Implementation of Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis with antiretroviral medications amongst men at high risk for HIV infection; a demonstration project

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000032550
• Date of registration: 19/01/2015
• Prospective Registration: Yes
• Primary sponsor: Cairns and Hinterland Hospital and Health Service
• Public title: Implementation of Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis with antiretroviral medications amongst men at high risk for HIV infection; a demonstration project
• Scientific title: Implementation of HIV pre-exposure prophylaxis with antiretroviral medications amongst men at high risk for HIV infection; a demonstration project to evaluate feasibility, acceptability and adherence
• Date of first enrolment: 02/02/2015
• Target sample size: 3000
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12615000032550.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Non-randomised trial;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: A/Prof Darren Russell

• Name: Mr Simon Doyle-Adams

Key inclusion & exclusion criteria

Inclusion criteria: Men who have sex with men at risk of acquiring HIV due to high risk sexual practices. Willing and able to provide written informed consent. HIV negative at enrolment, medicare eligible, willing and able to partake in study procedures, fluent in English
Exclusion criteria: HIV infected or signs or symptoms of acute HIV infection, creatinine clearance <60ml/min, active clinically significant medical problems including active TB, poorly controlled cardiac disease, previous or currently diagnosed malignancy requiring further treatment. Hepatitis B surface antigen positive, current use of ART, including nucleoside analogues, non-neucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, interferon or interleukein therapy any investigational agents that may interact or affect PrEP medication and any nephrotoxic agents. Mental health issues, memory loss or other cognitive impairment or intellectual disability that may compromise participant safety and/or regimen adherence. Factors/conditions that may compromise a participant's retention in the study. Unwilling to adhere to any of the required study procedures

Age minimum: 18 Years
Age maximum: No limit
Gender: Males

Health Condition(s) or Problem(s) studied

Infection - Acquired immune deficiency syndrome (AIDS / HIV)

HIV prevention;
HIV prevention

Public Health - Other public health

Intervention(s)

Intervention model: single group assignment
Masking: Open label
Primary Purpose: prevention
Drug: emtricitabine/tenofovir disoproxil fumarate
a) Name of intervention: emtricitabine (200mg)/tenofovir disoproxil fumarate(300mg) (Truvada)
b) Dose administered: One tablet once a day
c) Duration of administration: Up to 12 months
d) Mode of administration - oral tablet

Strategies to monitor adherence: follow up at 1,3,6,9 and 12 months including tablet count and client surveys at 1,6 and 12 months

Primary Outcome(s)

Feasibility of PrEP provision through sexual health clinics and general practice services in Queensland
This will be assessed by the Implementation processes and feedback from all sites [12 Months]

Adherence to PrEP
This will be assessed by percentage and patterns of prescribed doses taken estimated from self report. Percentage of prescribed doses taken estimated by tablet count.[12 Months]

Acceptability of this model of PrEP provision
This will be assessed by the proportion of clients eligible to participate but decline to do so. Participant self discontinuation of PrEP, product experience and likelihood of future PrEP use post study[12 Months]

Secondary Outcome(s)

safety and side effects. Possible side effects include renal impairment this will be monitored at 3 and 9 months by checking creatinine clearance. Surveys will be conducted at 3, 6 , 9 and 12 months.[12 months]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

State of Queensland

Ethics review

Status: Approved
Approval date:
Contact:

Gold Coast Hospital and Health Service HREC