“Implementation strategies for new point-of-care tests for early infant diagnosis”
The purpose of the study is to evaluate the feasibility of using new point-of-care tests for Early Infant Diagnosis (EID) of HIV-exposed infants in hospitals & Health Centers in Zambia. NSEBA has three main aims as follows:
- Evaluate the feasibility of implementing point-of-care tests for early infant diagnosis of HIV infection at 6 weeks and 6 months of age in both hospital-based and rural health center clinics in rural Zambia.
- Compare the performance characteristics of point-of-care tests relative to HIV DNA testing for early infant diagnosis of HIV infection in the first 48 hours of life in rural and urban Zambia.
- Evaluate implementation strategies and their associated costs for point-of-care tests for early infant diagnosis of HIV infection in rural Zambia.
Study Leadership: Dr. Philip Thuma and colleagues from Macha Research Trust in Macha, Dr. Simon Mutembo from MoH, Dr. Jane Mutanga from Livingstone Central Hospital, and Dr. Catherine Sutcliffe and William Moss, researchers at the Johns Hopkins University Bloomberg School of Public Health in the United States.
Study Sites: Sites are located in Choma and Namwala Districts (Macha Hospital and Mapanza, Moboola, Mangunza and Nalube Rural Health Centers) and in Livingstone (Livingstone Central Hospital and Maramba, Libuyu, Linda and Mahatma Gandhi Clinics).
Study Methods: Infants exposed to HIV and requiring testing for early infant diagnosis will be enrolled into a study and followed until the end of the HIV testing period. Infants will be enrolled from maternity wards and other locations where early infant testing occurs. Study visits will occur at birth and at clinic visits when routine early infant testing occurs: 6 weeks, 6 months, 12 months and 18 months and/or 2 months post-weaning.
Study procedures at each visit
- Mothers will spend ~20 minutes answering some questions, including questions about medications that the mother or the child received when the child was born.
- A blood sample (for the point-of-care test) and dried blood spot sample (for the DNA PCR test) will be collected from the child.
- The research team will check the child’s medical record. The new point-of-care HIV test will be for research purposes only since it is not yet an approved test; results will not be returned to the mother or doctors or nurses at the clinic. Mothers will come back to the clinic to collect their child’s HIV results when the DNA PCR results from the central lab are returned.
Study Impact: Results from this study could impact how a point-of-care test is included in guidelines for early infant diagnosis and will provide information on ways in which the test could be implemented in rural hospitals and health centers.
- An evaluation of the feasibility of implementing a point-of-care test for early infant diagnosis in a rural setting.
- An economic analysis comparing strategies for implementing a point-of-care test for early infant diagnosis in a rural setting.
- An evaluation of the validity of the point-of-care test for early infant diagnosis at birth.
- A comparison of birth and the 6-day post-natal visit as time points for early infant diagnosis.
PART STUDY – (HIV/AIDS)
Pediatric Anti Retro-viral Treatment (PART)
This CDC-funded research study of rural African children on anti-retroviral medication for AIDS, is now in its 7th year at Macha, under the direction of Dr. Bill Moss from Hopkins. It is now one of the longest running cohort studies of children with HIV in Africa, and seeks to determine the factors that lead to a good outcome for these children. It also looks at ways to enhance early diagnosis and treatment initiation in HIV infected infants, including use of a p24 antigen ELISA method as well as a p24 “point of care” test to diagnose HIV during early infancy.