A systematic effort to promote HIV testing, linkage to care for people diagnosed with HIV and circumcision for those testing negative can result in high levels of diagnosis, linkage to care and viral suppression in rural communities, a randomised study of combination HIV prevention conducted in South Africa and Uganda has shown.
The findings were presented by Dr Ruanne Barnabas of the University of Washington Department of Global Health on Monday at the Eighth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2015) in Vancouver, Canada.
Combination HIV prevention has been promoted by UNAIDS as essential in high-prevalence settings, but there have been remarkably few studies which assess the efficacy of a combination of approaches, especially in multifactorial designs. Combination HIV prevention studies are needed to test how different approaches work together and how limited resources can be used efficiently to maximise diagnosis, linkage to care and uptake of prevention services.
Efforts to maximise HIV diagnosis through community-based testing provides an important opportunity both for diagnosing people with HIV infection and linking them to care, and identifying people who are HIV-negative and in need of prevention services. Reaching younger men who might benefit from circumcision has been a particular challenge
Several large community-based studies have previously examined how to maximise the uptake of HIV testing and achieve linkage to HIV care for those diagnosed with HIV. Two large multi-disease prevention campaigns, in Kenya and Uganda, showed that it was possible to achieve very high uptake of HIV testing through running time-limited campaigns in a locality, during which people were offered commodities such as water filters or screening for a range of health problems such as diabetes in addition to HIV testing. These studies also examined linkage to care, but did not compare methods of linkage to care.
The Project ACCEPT randomised study showed that widespread community mobilisation and the provision of mobile testing services were sufficient to result in a 14% fall in HIV incidence in the communities which received the intervention, when compared to the provision of standard voluntary counselling and testing services.
But there is still a big gap between HIV diagnosis and starting antiretroviral therapy. Large numbers of people diagnosed with HIV either never make it to the clinic to be assessed for antiretroviral therapy eligibility, or else don’t return when told that they are not yet eligible. Efforts to improve linkage to care after diagnosis are critical for preventing a situation where people stay away from medical care until they are sick, and for maximising the number of people who are able to benefit from antiretroviral therapy. Numerous speakers at the conference agreed that improving linkage to care is now one of the most critical challenges facing HIV programmes as they work to achieve the UNAIDS 90-90-90 target.
The Linkages study, developed by the University of Washington’s Department of Global Health, was designed to test a number of different approaches to maximising linkage to care, initiation of antiretroviral therapy and uptake of voluntary medical male circumcision. HIV testing was offered in two communities in rural Kwazulu Natal, South Africa, and rural Sheema district, Uganda.
750 uncircumcised men who tested negative were randomised to one of three interventions promoting medical male circumcision:
standard of care promotion at point of HIV testing
SMS follow-up with motivating, unidentifiable messages at months 1, 2 and 3
lay counsellor follow-up visits at months 1, 2 and 3.
The primary outcomes in this study arm were the proportion of HIV-uninfected men who visited a male circumcision clinic or outreach venue for information about circumcision, and the proportion who reported being circumcised by months 3 and 9 in the lay counsellor arm compared to the SMS follow-up arm, and to the male circumcision promotion at HIV testing arm.
The study found that both innovative methods of promoting circumcision resulted in an increase in uptake of approximately 70% when compared to standard of care, with the greatest impact in the first three months after testing.
HIV-positive linkage arm
1325 people who tested positive were randomised twice: the first randomisation was to determine CD4 cell count for treatment staging either by point of care CD4 test, or by referral to the clinic for CD4 testing.
Participants in each arm were then randomised to be linked to care through one of the following methods:
lay counsellor follow-up, consisting of home visits at months 1, 3 and 6, and counselling support for antiretroviral therapy initiation and adherence
accompaniment to the HIV clinic by lay counsellor
standard of care clinic referral.
The primary outcome in this study arm was the proportion of participants linked to care, and obtained a staging CD4 test, initiated antiretroviral therapy if eligible, or had a viral load <50 copies/ml within 9 months in the lay counsellor follow-up arm compared to the accompaniment and clinic referral arms.
The median CD4 cell count was 512 cells/mm3, 75% of participants were newly diagnosed and the median age of participants was 31 years. 29% of participants were male.
In the HIV-positive linkage to care randomisation, both lay counsellor follow-up and accompaniment to HIV clinic by lay counsellor were significantly more effective than standard clinic referral in ensuring linkage to care. 98% of people in the clinic visit facilitation arm (p < 0.001) and 93% in the lay counsellor follow-up arm (p < 0.044) were linked to the HIV clinic compared to 89% of those who received standard referral. There was also a significant difference in antiretroviral therapy initiation among those randomised to the lay counsellor follow-up arm, who received therapy initiation and adherence counselling at home. 41% in this arm started antiretroviral therapy, compared to 34% in the standard of care arm (p < 0.028). Clinic visit facilitation did not result in an increased rate of therapy initiation (37% vs 34%, p = 0.260). Although obtaining a staging CD4 count was significantly more likely in those offered a point of care test, there was no difference in the uptake of clinic visits, antiretroviral therapy or viral suppression according to the method of receiving a staging CD4 count.
In fact, the main barrier to antiretroviral therapy initiation appeared not to be related to how people were linked to care, but what happened when they attended the clinic. Only 67% of people eligible for therapy had started treatment within nine months of being randomised. Of those who did not initiate therapy, 45% found the logistics of attending the clinic – including multiple visits and waiting time – defeated them, while 44% were told they were not yet eligible for treatment.
These results show that strategies which make engagement with clinics easier pay dividends in linkage to care and uptake of treatment, but treatment programmes need to look at local priorities for improving linkage to care, said Dr Ruanne Barnabas. “We need to get very granular in how we look at linkage to care,” she concluded.
Barnabas R et al. Community-based HIV testing and linkage effectively delivers combination HIV prevention: results from a multisite randomized trial. Eighth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Vancouver, abstractMOAC0105LB, 2015.
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