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Support intervention did not improve ART initiation, TB treatment completion

An intervention using health system navigators, phone support and text message reminders did not improve rates of people living with HIV initiating antiretroviral therapy (ART) or completing treatment for tuberculosis (TB), investigators report in the Journal of Acquired Immune Deficiency Syndromes.

According to AidsMap, people newly diagnosed with HIV in Durban, South Africa, were randomised to receive support from trained health navigators or to receive the standard of care. The intervention showed no benefit, with rates of antiretroviral initiation, TB treatment completion and mortality similar between the intervention and standard-of-care groups.

“We did not find an effect of time-limited health system navigation on rates of ART initiation and TB treatment completion among people newly diagnosed with HIV in Durban,” write the authors. “Further studies are urgently needed to identify strategies for improving entry to HIV/TB care in high-burden settings.”

Over 6.3 million people are living with HIV in South Africa and approximately 200,000 individuals die each year because of HIV. The country has the largest antiretroviral treatment programme in the world but 60% of people living with HIV in South Africa are not on therapy. The severity of the HIV epidemic in South Africa is exacerbated by the TB epidemic, with an estimated 42% of all deaths in people with HIV due to this infection.

There is significant attrition at each stage of the HIV treatment cascade in South Africa and many other health settings. In the US, the use of health system navigators has been shown to be effective in helping people overcome barriers to care.

Investigators wanted to see if a similar intervention involving people newly diagnosed with HIV or HIV and TB co-infection was effective at increasing rates of antiretroviral initiation and completion of TB treatment.

They therefore designed a study involving 4903 individuals presenting for HIV testing at four healthcare facilities in Durban. People testing positive for HIV also underwent screening for TB and were randomised to the intervention arm or to receive standard of care.

The intervention consisted of an interview with a health system navigator during which barriers and facilitators to entering care were discussed and steps in the HIV/TB care pathway were described.

The navigator provided participants in the study with ongoing support, including five scheduled phone calls (weeks 1, 4, 8, 12 and 16 after enrolment) and four text message reminders to attend appointments and collect test results. People receiving standard of care were told to return to their treatment centre for their CD4 cell count result within two weeks of diagnosis and were contacted for referral to TB services if diagnosed.

A total of 1,899 participants (39%) were newly diagnosed with HIV; 51% were randomised to the intervention arm, the others received usual care. Overall, 49% were female and the mean age was 35 years.

Outcomes were completion of three months of HIV therapy, completion of six months of TB treatment and mortality.

CD4 cell count monitoring showed that 60% of the newly diagnosed people were eligible for ART (median CD4 cell count 112 cells/mm3). TB was diagnosed in 25% of people in the intervention arm and in 30% of people receiving usual care.

In the intervention arm, 22% of people eligible for ART completed three months of therapy and 41% of people with TB completed six months of TB treatment. This was no different from the treatment rates observed among people receiving usual care, with 28% of eligible people starting HIV therapy and 44% of people with TB co-infection completing six months of treatment.

Nor did the intervention have a benefit in terms of mortality rates: during nine months of follow-up, 14% of people in the intervention arm died compared to 13% of people who received the standard of care.

Individuals in the intervention arm received an average of 3.5 calls from the navigator, with each call lasting an average of 17 minutes. Analysis of participants alive at the end of the study showed that 22% of those receiving fewer than five calls reached the composite outcome (three months of HIV therapy/six months TB treatment) compared to 30% of people who received all five calls.

Mortality rates also differed according to phone contact, and were 22% among people receiving fewer than five calls but just 2.5% among people who received all five calls.

“A health system navigator intervention complemented by SMS reminders did not show efficacy at improving ART initiation or TB treatment completion,” conclude the authors. “Interventions for linkage to HIV and TB care may require higher intensity, more reliable 2-way communication between patients and more providers and provision of more tangible means of overcoming barriers.”

Authors

Bassett IV, Coleman SM, Giddy J, Bogart LM, Chaisson CE, Ross D, Jacobsen MM, Robine M, Govender T, Freedberg KA, Katz JN, Walensky RP, Losina E.

Abstract

A fraction of HIV-diagnosed individuals promptly initiate antiretroviral therapy (ART). We evaluated the efficacy of health system navigators for improving linkage to HIV and tuberculosis (TB) care among newly diagnosed HIV-infected outpatients in Durban, South Africa.

We conducted a randomized controlled trial (Sizanani Trial, NCT01188941) among adults (≥18 years) at 4 sites. Participants underwent TB screening and randomization into a health system navigator intervention or usual care. Intervention participants had an in-person interview at enrollment and received phone calls and text messages over 4 months. We assessed 9-month outcomes via medical records and the National Population Registry. Primary outcome was completion of at least 3 months of ART or 6 months of TB treatment for coinfected participants.

Four thousand nine hundred three participants were enrolled and randomized; 1899 (39%) were HIV-infected, with 1146 (60%) ART-eligible and 523 (28%) TB coinfected at baseline. In the intervention, 212 (39% of outcome-eligible) reached primary outcome compared to 197 (42%) in usual care (RR 0.93, 95% CI: 0.80 to 1.08). One hundred thirty-one (14%) HIV-infected intervention participants died compared to 119 (13%) in usual care; death rates did not differ between arms (RR 1.06, 95% CI: 0.84 to 1.34). In the as-treated analysis, participants reached for ≥5 navigator calls were more likely to achieve study outcome.

40% of ART-eligible participants in both study arms reached the primary outcome 9 months after HIV diagnosis. Low rates of engagement in care, high death rates, and lack of navigator efficacy highlight the urgency of identifying more effective strategies for improving HIV and TB care outcomes.

[link url="http://www.aidsmap.com/Health-system-navigators-didnt-improve-ART-initiation-or-TB-treatment-completion-rates-among-people-newly-diagnosed-with-HIV-in-Durban/page/3089718/"]AidsMap report[/link]

[link url="https://www.ncbi.nlm.nih.gov/pubmed/27632145"]Journal of Acquired Immune Deficiency Syndromes article[/link]

 

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