11 months

Secondary Outcomes (9)

• Assess adherence

  11 months

• drug level adherence

  11 months

• risk-taking behavior

  11 months

• factors affecting Adherence

  11 months

• Support of prEP Adherence

  11 months

Study Arms (1)

Once daily Truvada®

EXPERIMENTAL

One tablet of Truvada (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily

Drug: Once daily Truvada®

Interventions

Once daily Truvada® DRUG

At the enrollment visit, participant's eligibility is assessed per protocol and she is provided with a 30 day supply of Truvada and instructed to take one tablet orally once daily with or without food. Each tablet contains 200 mg emtricitabine (FTC) and 300 mg tenofovir disoproxil fumarate (TDF). Participants will receive Truvada at each clinic visit after it is confirmed that she is HIV negative. There will be a 1 month follow-up visit after enrollment. Thereafter, participants will have quarterly visits until April 2014.

Also known as: Truvada®

Once daily Truvada®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• FHI 360: lead
• Family Health Options Kenya: collaborator
• Gilead Sciences: collaborator
• Institute of Tropical Medicine: collaborator
• Sex Workers Outreach Programme: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

Family Health Options Kenya

Eldoret, Kenya

Location

Sex Workers Outreach Programme (SWOP)

Nairobi, Kenya

Location

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Jennifer Deese, MPH

  FHI 360

  PRINCIPAL INVESTIGATOR

• Amy Corneli, Ph.D.

  FHI 360

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 16, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

KE (2)