Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02474303
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : April 12, 2018
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
University of Washington
Westat
Information provided by (Responsible Party):
Souleymane Mboup, Réseau Africain de Recherche sur le SIDA

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Drug: Truvada Not Applicable

Detailed Description:

STUDY DESIGN This is a two-phase study, consisting of the following:

PHASE I - The feasibility evaluation for this study will take several forms.

  • Observations - Field-based assessment of service delivery at each of the five sites;
  • In-depth interviews - With policymakers, program managers, and service providers, as well as other community members and leaders; and
  • Focus groups with registered and unregistered female sex workers (FSW). PHASE II - This will be a prospective demonstration study of oral pre-exposure prophylaxis (PrEP) with Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) for FSW with 12 months of follow up and a 3-month accrual period. A total of 267 FSW will be enrolled.

OBJECTIVES

Primary Objectives:

  • Build a sustainable HIV PrEP program for FSW in Dakar, Senegal.
  • Demonstrate the feasibility of providing daily oral PrEP with FTC/TDF for 12 months to FSW at Ministry of Health (MoH)-run clinics in Pikine, Mbao, Rufisque and Diamniadio Health Centers) in Dakar.

POPULATION & SAMPLE SIZE

PHASE I:

  • 10 Key Informants: Policymakers, program managers, and service providers, as well as other community members and leaders.
  • Focus Group Participants: 8 Registered and 8 Unregistered HIV-negative FSW age 18 or older.

PHASE II:

• 267 HIV-negative FSW age 18 or older recruited from four public health centers in Dakar: Pikine, Mbao, Rufisque and Diamniadio Health Centers.

PROTOCOL EVALUATIONS

  • PHASE I: Qualitative data from observations, key informant interviews, and focus groups will be collected, analyzed and used to inform the implementation of Phase II.
  • PHASE II: Quantitative data will be collected using behavioral measures and clinical and laboratory evaluations. Data from electronic monitoring will also be collected.

STUDY DURATION 24 months

REGIMEN Daily oral PrEP with FTC/TDF for 12 months

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Demonstration Project of HIV Pre-exposure Prophylaxis (PrEP) With Tenofovir DF/Emtricitabine (TDF/FTC Among Female Sex Workers in Dakar, Senegal
Actual Study Start Date : July 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Arm Intervention/treatment
HIV Pre-exposure Prophylaxis (PrEP)
Truvada
Drug: Truvada
Demonstration Study




Primary Outcome Measures :
  1. The number/proportion of FSWs who remain in the program [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • 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)

Exclusion Criteria:

  • • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474303


Locations
Layout table for location information
Senegal
Centre de santé de Mbao
Dakar, Senegal
Centre de Santé de Rufisque
Dakar, Senegal
Centre de Santé Dominique de Pikine
Dakar, Senegal
centre hospitalier de Diamniadio
Dakar, Senegal
Sponsors and Collaborators
Réseau Africain de Recherche sur le SIDA
Bill and Melinda Gates Foundation
University of Washington
Westat
Investigators
Layout table for investigator information
Principal Investigator: Souleymane Mboup, Ph.D. RARS
Principal Investigator: Geoffrey S Gottlieb, M.D University of Washington
Principal Investigator: Moussa Sarr, M.D., MPH Westat
Layout table for additonal information
Responsible Party: Souleymane Mboup, Director, RARS, Réseau Africain de Recherche sur le SIDA
ClinicalTrials.gov Identifier: NCT02474303    
Other Study ID Numbers: OPP1084414
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Keywords provided by Souleymane Mboup, Réseau Africain de Recherche sur le SIDA:
Truvada
EMTRICITABINE/TENOFOVIR DISPROXIL FUMARATE
HIV PREEXPOSURE PROPHYLAXIS (PrEP)
Female Sex Workers
Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents