HIV InfectionsNCT03253757
PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation
An observational study of HIV Infections, run by St Stephens Aids Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- This study is non-interventional.
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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: 1. Have sex with men 2. Have had an HIV negative test during an earlier episode of care in the preceding year 3. Report condomless intercourse in the previous 3 months 4. Affirm their likelihood of having condomless intercourse in the next 3 months B. HIV negative partners of an HIV positive person when: 1. The HIV positive partner is not known to be virally suppressed (<200 copies/ml for 6 months or more) 2. 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
Who may be able to join
- 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:
- 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
Show all 18Show fewer
- 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
Who cannot join
- An acute viral illness that could be due to HIV seroconversion
- Any contraindication to Tenofovir Disoproxil (TD)/ Emtricitabine (FTC)-
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
- Conditions
- HIV Infections
- Being tested
- This study is non-interventional.
- Keywords
- PrEP, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study is non-interventional.Other
This study is non-interventional.
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Eligibility
The proportion of GUM clinic attendees meeting the eligibility criteria for PrEP
Measured: 3 years
PrEP Eligibility (duration)
The duration for which GUM clinic attendees are eligible for PreP
Measured: 3 years
PrEP Uptake
The proportion of PrEP eligible GUM clinic attendees prescribed PrEP
Measured: 3 years
PrEP Uptake (duration)
The duration for which eligible GUM clinic attendees use PrEP
Measured: 3 years
Secondary outcomes (3)
HIV
HIV diagnoses reported by sites and identified through the national surveillance dataset
Measured: 3 years
STIs
STI diagnoses (gonorrhoea, chlamydia, syphilis and hepatitis C) reported in the national surveillance dataset
Measured: 3 years
Adverse Events
- Serious suspected adverse drug reactions reported using the yellow card system
- Antiretroviral resistance associated mutations in participants with incident HIV infection
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England, NHS England
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253757
- Sponsor's protocol ID
- SSCR104
- Status last verified
- Aug 2017
- First submitted
- 16 Jun 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data used in the study will be pseudo-anonymised and used for the purposes of determining the implementation of PrEP in England.
Publications
Ogaz D, Chiavenna C, Mitchell HD, Cartier A, Golombek R, Charlett A, Jaffer S, Diamente V, Mohammed H, Carlin E, Williams P, Phillips M, Gill ON, Saunders J, Sullivan AK; Impact Study Group. Disrupted access and diverging pathways to sexual health services during COVID-19: insights from the PrEP Impact Trial in England. BMC Infect Dis. 2026 Jul 28;26(1):1885. doi: 10.1186/s12879-026-14044-5.
PubMed 42934544Sullivan 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.
PubMed 38040478
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation
- ClinicalTrials.gov ID
- NCT03253757
- Acronym / sponsor ID
- SSCR104
- Conditions
- HIV Infections
- Keywords
- PrEP, HIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Collaborators
- Public Health England, NHS England
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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: 1. Have sex with men 2. Have had an HIV negative test during an earlier episode of care in the preceding year 3. Report condomless intercourse in the previous 3 months 4. Affirm their likelihood of having condomless intercourse in the next 3 months B. HIV negative partners of an HIV positive person when: 1. The HIV positive partner is not known to be virally suppressed (<200 copies/ml for 6 months or more) 2. 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
Key inclusion criteria (18 listed)
- 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:
- 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
Key exclusion criteria (2 listed)
- An acute viral illness that could be due to HIV seroconversion
- Any contraindication to Tenofovir Disoproxil (TD)/ Emtricitabine (FTC)-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study is non-interventional.This study is non-interventional. | Other | – |
Primary outcome
PrEP Eligibility
Time frame: 3 years
The proportion of GUM clinic attendees meeting the eligibility criteria for PrEP
PrEP Eligibility (duration)
Time frame: 3 years
The duration for which GUM clinic attendees are eligible for PreP
PrEP Uptake
Time frame: 3 years
The proportion of PrEP eligible GUM clinic attendees prescribed PrEP
PrEP Uptake (duration)
Time frame: 3 years
The duration for which eligible GUM clinic attendees use PrEP
3 secondary outcomes
HIV
Time frame: 3 years
STIs
Time frame: 3 years
Adverse Events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Derived from this study: PubMed 42934544Ogaz D, Chiavenna C, Mitchell HD, Cartier A, Golombek R, Charlett A, Jaffer S, Diamente V, Mohammed H, Carlin E, Williams P, Phillips M, Gill ON, Saunders J, Sullivan AK; Impact Study Group. Disrupted access and diverging pathways to sexual health services during COVID-19: insights from the PrEP Impact Trial in England. BMC Infect Dis. 2026 Jul 28;26(1):1885. doi: 10.1186/s12879-026-14044-5.
- Derived from this study: PubMed 38040478Sullivan 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.
- Individual participant dataSharing planned: No. All data used in the study will be pseudo-anonymised and used for the purposes of determining the implementation of PrEP in England.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by St Stephens Aids Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Reaney (07887476175, impact@ststcr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Eligibility (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03253757, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.