Demonstration Project of PrEP Among Female Sex Workers in Dakar, Senegal

NCT02474303 | Completed

• 1 other identifier: OPP1084414
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 4

Brief Summary

Recent breakthroughs in antiretroviral (ARV)-based prevention provide new opportunities to rethink HIV prevention and treatment strategies, especially for key populations such as Female Sex Workers (FSWs). Antiretroviral (ARV)-based prevention of HIV transmission has the potential to have a profound population-level impact on the course of the HIV/AIDS pandemic. Several recently completed randomized controlled trials of HIV Pre-exposure Prophylaxis (PrEP) have shown efficacy at reducing HIV acquisition in high-risk populations. How to translate these trial results into population-level effects is the next critical step. PrEP "demonstration" projects, in collaboration with local stakeholders and at sites of routine care for high-risk populations provide an opportunity to move promising research results into actual public health benefits. With these key features in mind, the investigators propose an HIV PrEP demonstration project in FSW in Dakar, Senegal, West Africa. The objective of the proposed demonstration project with Tenofovir DF/Emtricitabine (TDF/FTC) among Female Sex Workers (FSW) in Dakar Senegal is to build a sustainable HIV PrEP program for FSW in Dakar, Senegal while demonstrating the feasibility of providing daily oral PrEP with Truvada (TDF/FTC) for 12 months to the enrolled FSW at Ministry of Heath run clinics (Pikine, Mbao, Rufisque and Diamniadio Health Centers). Critical milestones for this demonstration project with be feasibility, uptake, acceptability, use of TDF/FTC PrEP and programmatic retention of FSWs in Dakar MoH clinics. The investigators have assembled an expert team from RARS,The University of Washington, and Westat that have had greater than 2 decades of collaboration on HIV related projects in FSWs in Senegal. The investigators expect the results of this project will show that Senegal provides a unique opportunity to assess acceptability, feasibility, uptake and effectiveness of oral HIV PrEP at reducing HIV transmission in a high-risk FSW population.

Conditions

HIV/AIDS

Keywords

Truvada; EMTRICITABINE/TENOFOVIR DISPROXIL FUMARATE; HIV PREEXPOSURE PROPHYLAXIS (PrEP); Female Sex Workers

Outcome Measures

Primary Outcomes (1)

• The number/proportion of FSWs who remain in the program

  12 months

Study Arms (1)

HIV Pre-exposure Prophylaxis (PrEP)

OTHER

Truvada

Drug: Truvada

Interventions

Truvada DRUG

Demonstration Study

HIV Pre-exposure Prophylaxis (PrEP)

Eligibility Criteria

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

You may qualify if:

• Completion of the written informed consent process prior to undergoing any screening evaluations
• ≥ 18 years and older
• Active sex work (Paid sex within the past six months)
• In general good health, confirmed by medical history and physical examination
• Has laboratory evidence of absence of HIV infection, defined as a negative 4th generation HIV ELISA test prior to enrollment
• Serum creatinine less than or equal to the upper limit of normal (ULN) and calculated creatinine clearance of at least 70 mL/minute by Cockcroft-Gault formula
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5 times ULN
• Hemoglobin greater than 8.5 g/dL
• Does not report intention to relocate out of the study area during the course of the study
• If able to become pregnant, self-reported use of an effective method of contraception at enrollment, and intending to use an effective method during the follow-up period
• Without signs or symptoms of acute HIV infection (acute retroviral syndrome)

You may not qualify if:

• HIV-1 and HIV-2 screening tests are reactive
• Is enrolled in any other clinical product trial
• Serious and active medical condition
• Proteinuria 2+ or greater at screening
• Glucosuria 2+ or greater at screening
• Use of disallowed medications (\*See note below)
• Presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent
• Intoxicated or under the influence of alcohol or other drugs at the time of screening
• Pregnant females and females who are breast-feeding
• Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Sponsors & Collaborators

• Réseau Africain de Recherche sur le SIDA: lead
• Bill and Melinda Gates Foundation: collaborator
• University of Washington: collaborator
• Westat: collaborator

Study Sites (4)

Centre de santé de Mbao

Dakar, Senegal

Location

Centre de Santé de Rufisque

Dakar, Senegal

Location

Centre de Santé Dominique de Pikine

Dakar, Senegal

Location

centre hospitalier de Diamniadio

Dakar, Senegal

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

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

• Souleymane Mboup, Ph.D.

  RARS

  PRINCIPAL INVESTIGATOR

• Geoffrey S Gottlieb, M.D

  University of Washington

  PRINCIPAL INVESTIGATOR

• Moussa Sarr, M.D., MPH

  Westat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, RARS

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: June 17, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

SE (4)