Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) for Sex Workers in India (PrEP-India)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University of Manitoba
Sponsor:
Collaborators:
World Health Organization
DMSC
Ashodaya Samithi
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT02148094
First received: May 22, 2014
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

Female sex workers (FSWs) in India are at high risk of HIV infection, and while correct and consistent condom use is an effective means of preventing HIV transmission, many FSWs have difficulty insisting on their use. Alternative HIV prevention options are needed for FSWs who are unable to correctly and consistently use condoms with their clients or regular partners. Oral pre-exposure prophylaxis (PrEP) may be an important tool to fill this critical prevention gap, and a demonstration project is required to assess the impact and feasibility of the use of PrEP as an HIV prevention intervention among most at risk FSWs in India.

The proposed project will take place at two sites in India and will assess the use of a risk assessment tool to identify FSWs who would most benefit from PrEP, collect information about the reasons why FSWs choose to accept or decline PrEP, evaluate two different PrEP delivery strategies (weekly clinic pick-up or home delivery by peer educators every second day), monitor adherence to and discontinuation of PrEP, and evaluate unintended consequences of the use of PrEP in these communities (e.g. reduction of condom use, drug side effects or adverse events, social harms or resistance). To ensure the safety of study participants, a community advisory board will be set up and will meet regularly to inform study staff of any concerns that the community may have related to the study, so that the study staff can respond in a timely manner. A data safety and monitoring board will also be established to monitor participant safety.


Condition Intervention Phase
HIV Infection
Drug: Truvada
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Closing a Critical HIV Prevention Gap: Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) as Part of an HIV Combination Preventive Intervention for Sex Workers in Kolkata and Mysore-Mandya, India

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Sustained uptake and adherence to oral PrEP among female sex workers [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    We will assess the acceptability and feasibility of two approaches to PrEP delivery: 1) peer educator delivery every other day; or 2) weekly clinic pick-up. Study staff will measure PrEP initiation, adherence and discontinuation. They will record these events in participant records, and quarterly visits will be used to assess adherence through biological tests and questionnaires. PrEP will be delivered as part of a package of HIV prevention services, and therefore use of other prevention strategies, such as condom use, will also be monitored. Data on drug adherence and condom use will be collected through various means. An ethnographic study will be designed to understand factors that may promote or impede adherence to PrEP, as well as changes in risk behaviour (reduction in condom use). In addition to this, peer educators will use a pictorial tool to document these items (e.g., frequency and patterns of sexual activity, condom use, and PrEP use).


Secondary Outcome Measures:
  • Identification of female sex workers willing to take PrEP [ Time Frame: 18 months after study commencement ] [ Designated as safety issue: No ]
    We propose to develop and use of a risk screening tool to identify female sex workers who are most vulnerable to HIV. This tool will guide recruitment into the demonstration study and could later assist health providers in deciding who will benefit most from PrEP for HIV prevention. In addition, this study will assess the proportion of FSWs identified by the risk screening tool who are willing to take PrEP. Quantitative and qualitative evaluations will identify factors related to the decision to initiate PrEP as well as reasons why FSWs decline PrEP

  • Oral HIV PrEP as part of a combined prevention package delivered safely for female sex workers [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The most common side effects of FTC/TDF are minor and short-lived (i.e. first several weeks). Quarterly clinic visits will assess physical health, side effects, adverse events and any other social harms or concerns with PrEP use. This study will invest in continuous engagement with communities of female sex workers according to good participatory practice guidelines to provide correct information about PrEP, keep communities continuously engaged, and maintain adherence to PrEP. A community advisory board (CAB) and a Data Safety and Monitoring Board (DSMB) will be set up. The CAB will meet monthly and on an as needed basis. The DSMB will be set up to ensure that the rights of the study participants are safeguarded in a transparent fashion, and to monitor their safety by scrutinizing any adverse events.

  • Effective delivery of oral HIV PrEP demonstrated in context of National Targeted Interventions [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    This study proposes to deliver PrEP within the context of the National Program of Targeted Interventions in order to demonstrate that PrEP is feasible in "real world" settings. DMSC and Ashodaya currently implement targeted intervention programs for female sex workers in Kolkata and Mysore/Mandya, respectively. These programs provide outreach by peer educators and outreach workers, clinic services (e.g. HIV testing and counseling, STI screening and treatment), and referrals for HIV care and treatment for brothel- and street-based FSWs. This study will evaluate the addition of PrEP to this existing service delivery model. It will also show willingness of participants to enroll in a demonstration study and to use oral PrEP without reimbursements or incentives for participation.


Estimated Enrollment: 2000
Study Start Date: November 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Truvada
Participants will be initiated on PrEP and asked to select one of two PrEP delivery options. Participants will return to the study site every three months for an additional follow-up visit. At follow-up visits, participants will receive HIV testing and counselling, pregnancy testing, syndromic screening for STIs, and clinical diagnosis of adverse events. Those who test HIV-positive will be discontinued on PrEP, exited from the study and referred for HIV care and treatment. Those who have an adverse event will be clinically evaluated to determine whether they should suspend PrEP use and will be provided with the appropriate management for the adverse event. Participants who test HIV-negative will receive patient-centred counselling around PrEP.
Drug: Truvada
The demonstration project will use a prospective cohort design, enrolling individuals and following them up at multiple intervals over the course of 16 months. Study participants will be asked to take one tablet of Truvada daily, as HIV Pre-Exposure Prophylaxis, over this period. They will be asked to attend 7 regular visits at the project sites over the course of the project. In between visits, they will receive peer educator home visits every other day, as part of regular DMSC (Kolkata) and Ashodaya (Mysore/Mandya) outreach prevention activities. We plan to enroll 2000 female sex workers equally split between the two sites.
Other Name: emtricitabine and tenofovir disoproxil fumarate

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identification as a current FSW
  • Age 18 and older
  • Self-reported interest in and willingness to take PrEP
  • Score cutoff on risk screening tool / PrEP indication tool
  • HIV-negative test at time of enrollment (per testing algorithm)
  • No clinical signs of acute HIV infection
  • Hepatitis-B virus antigen negative (upon screening)
  • Creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula) (upon screening)
  • Not currently taking PrEP or enrolled in another PrEP demonstration project
  • Negative urine pregnancy test at time of enrollment
  • Lives within the catchment area of the project site and no plans to move away from the project area in the next 16 months

Exclusion Criteria:

  • Under 18
  • Does not meet inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02148094

Contacts
Contact: Stephen Moses, MD, MPH +1.204.7893434 smoses@cc.umanitoba.ca

Locations
India
Ashodaya Samithi clinic Not yet recruiting
Mysore, Karnataka, India
Contact: Sushena Reza-Paul, MBBS    +91.9880764358    sushenar@gmail.com   
DMSC Clinic Not yet recruiting
Kolkata, West Bengal, India
Contact: Smarajit Jana, MBBS    +91.9910203311    smarajitjana@gmail.com   
Sponsors and Collaborators
University of Manitoba
World Health Organization
DMSC
Ashodaya Samithi
Investigators
Principal Investigator: Sushena Reza-Paul, MBBS University of Manitoba, Ashodaya Samithi
Principal Investigator: Smarajit Jana, MBBS DMSC
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02148094     History of Changes
Other Study ID Numbers: B2014:050
Study First Received: May 22, 2014
Last Updated: May 28, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
HIV
AIDS
India
Prevention
Female sex workers
PrEP
Pre-exposure prophylaxis
Truvada
Tenofovir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 16, 2014