Same-day viral load test installed in Uganda, but people with HIV still received results months later

Despite having an on-site viral load testing platform that provided same-day results and reduced the wait time from a median of 51 days, most people attending a clinic in rural Uganda still chose to receive their results during their next clinic visit, which was usually at least a month away, researchers from Mbarara University Uganda report in the journal PLOS Global Public Health.

"Our results also demonstrate that without changes in existing clinic processes and patient preferences, the advantages of an on-site rapid molecular platform may be negated. As evidence of this, we observed that the vast majority of patients elected not to receive results via one of the expedited options," they say.

According to the researchers, the stigma attached to visiting ART clinics and a lack of understanding about the significance of viral load testing among both patients and healthcare providers may have contributed to participants not waiting for their results. They recommend rearranging clinic workflows so patients scheduled for viral load testing can have their blood drawn as soon as they arrive instead of waiting until the end of their visit to reduce wait time.

Viral load monitoring is crucial in HIV care as it helps detect treatment failure earlier and prompts timely initiation of second-line antiretroviral therapies (ART). In 2015, Uganda adopted viral load testing as the preferred approach for monitoring response to ART. In line with World Health Organization guidance, testing is provided six months after starting ART, with repeat tests offered annually for those who are virally suppressed. People with a viral load above 1000 copies/ml are offered viral load test after three months of intensive adherence counselling.

However, most people with HIV reside in rural areas and receive care at lower-level health clinics that lack on-site testing. Consequently, blood samples are collected from these clinics and transported via motorcycle to the nearest district hospital. From there, samples are shipped by bus to the national laboratory in the capital city, Kampala, for testing.

Unfortunately, this strategy may result in specimens being lost or spoiled during transit. Additionally, long delays between testing and receiving results could increase the risk of inaction, particularly for those whose VL results are ≥1,000 copies/ml.

The researchers, therefore, conducted a study to determine if the systems and processes for using a near point-of-care test were available at lower-level health centres in rural Uganda.

The study

The open-label pilot study was conducted in 2020 and 2021 at the Bugoye Level III Health Center in the rural highlands of western Uganda, which sees about 500 people living with HIV per week. Adult HIV prevalence in the region is 5.7%, similar to the national estimate (6.2%), but rates of viral suppression in the region are modestly lower than the national average as well as that observed in urban areas.

The investigators installed an on-site GeneXpert platform. Study participants underwent parallel VL testing at both the central laboratory (standard of care) and on-site using the GeneXpert HIV-1 assay. GeneXpert provides results in 90 minutes and is able to measure viral load down to 40 copies/ml, whereas the standard of care test using dried blood spot samples measures down to 840 copies/ml.

Everyone aged 18 and above receiving care for HIV at the ART clinic was eligible to participate. A total of 242 participants with a median age of 37 years were enrolled in the study. The majority (72%) were women, 66% were married, and had been on ART for about five years. Most participants had experienced at least one ART regimen switch.

A two-day practical training programme for study staff and laboratory technicians from the health centre was also conducted. The primary outcome was the number of VL tests successfully performed each clinic day. Secondary outcomes included the time it took for the test results to return to the clinic, and the participant's preferences for receiving their results, either by waiting at the clinic or receiving a phone call.

Results

A total of 111 tests were done throughout the study period: During phase one, which took place during strict COVID-19 lockdowns when only dried blood spot testing was available, 24 tests were conducted and sent to the central lab. In phase two, when the Xpert assay was available on-site, the clinic conducted 87 parallel tests.

During both study phases, it took a median of 51 days from when the sample was collected and sent to the central lab to when the health centre received the test results.

Of the 87 samples sent to the central lab in phase two, 80 were returned to the facility. However, seven samples were yet to be returned by the end of the study, with five outstanding for over 120 days. In contrast, most results (78%) from the Xpert assay were available on the same day.

When participants were asked how they would like to receive their results, most (87%) elected to have them at the next visit. The median time-to-patient was, therefore, similar between the central lab and the Xpert assay, at just under three months.

Only eight participants chose to remain at the clinic for their results, and three elected to receive results by phone. All those who elected to wait received their results the same day, while those who requested a phone call received results within 24 hours.

"A number of participants in our study… expressed an aversion to remaining at the clinic to receive their VL results,” the researchers comment. “While not stated overtly, this sentiment may reflect longstanding stigma at being seen at the ART clinic. It may also represent low knowledge among participants—as well as the providers—regarding the importance of VL testing."

Qualitative data

Because knowledge and perceptions of viral load testing are critical in achieving improved treatment outcomes, including viral suppression, a separate qualitative study by researchers from Makerere University College of Health Sciences in Uganda explored the meaning that people living with HIV attach to viral load testing.

They conducted in-depth interviews with 32 people attending eight high-volume health facilities across Uganda.

The participants were between the ages of 24 and 50, with 53% female and 56% married. They had been on ART for an average of 6.5 years and were mostly subsistence farmers. All participants were on dolutegravir-based first-line regimens and had records indicating they were virally suppressed.

"One relatively simple intervention may be rearranging clinic workflows."

The descriptions of viral load testing used by the participants nearly matched the medical meaning, and many people living with HIV understood what viral load testing was.

For example, in the central region where Luganda is the most widely spoken language, participants described viral load as 'Obungi bw'akawuka mu musaayi' (the amount of HIV in the blood). The Acholi speakers of Northern Uganda described it as 'Pimo dwong onyo nok pa kwidi twojonyo iremo' (the number of viruses in the blood). The Eastern region Ateso speakers' say 'Etiai lo ekurut kotoma akuwan' (the amount of the virus in the body).

Perceived benefits of viral load testing were the ability to show the amount of HIV in the body, how the people living with HIV take their drugs, whether the drugs are working, and also guide the next treatment steps for the patients.

There were numerous complaints about the time spent waiting at health facilities to take a test and the delayed or lost results, as this participant shared:

“They delay bringing our results and, in most cases, it comes late, and other times the results get lost from the lab for good [and never to be traced], and there is a patient I know who has been complaining that they usually draw her blood to test for her VL and that she has never received the test results. And I also encourage her to ask about it during their clinic visits.”

Conclusion

“There is need to improve results turnaround time for viral load test results by scaling up remote VL results printing in health facilities, increase health workers and motivate them well and also scale up community based VL services,” says the researchers.

In the first study, the researchers also suggest rearranging clinical workflows to solve the long wait times at the facility.

"One relatively simple intervention may be rearranging clinic workflows, which currently relegate phlebotomy and laboratory testing as the final step before discharge. With prior review of scheduled attendees, patients due for VL testing could have blood drawn on arrival, thereby reducing potential wait times," they conclude.