Entry into HIV care can be increased by around 40% if people receive a point-of-care CD4 test and counselling sessions to overcome personal barriers to seeking HIV care, a large randomised study in South Africa has shown. However, the study also found that only half of the people who received the most effective linkage intervention and who were in need of immediate treatment made it onto treatment within six months of their HIV diagnosis, highlighting the need for further improvements in linkage to HIV care.
The findings from the Thol’impolo study were presented last week at the Conference on Retroviruses and Opportunistic Infections (CROI 2016) in Boston by Christopher Hoffmann of Johns Hopkins University School of Medicine, Baltimore.
Linkage to care after diagnosis is an essential precondition for timely initiation of antiretroviral therapy (ART), but many people fail to progress from the place where they were diagnosed – often in the community – to a medical facility. Studies conducted in southern Africa published between 2011 and 2015 show that the gap between diagnosis and linkage to care can be alarmingly wide: these studies reported anywhere between 8.5 and 69% of people diagnosed with HIV made it into care within 90 to 180 days of diagnosis. The length of the interval between diagnosis and linkage to care, and between diagnosis and starting ART is especially critical in people with CD4 cell counts below 350 cells/mm3, where delayed treatment initiation is associated with a high risk of progression to symptomatic disease.
The Thol’impolo study was designed to overcome barriers in linkage to care and antiretroviral initiation following HIV diagnosis through mobile testing and counselling units in South Africa. Although mobile testing and counselling is effective in increasing the rate of diagnosis among men, among people who are unaware of their HIV risk and people who are asymptomatic, these are also groups which have a higher probability of loss from the continuum of care, whether because of work commitments, lack of awareness of the need for treatment or difficulties in coming to terms with an HIV diagnosis.
The Thol’impolo study was designed to compare interventions addressing three types of barriers:
Health perceptions, specifically regarding understanding of the need for HIV treatment. Participants in this arm of the study received a point-of-care CD4 test and counselling regarding the meaning of a point-of-care CD4 test result and the need to start treatment.
Personal barriers, in particular stigma, disclosure and self-confidence. Participants in this arm of the study received a point-of-care CD4 test and up to five counselling sessions based on the CDC ARTAS approach to emphasise personal strengths plus follow up by text message or personal visit.
Structural barriers, specifically transport and affordability. Participants in this arm of the study received a point-of-care CD4 test and transport reimbursement in the form of vouchers, cash or mobile phone credit for three clinic visits ($10 for rural residents, $6 for periurban and urban residents).
Interventions were compared with a standard-of-care study arm, in which participants received counselling to enter care and a referral letter, without a point-of-care CD4 test. Participants were randomised individually.
The study recruited adults who had been diagnosed with HIV by mobile counselling and testing units operating in seven districts in South Africa, and randomised 2558 participants (approximately 152 participants were later found to be in HIV care already, and so were excluded from the analysis).
The primary study outcome was self-reported entry into care within 90 days of referral (verified by mobile phone follow up or home visit at 90 and 180 days after study entry), with secondary outcomes of 90-day entry into care verified by chart review and initiation of antiretroviral therapy within 180 days of referral, verified by chart review. Entry into care was defined as clinic attendance for HIV care at which a file was opened on the participant and blood was drawn for CD4 count or other pre-ART baseline tests.
Approximately 60% of study participants were women, 62% lived in urban or periurban areas and 81% has taken an HIV test as a routine test. Of those in the arms who received CD4 counts prior to clinic attendance, 32 to 36% had a CD4 cell count below 350 cells/mm3 and 25 to 29% had a CD4 cell count between 350 and 500 cells/mm3, according to study arm.
Available for analysis (n) |
Uptake of intervention |
90-day entry into care (self report) |
90-day entry into care (clinic record) |
180-day ART initiation (clinic record) |
|
Standard of care |
591 |
n/a |
50% |
29% |
13% |
POC CD4 + treatment counselling |
614 |
97.4% |
51% |
30% |
16% |
POC CD4 + personal counselling |
603 |
62% at least one session |
55% |
38% |
18% |
POC CD4 + transport |
590 |
48% |
49% |
31% |
15% |
Contact or clinical record review was successful for 89% of study participants. Those randomised to the care facilitation (personal counselling) arm were significantly more likely to demonstrate 90-day entry into care (hazard ratio 1.4, 95% CI 1.1-1.7) and ART initiation within 180 days (HR 1.4, 95% CI 1.1-1.9) when compared to the standard-of-care arm. Other comparisons with the standard-of-care arm were non-significant.
The study investigators found that if linkage took place, it did so fairly rapidly. “Most people are either in by three months or not in”, said Christopher Hoffmann.
Approximately half of those eligible initiated ART – South African guidelines during the study period recommended treatment for people with CD4 cell counts below 350 cells/mm3 – so care facilitation increased the likelihood of starting ART within 180 days by 40%. Challenges in delivering transport reimbursement may have influenced the effectiveness of that strategy, said Christopher Hoffmann, but he also noted that lack of transport access was not a barrier to care in this study population. In urban and periurban areas the average distance to a clinic was 2.5km.
One challenge to the conventional wisdom in these results was the finding that point-of-care CD4 testing alone did not improve entry into care. Participants appeared to need further support and follow up, leading Christopher Hoffmann to conclude that a combination of individual-level strategies may be needed in order to improve entry into care.
Hoffmann C et al. A randomized trial to accelerate HIV care and ART initiation following HIV diagnosis. Conference on Retroviruses and Opportunistic Infections, Boston, abstract 113LB, 2016.