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| Name | Class |
|---|---|
| Programme PAC-CI | UNKNOWN |
| Aprosam, San Pedro | UNKNOWN |
| Institut de Recherche pour le Developpement | OTHER_GOV |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive package of sexual and reproductive health services | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of quarterly visits | Proportion of completed study visits | up to 24 months |
| Proportion with at least one diagnosed STI | up to 24 months | |
| Occurrence of an unwanted pregnancy in the last 12 months | up to 24 months | |
| Initiation of PrEP | Among those eligible for PrEP, proportion having initiating PrEP | over 24 months |
| 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 |
| Number of participants in HIV care at 18 months (retention) | Among those HIV-infected at baseline | 18 months |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Marie Masumbuko | Contact | +225 21755960 | masumbukojm@gmail.com | |
| Marcellin Nouanman | Contact | +225 21755960 | nouaman_et_vie@yahoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Larmarange, PhD | Institut de Recherche pour le Développement (IRD) | Principal Investigator |
| Sege Eholié, MD PhD | Programme PAC-CI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aprosam | Recruiting | San-Pedro | Côte d’Ivoire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34863122 | Derived | Becquet V, Nouaman M, Plazy M, Agoua A, Zebago C, Dao H, Montoyo A, Jary A, Coffie PA, Eholie S, Larmarange J; the ANRS 12381 PRINCESSE team. A community-based healthcare package combining testing and prevention tools, including pre-exposure prophylaxis (PrEP), immediate HIV treatment, management of hepatitis B virus, and sexual and reproductive health (SRH), targeting female sex workers (FSWs) in Cote d'Ivoire: the ANRS 12381 PRINCESSE project. BMC Public Health. 2021 Dec 4;21(1):2214. doi: 10.1186/s12889-021-12235-0. |
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The detailed IPD will be developed in the first year of project implementation to determine exact data that will be shared.
within 24 months after trial's end
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|
| 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 |
| 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 |
| 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 |
| Composition of the vaginal microbiota | Percentage of cervical lesions at M0 and M12 | up to 12 months |
| Percentage of HPV infection and distribution of subtypes | up to 12 months |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006509 | Hepatitis B |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D034121 | Reproductive Health Services |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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