Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica

Sponsor
Ohio State University (Other)
Overall Status
Completed
CT.gov ID
NCT03775642
Collaborator
FHI 360 (Other), Epidemiology Research and Training Unit of the Jamaica Ministry of Health (Other), The University of The West Indies (Other)
225
1
2
9.5
23.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention video
  • Behavioral: Control video
N/A

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

Study Type:
Interventional
Actual Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
Actual Study Start Date :
Nov 21, 2018
Actual Primary Completion Date :
Sep 5, 2019
Actual Study Completion Date :
Sep 5, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention video

The intervention video will employ debiasing strategies to correct women's misinformation about the safety of the IUD and implant safety.

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.

Placebo Comparator: Control video

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

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

Outcome Measures

Primary Outcome Measures

  1. Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use) [within 3 months of enrollment]

    Based on survey question on use of the IUD (y/n) and implant (y/n)

Secondary Outcome Measures

  1. Self-reported belief about IUD safety [3 months after enrollment]

    "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.

  2. Self-reported belief about implant safety [3 months after enrollment]

    "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. Self-reported attitudes toward LARC-related bleeding patterns [3 months after enrollment]

    "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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Epidemiology Training Unit Kingston Jamaica

Sponsors and Collaborators

  • Ohio State University
  • FHI 360
  • Epidemiology Research and Training Unit of the Jamaica Ministry of Health
  • The University of The West Indies

Investigators

  • Principal Investigator: Maria F Gallo, PhD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria F. Gallo, PhD, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier:
NCT03775642
Other Study ID Numbers:
  • 2017B0412
First Posted:
Dec 14, 2018
Last Update Posted:
Apr 16, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 16, 2020