Viral Hepatitis BNCT01199601
Blood-borne Infection Screening in an Afghan Antenatal Population
A study testing Concentrated postpartum counseling in people with Viral Hepatitis B and Contraception, run by Columbia University at 1 site in Afghanistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Hepatitis B, Contraception, Breast Feeding, Exclusive
- What is being tested?
- Concentrated postpartum counseling
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,291 participants
- Where
- 1 siteAfghanistan
- Study dates
- Jun 2008to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- medically unstable or imminently delivering (complete cervical dilation)
- husband unavailable or does not approve participation
- unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Educational Intervention to Determine Effect of Intrapartum Testing and Concentrated Postpartum Counseling on Birth Spacing, Breastfeeding, and Infant Vaccination Completion in a Kabul Urban Population.
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.
Read more
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.
Read the detailed 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.
- Conditions
- Viral Hepatitis B, Contraception, Breast Feeding, Exclusive, Effects of; Lack of Care of Infants
- Being tested
- Concentrated postpartum counseling
- Medical subject headings
- Hepatitis B, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated postpartum counselingBehavioural
Intrapartum testing and concentrated postpartum counseling for the female patient from a retrained provider focusing on correct breastfeeding practices, postpartum contraception, and infant vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Concentrated postpartum counseling | Experimental | Women randomized to receiving concentrated postpartum counseling from the retrained provider. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Correct Breastfeeding Practices to 1 Year
Assess whether patients randomized to the intervention exhibit correct breastfeeding practices (a composite variable in which exclusive breastfeeding occurs to 6 months and continued complementary breastfeeding continues to 12 months) after receiving concentrated postpartum counseling compared to women receiving standard of care.
Measured: 12 months
Completion of 9 Month Measles-mumps-rubella Vaccination on Time.
Assess whether patients randomized to the intervention were more likely to have children receiving the measles-mumps-rubella vaccination at 9 months of age after receiving concentrated postpartum counseling compared to women receiving standard of care.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startJun 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Viral Hepatitis BStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Catherine Todd, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199601
- Sponsor's protocol ID
- AAAD1784
- Other IDs
- 7K01TW007408-04
- Status last verified
- Apr 2017
- First submitted
- 9 Sep 2010
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Educational Intervention to Determine Effect of Intrapartum Testing and Concentrated Postpartum Counseling on Birth Spacing, Breastfeeding, and Infant Vaccination Completion in a Kabul Urban Population.
- ClinicalTrials.gov ID
- NCT01199601
- Acronym / sponsor ID
- AAAD1784
- Conditions
- Viral Hepatitis B, Contraception, Breast Feeding, Exclusive, Effects of; Lack of Care of Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,291 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- Jun 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 28 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentrated postpartum counseling | Experimental | Behavioral: Concentrated postpartum counselingWomen randomized to receiving concentrated postpartum counseling from the retrained provider. |
| Routine postpartum counseling | No intervention | –Women receiving intra-partum testing and post-partum counseling from existing cadres of hospital providers at standard of care. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- medically unstable or imminently delivering (complete cervical dilation)
- husband unavailable or does not approve participation
- unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concentrated postpartum counselingIntrapartum testing and concentrated postpartum counseling for the female patient from a retrained provider focusing on correct breastfeeding practices, postpartum contraception, and infant vaccination. | Behavioural | Concentrated postpartum counseling |
Primary outcome
Utilization of Postpartum Contraception
Time frame: 12 months
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.
2 secondary outcomes
Correct Breastfeeding Practices to 1 Year
Time frame: 12 months
Completion of 9 Month Measles-mumps-rubella Vaccination on Time.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Viral Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Todd, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated postpartum counseling in people with Viral Hepatitis B and Contraception, run by Columbia University at 1 site in Afghanistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Afghanistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization of Postpartum Contraception (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.