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Early Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV Prevention Among Female Sex Workers in Cotonou, Benin (TasP/PrEP)

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ClinicalTrials.gov Identifier: NCT02237027
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : July 19, 2017
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Gilead Sciences
Imperial College London
University of Bristol
Johns Hopkins University
Centre Muraz
Université de Montréal
Institut National en Santé Publique du Québec
Université d'Abomey-Calavi
National AIDS Control Organisation
Information provided by (Responsible Party):
Michel Alary, CHU de Quebec-Universite Laval

Brief Summary:

In the last few years, early treatment of HIV-infected individuals, or "treatment as prevention (TasP), and pre-exposure prophylaxis with antiretroviral drugs among HIV-negative people at very high-risk of acquiring the infection (PrEP) have emerged as highly promising biological preventive interventions to tackle the HIV pandemic within the framework of combination prevention, a multi-component strategy that has been promoted for the last five years. In West Africa, the evidence strongly suggests that female sex workers (FSWs) contribute very disproportionally to the HIV spread. This is why the investigators propose this TasP and PrEP demonstration project in Benin, where our group has been involved in HIV prevention research in the sex work milieu for the last two decades.

After a run-in phase for community preparedness and the development of a specific education program on adherence, the investigators plan to recruit 100 HIV-infected FSWs in the TasP component of the project (these women will receive a first-line antiretroviral treatment (ART) regimen as per the Benin guidelines) and 250 HIV-negative FSWs in the PrEP component (these women will receive Truvada®). The recruitment period will last for one year, followed by an additional one year of follow-up, for a total follow-up period varying between 12 and 24 months, depending on when a given woman is recruited in the study. During follow-up visits every three months, the investigators will closely monitor treatment adherence and changes in sexual behaviour, including the use of viral load testing among TasP participants and Truvada® plasma level testing for PrEP participants, as well as detection of prostate-specific antigen (PSA) and Y-chromosome DNA in vaginal fluids in all participants.

The investigators will evaluate the feasibility of TasP and PrEP through a set of indicators, including uptake, coverage, adherence, condom migration, occurrence of side effects and development of drug resistance, whereas mathematical modeling will be used to predict the potential impact of both interventions in the sex work milieu and the general population, based on the actual set of indicators observed. The study will be completed by an economic evaluation of the interventions and a cost-effectiveness analysis.

Finally, the investigators will disseminate the results to the study population and to the Beninese health authorities and ensure the broad implementation of these interventions in Benin if the demonstration project shows that they are feasible and relevant.


Condition or disease Intervention/treatment Phase
Adherence to Medication Regime Biological: TasP using ART regimen as per Benin guidelines Biological: PrEP using Truvada Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Demonstration Project of Early Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV Prevention Among Female Sex Workers in Cotonou, Benin
Study Start Date : October 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Arm Intervention/treatment
Experimental: TasP group
HIV positive female sex workers receiving TasP using ART regimen as per Benin guidelines
Biological: TasP using ART regimen as per Benin guidelines
Administration of ART to HIV positive female sew workers in order to prevent HIV transmission.

Experimental: PrEP group
HIV negative female sex workers receiving PrEP using Truvada
Biological: PrEP using Truvada
Administration of Truvada to HIV negative female sex workers in order to prevent HIV acquisition.
Other Name: Combination of Tenofovir disoproxyl fumarate 300mg and Emtricitabine 200 mg




Primary Outcome Measures :
  1. Percentage of participants adherent to treatment (self-report and pill count) [ Time Frame: Change from day 14 to months 3, 6, 9, 12, 15, 18, 21 and 24 ]
    To evaluate adherence to treatment in TasP and PrEP groups.

  2. Percentage of participants adherent to treatment (drug dosage in plasma) [ Time Frame: Change from day 14 to months 6, 12, and 24 ]
    Quantification of tenofovir and emtricitabine in plasma to evaluate adherence to treatment in PrEP group.

  3. Percentage of participants adherent to treatment (treatment failure) [ Time Frame: Change from baseline to months 6, 12, 18, and 24 ]
    Quantification of viral loads in TasP group to detect treatment failure, a very good marker of treatment adherence.


Secondary Outcome Measures :
  1. Percentage of HIV seroconversion among participants from PrEP group [ Time Frame: Change from baseline to months 3, 6, 9, 12, 15, 18, 21 and 24 ]
    HIV testing to detect newly infected participants in order to evaluate PrEP efficiency in preventing HIV infection.

  2. Occurence of side effects [ Time Frame: Change from baseline to months 6, 12, 18, and 24 ]
    Monitoring of complete blood count, glycaemia, renal function (creatinine level), and liver function (alanine aminotransferase level) to detect potential drug side effects in TasP and PrEP groups.

  3. Change in condom use (self-report) [ Time Frame: Change from baseline to months 3, 6, 9, 12, 15, 18, 21 and 24 ]
    Self-report on condom use. To compare condom migration according to HIV status and treatment groups and detect a potential risk compensation.

  4. Change in condom use (biomarkers) [ Time Frame: Change from baseline to months 6, 12, and 24 ]
    PSA and Yc-DNA, two biomarkers of unprotected intercourse, will be quantified in vaginal swabs to validate self-reported condom use in TasP and PrEP groups.

  5. Development of drug resistance [ Time Frame: Change from baseline to 24th month ]
    Genotyping of HIV in the TasP group at baseline and at 24 months in order to detect development of drug resistance to ART regimen.

  6. Coverage of interventions [ Time Frame: Baseline ]
    HIV testing coverage issues are critical for both TasP and PrEP feasibility so the proportion of the target population of professional FSWs who came for a screening visit will be assessed. The numerator of this indicator will be the number of people tested for HIV at screening and the denominator will be the number of professional sex workers in the catchment area of the study.

  7. Uptake of PrEP intervention [ Time Frame: Baseline ]
    Evaluation of the proportion of women enrolled in the PrEP group among FSWs testing HIV-negative at screening to determine if this preventive approach will be accepted as a useful addition to current protection practices adopted by HIV-negative FSWs.

  8. Retention in the study [ Time Frame: Change from baseline to every month until month 24 ]
    Evaluation of the proportion of women that continue the study. The number of women eligible for each of follow-up visit will be used as the denominator at the moment when retention is assessed.



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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

TasP

  • Inclusion Criteria:

    1. Being aged 18 years or more
    2. Being HIV-positive at screening and re-confirmed on a second sample
    3. Being HIV treatment naïve
  • Exclusion Criteria:

    1. Women showing a compromised renal or liver function at clinical follow-up could be excluded anytime during the course of the study.

PrEP

  • Inclusion Criteria:

    1. Being aged 18 years or more
    2. Being HIV-negative at screening and re-confirmed at the recruitment visit
  • Exclusion Criteria:

    1. Being pregnant of breastfeeding
    2. Women showing a compromised renal or liver function at clinical follow-up could be excluded anytime during the course of the study.

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): NCT02237027


Locations
Benin
Dispensaire IST (DIST)
Cotonou, Benin
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Bill and Melinda Gates Foundation
Gilead Sciences
Imperial College London
University of Bristol
Johns Hopkins University
Centre Muraz
Université de Montréal
Institut National en Santé Publique du Québec
Université d'Abomey-Calavi
National AIDS Control Organisation
Investigators
Principal Investigator: Michel Alary, MD, PhD CHU de Quebec-Universite Laval

Responsible Party: Michel Alary, Professor, MD, PhD, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02237027     History of Changes
Other Study ID Numbers: OPP1098973
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: January 2016

Keywords provided by Michel Alary, CHU de Quebec-Universite Laval:
HIV
Early treatment as prevention (TasP)
Pre-exposure prophylaxis (PrEP)
antiretroviral treatment
prevention
feasibility
female sex workers
Benin
West Africa

Additional relevant MeSH terms:
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents