We aim to follow serodifferent partnerships who initially report recently having had unprotected sexual intercourse in order to study (i) the risk of HIV transmission to partners, in particular in partnerships that continue not to use condoms…
ID
Source
Brief title
PARTNER study
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary analysis will be estimation of the rate of infection in partners
per person year of unprotected sex partnership where the index patient has
viral load <50 c/mL, excluding new infections that are shown to be
phylogentically distinct from the HIV positive partner*s virus; i.e.
transmission has not been from the HIV positive partner. This will be
calculated as the number of infections identified at the end of eligible
periods divided by the sum of the person time over eligible periods (see below
for definition of eligible periods).
Secondary outcome
In secondary analyses we will also estimate
(i) the rate of infection in partners per unprotected sex act where index
patient has viral load < 50 c/mL, as opposed to per person year (this will be
done by summing numbers of acts of anal and vaginal intercourse over eligible
periods)
(ii) the rate of infection if we replace 50 copies/mL by 200 copies/mL in the
above definition and
(iii) the rate of transmission if we insist that the next viral load value in
the HIV positive partner after the end of the period is also < 50 copies/mL,
(iv) the rate of transmission if we consider periods to be eligible if only
oral sex is reported,
(v) the rate of transmission if we ignore viral load measures made on the HIV
positive partner which are within 4 weeks of the end of the period (because of
the lag time in obtaining a result).
We will assess the proportion of partnerships that begin to adopt consistent
condom use (ie reporting by both partners of 100% of episodes of sexual
intercourse in which a condom was used) and assess factors associated with this
using logistic regression.
Background summary
It is consistently reported that a proportion of people with diagnosed HIV do
not always use a condom when having sexual intercourse with partners of
negative or unknown HIV status. There are likely to be many reasons for this,
and these reasons may have changed over time. It is important to study HIV
serodifferent partnerships (where one partner is HIV positive and the other HIV
negative) that report having unprotected sex to understand the reasons why
condoms are not used, and to see what factors are associated with partnerships
beginning to adopt consistent condom use. Increasingly, one reason for not
using condoms is likely to be due to the person being on antiretroviral therapy
with the plasma viral load being < 50 copies/mL, and statements on the likely
reduced infectiousness of people in this situation have been issued (1,2).
There is increasingly strong evidence that virally suppressive ART reduces
infectiousness of people with HIV through sex (1-21). However, precise
estimates of this risk of transmission from unprotected intercourse when the
infected person is on ART with a most recent plasma viral load < 50 copies/mL
are not available, particularly for men who have sex with men (MSM). It is
extremely important that more precise estimates are obtained, both for
counselling purposes, and for investigations into the potential prevention
effects of a policy of expanding ART coverage to be offered to all people with
diagnosed HIV.
It should be noted that while levels of HIV viral load in plasma are measured
as part of patient clinical care, levels of HIV in genital fluids are likely to
be more relevant for sexual transmission. The two are highly correlated and
antiretroviral therapy markedly reduces levels of HIV in semen (22-39), but
detectable levels of HIV RNA have been found in genital fluids among those with
plasma viral load, which is < 50 c/mL (40). Intercurrent sexually transmitted
infections can lead to a transient increase in viral load in the genital
compartment that could increase transmission risk temporarily (41). It should
also be noted that detectable levels of infectious virus being present in semen
or other genital fluids does not necessarily equate to the person being
infectious since presence of drug in the same fluid may act to prevent
infection of cells in the partner.
Study objective
We aim to follow serodifferent partnerships who initially report recently
having had unprotected sexual intercourse in order to study (i) the risk of HIV
transmission to partners, in particular in partnerships that continue not to
use condoms consistently and the HIV-positive partner is on therapy with a
viral load < 50 copies/mL and (ii) why some partnerships do not use condoms, to
describe the proportion who begin to adopt consistent condom use, and factors
associated with this.
Study design
This is an observational study in which HIV serodiscordant partnerships will be
followed over time, with 3-6 monthly reporting of transmission risk behaviour
and HIV testing for the HIV negative partner.
Study burden and risks
HIV positive partner
At baseline visit
To sign a consent for participation in the study, in which the partner is
identified by name and date of birth
To complete a baseline risk behaviour questionnaire (approximately 15 mins)
At each clinic follow-up visit while the partner remains under follow-up
To complete a follow up risk behaviour questionnaire (approximately 15 mins)
If HIV negative partner becomes infected with HIV:
To provide an additional blood sample so that virus can be compared anonymously
with that of the newly infected HIV negative partner
HIV negative partner
At baseline visit
To attend clinic (with or separately from the HIV positive partner) and sign
consent for participation in the study, in which the partner is identified by
name and date of birth
To test for HIV
To complete a baseline risk behaviour questionnaire (approximately 15 mins)
At 3-6 monthly intervals after the baseline visit
To complete a follow up risk behaviour questionnaire (approximately 20 mins)
To test for HIV
Note that the HIV negative partner has to fill out the questionnaire before
receiving the HIV test result
If becomes infected with HIV:
To provide an additional blood sample so that virus can be compared anonymously
with that of the HIV+ partner
Length of follow-up
We anticipate the study will take 1.5 years in order to recruit to the cohort.
Partnerships will be followed for 2 years.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria
- Confirmed HIV positive
- On ART (regardless of viral load)
- Age > 18
- Expected to remain under care at the clinic for as long as the participate in the study ;Has a partner not known to be HIV infected and the following criteria are met:
- The partners have had unprotected penetrative anal or vaginal intercourse together in the past month (during which period the HIV negative partner was aware of the HIV status of the HIV positive partner)
- The partners expect to have sex together again in the coming months
- Both partners consent to attend clinic to complete a risk behaviour questionnaire every 3-6 months for as long as they participate in the study.
- The HIV negative partner consents to testing for HIV at these visits.
- Both partners consent to provide a separate blood sample if the HIV negative partner should become infected with HIV (this is for an anonymous comparison of viruses * results will not be linked to the partnership)
Exclusion criteria
Pregnancy. (Only upon inclusion, if a woman (whether the negative or the positive partner) becomes pregnant during the study, then the partnership can continue in the study, if they wish to do so).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33075.018.10 |