Sexual and Reproductive Health (Including PrEP and HBV) for Female Sex Workers in Côte d'Ivoire

Study Overview
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Brief Summary
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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
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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: To analyse access to care and retention into care, and more generally female participants' healthcare trajectories through a quarterly follow-up of FSWs (infected with HIV or not) To measure female participants' health outcome over time of clinical, behavioural and social indicators To assess PrEP initiation, use and adherence To compare HIV management in the PRINCESSE system with the existing routine treatment and care To measure HBV testing, vaccination and treatment, as part of a decentralised management integrated with HIV PrEP, and possible interactions between HIV PrEP and HBV infection To document the unexpected consequences (positive or negative) of PRINCESSE system on the everyday life of female participants in particular, and on the sex industry in general To evaluate the impact of vaginal microbiota on bacterial sexually transmitted infections, human papillomavirus (HPV) infections and associated cervical lesions; the impact of the HPV type distribution on the vaccinal strategy and the added value of HPV PCR for the primary screening of cervical cancer; and the impact of antimicrobial resistance on the STI guidelines. Assess the a priori acceptability and appropriateness of different forms of long-acting PrEP for different sex workers profiles. Four data collection devices are included in the cohort: (i) clinical and safety data, (ii) socio-behavioural questionnaires, (iii) biological data, and (iv) in-depth interviews with female participants. Eight additional data collections are scheduled outside the cohort itself: (i) capture of medical and activity records of Aprosam for PRINCESSE participants; (ii) capture of medical records of HIV+ FSW patients not participating in the PRINCESSE cohort and routinely examined by the NGO partner; (iii) in-depth interviews with key informants in the FSW community; (iv) in-depth interviews with PRINCESSE follow-up actors (peer educators and caregivers) (v) individual biographical interviews with female sex workers recruited by Aprosam and Espace Confiance about long-acting PrEP, supplemented by (vi) focus group discussions with female sex workers; (vii) focus group discussions with sex workers assigned men at birth; (viii) individual interviews with community actors.

Official Title
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PrEP, Sexually Transmitted Infections, Contraception, Hepatitis B Virus, and Sexual Health for Female Sex Workers in Côte d'Ivoire

Conditions
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HIV Infections, Viral Hepatitis B, Sexually Transmitted Diseases, Contraception

Intervention / Treatment
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* Other: Comprehensive package of sexual and reproductive health services


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br> | Other: Comprehensive package of sexual and reproductive health services<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female sex workers