Clinical trial NCT03775642: Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
Official title: Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception Behavior
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: FHI 360
name: Epidemiology Research and Training Unit of the Jamaica Ministry of Health
name: The University of The West Indies
First posted: 2018-12-14
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)
timeFrame: within 3 months of enrollment
Secondary outcomes:
measure: Self-reported belief about IUD safety
timeFrame: 3 months after enrollment
measure: Self-reported belief about implant safety
timeFrame: 3 months after enrollment
measure: Self-reported attitudes toward LARC-related bleeding patterns
timeFrame: 3 months after enrollment
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: Epidemiology Training Unit
Study officials:
affiliation: Ohio State University
name: Maria F Gallo, PhD
role: PRINCIPAL_INVESTIGATOR
References: