Most people assume HIV testing involves blood. While blood is the most commonly used, saliva is an alternative specimen to test and diagnose HIV in adults and adolescents. Benefits of saliva-based testing include the ease of collecting samples and increased acceptability of HIV testing. One example of a saliva-based test is OraQuick, a device used to collect and rapidly test saliva.
The OraQuick test strip collects saliva from patients’ upper and lower gums, then is inserted into a tube to test for HIV. The saliva reacts to liquid in the tube and travels up the stick. If only the upper line appears, the test is negative. If both lines appear, the test is positive.
Saliva-based testing has produced very good results in adults; however, very few studies have evaluated this method among children Considering the ease of collecting saliva compared to drawing blood using a finger prick (ouch!), saliva-based testing is a good alternative for this population in need of early HIV testing, diagnosis, and care.
Last week, Global WACh and the University of Nairobi launched a new study to address this need. Led by Post-Doctoral Fellows, Drs. Anjuli Wagner and Irene Njuguna, the Saliva Testing and Video Information to Expand Uptake of Pediatric Testing (STEP-UP) project aims to validate the OraQuick test in children ages 18 months to 12 years old. The project will also develop and evaluate the effectiveness of video pre-test information session prior to HIV testing. Both strategies aim to increase pediatric HIV testing in outpatient clinics in Kenya, where high patient volumes make it difficult for healthcare staff to offer adequate HIV counseling to every client.
The STEP-UP study team completed a training to learn about OraQuick and how to perform the test. The team had a great time participating in team building exercises, practicing collecting saliva from one another, and ending the training with a team dinner. Check out photos below!
The STEP-UP study team from UW and the University of Nairobi
Lukio fills in questionnaire answers to a mobile data collection tool called Open Data Kit (ODK), while the OraQuick reaction is taking place in the background.
Tamasha practices using the OraQuick test kit, placing the test strip in the reaction fluid.
The study team will start recruiting participants this month in multiple clinics in Kisumu, Siaya, and Homa Bay counties in Kenya. They hope to test 1,050 children for HIV and the HIV video consultation in 150 participants. The team will also include a series of focus group discussion about patient and health care workers’ perceptions about using the OraQuick test and video consultation. The STEP-UP project is anticipated to end in August 2019.
We love receiving updates from our research partners in Kenya! Last week, two HIV-focused projects, led by the Kenyatta National Hospital, Global WACh, and International Clinical Research Center (ICRC), held successful staff trainings in Kisumu, Kenya. Both projects emphasize the use of oral pre-exposure antiretroviral prophylaxis, or PrEP, among adolescent girls and women who are at the greatest risk of HIV infection. PrEP is a daily anti-HIV medication that a person who does not have HIV takes to prevent infection. If taken daily as prescribed, PrEP is highly effective in stopping the HIV virus from taking hold and spreading throughout the body.
PrEP Implementation for Young Women and Adolescents (PrIYA) seeks to programmatically evaluate PrEP implementation, and determine best practices for providing PrEP to young women and adolescent girls in Maternal and Child Health (MCH) and Family Planning Clinics. At the training, PrIYA study staff discussed their successes and challenges after four months of providing PrEP clinical services, such as prescribing and counseling for the drug, follow-up care, and blood spot testing to measure drug levels to over 3,000 women. They also discussed their experiences to establish data tracking systems and improve ways to procure PrEP for their patients. More information on PrIYA is available here.
PrEP Implementation for Mothers in Antenatal Care (PrIMA) is a cluster-randomized trial in 20 MCH clinics that follows women during their pregnancies through nine months postpartum to assess HIV incidence and other outcomes among those who use PrEP and those who do not. Offering PrEP to women at the greatest risk of HIV may maximize effectiveness, safety, and cost-effectiveness. In anticipation of the study’s launch in October, forty new PrIMA staff members received training on the study procedures.
We look forward to sharing more updates as both studies progress. Stay tuned for future posts!
HIV infection can result in neurodevelopmental impairment in children. We do not yet understand the extent to which effective antiretroviral therapy (ART) prevents these delays, but Global WACh researcher Dr. Sarah Benki-Nugent’s recent study, conducted in collaboration with researchers at the University of Nairobi, has provided insight to help answer this question. Their study focused on HIV-infected infants in Nairobi Kenya who received ART from the time of infancy and compared their developmental milestone attainment to HIV-unexposed infants.
Sarah Benki-Nugent, MS, PhD, is the study’s lead investigator and Acting Assistant Professor at University of Washington Department of Global Health
Most HIV-infected infants in their study were extremely ill at the time of HIV diagnosis and many were first identified in the hospital. Unfortunately, late diagnosis continues to be common in Africa and UNAIDS has recently estimated that only about half of HIV-infected children are receiving treatment.
The study found that overall, HIV-infected infants had later age at attainment of milestones compared to unexposed infants. However, infants who had better responses to treatment had better developmental outcomes. Benki-Nugent and Kenyan research collaborator Dalton Wamalwa say, “We still don’t’ know how children will do in the long-term; however, this data suggests that effective response to ART provided some benefit, even in a group of infants who were very sick when first diagnosed.”
The study suggests that early HIV diagnosis and successful treatment are likely key factors in retaining cognitive and motor neurodevelopment in HIV-infected children. It is also likely critical, Dr. Benki-Nugent says, to provide additional strategies, such as parenting support for early childhood development alongside HIV treatment to help children reach their full potential.
Click here to read more about the researcher’s work recently featured in Infectious Disease Advisor.
Renee Heffron is the grant’s primary investigator.
Dr. Renee Heffron, co-director of our Global WACh Family Planning Working Group, has received new funding from the NIH to tie into the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Study. ECHO enrolls participants in sub-Saharan Africa for a randomized trial of three equally safe and effective contraceptive methods: the copper T intrauterine device (IUD); injectable depo-medroxyprogesterone acetate (DMPA), also known as the Depo shot; and the Jadelle implant.
For sub-Saharan African women at risk for becoming infected with HIV, it is important to build knowledge around potential associations of specific contraceptives with HIV acquisition. A number of observational studies have examined whether or not use of hormonal methods affects the risk of HIV acquisition. Some of these studies suggest that injectable methods—particularly the Depo shot—might increase a woman’s risk of acquiring HIV infection, while other studies show no association. The World Health Organization continuously reviews the information about contraceptives and, thus far, has determined that all of the contraceptives that will be used in the ECHO Study are safe for women at risk of HIV risk infection, but that more research is needed.
Photo by echo-consortium.com
With this additional funding, ECHO will now begin to measure biological markers periodically over the three-year trial period associated with the Depo shot, the Jadelle implant, and the copper IUD. These markers include vaginal microbiome, markers of inflammation, HIV target cells, protein signatures, and transcriptome to identify differences between women using the different contraceptives.
Read the full story from ASPPH here.
A collaboration between scientists at the University of Washington and the Fred Hutch Vaccine and Infectious Disease Division looks at antiretroviral use and Cytomegalovirus transmission in mothers and children in Kenya. Cytomegalovirus (CMV) is an opportunistic infection contracted by people with HIV. In Kenya, most HIV- exposed children acquire CMV within the first year of life, primarily through their mother’s breast milk. These infants with both HIV and CMV have an increased risk of disease progression, neurologic disease and death. Researchers within this collaboration evaluated the impact of highly active antiretroviral therapy (HAART) on CMV transmission and breast milk levels related to maternal HIV.
Jennifer Slyker is the study’s primary investigator.
The Science Spotlight team at Fred Hutch selected this team’s recent study for the December issue of Science Spotlight, a monthly online publication highlighting scientific investigation. Dr. Jennifer Slyker, Global WACh Assistant Director, says in the Spotlight: “We were surprised to see an effect on CMV transmission but not on CMV DNA levels in breast milk, which we think is the major mode of CMV transmission in the first year of life. Other groups have also observed this in observational studies. Our next step is to explore maternal and infant immune mechanisms of protection.”
The research concludes new findings to suggest that starting HAART later in pregnancy may decrease infant CMV infections, by mechanisms independent of breast milk CMV levels. These data also suggest that policy changes in high-HIV burden countries for starting pregnant women on lifetime antiretrovirals could have profound implications for the epidemiology of mother-to-child CMV transmission at a population level.
Read more about the study here in the December edition of the Science Spotlight.
Despite enormous expansion of HIV testing and treatment services in resource-limited settings, adolescents continue to be disproportionately affected by HIV. Lack of access to acceptable HIV testing, counseling, and treatment has been cited as a barrier to HIV care among adolescents. Additionally, health workers tasked with providing adolescent HIV services report feeling inadequately prepared to cope with the needs of this age group.
The SPEED study improves quality and accessibility of HIV care to meet the unique needs of adolescents. SPEED (Simulated Patient Encounters to promote Early Detection) uses patient actors to portray adolescent HIV patients as part of a clinical training intervention. This gives nurses and doctors in Kenya an opportunity to practice their skills diagnosing, caring for, and engaging adolescents living with HIV. The simulated encounters utilize a standardized patient script and provide opportunities for the trained actor and a faculty observer to deliver immediate feedback and support to the clinician.
Simulated patient interactions show great promise as a mechanism for health workers in low-resource settings to improve critical decision-making, patient interaction, and communication skills in working with adolescents. SPEED’s ultimate aim is for this increased provider confidence to in turn increase uptake and retention in adolescent HIV care.
a SPEED patient actor practices her case with a study nurse
Dr. Kate Wilson with the patient actor team
This week, SPEED has been busy training a new group of patient actors in Nairobi, Kenya. Actor training is part of the study’s first year of progress. Led by Global WACh and UW School of Nursing researcher Dr. Pamela Kohler and managed by Dr. Kate Wilson, SPEED’s interventions and analyses will be conducted over the next four years.
Last week at Nairobi Innovation Week, members of the CATCH study team spent three days showcasing their innovative visions for pediatric HIV care. This was an important opportunity for the team to highlight the successes and findings of CATCH: Counseling and Testing for Children at Home.
The CATCH study accomplishes what’s in its name by “catching” children ages 12 and under who have fallen through the cracks in HIV diagnosis systems. CATCH offers parents infected with HIV the opportunity to have their children tested, both in clinics or in the home. HIV-infected children are then linked to an HIV care clinic of choice, which ensures that children can receive much needed care. CATCH has been working and gathering data since the start of 2014, with funding for seven different sites in Nairobi and one in Western Kenya.
Throughout the three-day event, CATCH presented posters, modeled pediatric test kits, and engaged visitors with their approaches and ideas about HIV testing in children. “There was a great amount of enthusiasm for the translation of research findings into policy, particularly from senior University of Nairobi visitors and local media,” said Anjuli Wagner, a postdoctoral fellow in the Department of Global Health and member of the study team.
Each day, members from the CATCH team, including Anjuli Wagner, Cyrus Mugo, and Verlinda Otieno spoke with over 40 individuals interested in continuing to be part of the discussion about CATCH’s work. The team also visited with nearby stands and discovered valuable new connections with other pediatric health advocates.
CATCH team members tabling at Nairobi Innovation Week
We’re sending CATCH our congratulations for their engagement and innovation in Nairobi!
For more information about CATCH, take a look at this animated depiction of the project.
The Kenya Pediatric Studies (KPS) team has been working hard on an important study called CATCH (Counseling and Testing for Children at Home). The CATCH study does just what the name says by “catching” children ages 12 and under who have fallen through the cracks in HIV diagnosis systems.
There are 3.3 million children in the world living with HIV. Half of HIV-infected children that go untreated will die by the age of two. There are some great programs in place to help prevent mother-to-child transmission (PMTCT) during pregnancy, birth, and breastfeeding; but going through all the steps in these systems can be challenging, and medication is not always successful at preventing infection in babies.
Children born before PMTCT systems were widely available may not have had the chance to be tested. Additionally, if a mother finds out that she has HIV after her child has been born, there may be a missed opportunity to test her child. Many HIV-infected young children with a missed diagnosis are admitted to the hospital when they are already very sick and they don’t respond well to HIV treatment. The CATCH team aims to find children who may have missed diagnosis in PMTCT and get them the care they need before it’s too late.
CATCH is working to bridge the gap by approaching parents already in treatment and asking if they have any children who have not been tested and would like to have these children tested. CATCH offers testing both in clinics and at the home for those parents who prefer not to bring their children to the clinic. HIV-infected children are then linked to an HIV care clinic of choice, which ensures that children can live happy and healthy lives because of much needed care.
One issue that the CATCH team has run into is the issue of disclosure of HIV status to children. “Telling a child they have HIV is hard because you’re also potentially exposing the parents’ status as well. Kids also have a difficult time processing the news and will sometimes talk with friends, which can lead to possible stigma for the family,” says Anjuli Wagner, a PhD candidate in the Department of Epidemiology and member of the CATCH study team. Still, studies suggest that disclosure does seem to improve outcomes for infected children.
The CATCH study originally intended to focus on all children ages 0-18, but they discovered through discussions with bioethicists and their community advisory board that adolescents have a unique set of needs that are quite different from those of younger children. With adolescents, it’s challenging to decide who can give permission for the HIV test, who should receive the results of the test, and how best to support a young person who is gaining independence to cope with their diagnosis. To address these challenges inherent in adolescent HIV testing, another study called ‘DASH’ was created. DASH (Developing Adolescent Strategies for HIV testing) is focusing on voluntary counseling and testing for adolescents and is just another way the Kenya Pediatric Studies and Global WACh teams are making sure all the bases are covered for appropriate testing and treatment for children and adolescents.
CATCH currently has funding for 7 different sites in Nairobi and one in Western Kenya and we’re looking forward to seeing those results!