- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03985085
Sexual and Reproductive Health (Including PrEP and HBV) for Female Sex Workers in Côte d'Ivoire (ANRS 12381)
PrEP, Sexually Transmitted Infections, Contraception, Hepatitis B Virus, and Sexual Health for Female Sex Workers in Côte d'Ivoire
Study Overview
Status
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Marie Masumbuko
- Phone Number: +225 21755960
- Email: masumbukojm@gmail.com
Study Contact Backup
- Name: Marcellin Nouanman
- Phone Number: +225 21755960
- Email: nouaman_et_vie@yahoo.fr
Study Locations
-
-
-
San Pedro, Côte D'Ivoire
- Recruiting
- Aprosam
-
Contact:
- Clémence Zebago, MD
- Phone Number: +225 34000289
- Email: zebsonclear@yahoo.fr
-
Contact:
- Aline Agoua, MD
- Phone Number: +225 34000289
- Email: alineasserayagoua@gmail.com
-
Sub-Investigator:
- Clémence Zebago, MD
-
Sub-Investigator:
- Aline Agoua, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention arm
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion rate of quarterly visits
Time Frame: up to 24 months
|
Proportion of completed study visits
|
up to 24 months
|
Proportion with at least one diagnosed STI
Time Frame: up to 24 months
|
up to 24 months
|
|
Occurrence of an unwanted pregnancy in the last 12 months
Time Frame: up to 24 months
|
up to 24 months
|
|
Initiation of PrEP
Time Frame: over 24 months
|
Among those eligible for PrEP, proportion having initiating PrEP
|
over 24 months
|
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)
|
up to 24 months
|
Number of participants in HIV care at 18 months (retention)
Time Frame: 18 months
|
Among those HIV-infected at baseline
|
18 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
|
over 24 months (survival analysis)
|
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
|
over 24 months
|
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
|
over 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
|
within 12 months after PrEP discontinuation
|
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
|
over 24 months
|
Composition of the vaginal microbiota
Time Frame: up to 12 months
|
Percentage of cervical lesions at M0 and M12
|
up to 12 months
|
Percentage of HPV infection and distribution of subtypes
Time Frame: up to 12 months
|
up to 12 months
|
|
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
|
up to 12 months
|
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
|
over 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Joseph Larmarange, PhD, Institut de Recherche pour le Développement (IRD)
- Principal Investigator: Sege Eholié, MD PhD, Programme PAC-CI
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANRS 12381 PRINCESSE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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