Contraception BehaviorNCT03775642
Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
A study testing Intervention video in people with Contraception Behavior, run by Ohio State University at 1 site in Jamaica.
Trial summary
The primary hypothesis is that the intervention video - based on strategies from cognitive psychology - can correct women's misinformation about long-acting reversible contraception (LARC) and result in higher use of LARC. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior
- What is being tested?
- Intervention video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteJamaica
- Study dates
- 21 Nov 2018to 5 Sep 2019
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- present at the Comprehensive Health Centre;
- 18-25 years of age; and
- sexually active (defined as ≥1 penile-vaginal act in past month);
Who cannot join
- known to be pregnant;
- sterilized;
- breastfeeding;
- currently using the IUD or implant; or
- want pregnancy in the next 12 months
Trial locations and contacts
1 site in 1 country.
About this study
The primary hypothesis is that the intervention video - based on strategies from cognitive psychology - can correct women's misinformation about long-acting reversible contraception (LARC) and result in higher use of LARC. While there are no direct benefits to participants from being in the study, the research could benefit women in general by providing evidence to help prevent unintended pregnancy. Unlike many interventions that are not feasible for scaling up once shown to be effective in changing people's behavior, the proposed intervention has been carefully designed to impose a low burden to clinic staff and require few resources for translating to wider use. Thus, the investigators expect the intervention to have high potential for influencing clinical care and research for addressing the overall goal of reducing unintended pregnancy.
Read the detailed description
The investigators will conduct a randomized trial (RT) of consenting adult women (N=220) to test the effectiveness of the final intervention video.
Participants in the RT will complete the "Enrollment Questionnaire" and then will be randomized to either watch a short video on 1) debiasing about LARC safety (intervention arm; n=110) or 2) vector control (control arm; n=110) (Figure 2). Participants then will have the option of receiving routine contraceptive services that follow standard care. After three months, trained interviewers will contact participants to administer the short "Follow-up Questionnaire" via telephone. To corroborate participant reporting of contraception use during follow-up, the investigators also will extract data on LARC use from participant medical records.
- Conditions
- Contraception Behavior
- Being tested
- Intervention video, Control video
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention videoBehavioural
The intervention video will employ the debiasing strategies. It will avoid directly articulating contraception-related myths, but instead will provide a limited number of alternative explanations related to IUD and implant safety.
Control videoBehavioural
The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration
| Study group | Role | What they receive |
|---|---|---|
| Intervention video | Experimental | The intervention video will employ debiasing strategies to correct women's misinformation about the safety of the IUD and implant safety. Receives: Behavioral: Intervention video |
| Control video | Placebo comparator | The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration. Receives: Behavioral: Control video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)
Based on survey question on use of the IUD (y/n) and implant (y/n)
Measured: within 3 months of enrollment
Secondary outcomes (3)
Self-reported belief about IUD safety
"Do you think the IUD is very safe, mostly safe, mostly unsafe, or very unsafe?" Responses will be coded as 1-4 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm.
Measured: 3 months after enrollment
Self-reported belief about implant safety
"Do you think the implant is very safe, mostly safe, mostly unsafe, or very unsafe?" Responses will be coded as 1-4 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm.
Measured: 3 months after enrollment
Self-reported attitudes toward LARC-related bleeding patterns
"How do you feel about your bleeding pattern?" Response options consist of "very satisfied, satisfied, neutral, unsatisfied, very unsatisfied." Responses will be coded as 1-5 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start21 Nov 2018
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- FHI 360, Epidemiology Research and Training Unit of the Jamaica Ministry of Health, The University of The West Indies
- Responsible party
- Principal investigator, Maria F. Gallo, PhD, Ohio State University
- Investigators
- Maria F Gallo, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775642
- Sponsor's protocol ID
- 2017B0412
- Status last verified
- Apr 2020
- First submitted
- 11 Dec 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- 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 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
- ClinicalTrials.gov ID
- NCT03775642
- Acronym / sponsor ID
- 2017B0412
- Conditions
- Contraception Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- FHI 360, Epidemiology Research and Training Unit of the Jamaica Ministry of Health, The University of The West Indies
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 14 Dec 2018 (actual)
- 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 primary hypothesis is that the intervention video - based on strategies from cognitive psychology - can correct women's misinformation about long-acting reversible contraception (LARC) and result in higher use of LARC. While there are no direct benefits to participants from being in the study, the research could benefit women in general by providing evidence to help prevent unintended pregnancy. Unlike many interventions that are not feasible for scaling up once shown to be effective in changing people's behavior, the proposed intervention has been carefully designed to impose a low burden to clinic staff and require few resources for translating to wider use. Thus, the investigators expect the intervention to have high potential for influencing clinical care and research for addressing the overall goal of reducing unintended pregnancy.
Detailed description
The investigators will conduct a randomized trial (RT) of consenting adult women (N=220) to test the effectiveness of the final intervention video.
Participants in the RT will complete the "Enrollment Questionnaire" and then will be randomized to either watch a short video on 1) debiasing about LARC safety (intervention arm; n=110) or 2) vector control (control arm; n=110) (Figure 2). Participants then will have the option of receiving routine contraceptive services that follow standard care. After three months, trained interviewers will contact participants to administer the short "Follow-up Questionnaire" via telephone. To corroborate participant reporting of contraception use during follow-up, the investigators also will extract data on LARC use from participant medical records.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention video | Experimental | Behavioral: Intervention videoThe intervention video will employ debiasing strategies to correct women's misinformation about the safety of the IUD and implant safety. |
| Control video | Placebo comparator | Behavioral: Control videoThe video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- present at the Comprehensive Health Centre;
- 18-25 years of age; and
- sexually active (defined as ≥1 penile-vaginal act in past month);
Key exclusion criteria (5 listed)
- known to be pregnant;
- sterilized;
- breastfeeding;
- currently using the IUD or implant; or
- want pregnancy in the next 12 months
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 |
|---|---|---|
| Intervention videoThe intervention video will employ the debiasing strategies. It will avoid directly articulating contraception-related myths, but instead will provide a limited number of alternative explanations related to IUD and implant safety. | Behavioural | Intervention video |
| Control videoThe video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration | Behavioural | Control video |
Primary outcome
Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)
Time frame: within 3 months of enrollment
Based on survey question on use of the IUD (y/n) and implant (y/n)
3 secondary outcomes
Self-reported belief about IUD safety
Time frame: 3 months after enrollment
Self-reported belief about implant safety
Time frame: 3 months after enrollment
Self-reported attitudes toward LARC-related bleeding patterns
Time frame: 3 months after enrollment
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 16 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Maria F Gallo, PhD principal investigator
Ohio State 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 Intervention video in people with Contraception Behavior, run by Ohio State University at 1 site in Jamaica.
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 3 inclusion and 5 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 16 Apr 2020. 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 Jamaica. 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. Some participants in this study may receive a placebo. 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?
Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use) (time frame: within 3 months of enrollment). 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 16 Apr 2020.