Back HIV/AIDS HIV/AIDS Topics HIV Treatment Starting HIV Treatment at First Clinic Visit After Diagnosis Improves Outcomes

Starting HIV Treatment at First Clinic Visit After Diagnosis Improves Outcomes

alt

A South African program aimed at shortening the usual process of HIV diagnosis, counseling, and preparation for antiretroviral therapy (ART) led to more people initiating treatment and achieving viral suppression, according to findings from the RapIT study published in the May 10 edition of PLoS Medicine.

The START and Temprano trials have shown that starting ART promptly reduces the occurrence of AIDS-related events, serious non-AIDS illness, and death. The World Health Organization now recommendstreatment for everyone diagnosed with HIV, regardless of CD4 T-cell count. Yet despite these new guidelines, many people with HIV start treatment too late, after they have already developed extensive immune system damage.

Sydney Rosen from Boston University School of Public Healthand colleagues estimated the effect of an accelerated initiation algorithm that allowed treatment-eligible individuals to receive their first supply of antiretroviral medications on the day of their first HIV-related clinic visit. Results were previously presented in partat the 2016 Conference on Retroviruses and Opportunistic Infections (CROI).

Many people in sub-Saharan Africa are lost to care between HIV testing and treatment initiation, in part due to a lengthy and burdensome process that imposes long waits and multiple clinic visits, the study authors noted as background. At CROI Rosen suggested that this complex process is a legacy of scarce and toxic drugs used in the past and the belief that people need time, counseling, and education to become ready for lifelong therapy.

In a typical scenario a person might take an HIV test, give a blood sample, and complete a tuberculosis (TB) screen during their first visit, obtain CD4 and TB results and start TB treatment if needed on their second visit, and undergo counseling and adherence education during their third, fourth, and fifth visits, before finally receiving antiretrovirals on their sixth visit.

RapIT (NCT01710397) was a randomized controlled trial was designed to assess single-visit treatment initiation at 2 public sector clinics in South Africa -- a primary health clinic and a hospital-based HIV clinic. The RapIT protocol aimed to condense HIV testing, counseling, and dispensing of antiretrovirals into a single clinic visit, ideally on the same day a person tests HIV-positive.

Between May 2013 and August 2014, RapIt enrolled 377 people who received a positive HIV test or their first treatment-eligible CD4 count. More than half were women (though pregnant women were excluded), the median age was about 35 years, and the media CD4 count was 210 cells/mm3, indicating advanced immune suppression. About 40% had tested HIV-positive the same day.

Participants were randomly assigned to either the rapid protocol or the standard multi-visit protocol. The 187 patients in the rapid arm received a point-of-care CD4 test if not already done, and those eligible for ART (based on older CD4-dependent treatment guidelines) received a TB test if symptomatic, blood tests, a physical exam, education, counseling, and were given antiretrovirals. The 190 patients in the standard arm had 3 to 5 additional clinic visits over a 2 to 4 week period before receiving ART. Most started on a standard first-line ART regimen unless contraindicated; drug resistance testing was not done prior to dispensing antiretrovirals.

Results

  • 97% of participants in the rapid arm initiated HIV treatment within 90 days of enrollment, compared with 72% in the standard arm (relative risk 1.36).
  • 72% of people in the rapid arm started ART the same day and another 7% did so the following day.
  • The median time from study enrollment to dispensing of the first supply of antiretrovirals was 2.4 hours for those who started the same day. 
  • 64% of participants in the rapid arm achieved viral suppression by 10 months, compared with 51% in the standard arm (relative risk 1.26).
  • 81% of patients in the rapid arms and 64% in the standard arm were retained in care, defined as having a clinic visit between months 5 and 10 after study enrollment.
  • Among patients who started ART within 90 days, the likelihood of dropping out of treatment during the first 10 months did not differ significantly between the 2 arms (hazard ratio 1.06).
  • However, most loss to care involved never starting treatment in the standard arm (78%), but usually occurred after ART initiation in the rapid arm (86%).
  • Improved outcomes were especially evident for men under age 35 (34% difference in viral suppression), but the difference was not significant for older women or men.

Rapid treatment initiation "appeared acceptable to patients at the time it was offered and feasible to implement at both study sites," the study authors wrote. Nearly 4 out of 5 patients offered the intervention accepted ART initiation on the same day or the next day, and they "consistently expressed appreciation for the opportunity to start immediately."

For the 48 people in the rapid arm who did not start treatment on the same day, reasons included need for clinical confirmation of TB or a stage 3 or 4 condition, needing TB treatment, insufficient time to complete all steps on the same day, patient preference, and lack of electricity in the clinic due to power outages.

The researchers noted that nothing in the rapid initiation procedure differed fundamentally from existing clinic procedures. The intervention was delivered by study nurses and counselors with the same qualifications as existing clinic staff and the intervention imposed "no major burdens" on site management. The main technical training requirement was for using point-of-care test instruments, which also required a secure location within the clinic, temperature control, and electricity.

"Offering single-visit ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%," the researchers concluded. "This intervention should be considered for adoption in the public sector in Africa."

"The patients who likely benefited most from RapIT were those who would not otherwise have initiated treatment at all, or who would have waited until they were sick enough to compromise their prognosis on treatment," they suggested in their discussion. "In the standard arm, most patients who did not start treatment did not return to the study clinics for even one more visit, underscoring the importance of taking full advantage of the first visit to get as many patients started on treatment as possible. For those who would have initiated treatment, just not as soon, there is some evidence that even relatively short delays may be harmful…Delaying treatment initiation thus both deters some patients from starting at all and jeopardizes outcomes for those who do start."

6/15/16

Reference

S Rosen, M Maskew, MP Fox, et al. Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial. PLoS Medicine. May 10, 2016.