The Role of Home Packs of HIV Post-Exposure Prophylaxis for Sexual Exposure (PEPSE) to Improve the Speed and Appropriate Uptake of PEPSE in High Risk Individuals
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- Number of hours from HIV risk exposure to PEPSE
Study Overview
Brief Summary
The study is looking at a new way to reduce the risk of catching HIV. Post-exposure Prophylaxis for sexual exposure (PEPSE) is where a month of HIV drugs can be given to reduce the chance of getting HIV, after a risk. To improve its use the Investigators want to see whether providing a 5-day course of PEPSE for people to keep at home (HOME PEPSE) will lead to it being taken much quicker than having to get it from sexual health clinics or A&E. The HOME PEPSE packs contain HIV tablets that are used in routine HIV care. However the type of HIV drugs are slightly different to those currently used in PEPSE and the Investigators hope that they will have fewer side effects. HOME PEP consists of Truvada and Maraviroc.
140 gay men who are at high risk of getting HIV will be randomised to one of two groups. Group A will receive HOME PEPSE immediately and group B will receive HOME PEPSE after 48 weeks on the study.
Detailed Description
HIV causes significant morbidity and the estimated lifetime cost of one HIV transmission is £0.5-1 million. Despite enormous prevention efforts, transmission rates in the UK remain stable. The population most at risk of acquiring HIV in the UK are men who have sex with men (MSM), who are estimated to number over 500,000 (3.6% of the male population). The estimated prevalence of HIV among MSM aged between 15 and 44 years old is approximately 5%.
In 2013 the highest ever number of new HIV diagnoses (3,000) among MSM was reported and 85% of these were estimated to have been acquired in the UK.
This is supported by a concomitant increase in reported high risk behaviours such as condomless anal sex, from 24.3% to 36.5% of the cohort surveyed in London gyms in 1998 and 2008 respectively. In London, approximately 80% MSM are HIV negative: however high-risk sex continues in the presence of an increasing pool of HIV infected individuals. As such effective HIV prevention interventions are urgently needed to keep such individuals uninfected.
Despite sustained education and public health messages high levels of condomless sex among MSM are reported. HIV prevention tools include condoms, Post-Exposure Prophylaxis following Sexual Exposure (PEPSE), HIV pre-exposure prophylaxis (PrEP), HIV testing to reduce the undiagnosed fraction, antiretroviral treatment (ART) -as-prevention and circumcision. Clinical trials are underway to evaluate the efficacy and cost effectiveness of these approaches.
PEPSE is a key component of HIV prevention. A prospective randomised-controlled trial to determine the efficacy of PEPSE has been precluded due to the high number of participants that would be required for such a study. A case-control study conducted in healthcare workers suggested that the use of zidovudine (AZT) for post exposure prophylaxis after percutaneous exposure to HIV-infected blood was associated with a significant (OR 0.19 (95% CI 0.06-0.52) decrease in the risk of HIV transmission. In addition, mother to child transmission studies where only the neonate received ART have demonstrated a protective effect.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male gender at birth, age ≥18 years
- •HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomization
- •Willing and able to provide written informed consent
- •And any one of:
- •condomless anal sex with a male on >1 occasion within the 90 days prior to randomization
- •bacterial rectal sexually transmitted infection (STI) within the 90 days prior to randomization
- •use of PEPSE in the 12 months prior to randomization following possible exposure to HIV through unprotected anal intercourse (UAI) with a male
Exclusion Criteria
- •An acute viral illness that could be due to HIV seroconversion
- •Any contraindications to Truvada or maraviroc according to the current SmPC
- •allergic to soy or peanuts
- •concomitant use of antihypertensive agents
- •history of postural hypotension
- •known hepBsAg positive
- •current participation in a HIV PrEP or PEPSE study
- •Any other active clinically significant condition, or findings during screening medical history or examination, or abnormality on screening laboratory blood tests that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial.
Arms & Interventions
Arm A: Home PEPSE (Immediate)
Patients randomised to the immediate arm (ARM A) will receive a 5 day PEPSE 'Home pack' containing Truvada® (tenofovir disoproxil -as fumarate- 245 mg, emtricitabine 200 mg), ONE tablet OD and Maraviroc 300 mg, TWO tablets OD.
Intervention: Maraviroc (Drug)
Arm A: Home PEPSE (Immediate)
Patients randomised to the immediate arm (ARM A) will receive a 5 day PEPSE 'Home pack' containing Truvada® (tenofovir disoproxil -as fumarate- 245 mg, emtricitabine 200 mg), ONE tablet OD and Maraviroc 300 mg, TWO tablets OD.
Intervention: Truvada (Drug)
Outcomes
Primary Outcomes
Number of hours from HIV risk exposure to PEPSE
Time Frame: 48 weeks
In those accessing PEPSE, the number of hours from HIV sexual risk exposure to initiating PEPSE over 48 weeks.
Secondary Outcomes
No secondary outcomes reported