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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03985085
Acronym
ANRS 12381
Enrollment
500
Registered
2019-06-13
Start date
2019-11-26
Completion date
2023-06-30
Last updated
2022-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

female sex workers

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.

Interventions

OTHERComprehensive 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.

Sponsors

Programme PAC-CI
CollaboratorUNKNOWN
Aprosam, San Pedro
CollaboratorUNKNOWN
Institut de Recherche pour le Developpement
CollaboratorOTHER_GOV
ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Completion rate of quarterly visitsup to 24 monthsProportion of completed study visits
Proportion with at least one diagnosed STIup to 24 months
Occurrence of an unwanted pregnancy in the last 12 monthsup to 24 months
Initiation of PrEPover 24 monthsAmong those eligible for PrEP, proportion having initiating PrEP
Adherence to PrEPup to 24 monthsamong 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)18 monthsAmong those HIV-infected at baseline
Occurrence of virological failureover 24 months (survival analysis)Among those HIV-infected and having initiated antiretroviral treatment, proportion with two consecutive detectable viral loads
HBV vaccination rateover 24 monthsamong 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
Initiation and number of participants on TDF (retention) for patients with a treatment for HBV mono-infectionover 24 monthsamong those with positive HBs-antigen and a F3-F4 fibrosis
Proportion with increase in transaminase level (flares) after PrEP discontinuationwithin 12 months after PrEP discontinuationAmong those who started and stopped PrEP and with a positive HBs antigen
Number of adverse social events occurring in the daily life of participantsover 24 monthsAssessment of adverse social events occurring in the daily life of participants
Composition of the vaginal microbiotaup to 12 monthsPercentage of cervical lesions at M0 and M12
Percentage of HPV infection and distribution of subtypesup to 12 months
Percentage of resistant bacterial STIsup to 12 monthsPercentage 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 profilesover 12 monthsPercentage of acceptability will be measured with in-depth individual interviews conducted with sex workers using a semi-structured interview guide including a biographical grid

Countries

Côte d’Ivoire

Contacts

Primary ContactJean-Marie Masumbuko
masumbukojm@gmail.com+225 21755960
Backup ContactMarcellin Nouanman
nouaman_et_vie@yahoo.fr+225 21755960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026