Tuberculosis (TB) preventive therapy uptake and continuation were much higher when it was provided through a community-based model compared to the standard clinic-based model, a study carried out in KwaZulu-Natal found, with the team presenting the findings at the recent Conference for Retroviruses and Opportunistic Infections in Seattle, USA.
TB preventive therapy is recommended for people with HIV in South Africa, a group at an increased risk of developing TB, writes Elri Voigt for Spotlight, and the risk being higher when someone’s CD4 count is low, indicating the immune system is compromised.
The most commonly used TB therapy in SA Africa is an isoniazid pill taken for six or more months (IPT or isoniazid preventive therapy). A shorter three-month regimen (3HP) comprising the drugs rifapentine and isoniazid is being piloted in some districts.
But the uptake of preventive therapy is suboptimal, says Dr Adrienne Shapiro, a co-author of the recent study.
An infectious disease specialist, epidemiologist, and assistant professor at the University of Washington, she lists several reasons for the suboptimal uptake, including TB prevention medication not being available at the clinics when patients come to initiate HIV treatment as well as complicated, often-changing guidelines for initiation.
There is also high staff turnover and lack of clinician confidence in what the right process for initiation is or in whether TPT works, to begin with.
“Clinics, particularly for ART (antiretroviral therapy) initiation, are very busy. There’s lots happening and the priority of TB preventive therapy is often not as high as the priority for other things, especially starting ART,” she says.
Shapiro tells Spotlight their study “wanted to address these inefficiencies for both patients and clinicians by simplifying the process and continuing to deliver TB preventive therapy with ART… in a programme where the ART delivery process was simplified and decentralised from the clinic”.
Study design
The new findings are from a sub-study of a larger study called DOART. DOART looked at whether community-based ART initiation and delivery would improve HIV virologic suppression.
In DOART, people with HIV in a rural and a peri-urban region of KwaZulu-Natal were randomised into one of three study arms for ART initiation and resupply of ART. One was the standard clinic-based ART with initiation and refills done at a public health sector clinic according to the clinic schedule.
The second was a community arm where ART was initiated in the community via a mobile clinic van and refills provided.
And finally, a hybrid arm where participants initiated ART at the clinic and then, after initiation, received refills in the community through nurses in a mobile clinic van.
Enrolment was between February 2017 and February 2019, with a one-year follow-up.
Within the sub-study, IPT followed the ART distribution in each study arm. In the community and hybrid study arms, participants were initiated on ART and seen one month later for a follow-up and given the option of initiating IPT. After this, they were seen at quarterly follow-up visits for their ART and IPT refills. TB symptom screens and adherence assessments were done at each visit. The clinic arm followed the standard practices of a public health sector clinic.
Eligibility for participating in the DOART study was being clinically stable, not on ART, having a CD4 count of greater than 100, and screening negative for TB symptoms.
“For participants who did not initiate IPT at the month one visit, catch-up IPT could start at any subsequent visit,” Shapiro says.
IPT initiation and continuation in the community and hybrid arms were measured with medication dispensing records and self-reported adherence given at the follow-up visits. In the clinic arm, initiation and continuation were measured by reviewing clinic charts, as participants did not have in-person follow-up by the study team until the end of the study.
A total of 1 039 participants initiated ART during DOART and then had the opportunity to initiate IPT. Of those, 55% initiated IPT at any point during the study. The study saw higher initiation of IPT in the rural region compared to the peri-urban region.
Large differences
The best results for starting IPT were seen in the community-based arm where 90% of those who started ART also started IPT.
Within the clinic arm, 20% of participants started IPT and in the hybrid arm, 45% started IPT.
In terms of continuing IPT, in the clinic arm, 48% of those who started IPT continued to take it. In the hybrid arm, it was 84% and in the community arm, 89% of those who started IPT continued to take it.
“We found that initiation and continuation of TB preventive therapy were significantly higher with community-delivered HIV care than clinic-based treatment,” says Shapiro. “In the DOART study, multi-month dispensing of IPT was safe and use of point-of-care urine Isoniazid testing can enhance adherence monitoring.”
“Community-based integrated IPT delivery eliminated both provider and patient barriers to TPT by simplifying the process for both patients and providers.”
On whether there were concerns around initiating IPT outside the clinic in the community arm, Shapiro says all participants had one visit with a clinician and were screened for eligibility criteria and TB beforehand. And those in the community arm were seen by a nurse during the quarterly follow-up visits in the mobile vans to get their ART and IPT refills.
“Because there was still a nurse contact in the community arm, that achieved the level of consistency with the kind of care someone would receive in a clinic.”
Implications of results
Makaita Gombe, a health economist at Aurum Institute, who focuses on increasing efficiency in TB/HIV service delivery, said the findings “show that community models of care are an important aspect of clinical care for people with HIV”.
The Aurum Institute is a research and health systems management organisation that concentrates on TB and HIV prevention, treatment, and care.
She said it was feasible to potentially combine TPT and ART delivery services in community and clinic delivery settings to improve uptake and adherence to TPT, as this solves some of the socio-economic issues, eliminating problems like travel.
“Overburdened health systems also do not allow time for clinicians to dispense ART and counsel clients on TPT,” she says.
“Innovations like community initiations of TPT increase uptake because they meet the clients at their doorstep, enabling to stay healthy without disrupting their livelihoods.
“Advances in TPT options also allow patient-centred care with an expanded suite of TPT options available in South Africa as 3HP has been included in the national guidelines, further reducing TPT to three months, taken once weekly.”
Prospects for 3HP
Shapiro says the next investigation is how 3HP can be provided with ART. “We’re very interested in doing another round of studies looking at 3HP delivery, both in the community and in clinics to try to improve uptake. We are also thinking about monitoring and adherence to make sure when people get medication, they are actually taking it and completing it in full.”
They had tried to keep study conditions as true to the clinic setting as possible, she adds, so the IPT regimen given for six months was used because that’s what the public healthcare clinics they worked with in KZN were providing to patients.
The study was close to real-world conditions in other ways too. No additional training was given to the study nurses, only refresher training in the community and hybrid arms about what IPT is, what doses to give, and possible side effects.
Real-world challenges
The study experienced some challenges relating to stockouts of the IPT medication at the public sector supplying medication to the study. It was also sometimes difficult to get hold of participants in the community and hybrid arms to set up their quarterly refill visits.
As in the real world, treatment adherence was also not perfect. The researchers monitored adherence using a urine dipstick test in a subset of participants for the community and hybrid arms to see if they were actually taking the IPT.
A total of 255 participants who self-reported taking IPT were tested. Of those, 63% had a positive urine dipstick test confirming the presence of Isoniazid. Within the study, says Shapiro, this discrepancy between self-reported adherence and a positive urine test allowed the nurses to ask patients about whether they were actually taking their medication and address possible concerns.
“[It] created an opportunity for good adherence counselling, messaging, and some additional education that generally led to people deciding they would take it in future.”
Feasible for the public sector?
Parts of the study that were novel at the time were in the community-based and hybrid arms – notably, the mobile clinic vans going to the community that delivered the services and the longer time frame in which IPT refills were given. Another novel approach was simplifying the delivery of ART and IPT by giving it all together.
“When the nurses were delivering a package of ART and IPT, it was all in one place and prepacked. It And that’s different from what would happen in the clinics where often people need to go to two different pharmacies to collect the ART and IPT,” Shapiro says.
Another novel approach was that study nurses in the community and hybrid arms had a mobile app prompting them to initiate IPT and screen for TB symptoms. However, Shapiro said this could easily be converted into paper-based prompts.
Overall, many aspects of the study are feasible to implement in a public sector clinic setting.
While the mobile van delivery system might not be available to all clinics, strategies from the study could easily be used, like simplifying IPT delivery for people with HIV who are initiating ART.
“When we look at the major difference in the IPT uptake, it’s really between that clinic-based arm and the community arm and so much of it in the clinic-based arm is that patients were just never given that first dose of IPT in the clinics,” she says.
She said it was important to work at simplifying TB preventive therapy initiation, be it in the community or the clinic. “If we can overcome that barrier, we can do quite a lot. Much of what we learned was about the importance of simplifying delivery, making it clear for clinicians that TB preventive therapy is just part of how you start, I think that can quite feasibly be integrated into public sector programmes.”
See more from MedicalBrief archives:
World TB Day – Drug-resistant TB spreading; poor infection control in SA
Staff shortages and long waiting times plague KZN Health
KZN project reaches UN target a year ahead of schedule
Drug-resistant TB mostly being spread person-to-person in SA