CROI 2016: Personalized Counseling Improves Rate of Entry into HIV Care


Entry into HIV care can be increased by around 40% if people receive a point-of-care CD4 test and counseling sessions to overcome personal barriers to seeking HIV care, according to a large randomized study in South Africa presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2016) last month in Boston. 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 antiretroviral therapy (ART) within 6 months of their HIV diagnosis, highlighting the need for further improvements in linkage to HIV care.

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Linkage to care after diagnosis is an essential precondition for timely initiation of ART, but many people do not progress from the place where they were diagnosed -- often in the community -- to a medical facility for treatment. 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 for 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, presented by Christopher Hoffmann of Johns Hopkins University School of Medicine in Baltimore, was designed to overcome barriers in linkage to care and ART initiation following HIV diagnosis through mobile testing and counseling units in South Africa.

Although mobile testing and counseling is effective in increasing the rate of diagnosis among men, among people who are unaware of their HIV risk, and among 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 3 types of barriers:

Interventions were compared with a standard-of-care study arm, in which participants received counseling to enter care and a referral letter, without a point-of-care CD4 test. Participants were randomized individually.

The study recruited adults who had been diagnosed with HIV by mobile counseling and testing units operating in 7 districts in South Africa, and randomized 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 treatment 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 peri-urban areas, and 81% has taken an HIV test as a routine test. Of those in the arms who received CD4 results prior to clinic attendance, 32% to 36% had a CD4 count below 350 cells/mm3 and 25% to 29% had a CD4 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






POC CD4 + treatment counseling






POC CD4 + personal counseling


62% at least 1 session




POC CD4 + transport






Contact or clinical record review was successful for 89% of study participants. Those randomized to the care facilitation (personal counseling) arm were significantly more likely to demonstrate 90-day entry into care (hazard ratio [HR] 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 3 months or not in”, said 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 transportation reimbursement may have influenced the effectiveness of that strategy, Hoffmann said, but he also noted that lack of transportation access was not a barrier to care in this study population. In urban and peri-urban areas the average distance to a clinic was 2.5 km.

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 Hoffmann to conclude that a combination of individual-level strategies may be needed in order to improve entry into care.



C Hoffmann, T Mabuto, S Ginindza, et al. A Randomized Trial to Accelerate HIV Care and ART Initiation Following HIV Diagnosis.Conference on Retroviruses and Opportunistic Infections. Boston, February 22-25, 2016. Abstract 113LB.