PrEP, Sexually Transmitted Infections, Contraception, Hepatitis B Virus, and Sexual Health for Female Sex Workers in Côte d'Ivoire
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Composition of the vaginal microbiota
Study Overview
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.
Detailed Description
PRINCESSE is a single-arm interventional cohort of 500 female sex workers (FSWs) in San Pedro, Cote d'Ivoire (400 HIV-negative FSW and 100 HIV-positive FSW).
It consists in the 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.
The main objective is to develop, document and analyze a community-based healthcare package combining testing, prevention tools including pre-exposure prophylaxis (PrEP), immediate HIV treatment, management of Hepatitis B virus and sexual and reproductive health (SRH)
Specific objectives are:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Participation in another biomedical and/or behavioural study on HIV, viral hepatitis or Sexually Transmitted Infections
Arms & Interventions
Intervention arm
Intervention: Comprehensive package of sexual and reproductive health services (Other)
Outcomes
Primary Outcomes
Composition of the vaginal microbiota
Time Frame: up to 12 months
Percentage of cervical lesions at M0 and M12
Occurrence of an unwanted pregnancy in the last 12 months
Time Frame: up to 24 months
Proportion with increase in transaminase level (flares) after PrEP discontinuation
Time Frame: within 12 months after PrEP discontinuation
Among those who started and stopped PrEP and with a positive HBs antigen
Number of adverse social events occurring in the daily life of participants
Time Frame: over 24 months
Assessment of adverse social events occurring in the daily life of participants
Completion rate of quarterly visits
Time Frame: up to 24 months
Proportion of completed study visits
Proportion with at least one diagnosed STI
Time Frame: up to 24 months
Occurrence of virological failure
Time Frame: over 24 months (survival analysis)
Among those HIV-infected and having initiated antiretroviral treatment, proportion with two consecutive detectable viral loads
HBV vaccination rate
Time Frame: over 24 months
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
Percentage of HPV infection and distribution of subtypes
Time Frame: up to 12 months
Initiation of PrEP
Time Frame: over 24 months
Among those eligible for PrEP, proportion having initiating PrEP
Adherence to PrEP
Time Frame: up to 24 months
among those on PrEP, proportion being adherent (measured through self-report, pill count and drug detection in plasma)
Number of participants in HIV care at 18 months (retention)
Time Frame: 18 months
Among those HIV-infected at baseline
Initiation and number of participants on TDF (retention) for patients with a treatment for HBV mono-infection
Time Frame: over 24 months
among those with positive HBs-antigen and a F3-F4 fibrosis
Percentage of resistant bacterial STIs
Time Frame: up to 12 months
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
Percentage of acceptability of different forms of long-acting PrEP for different sex workers profiles
Time Frame: over 12 months
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
Secondary Outcomes
No secondary outcomes reported