HIV/AIDSNCT02474303
Demonstration Project of PrEP Among Female Sex Workers in Dakar, Senegal
A study testing Truvada in people with HIV/AIDS, run by Réseau Africain de Recherche sur le SIDA at 4 sites in Senegal.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Truvada
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 4 sitesSenegal
- Study dates
- Jul 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
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- 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)
Who cannot join
- • 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)
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- 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
Trial locations and contacts
4 sites in 1 country.
Senegal4 sites
Centre de santé de Mbao
Dakar
Centre de Santé de Rufisque
Dakar
Centre de Santé Dominique de Pikine
Dakar
centre hospitalier de Diamniadio
Dakar
About this study
Official title: A Demonstration Project of HIV Pre-exposure Prophylaxis (PrEP) With Tenofovir DF/Emtricitabine (TDF/FTC Among Female Sex Workers in Dakar, Senegal
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.
Read the 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
- Conditions
- HIV/AIDS
- Being tested
- Truvada
- Keywords
- Truvada, EMTRICITABINE/TENOFOVIR DISPROXIL FUMARATE, HIV PREEXPOSURE PROPHYLAXIS (PrEP), Female Sex Workers
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvadaDrug
Demonstration Study
| Study group | Role | What they receive |
|---|---|---|
| HIV Pre-exposure Prophylaxis (PrEP) | Other | Truvada Receives: Drug: Truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number/proportion of FSWs who remain in the program
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Réseau Africain de Recherche sur le SIDA
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Washington, Westat
- Responsible party
- Principal investigator, Souleymane Mboup, Réseau Africain de Recherche sur le SIDA
- Investigators
- Souleymane Mboup, Ph.D., Principal investigator, RARSGeoffrey S Gottlieb, M.D, Principal investigator, University of WashingtonMoussa Sarr, M.D., MPH, Principal investigator, Westat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474303
- Sponsor's protocol ID
- OPP1084414
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2015
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Demonstration Project of HIV Pre-exposure Prophylaxis (PrEP) With Tenofovir DF/Emtricitabine (TDF/FTC Among Female Sex Workers in Dakar, Senegal
- ClinicalTrials.gov ID
- NCT02474303
- Acronym / sponsor ID
- OPP1084414
- Conditions
- HIV/AIDS
- Keywords
- Truvada, EMTRICITABINE/TENOFOVIR DISPROXIL FUMARATE, HIV PREEXPOSURE PROPHYLAXIS (PrEP), Female Sex Workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Réseau Africain de Recherche sur le SIDAUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Washington, Westat
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| HIV Pre-exposure Prophylaxis (PrEP) | Other | Drug: TruvadaTruvada |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • Completion of the written informed consent process prior to undergoing any screening evaluations
Key exclusion criteria (10 listed)
- • HIV-1 and HIV-2 screening tests are reactive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruvadaDemonstration Study | Drug | HIV Pre-exposure Prophylaxis (PrEP) |
Primary outcome
The number/proportion of FSWs who remain in the program
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Souleymane Mboup, Ph.D. principal investigator
RARS
Geoffrey S Gottlieb, M.D principal investigator
University of Washington
Moussa Sarr, M.D., MPH principal investigator
Westat
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Truvada in people with HIV/AIDS, run by Réseau Africain de Recherche sur le SIDA at 4 sites in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number/proportion of FSWs who remain in the program (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.