Cytomegalovirus InfectionsCDC/CMVNCT01819519
Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus
A study testing Educational Intervention in people with Cytomegalovirus Infections and Pregnancy, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
The purpose of this study is to develop a brief screening and behavioral intervention for the prevention of congenital cytomegalovirus (CMV) that will both be acceptable to clinic staff and feasible to implement as part of routine clinical prenatal care, and to test whether behavioral intervention for susceptible… Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infections, Pregnancy, Behavior
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women lacking evidence of acute CMV infection is defined as one of the following: A negative IgM antibody (<1.00 Index) and negative IgG antibody (<6.0 AU/ml) or A negative IgM antibody (<1.00 Index) and positive IgG antibody (≥6.0 AU/ml)
- Gestational age during CMV screening will be no later than 20 weeks based on clinical information and evaluation of the earliest ultrasound.
- Enrollment will occur no later than 20 weeks' gestation.
- Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 20 weeks' by project gestational age is acceptable.
- English and Spanish-speaking women of any age will be offered enrollment
Who cannot join
- Planned termination of pregnancy
- Women with a previous child with congenital CMV
- Intention of leaving the prenatal practice
- Known major fetal anomalies or demise
- Multiple gestation
- Known HIV infection
Show all 9Show fewer
- Primary CMV infection, as determined by a positive IgM antibody, a positive IgG antibody and low IgG avidity or positive IgM antibody and negative IgG antibody
- An old and a recent CMV infection, as determined by a positive IgM antibody, positive IgG antibody and high IgG avidity.
- Non-Spanish or English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Development and Evaluation of a Clinic-Based Screening and Brief Intervention for Changing Behaviors Related to Cytomegalovirus Transmission in Pregnant Women
The purpose of this study is to develop a brief screening and behavioral intervention for the prevention of congenital cytomegalovirus (CMV) that will both be acceptable to clinic staff and feasible to implement as part of routine clinical prenatal care, and to test whether behavioral intervention for susceptible pregnant women can lead to a behavioral change that is likely to lead to decreased primary CMV infection. The study research assistants will enroll pregnant women who are less than 20 weeks' gestation, either English or Spanish-speaking and that do not have a primary CMV infection (never been infected or previously infected). Enrollment will occur during the woman's prenatal visit.
Read the detailed description
The study is a randomized single-masked clinical trial of behavioral intervention versus standard care of pregnant women lacking evidence of acute CMV infection that have consented to be screened as part of the Maternal Fetal Medicine Units Network multi-centered randomized clinical trial, in which pregnant women are screened with CMV serology for IgM, IgG, and IgG avidity.
Eligible pregnant women will be randomized to one of two treatment groups:
- Control Group - no intervention
- Intervention Group - brief intervention and educational materials Written informed consent will be obtained from patients before they can be screened for the study by CMV testing (IgM, IgG, and IgG avidity) as per the protocol for screening in the MFMU study.
All women presenting for prenatal care no later than 20 weeks gestational age without a known multifetal gestation are eligible for CMV screening Those with evidence of primary infection will be offered participation in the MFMU randomized trial of CMV hyperimmune globulin to prevent congenital infection. Women lacking evidence of acute infection will be eligible for randomization into this study. Patients must be randomized no later than 20 weeks gestation.
If eligible and no more than 20 weeks gestation, the patient will be randomized. If the patient is randomized in the control group, she will continue her routine prenatal care inclusive of the CDC brochure that she received at the time of her venipuncture for serologic screening and assessment of hygiene behaviors. If the patient is randomized into the intervention group, we will deliver a face-face educational intervention during her next routine prenatal visit. In addition to the intervention, the patient will include educational material to take home.
Both groups will be assessed for performance of hygiene behaviors as a baseline assessment at the time of consent. A second assessment will occur at least 12 weeks after enrollment during the third trimester between 28-36 weeks of gestation. The follow-up assessment will be completed by a different research assistant from the unblinded educator. A Kessler 10 (K10) survey will also be completed in addition to the baseline and follow-up assessment.
The follow-up assessment will take place during the participant's third trimester between 28-36 weeks of gestation, depending on duration of enrollment and likelihood of early delivery. The enrollment duration will vary from approximately 14-20 weeks.
- Conditions
- Cytomegalovirus Infections, Pregnancy, Behavior
- Being tested
- Educational Intervention
- Keywords
- Intervention studies, Pregnancy, Cytomegalovirus Infections
- Medical subject headings
- Cytomegalovirus Infections, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
The patient will told if previously infected or seronegative and what is the risk of the becoming infected. The research assistant will deliver a 5-10 minutes educational intervention, which will consist of a CMV video and some Q\&A.
| Study group | Role | What they receive |
|---|---|---|
| Standard Prenatal Care | No intervention | Participants will receive standard prenatal care from the time they are screened for CMV to delivery. This includes a CMV brochure. |
| Educational Intervention | Experimental | This group will be approached during a routine prenatal visit and will receive a 5-10 minute educational intervention (CMV prevention video, preventive information, weekly text messages/emails as reminders for hygiene behaviors, developmental calendar with hygiene reminders). Receives: Behavioral: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hygiene Behaviors
The primary outcome is defined as a change in the participant's hygiene behaviors determined by the differences between the baseline and follow-up behavioral assessment compliance scores. Each question in these assessments will be assigned a score from 0-5 (5 = desired preventative behavior).
Measured: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Secondary outcomes (6)
Behavior Change based on Serostatus
Did knowing the serostatus affect hygiene behavior change, as defined by a change in compliance scores between baseline and follow-up visits?
Measured: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Change in K10 after Intervention
Was there a change in stress and anxiety (measured by the K10 assessment scores) before and after the intervention?
Measured: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Behavior Change based on Socioeconomics
Was behavior change influenced by socioeconomic status? Behavior change is defined by the difference in compliance scores between baseline and follow-up visits
Measured: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Racial associations with hygiene behavior change
Was behavior change influenced by race? Behavior change is defined by the difference in compliance scores between baseline and follow-up visits
Measured: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Behavior Change related to Children at home
Was behavior change influenced by the number of children living at home? Behavior change is defined by the difference in compliance scores between baseline and follow-up visits
Measured: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Behavior Change and Occupation Association
Was behavior change influenced by participants' occupation? Behavior change is defined by the difference in compliance scores between baseline and follow-up visits
Measured: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Brenna Hughes, Women and Infants Hospital of Rhode Island
- Investigators
- Brenna Anderson, MD, Principal investigator, Women & Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819519
- Sponsor's protocol ID
- RFA-DD-12-005
- Acronym
- CDC/CMV
- Status last verified
- Jun 2015
- First submitted
- 18 Mar 2013
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hughes BL, Gans KM, Raker C, Hipolito ER, Rouse DJ. A Brief Prenatal Intervention of Behavioral Change to Reduce the Risk of Maternal Cytomegalovirus: A Randomized Controlled Trial. Obstet Gynecol. 2017 Oct;130(4):726-734. doi: 10.1097/AOG.0000000000002216.
PubMed 28885428
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Clinic-Based Screening and Brief Intervention for Changing Behaviors Related to Cytomegalovirus Transmission in Pregnant Women
- ClinicalTrials.gov ID
- NCT01819519
- Acronym / sponsor ID
- CDC/CMV / RFA-DD-12-005
- Conditions
- Cytomegalovirus Infections, Pregnancy, Behavior
- Keywords
- Intervention studies, Pregnancy, Cytomegalovirus Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a brief screening and behavioral intervention for the prevention of congenital cytomegalovirus (CMV) that will both be acceptable to clinic staff and feasible to implement as part of routine clinical prenatal care, and to test whether behavioral intervention for susceptible pregnant women can lead to a behavioral change that is likely to lead to decreased primary CMV infection. The study research assistants will enroll pregnant women who are less than 20 weeks' gestation, either English or Spanish-speaking and that do not have a primary CMV infection (never been infected or previously infected). Enrollment will occur during the woman's prenatal visit.
Detailed description
The study is a randomized single-masked clinical trial of behavioral intervention versus standard care of pregnant women lacking evidence of acute CMV infection that have consented to be screened as part of the Maternal Fetal Medicine Units Network multi-centered randomized clinical trial, in which pregnant women are screened with CMV serology for IgM, IgG, and IgG avidity.
Eligible pregnant women will be randomized to one of two treatment groups:
- Control Group - no intervention
- Intervention Group - brief intervention and educational materials Written informed consent will be obtained from patients before they can be screened for the study by CMV testing (IgM, IgG, and IgG avidity) as per the protocol for screening in the MFMU study.
All women presenting for prenatal care no later than 20 weeks gestational age without a known multifetal gestation are eligible for CMV screening Those with evidence of primary infection will be offered participation in the MFMU randomized trial of CMV hyperimmune globulin to prevent congenital infection. Women lacking evidence of acute infection will be eligible for randomization into this study. Patients must be randomized no later than 20 weeks gestation.
If eligible and no more than 20 weeks gestation, the patient will be randomized. If the patient is randomized in the control group, she will continue her routine prenatal care inclusive of the CDC brochure that she received at the time of her venipuncture for serologic screening and assessment of hygiene behaviors. If the patient is randomized into the intervention group, we will deliver a face-face educational intervention during her next routine prenatal visit. In addition to the intervention, the patient will include educational material to take home.
Both groups will be assessed for performance of hygiene behaviors as a baseline assessment at the time of consent. A second assessment will occur at least 12 weeks after enrollment during the third trimester between 28-36 weeks of gestation. The follow-up assessment will be completed by a different research assistant from the unblinded educator. A Kessler 10 (K10) survey will also be completed in addition to the baseline and follow-up assessment.
The follow-up assessment will take place during the participant's third trimester between 28-36 weeks of gestation, depending on duration of enrollment and likelihood of early delivery. The enrollment duration will vary from approximately 14-20 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Prenatal Care | No intervention | –Participants will receive standard prenatal care from the time they are screened for CMV to delivery. This includes a CMV brochure. |
| Educational Intervention | Experimental | Behavioral: Educational InterventionThis group will be approached during a routine prenatal visit and will receive a 5-10 minute educational intervention (CMV prevention video, preventive information, weekly text messages/emails as reminders for hygiene behaviors, developmental calendar with hygiene reminders). |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Pregnant women lacking evidence of acute CMV infection is defined as one of the following: A negative IgM antibody (<1.00 Index) and negative IgG antibody (<6.0 AU/ml) or A negative IgM antibody (<1.00 Index) and positive IgG antibody (≥6.0 AU/ml)
- Gestational age during CMV screening will be no later than 20 weeks based on clinical information and evaluation of the earliest ultrasound.
- Enrollment will occur no later than 20 weeks' gestation.
- Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 20 weeks' by project gestational age is acceptable.
- English and Spanish-speaking women of any age will be offered enrollment
Key exclusion criteria (9 listed)
- Planned termination of pregnancy
- Women with a previous child with congenital CMV
- Intention of leaving the prenatal practice
- Known major fetal anomalies or demise
- Multiple gestation
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 |
|---|---|---|
| Educational InterventionThe patient will told if previously infected or seronegative and what is the risk of the becoming infected. The research assistant will deliver a 5-10 minutes educational intervention, which will consist of a CMV video and some Q\&A. | Behavioural | Educational Intervention |
Primary outcome
Change in Hygiene Behaviors
Time frame: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
The primary outcome is defined as a change in the participant's hygiene behaviors determined by the differences between the baseline and follow-up behavioral assessment compliance scores. Each question in these assessments will be assigned a score from 0-5 (5 = desired preventative behavior).
6 secondary outcomes
Behavior Change based on Serostatus
Time frame: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Change in K10 after Intervention
Time frame: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Behavior Change based on Socioeconomics
Time frame: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Racial associations with hygiene behavior change
Time frame: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Behavior Change related to Children at home
Time frame: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Behavior Change and Occupation Association
Time frame: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 28885428Hughes BL, Gans KM, Raker C, Hipolito ER, Rouse DJ. A Brief Prenatal Intervention of Behavioral Change to Reduce the Risk of Maternal Cytomegalovirus: A Randomized Controlled Trial. Obstet Gynecol. 2017 Oct;130(4):726-734. doi: 10.1097/AOG.0000000000002216.
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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.
Brenna Anderson, MD principal investigator
Women & Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Cytomegalovirus Infections and Pregnancy, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
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 5 inclusion and 9 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 3 Jun 2015. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Hygiene Behaviors (time frame: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01819519, which also lists 1 linked publication.
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 3 Jun 2015.