None listed
Conditions
Brief summary
The aim of this study is to evaluate the feasibility of prescribing a medication called Truvada daily to a sample of gay and bisexual men at high risk of acquiring HIV to prevent them acquiring HIV infection. Objectives are to assess the acceptability of daily PrEP by measuring adherence to medication, average duration of taking PrEP and average study retention time for participants. We also wish to assess the behavioural impact of taking daily PrEP including sexual partnering and condom use on participants. This will involve following participants 3 monthly for STI and HIV testing, assessment of adherence to medication, recording adverse effects and will involve participants completing a behavioural on-line survey at baseline and 3 monthly. The sample size will be 150 participants and the study duration will be over 24 months.
Interventions
The aim is to assess the implementation of a novel HIV prevention intervention (PrEP or pre-exposure prophylaxis) at Auckland Regional Sexual Health Service (ARSHS) clinics to individuals at high risk of HIV infection. The purpose is reduce new HIV infections in participants.
Specific objectives are to investigate:
a) Acceptability of PrEP for those invited into the study; by measuring adherence; duration; retention;
b) Risk behaviours on PrEP including sexual partnering; condom use; STI and H
The aim is to assess the implementation of a novel HIV prevention intervention (PrEP or pre-exposure prophylaxis) at Auckland Regional Sexual Health Service (ARSHS) clinics to individuals at high risk of HIV infection. The purpose is reduce new HIV infections in participants. Specific objectives are to investigate: a) Acceptability of PrEP for those invited into the study; by measuring adherence; duration; retention; b) Risk behaviours on PrEP including sexual partnering; condom use; STI and HIV incidence; c) Factors (socio-demographic and attitudes) associated with PrEP acceptability, adherence, retention and behaviours; d) The views and experiences of PrEP users including disclosure; stigma; sexual negotiation. Design: Open-label single-arm treatment evaluation study Gay and bisexual men who fit the behavioural inclusion criteria of being considered high-risk for acquiring HIV will be invited to participate. Participation will require written informed consent. All participants will be prescribed a fixed-dose co- formulation of tenofovir 300mg/emtrictabine 200mg(Trade name Truvada) for daily administration orally. Participants will be followed up 3 monthly for HIV and STI testing and assessment for possible adverse effects. Participants will also be rquired to complete an on-line behavioural survey at baseline and every 3 months to assess any possible behavioural impacts of taking PrEP. The sample size will be limited to 150 participants due to requirements that implementation of the study should not adversely impact on operational and budgetry requirements of the Auckland regional Sexual health Service.There will be no control group as previous studies have shown this intervention to be effective and this is intended to be a demonstration project. WHO is encouraging countries to undertake demonstration projects to facilitate understanding of the safety, effectiveness and sustainability of daily oral PrEP and its use as an addition to existing HIV prevention efforts. Study duration 24 months
Sponsors
Auckland District Health Board
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be eligible to participate men will have to: * Be aged 18 or over and be eligible for funded care in New Zealand * Be resident in Auckland * Be willing and able to provide informed written consent for participation * Be willing and able to take part in all required study procedures * Be willing to provide telephone number(s) and/or email addresses to be contacted during the study period * Have reasonable proficiency in written and spoken English (necessary to complete attitude, behavioural and lifestyle surveys) They must also have the following behavioural eligibility criteria : * Being likely to have multiple events of condomless anal intercourse (CAS) in the next 3 months (sustained risk) and also have any of the following: * A regular sexual partner of an HIV-infected man who is not on anti-retroviral therapy or has detectable viral load with whom condomless anal sex has occurred in the previous 3 months OR * At least one episode of receptive condomless anal intercourse with any casual male partner with HIV infection who is not on anti-retroviral therapy or with a male partner of unknown HIV test status in the previous 3 months OR * A diagnosis of rectal gonorrhoea or rectal chlamydia during the previous 3 months OR * Other high-risk behaviour such as a history of methamphetamine use in the previous 3 months
Exclusion criteria
Potential participants will be excluded for any of the following reasons: * Anyone who is HIV-1 infected at baseline or who has symptoms consistent with acute HIV infection * Anyone unwilling to adhere to any of the required study procedures including attendance at scheduled assessments. * Anyone unwilling to provide written consent to participate * Anyone with an estimated creatinine clearance (glomerular filtration rate [GFR]) of less than 60ml per minute. * Anyone with clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) * Anyone concurrently taking a nephrotoxic agent (e.g., high-dose non-steroidal anti-inflammatory drugs / NSAIDs) * Anyone who has an allergy to tenofovir disoproxil fumarate and/or emtricitabine (based on self-report or recorded). * Anyone with mental health issues, memory loss or other cognitive impairment or intellectual disability that may compromise participant safety and/or regimen adherence * Anyone with co-existing factors or conditions that may compromise a participant’s retention in the study (eg incarceration, planned relocation or potential absence from Auckland for a period of 3 months or longer during the course of the study
Outcome results
None listed