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.”