Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03775642
Other study ID # 2017B0412
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 21, 2018
Est. completion date September 5, 2019

Study information

Verified date April 2020
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date September 5, 2019
Est. primary completion date September 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- present at the Comprehensive Health Centre;

- 18-25 years of age; and

- sexually active (defined as =1 penile-vaginal act in past month);

Exclusion Criteria:

- known to be pregnant;

- sterilized;

- breastfeeding;

- currently using the IUD or implant; or

- want pregnancy in the next 12 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention video
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 video
The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration

Locations

Country Name City State
Jamaica Epidemiology Training Unit Kingston

Sponsors (4)

Lead Sponsor Collaborator
Ohio State University Epidemiology Research and Training Unit of the Jamaica Ministry of Health, FHI 360, The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) within 3 months of enrollment
Secondary 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. 3 months after enrollment
Secondary 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. 3 months after enrollment
Secondary 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 3 months after enrollment
See also
  Status Clinical Trial Phase
Recruiting NCT05889689 - Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters N/A
Withdrawn NCT03725358 - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon. N/A
Completed NCT02234271 - Plan A Birth Control: Randomized Controlled Trial of a Mobile Health Application for Contraception Information N/A
Enrolling by invitation NCT05216003 - Pregnancy at a Time That Is Happy and Healthy for You N/A
Not yet recruiting NCT03612518 - An mHealth Trial to Promote the Use of Postpartum Contraception N/A
Completed NCT04136613 - Utility of Immediate Post Placental Insertion of Intrauterine Device During Cesarean Delivery N/A
Completed NCT03366636 - Project Legacy Impact Evaluation Study N/A
Recruiting NCT06100679 - Responsible Engaged and Loving (REAL) Fathers Intervention Evaluation N/A
Completed NCT03571932 - Assessment of Family Planning and Immunization Service Integration in Liberia
Completed NCT03165838 - Effectiveness of Shortened Time Interval to Postpartum Visit in Improving Postpartum Attendance N/A
Completed NCT04120376 - Reducing Adolescent Pregnancy N/A
Completed NCT03400410 - Hormonal Contraceptive Health Education for Adolescent Males N/A
Not yet recruiting NCT05988983 - The Over The Counter Pill National Study
Not yet recruiting NCT05362019 - Effects of One-to-one Service on the Continuation and Satisfaction of Contraceptive Use. N/A
Completed NCT01360216 - Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training N/A
Completed NCT03559634 - Contraception Initiation Feasibility in the Pediatric ED N/A
Enrolling by invitation NCT05022134 - Evaluating the Impact of CHOICE-AYA on Contraceptive Use, Continuation and Satisfaction N/A
Active, not recruiting NCT03733678 - A Randomized-Controlled Trial to Increase the Uptake of LARCs in Cameroon N/A
Completed NCT03500978 - Factors Predicting Ineffective Contraception Use N/A
Recruiting NCT06307002 - Evaluating What's My Method? in Barbados N/A