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Sexual and Reproductive Health (Including PrEP and HBV) for Female Sex Workers in Côte d'Ivoire (ANRS 12381)

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ClinicalTrials.gov Identifier: NCT03985085
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborators:
Programme PAC-CI
Aprosam, San Pedro
Institut de Recherche pour le Developpement
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

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.

Condition or disease Intervention/treatment Phase
HIV Infections Viral Hepatitis B Sexually Transmitted Diseases Contraception Other: Comprehensive package of sexual and reproductive health services Not Applicable

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

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.

Four 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: PrEP, Sexually Transmitted Infections, Contraception, Hepatitis B Virus, and Sexual Health for Female Sex Workers in Côte d'Ivoire
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention arm 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.





Primary Outcome Measures :
  1. Completion rate of quarterly visits [ Time Frame: up to 24 months ]
    Proportion of completed study visits

  2. Proportion with at least one diagnosed STI [ Time Frame: up to 24 months ]
  3. Occurrence of an unwanted pregnancy in the last 12 months [ Time Frame: up to 24 months ]
  4. Initiation of PrEP [ Time Frame: over 24 months ]
    Among those eligible for PrEP, proportion having initiating PrEP

  5. 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)

  6. Number of participants in HIV care at 18 months (retention) [ Time Frame: 18 months ]
    Among those HIV-infected at baseline

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985085


Contacts
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Contact: Jean-Marie Masumbuko +225 21755960 masumbukojm@gmail.com
Contact: Marcellin Nouanman +225 21755960 nouaman_et_vie@yahoo.fr

Locations
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Côte D'Ivoire
Aprosam Not yet recruiting
San Pedro, Côte D'Ivoire
Contact: Clémence Zebago, MD    +225 34000289    zebsonclear@yahoo.fr   
Contact: Aline Agoua, MD    +225 34000289    alineasserayagoua@gmail.com   
Sub-Investigator: Clémence Zebago, MD         
Sub-Investigator: Aline Agoua, MD         
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Programme PAC-CI
Aprosam, San Pedro
Institut de Recherche pour le Developpement
Investigators
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Principal Investigator: Joseph Larmarange, PhD Institut de Recherche pour le Développement (IRD)
Principal Investigator: Sege Eholié, MD PhD Programme PAC-CI

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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03985085     History of Changes
Other Study ID Numbers: ANRS 12381 PRINCESSE
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The detailed IPD will be developed in the first year of project implementation to determine exact data that will be shared.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Analytic Code
Time Frame: within 24 months after trial's end

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
female sex workers

Additional relevant MeSH terms:
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Infection
Hepatitis
HIV Infections
Hepatitis B
Sexually Transmitted Diseases
Liver Diseases
Digestive System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human
Genital Diseases, Male
Genital Diseases, Female