HIV
Conditions
Brief summary
In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are growing numbers of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing interest in using these technologies to alleviate critical testing needs. This protocol describes an observational study looking at the patient impact of implementing POC EID technologies within the routine standard of care at seven facilities.
Interventions
DEVICEPOC EID
Sponsors
Ministry of Health, Malawi
UNICEF
Clinton Health Access Initiative Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
Yes
Inclusion criteria
* Younger than 12 months of age * Clinical or other indication for an EID test (screen or confirmation), such as birth to an HIV-positive mother
Exclusion criteria
* Older than 12 months of age * Serious medical conditions which would make testing dangerous for the infant, or disrupt the accuracy of normal laboratory analysis and its interpretation * Already initiated ART
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ART initiation retention | 6-9 months | Proportion of HIV-positive infants initiated on anti-retroviral therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test turnaround time | 6-9 months | Number of days from testing to result being received by the health care facility |
| Tests received | 6-9 months | Proportion of tests received by the health care facility |
Countries
Malawi
Outcome results
None listed