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Table 1 Outline of Core Protocol for PCPPP

From: Recruitment and retention of women in a large randomized control trial to reduce repeat preterm births: the Philadelphia Collaborative Preterm Prevention Project

  Intervention Usual Care/Controls
Risk factor   
   Infection Assessment: Standard medical diagnostics for STD's and urogenital tract infections, including Bacterial Vaginosis (BV), Chlamydia, Gonorrhea, and Syphilis. Tests were conducted at the centralized clinical setting; all lab results were reviewed by the study-trained laboratory coordinator.
Treatment: Follow-up and standard medical treatment for all conditions identified; supervised by the study medical team and free of charge.
Assessment: standard medical diagnostics for BV only.
   Periodontal Disease Assessment: Screening for clinical periodontal disease including soft tissue exam for oral cancer, Plaque Scores, Gingivitis Index Scores, Probing Pocket Depth, Bleeding Upon Probing, Clinical Attachment Level, and cementoenamel junction. Assessment was completed by the study registered dental hygienist.
Treatment: Individually-tailored intervention including oral hygiene education and comprehensive clinical treatment for all conditions identified. Presence of periodontal disease was confirmed through x-ray and clinical exam by a DDM. Treatment for periodontal disease was provided by or under direct supervision of a periodontist/DDM, free of charge
Assessment: Same as for Intervention Group
   Smoking Assessment: Evaluation of smoking status during pregnancy and postpartum using standardized questionnaire. Questionnaire was administered by study staff.
Treatment: Referral and follow-up for smokers, who were offered individually-tailored one-on-one cessation counseling and pharmacotherapies, including standard nicotine replacement therapy, and bupropion. One-on-one counseling was provided free of charge by smoking cessation counselor; pharmacotherapy was provided and prescribed by physician free of charge
Assessment: Same as for Intervention Group
   Inadequate Nutrition/Weight Assessment: Documentation of clinical, body weight/mass, including weight change, skin fold thickness and waist circumference; evaluation of diet and nutritional intake. The assessments were completed by a certified Dietician with a Master's degree in Human Nutrition.
Treatment: Individually-tailored program of nutritional education and diet supplementation, including vitamins; food assistance if necessary; development of a weight loss program (including exercise), if appropriate.
Assessment: Same as for Intervention Group
   Major Depressive Disorder Assessment: Screening with Center for Epidemiological Studies of Depression Scale (CES-D ≥16) followed by a diagnostic interview with the Structured Clinical Interview for DSM Disorders (SCID) for those with a positive screen. The SCID was administered by appropriately trained study physician or social worker.
Treatment: Participants who were diagnosed with current major depressive disorder were offered medial treatments comprised of cognitive behavioral therapy, antidepressant psychopharmacology, following manualized protocols, or the combination of the two treatments. Women who declined these therapies were offered supportive counseling and problem solving training delivered by clinical social workers in home visits.
Assessment: Same as for Intervention Group, although SCID was not performed for those who screened positive for depressive symptomatology
Maternal Stress   
   a. Literacy Assessments: Short Test of Functional Health Literacy in Adults (inadequate and marginal: English and Spanish), Test of Adult Basic Education - Reading Locator (levels E&M; TABE). Questionnaire was administered by study staff.
Treatment: An individually tailored learner-driven intervention model was utilized using a contextual adult educational curriculum focused on building skills for navigating hurdles to maternal-infant care and family management/economics. Adult literacy skills were developed through working individually with professional adult educators on specific challenges faced by the participants and selected by them.
Assessment: Same as for Intervention Group
b. Housing
Instability
Assessment: Comprehensive assessment of housing status and stability conducted by study staff.
Treatment: Housing assistance, when appropriate, was provided in the form of cash grants for down payments or back rent, relocation services, or resolution of landlord/renter disputes, provided under the direction of a MSW, with experience in resolving housing-related issues.
Assessment: Same as for Intervention Group