Demonstration Project of PrEP Among Female Sex Workers in Dakar, Senegal
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|ClinicalTrials.gov Identifier: NCT02474303|
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Drug: Truvada||Not Applicable|
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.
- 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
- 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.
• 267 HIV-negative FSW age 18 or older recruited from four public health centers in Dakar: Pikine, Mbao, Rufisque and Diamniadio Health Centers.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||267 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
HIV Pre-exposure Prophylaxis (PrEP)
- The number/proportion of FSWs who remain in the program [ Time Frame: 12 months ]
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
|Centre de santé de Mbao|
|Centre de Santé de Rufisque|
|Centre de Santé Dominique de Pikine|
|centre hospitalier de Diamniadio|
|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|