PrEP Impact Trial: A Pragmatic Health Technology Assessme... | NCT03253757

Studies
PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation

NCT03253757

Sponsor

St Stephens Aids Trust

Status

Unknown status

Last Update Posted

Aug 18, 2017Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

HIV Infections

Interventions

This study is non-interventional.

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Estimated

Primary Completion Date

Sep 1, 2020Estimated

Completion Date

Sep 1, 2020Estimated

First Submitted Date

Jun 16, 2017

First Submission Date that Met QC Criteria

Aug 15, 2017

First Posted Date

Aug 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2017

Last Update Posted Date

Aug 18, 2017Actual

Name	Class
Public Health England	OTHER_GOV
NHS England	OTHER_GOV

Description Module

Brief Summary

HIV pre-exposure prophylaxis (PrEP) is the use of anti-HIV medicines by HIV negative people in order to prevent them from becoming HIV positive if exposed to HIV.

Currently, the combination drug containing tenofovir and emtricitabine is licensed in Europe for use as HIV PrEP. We know from previous studies worldwide that this combination drug is very good at reducing the risk of HIV infection and several countries have implemented PrEP programmes to provide PrEP to individuals at high risk of HIV.

However, it is difficult to effectively plan for a national PrEP programme in England without knowing how many people will need PrEP, how many will want to take PrEP, and how long they will stay on PrEP.

In order to find this out, the PrEP Impact Trial will make PrEP available to at least 10,000 people over three years. HIV negative men and women attending sexual health clinics in England will have their risk of HIV assessed by their care team and be offered PrEP if they meet the eligibility criteria. Through the trial we will be able to measure how many attendees at sexual health clinics meet eligibility criteria for PrEP, how many of these take up the offer of PrEP and how long they remain on PrEP for.

There will not be any additional tests other than those recommended for the safe delivery of PrEP. These include tests for sexually transmitted infections (STIs) and HIV as well as urine and blood tests to monitor kidney function. Information about attendances and test results will be anonymously collected through the existing data reporting system that sexual health clinics currently use to report to Public Health England.

Detailed Description

Not provided

Name	Type	Description	Arm Group Labels	Other Names
This study is non-interventional.	Other	This study is non-interventional.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PrEP Eligibility	The proportion of GUM clinic attendees meeting the eligibility criteria for PrEP	3 years
PrEP Eligibility (duration)	The duration for which GUM clinic attendees are eligible for PreP	3 years
PrEP Uptake	The proportion of PrEP eligible GUM clinic attendees prescribed PrEP	3 years
PrEP Uptake (duration)	The duration for which eligible GUM clinic attendees use PrEP	3 years

Secondary Outcomes

Measure	Description	Time Frame
HIV	HIV diagnoses reported by sites and identified through the national surveillance dataset	3 years
STIs	STI diagnoses (gonorrhoea, chlamydia, syphilis and hepatitis C) reported in the national surveillance dataset

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant populations for this trial will be men and women attending GUM clinics who belong to one of three populations recognised to be at high risk for HIV, namely:

A. Men (cisgender and transgender) and transgender women who:

Have sex with men
Have had an HIV negative test during an earlier episode of care in the preceding year
Report condomless intercourse in the previous 3 months
Affirm their likelihood of having condomless intercourse in the next 3 months

B. HIV negative partners of an HIV positive person when:

The HIV positive partner is not known to be virally suppressed (<200 copies/ml for 6 months or more)
Condomless intercourse is anticipated before treatment of the HIV positive partner takes effect

C.HIV negative persons who:

1. Are clinically assessed and considered to be at similar high risk of HIV acquisition as those with a serodiscordant partner who is not known to be virally suppressed

Participants will therefore be considered eligible for trial enrolment if they fulfil all the following individual eligibility criteria:

Belongs to one of the three at high HIV risk populations described above
Aged 16 years or over (no upper limit)
Considered to be HIV negative on the day of enrolment
Willing and able to provide informed consent
Willing to adhere to the recommended PrEP regimen
Willing to re-attend the trial clinic at appropriate intervals for risk assessment

Exclusion Criteria:

An acute viral illness that could be due to HIV seroconversion
Any contraindication to Tenofovir Disoproxil (TD)/ Emtricitabine (FTC)-

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The participant populations for this trial will be men and women attending GUM clinics who belong to one of three populations recognised to be at high risk for HIV, namely:

A. Men (cisgender and transgender) and transgender women who:

Have sex with men
Have had an HIV negative test during an earlier episode of care in the preceding year
Report condomless intercourse in the previous 3 months
Affirm their likelihood of having condomless intercourse in the next 3 months

B. HIV negative partners of an HIV positive person when:

The HIV positive partner is not known to be virally suppressed (<200 copies/ml for 6 months or more)
Condomless intercourse is anticipated before treatment of the HIV positive partner takes effect

C.HIV negative persons who:

1. Are clinically assessed and considered to be at similar high risk of HIV acquisition as those with a serodiscordant partner who is not known to be virally suppressed

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Hannah Reaney	Contact	07887476175		impact@ststcr.com

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38040478	Derived	Sullivan AK, Saunders J, Desai M, Cartier A, Mitchell HD, Jaffer S, Ogaz D, Chiavenna C, Charlett A, Diamente V, Golombek R, Manavi K, Priestley C, Waters LJ, Milinkovic A, McOwan A, Estcourt C, Sabin CA, Rodger A, Gold D, Gazzard BG, McCormack S, Gill ON; Impact Study Group. HIV pre-exposure prophylaxis and its implementation in the PrEP Impact Trial in England: a pragmatic health technology assessment. Lancet HIV. 2023 Dec;10(12):e790-e806. doi: 10.1016/S2352-3018(23)00256-4.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral