HIV InfectionsANRS 12381NCT03985085
Sexual and Reproductive Health (Including PrEP and HBV) for Female Sex Workers in Côte d'Ivoire
A study testing Comprehensive package of sexual and reproductive health services in people with HIV Infections and Viral Hepatitis B, run by ANRS, Emerging Infectious Diseases at 1 site in Côte d’Ivoire.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Viral Hepatitis B, Sexually Transmitted Diseases
- What is being tested?
- Comprehensive package of sexual and reproductive health services
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- 26 Nov 2019to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participation in another biomedical and/or behavioural study on HIV, viral hepatitis or Sexually Transmitted Infections
Trial locations and contacts
1 site in 1 country.
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
Aprosam
San-Pedro
Clémence Zebago, MD, +225 34000289, zebsonclear@yahoo.fr
Aline Agoua, MD, +225 34000289, alineasserayagoua@gmail.com
About this study
Official title: PrEP, Sexually Transmitted Infections, Contraception, Hepatitis B Virus, and Sexual Health for Female Sex Workers in Côte d'Ivoire
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.
Read the 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.
- Being tested
- Comprehensive package of sexual and reproductive health services
- Keywords
- female sex workers
- Medical subject headings
- HIV Infections, Hepatitis B, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive package of sexual and reproductive health servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Other: Comprehensive package of sexual and reproductive health services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of quarterly visits
Proportion of completed study visits
Measured: up to 24 months
Proportion with at least one diagnosed STI
Measured: up to 24 months
Occurrence of an unwanted pregnancy in the last 12 months
Measured: up to 24 months
Initiation of PrEP
Among those eligible for PrEP, proportion having initiating PrEP
Measured: over 24 months
Adherence to PrEP
among those on PrEP, proportion being adherent (measured through self-report, pill count and drug detection in plasma)
Measured: up to 24 months
Number of participants in HIV care at 18 months (retention)
Among those HIV-infected at baseline
Measured: 18 months
Occurrence of virological failure
Among those HIV-infected and having initiated antiretroviral treatment, proportion with two consecutive detectable viral loads
Measured: 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
Measured: over 24 months
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
Measured: 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
Measured: 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
Measured: over 24 months
Composition of the vaginal microbiota
Percentage of cervical lesions at M0 and M12
Measured: up to 12 months
Percentage of HPV infection and distribution of subtypes
Measured: 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
Measured: 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
Measured: over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start26 Nov 2019
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Programme PAC-CI, Aprosam, San Pedro, Institut de Recherche pour le Developpement
- Responsible party
- Sponsor
- Investigators
- Joseph Larmarange, PhD, Principal investigator, Institut de Recherche pour le Développement (IRD)Sege Eholié, MD PhD, Principal investigator, Programme PAC-CI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985085
- Sponsor's protocol ID
- ANRS 12381 PRINCESSE
- Acronym
- ANRS 12381
- Status last verified
- Jun 2022
- First submitted
- 13 Mar 2019
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The detailed IPD will be developed in the first year of project implementation to determine exact data that will be shared.
Publications
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.
PubMed 34863122
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP, Sexually Transmitted Infections, Contraception, Hepatitis B Virus, and Sexual Health for Female Sex Workers in Côte d'Ivoire
- ClinicalTrials.gov ID
- NCT03985085
- Acronym / sponsor ID
- ANRS 12381 / ANRS 12381 PRINCESSE
- Keywords
- female sex workers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Programme PAC-CI, Aprosam, San Pedro, Institut de Recherche pour le Developpement
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Comprehensive package of sexual and reproductive health services |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- Participation in another biomedical and/or behavioural study on HIV, viral hepatitis or Sexually Transmitted Infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive package of sexual and reproductive health servicesImplementation 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. | Other | Intervention arm |
Primary outcome
Completion rate of quarterly visits
Time frame: up to 24 months
Proportion of completed study visits
Proportion with at least one diagnosed STI
Time frame: up to 24 months
Occurrence of an unwanted pregnancy in the last 12 months
Time frame: up to 24 months
Initiation of PrEP
Time frame: over 24 months
Among those eligible for PrEP, proportion having initiating PrEP
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)
Number of participants in HIV care at 18 months (retention)
Time frame: 18 months
Among those HIV-infected at baseline
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
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
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
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
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
Composition of the vaginal microbiota
Time frame: up to 12 months
Percentage of cervical lesions at M0 and M12
Percentage of HPV infection and distribution of subtypes
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Derived from this study: PubMed 34863122Becquet 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.
- Individual participant dataSharing planned: Yes. The detailed IPD will be developed in the first year of project implementation to determine exact data that will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Larmarange, PhD principal investigator
Institut de Recherche pour le Développement (IRD)
Sege Eholié, MD PhD principal investigator
Programme PAC-CI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive package of sexual and reproductive health services in people with HIV Infections and Viral Hepatitis B, run by ANRS, Emerging Infectious Diseases at 1 site in Côte d’Ivoire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marie Masumbuko (+225 21755960, masumbukojm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate of quarterly visits (time frame: up to 24 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.