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

HIV Infections Clinical Trial

— ANRS 12381  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03985085
• Other study ID #: ANRS 12381 PRINCESSE
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: June 2023

Study information

• Verified date: June 2022
• Source: ANRS, Emerging Infectious Diseases
• Contact: Jean-Marie Masumbuko
• Phone: +225 21755960
• Email: masumbukojm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Hepatitis
• Hepatitis B
• HIV Infections
• Infections
• Sexually Transmitted Diseases
• Viral Hepatitis B

Intervention

Other:
• Comprehensive package of sexual and reproductive health services
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.

Locations

Country	Name	City	State
Côte D'Ivoire	Aprosam	San Pedro

Sponsors (4)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Aprosam, San Pedro, Institut de Recherche pour le Developpement, Programme PAC-CI

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of quarterly visits	Proportion of completed study visits	up to 24 months
Primary	Proportion with at least one diagnosed STI		up to 24 months
Primary	Occurrence of an unwanted pregnancy in the last 12 months		up to 24 months
Primary	Initiation of PrEP	Among those eligible for PrEP, proportion having initiating PrEP	over 24 months
Primary	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
Primary	Number of participants in HIV care at 18 months (retention)	Among those HIV-infected at baseline	18 months
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Composition of the vaginal microbiota	Percentage of cervical lesions at M0 and M12	up to 12 months
Primary	Percentage of HPV infection and distribution of subtypes		up to 12 months
Primary	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
Primary	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