Blood-borne Infection Screening in an Afghan Antenatal Population

NCT01199601 | Completed Results

• 2 other identifiers: AAAD17847K01TW007408-04
• Study Type: interventional
• Target: 1,291
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Utilization of Postpartum Contraception

  Determine whether the re-training and assignment of healthcare providers dedicated to intrapartum rapid testing and intensive post-partum counseling will positively impact postpartum contraceptive use as compared to any counseling provided by existing health providers for these services among women delivering in public health maternity hospitals in Kabul, Afghanistan.

  12 months

Secondary Outcomes (2)

• Correct Breastfeeding Practices to 1 Year

  12 months

• Completion of 9 Month Measles-mumps-rubella Vaccination on Time.

  12 months

Study Arms (2)

Concentrated postpartum counseling

EXPERIMENTAL

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

Behavioral: Concentrated postpartum counseling

Routine postpartum counseling

NO INTERVENTION

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

Interventions

Concentrated postpartum counseling BEHAVIORAL

Intrapartum testing and concentrated postpartum counseling for the female patient from a retrained provider focusing on correct breastfeeding practices, postpartum contraception, and infant vaccination.

Concentrated postpartum counseling

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Maternity Hospitals

Kabul, Afghanistan

Location

MeSH Terms

Conditions

Hepatitis B; Breast Feeding

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Feeding Behavior; Behavior

Results Point of Contact

• Title: Dr. Catherine Todd
• Organization: Columbia University

cst2121@columbia.edu

212-305-4805

Study Officials

• Catherine Todd, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: June 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 17, 2017
• Results First Posted: March 28, 2014

Record last verified: 2017-04

Locations

AF (1)