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SCOPE: Strategies to Combine PrEP With Prevention Efforts

NCT01832571 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-07-15

No results posted yet for this study

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

Interventions

DRUG

Once daily Truvada®

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.

Sponsors & Collaborators

  • Family Health Options Kenya

    collaborator UNKNOWN

  • Gilead Sciences

    collaborator INDUSTRY

  • Institute of Tropical Medicine

    collaborator OTHER_GOV

  • Sex Workers Outreach Programme

    collaborator UNKNOWN

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • FHI 360

    lead OTHER

Principal Investigators

  • Jennifer Deese, MPH · FHI 360

  • Amy Corneli, Ph.D. · FHI 360

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01832571 on ClinicalTrials.gov