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PRINCESSE (PrEP, sexually transmitted infections, contraception, viral hepatitis B, sexual health for sex workers in Côte d'Ivoire)

The ANRS 12361 PREP-CI study, which examined the feasibility and relevance of a PrEP program for sex workers in Côte d’Ivoire, confirmed that the sex worker population in Côte d’Ivoire is at risk for HIV and made the following findings: …

Project Details

Principal Investigator

Dr. Marcelin Nouanman

Duration

36 months

Sponsor

ANRS

Objectives

Main Objectives
Develop, document, and analyze a community-based care program that combines screening, comprehensive prevention—including pre-exposure prophylaxis (PrEP)—immediate HIV treatment, hepatitis B care, and sexual and reproductive health (SRH)
Secondary Objectives
  • Secondary Objective 1: Analyze access to care and retention, and more generally the participants’ care pathways, through quarterly follow-up of TS (whether or not they are HIV-positive)
  • Secondary Objective 2: Measure changes in participants’ health status over time using clinical, behavioral, and social indicators
  • Secondary Objective 3: Evaluate the initiation, use, and adherence to PrEP
  • Secondary Objective 4: Compare HIV care within the PRINCESSE program with existing
    routine care Secondary Objective 5: Measure hepatitis B screening, vaccination, and treatment within the context of decentralized care integrated with HIV PrEP services, as well as any potential interactions between HIV PrEP and HBV infection
  • Secondary Objective 6: Document the unintended (positive or negative) consequences of the PRINCESSE program on the daily lives of participants in particular and on the sex work market in general
     

Description & Context

The ANRS 12361 PREP-CI study, which examined the feasibility and relevance of a PrEP program for sex workers in Côte d’Ivoire, confirmed that the sex worker population in Côte d’Ivoire is at risk for HIV and made the following findings:
 •    All sex workers have unmet sexual and reproductive health needs, regardless of whether they are HIV-positive or HIV-negative, or whether they wish to start PrEP•
    The operational implementation of HIV PrEP requires (re)thinking chronic care for sex workers who are not infected with HIV as part of a comprehensive sexual and reproductive health care package.
•    In a context of high hepatitis B prevalence, making ARVs available for HIV prevention cannot be done without also making those same ARVs available for the treatment of hepatitis B.
•    To minimize the stigma associated with entering care, the management of HIV-infected sex workers and preventive follow-up for uninfected sex workers cannot be separated.
•    Access to community clinics following activities conducted as part of an advanced strategy (at prostitution sites) remains insufficient.
• The high mobility of sex workers is an obstacle to continuity of care

Following the results of the ANRS 12361 PrEP-CI exploratory project, we designed, in collaboration with Ivorian community stakeholders, a health intervention called PRINCESSE, focusing on comprehensive sexual and reproductive health care for sex workers in San Pedro. 
The uniqueness of this intervention lies in the combination of HIV PrEP (for HIV-negative sex workers) with early care for HIV-positive women, addressing HBV infection (screening, vaccination, and treatment), screening and treatment of sexually transmitted infections, access to contraception, menstrual health counseling, and the identification of substance use issues (alcohol, tobacco, drugs, etc.). 
The PRINCESSE study is a single-arm interventional cohort of 500 sex workers in San Pedro (400 HIV-negative and 100 HIV-positive). Four data collection components are integrated into the cohort: (i) clinical and tolerability data, (ii) sociBEHAVIORAL questionnaires, (iii) biological data, and (iv) in-depth interviews with participants. 
Four additional data collection efforts are planned outside the cohort itself: (i) collection of medical and activity records from the NGO Aprosam for PRINCESSE participants; (ii) collection of medical records for HIV-positive patients who are not participating in the PRINCESSE cohort but are seen routinely by partner NGOs; (iii) in-depth interviews with key informants in the sex worker community; (iv) in-depth interviews with PRINCESSE follow-up staff (peer educators and healthcare providers).
These health services will be available both at mobile clinics organized for quarterly follow-up (10 intervention sites, with each site visited every two weeks) and at the permanent clinic of the partner community-based organization, at each participant’s discretion.
 

Study Criteria

Inclusion
  • Inclusion Criterion 1: Be a woman 18 years of age or older
  • Inclusion criterion 2: Identify as a sex worker
  • Inclusion criterion 3: Be willing to participate in regular clinical follow-up
  • Inclusion criterion 4: Agree to participate in the study and sign the informed consent form
  • Inclusion criterion 5: Regardless of HIV status (infected or not)
  • Inclusion Criterion 6: Whether or not the participant has previously taken antiretroviral medications
  • Inclusion Criterion 7: Whether or not
      the participant is already receiving care from the NGO Aprosam
Exclusion

Exclusion criterion: Participation in another biomedical and/or behavioral study on HIV, viral hepatitis, or sexually transmitted infections

Research Team

The research team has not yet been filled in for this project.

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We are open to partnerships with international research institutions and doctoral students.

Research Request

Estimated response time: 3-5 business days.

Keywords

COHORTE
Exploration

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