Blood-borne Infection Screening in an Afghan Antenatal Population

Columbia University

Status: Completed

Conditions: Contraception; Breast Feeding, Exclusive; Viral Hepatitis B; Effects of; Lack of Care of Infants

Treatments: Behavioral: Concentrated postpartum counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01199601

7K01TW007408-04 (U.S. NIH Grant/Contract)

AAAD1784

Details and patient eligibility

About

Baseline information indicates there are measurable levels of hepatitis B SAg and low utilization of postpartum contraception, correct breastfeeding practices, or adherence to infant vaccination schedules in Kabul, Afghanistan. This intervention will randomize hospitals to assess the following aims:

Aim 1: To determine whether the re-training and assignment of health care providers dedicated to intrapartum rapid testing and post-partum counseling will positively impact maternal and neonatal health indicators as compared to utilization of existing health providers for these services among women delivering in publish health maternity hospitals in Kabul, Afghanistan.

Aim 2: To assess whether patients randomized to the intervention and their spouses perceive value in concentrated post-partum counseling.

Aim 3: To investigate whether an intervention providing immediate post-partum provision of a long-acting family planning method would be feasible and acceptable to both men and women in Kabul, Afghanistan.

Full description

Outcomes are assessed through questionnaire responses and inspection of vaccination cards at six month intervals by trained study staff through one year total study time. Differences between groups will be assessed with generalized linear mixed modeling. Information obtained to address Aim 3 will be gathered at the 12 month follow-up and analyzed with simple proportions and Chi-square test to assess differences between sexes and other socioeconomic indicators.

Enrollment: 1,291 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• admitted for obstetric care
• Dari or Pashto speaking
• not previously participated in the study
• in medically stable condition
• accompanied by and have approval of a spouse
• able to provide informed consent

Male participants must be the confirmed spouses of the female participants, have a working telephone, and able to provide informed consent.

Exclusion criteria

• medically unstable or imminently delivering (complete cervical dilation)
• husband unavailable or does not approve participation
• unable to provide consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,291 participants in 2 patient groups

Concentrated postpartum counseling

Experimental group

Description:

Women randomized to receiving concentrated postpartum counseling from the retrained provider.

Treatment:

Behavioral: Concentrated postpartum counseling

Routine postpartum counseling

No Intervention group

Description:

Women receiving intra-partum testing and post-partum counseling from existing cadres of hospital providers at standard of care.