Sexual and Reproductive Health (Including PrEP and HBV) for Female Sex Workers in Côte d'Ivoire
ANRS 12381
PrEP, Sexually Transmitted Infections, Contraception, Hepatitis B Virus, and Sexual Health for Female Sex Workers in Côte d'Ivoire
1 other identifier
interventional
500
1 country
1
Brief Summary
The PRINCESSE study will implement a comprehensive package of services in sexual and reproductive health for female sex workers in the region of San Pedro in Cote d'Ivoire, including screening, prevention and treatment for HIV, viral hepatitis B, sexually transmitted infections and family planning. All services will be available in mobiles clinics operating on prostitution sites and organized for a chronic follow-up of participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Nov 2019
Typical duration for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2019
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedStudy Start
First participant enrolled
November 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 7, 2022
June 1, 2022
3.5 years
March 13, 2019
June 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Completion rate of quarterly visits
Proportion of completed study visits
up to 24 months
Proportion with at least one diagnosed STI
up to 24 months
Occurrence of an unwanted pregnancy in the last 12 months
up to 24 months
Initiation of PrEP
Among those eligible for PrEP, proportion having initiating PrEP
over 24 months
Adherence to PrEP
among those on PrEP, proportion being adherent (measured through self-report, pill count and drug detection in plasma)
up to 24 months
Number of participants in HIV care at 18 months (retention)
Among those HIV-infected at baseline
18 months
Occurrence of virological failure
Among those HIV-infected and having initiated antiretroviral treatment, proportion with two consecutive detectable viral loads
over 24 months (survival analysis)
HBV vaccination rate
among those needing hepatitis B vaccination, proportion with complete vaccination (3 doses if HIV-negative, 8 doses if HIV-positive) at the end of the trial
over 24 months
Initiation and number of participants on TDF (retention) for patients with a treatment for HBV mono-infection
among those with positive HBs-antigen and a F3-F4 fibrosis
over 24 months
Proportion with increase in transaminase level (flares) after PrEP discontinuation
Among those who started and stopped PrEP and with a positive HBs antigen
within 12 months after PrEP discontinuation
Number of adverse social events occurring in the daily life of participants
Assessment of adverse social events occurring in the daily life of participants
over 24 months
Composition of the vaginal microbiota
Percentage of cervical lesions at M0 and M12
up to 12 months
Percentage of HPV infection and distribution of subtypes
up to 12 months
Percentage of resistant bacterial STIs
Percentage of M.genitalium infections with mutations resistant to macrolide and fluoroquinolone at M0 and M12 Percentage of N.gonorrhoeae infections with resistance genes resistant to fluoroquinolone, ceftriaxone and cyclin at M0 and M12
up to 12 months
Percentage of acceptability of different forms of long-acting PrEP for different sex workers profiles
Percentage of acceptability will be measured with in-depth individual interviews conducted with sex workers using a semi-structured interview guide including a biographical grid
over 12 months
Study Arms (1)
Intervention arm
EXPERIMENTALInterventions
Implementation of a comprehensive sexual and reproductive health care package for female sex workers in Côte d'Ivoire, combining an HIV PrEP offer (for HIV- FSW) with early treatment of HIV+ FSW, management of HBV infection (testing, vaccination and treatment), testing and treatment of sexually transmitted infections (STIs) and their consequences, a contraception offer, a quarterly screening of pregnancies, menstrual management counselling and identification of addiction. This healthcare package will be available both in mobile clinics organized for a quarterly follow-up (10 intervention sites, each site being visited every two weeks) and in the fixed clinic of the partner community-based NGO, at the discretion of each female participant.
Eligibility Criteria
You may qualify if:
- Being a woman over 18 years of age
- Self-reporting as being a sex worker
- Wishing to enrol in a regular clinical follow-up
- Agreeing to participate in the study and signing the informed consent form
- Regardless of HIV status (infected or not)
- Whether or not the participant has already taken antiretrovirals
- Whether or not the participant is already followed by Aprosam
You may not qualify if:
- Participation in another biomedical and/or behavioural study on HIV, viral hepatitis or Sexually Transmitted Infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- Programme PAC-CIcollaborator
- Aprosam, San Pedrocollaborator
- Institut de Recherche pour le Developpementcollaborator
Study Sites (1)
Aprosam
San-Pédro, Côte d’Ivoire
Related Publications (1)
Becquet V, Nouaman M, Plazy M, Agoua A, Zebago C, Dao H, Montoyo A, Jary A, Coffie PA, Eholie S, Larmarange J; the ANRS 12381 PRINCESSE team. A community-based healthcare package combining testing and prevention tools, including pre-exposure prophylaxis (PrEP), immediate HIV treatment, management of hepatitis B virus, and sexual and reproductive health (SRH), targeting female sex workers (FSWs) in Cote d'Ivoire: the ANRS 12381 PRINCESSE project. BMC Public Health. 2021 Dec 4;21(1):2214. doi: 10.1186/s12889-021-12235-0.
PMID: 34863122DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Larmarange, PhD
Institut de Recherche pour le Développement (IRD)
- PRINCIPAL INVESTIGATOR
Sege Eholié, MD PhD
Programme PAC-CI
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2019
First Posted
June 13, 2019
Study Start
November 26, 2019
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
June 7, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR, ANALYTIC CODE
- Time Frame
- within 24 months after trial's end
The detailed IPD will be developed in the first year of project implementation to determine exact data that will be shared.