Clinical trial NCT03985085: Sexual and Reproductive Health (Including PrEP and HBV) for Female Sex Workers in Côte d'Ivoire
Official title: PrEP, Sexually Transmitted Infections, Contraception, Hepatitis B Virus, and Sexual Health for Female Sex Workers in Côte d'Ivoire
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Viral Hepatitis B
Sexually Transmitted Diseases
Contraception
Keywords: female sex workers
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Programme PAC-CI
name: Aprosam, San Pedro
name: Institut de Recherche pour le Developpement
First posted: 2019-06-13
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

1. 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)
2. To measure female participants' health outcome over time of clinical, behavioural and social indicators
3. To assess PrEP initiation, use and adherence
4. To compare HIV management in the PRINCESSE system with the existing routine treatment and care
5. 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
6. 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
7. 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.
8. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion rate of quarterly visits
timeFrame: up to 24 months
measure: Proportion with at least one diagnosed STI
timeFrame: up to 24 months
measure: Occurrence of an unwanted pregnancy in the last 12 months
timeFrame: up to 24 months
measure: Initiation of PrEP
timeFrame: over 24 months
measure: Adherence to PrEP
timeFrame: up to 24 months
measure: Number of participants in HIV care at 18 months (retention)
timeFrame: 18 months
measure: Occurrence of virological failure
timeFrame: over 24 months (survival analysis)
measure: HBV vaccination rate
timeFrame: over 24 months
measure: Initiation and number of participants on TDF (retention) for patients with a treatment for HBV mono-infection
timeFrame: over 24 months
measure: Proportion with increase in transaminase level (flares) after PrEP discontinuation
timeFrame: within 12 months after PrEP discontinuation
measure: Number of adverse social events occurring in the daily life of participants
timeFrame: over 24 months
measure: Composition of the vaginal microbiota
timeFrame: up to 12 months
measure: Percentage of HPV infection and distribution of subtypes
timeFrame: up to 12 months
measure: Percentage of resistant bacterial STIs
timeFrame: up to 12 months
measure: Percentage of acceptability of different forms of long-acting PrEP for different sex workers profiles
timeFrame: over 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Pedro
country: Côte D'Ivoire
facility: Aprosam
Study officials:
affiliation: Institut de Recherche pour le Développement (IRD)
name: Joseph Larmarange, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Programme PAC-CI
name: Sege Eholié, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.