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

Phase 4

• Conditions: HIV prevention; Infection - Acquired immune deficiency syndrome (AIDS / HIV); Public Health - Other public health

• Registration Number: ACTRN12615000032550
• Lead Sponsor: Cairns and Hinterland Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Male
• Target Recruitment: 3000

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of PrEP provision through sexual health clinics and general practice services in Queensland <br>This will be assessed by the Implementation processes and feedback from all sites [12 Months];Acceptability of this model of PrEP provision <br>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];Adherence to PrEP<br>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]

Secondary Outcome Measures

Name	Time	Method
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]