Providing information on how to navigate care pathways,
psychosocial support, and immediate antiretroviral therapy (ART) to
HIV-positive people who inject drugs in Ukraine, Vietnam and Indonesia
increased retention in care, ART use, viral suppression as well as use of
methadone and other medication-assisted treatment (MAT) for drug use, according
to a randomised trial recently published in The
Lancet.
There also appeared to be an effect on new HIV infections in
injecting partners, although HIV incidence was low and it would therefore be
difficult to design a larger study to validate this finding.
“To our knowledge,
our study is the first to have investigated and rigorously documented the
efficacy of systems navigation and psychosocial counselling on ART uptake, MAT
uptake, mortality, and potential HIV transmission among PWID [people who inject drugs] with HIV,” write
the authors. “The flexible, integrated navigation and psychological counselling
intervention had strong effects on ART and ART uptake and overall mortality,
with a promising effect on HIV seroconversion.”
The authors of an editorial accompanying the study suggest
that evidence-based combination prevention has the potential to end HIV
epidemics among people who inject drugs in these settings. “Enough is known
about how to reduce HIV transmission among PWID that multiple implementation
science studies should be done in the effort to end HIV epidemics among PWID in
low- and middle-income countries.”
People who inject drugs have a high incidence of HIV. Overall, people who inject drugs also have
poorer engagement with HIV care than other patient groups. Access to
appropriate HIV and drug-treatment and prevention services can be limited by
stigma, complex bureaucracy and punitive government policies. Many HIV-positive people who inject drugs start ART late, resulting in an increased risk of transmitting HIV to
injecting partners and also higher mortality risk.
Recruitment to the study took place between 2015 and 2016 at
sites in the Ukraine, Vietnam and Indonesia. All these countries have ongoing
HIV epidemics among people who inject drugs and MAT is available.
Adult HIV-positive people who inject drugs with a viral load above 1000
copies/ml were recruited as index participants. Each HIV-positive participant
was asked to recruit at least one HIV-negative partner with whom they injected
drugs.
The HIV-positive index patients were randomised into two
groups. The first received standard of care: referral to HIV and MAT services,
harm reduction services, risk reduction counselling and testing for
co-infections.
People who received the integrated intervention received the
standard harm reduction package plus:
- Support from a ‘systems
navigator’ to facilitate engagement and retention in ART and MAT services.
Barriers to care were addressed and help was given in such as scheduling
appointments, dealing with administrative requirements and answering health-related
questions.
- Psychosocial counselling:
motivational interviewing, problem solving, skills building, and goal setting
in relation to ART and MAT.
- Immediate ART, regardless of CD4
cell count.
The
study’s primary objective was to determine the feasibility of a future, larger
randomised trial by estimating HIV incidence among injecting partners in the
standard-of-care group; enrolment and retention in care among HIV-positive
index patients; and uptake of the intervention over 52 weeks of follow-up. The
key secondary outcomes were the effect of the intervention on uptake of ART,
MAT and viral suppression.
The study population consisted of 502 HIV-positive index
cases and 806 HIV-negative injecting partners. Most (87%) were men.
At baseline, the HIV-positive participants had a median
viral load of 40,000 copies/ml, median CD4 cell count was 293 cells/mm3 and
80% were ART naïve. Use of methadone or other MAT was low in both index
patients and their partners (22% vs 19%).
A quarter of index patients were randomised to receive the
integrated intervention; the rest were allocated to standard of care.
In the intervention arm, retention in the study up to 52
weeks was good for both index participants and injecting partners (86% and 80%,
respectively). Index cases had a median of five meetings with their system
navigator in the first eight weeks after enrolment. Over half of these meetings
were by phone and three-quarters lasted less than ten minutes.
Index cases had a median of seven appointments with their
counsellors. These tended to be longer and most commonly addressed ART
adherence, engagement in care, risk reduction, HIV literacy, communication
skills to discuss adherence challenges with HIV care providers, and dealing
with HIV infection. Participants were encouraged to bring a family member,
partner or other support person to counselling sessions; three-quarters were
accompanied to at least one session.
Results at 52 weeks were:
- Uptake of ART was significantly
higher in the intervention group than the standard-of-care group (72% vs 43%).
- Viral suppression was
significantly higher in the intervention group than the standard-of-care group
(41% vs 24%), although it remained sub-optimal.
- Uptake of methadone or other MAT
was significantly higher in the intervention group than the standard-of-care
group (41% vs 25%), although it remained sub-optimal.
- Mortality was significantly lower
in the intervention group than the standard-of-care group (5.6 vs 12.1 deaths
per 100 person-years).
- Incidence in injecting partners:
no partners in the intervention group were newly infected with HIV, whereas there
were seven new infections in the standard-of-care group (1% incidence per year).
However, the study was not powered to detect a difference in incidence and this
result was not statistically significant.
Results were better in Vietnam and Ukraine than in
Indonesia, possibly due to Indonesian participants being less engaged with the
counselling and being more likely to have previously had HIV treatment (and
therefore drug resistance).
“A scalable, integrated intervention combining systems navigation
and flexible psychosocial counselling, increased self-reported ART, viral
suppression, and self-reported MAT, and reduced mortality,” conclude the
authors.
“The intervention might have reduced HIV incidence, but
incidence was low in both groups of uninfected partners. The low incidence
presents a challenge for any similar future trial assessing transmission and
precludes a future, randomised controlled trial.”