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

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

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:

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

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

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

Exclusion Criteria:

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