Table 2 Summary of data collection for the Maduo study, Gaborone Botswana, 2019–2022
Category | Measure | Definition | Time point | Source |
|---|---|---|---|---|
Adverse neonatal outcomes | Infant CT/NG infection | Positive for CT/NG using the GeneXpert and infant ocular and nasopharyngeal specimens | Postnatal | Study records |
Infant conjunctivitis | Red or swollen eyelids, discharge from the eyes | Postnatal | Patient held and clinic obstetric record | |
Infant pneumonia | Cough or difficult breathing plus at least one of the following: Fast breathing Lower chest wall indrawing In addition, either crackles or pleural rub may be present on chest auscultation | Postnatal | Patient held and clinic obstetric record | |
Preterm delivery | Delivery < 37 weeks, 0 days gestational age | Postnatal | Patient held and clinic obstetric record | |
Low birth weight | < 2500 g | Postnatal | Patient held and clinic obstetric record | |
CT/NG Treatment group | Care in testing clinic Care in SoC clinic | Enrolled in either the testing or SoC clinic at baseline | Baseline | Study records |
HIV Status | HIV Negative HIV Positive Known Positive Newly Diagnosed | HIV negative if never diagnosed with HIV prior to or during pregnancy HIV positive if a positive diagnosis was received prior to or during pregnancy. We will conduct a sub analysis among women with a known (prior to conception) and new (during pregnancy) HIV diagnosis | Baseline, 3rd trimester, postnatal | Patient held and clinic obstetric record |
Antiretroviral history | Not on ART On ART Initiated during pregnancy Initiated prior to conception | Not on ART if not initiated or discontinued during pregnancy On ART if ART use reported at baseline, third trimester and postnatal care ART duration measured as initiated during pregnancy or initiated prior to conception. We will also conduct a sub-analysis among women on ART for < 2, 2–5, or > 5 years | Baseline, 3rd trimester, postnatal | Patient held and clinic obstetric record |
Viral Suppression | Virally suppressed Not virally suppressed | Virally suppressed when HIV-1 RNA < 400 copies/mL at all time points Not virally suppressed when HIV-1 RNA ≥ 400 copies/mL at any time point | Baseline, 3rd trimester, postnatal | Patient held and clinic obstetric record |
Potential maternal confounding factors | Maternal socio-demographics | Age, education, employment status, income level | Baseline | Questionnaire (self-report) |
Obstetric history | Parity, number of previous miscarriages, preterm birth, low birth weight infants | Baseline | Patient held record and participant self-report | |
Other maternal conditions and treatments | Urinary tract infection, syphilis diagnosis, genital ulcer, gestational diabetes (fasting glucose ≥ 92 mg/dL, 1-h glucose ≥ 180 mg/dL, or 2-h glucose ≥ 153 mg/dL), anemia (hemoglobin ≤ 10 g/dL, gestational hypertension (at least one blood pressure elevation of systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg after 20 weeks pregnancy), body mass index, SARS-COV-19 infection | Baseline, 3rd trimester, postnatal | Patient held and clinic obstetric record | |
Antibiotic usage during pregnancy | Azithromycin, Erythromycin, Doxycycline, Metronidazole, Ceftriaxone | Baseline, 3rd trimester, postnatal | Patient held and clinic obstetric record | |
Other risk factors | Maternal alcohol use (AUDIT-C), smoking (any during pregnancy) | Baseline, 3rd trimester, postnatal | Questionnaire (self-report) | |
Partner characteristics | Number of current partners, length of relationships, marital status, children, intimate partner violence (Conflict Tactics Scale) | Baseline, 3rd trimester, postnatal | Questionnaire (self-report) | |
Partner treatment | Partner treatment outcomes and timing of treatment | Baseline, 3rd trimester, postnatal | Questionnaire (self-report) | |
Healthcare utilization | Routine ANC | Number of ANC visits between first ANC and third trimester and deliver | 3rd trimester, postnatal | Patient held and clinic obstetric record |
Antenatal admissions | Number of inpatient admissions and length of stay between baseline and postnatal care | 3rd trimester, postnatal | Patient held and clinic obstetric record | |
Infant admissions | Number of inpatient admissions and length of stay | Postnatal, immunization | Patient held and clinic obstetric record | |
Infant interventions | Emergency transportation by ambulance Medication, radiology, laboratory, and respiratory care services | Postnatal, immunization | Patient held and clinic obstetric record |