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Clinical Trials/NCT03660514
NCT03660514
Completed
Not Applicable

Jovenes Sanos: Preventing IPV and Reproductive Coercion Among Underserved Adolescents

University of California, San Diego3 sites in 2 countries124 target enrollmentSeptember 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unintended Pregnancy
Sponsor
University of California, San Diego
Enrollment
124
Locations
3
Primary Endpoint
Recent RC
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The primary purpose of this research is to conduct a small matched cluster control trial of an intervention designed to address reproductive coercion and unintended pregnancy (ARCHES - Addressing Reproductive Coercion within Healthcare Settings) adapted to the Mexican cultural and family planning healthcare context ( renamed Jovenes Sanos) in order to provide initial data regarding acceptability, feasibility and efficacy in this high need low-and-middle-income country.

Detailed Description

The project consortium will implement the ARCHES model across two community health centers in Tijuana, Baja California, Mexico. A 2-armed pilot study of ARCHES (adapted) will be conducted with 80 female FP clients (40 intervention, 40 control) ages 16-20 drawn from 2 comparable community health centers randomly assigned to either intervention or control (i.e. standard of care). Baseline data will be collected prior to routine FP service delivery, with a short exit survey conducted immediately following the clients' FP appointment (ARCHES or standard FP counseling will be provided during this visit). Follow-up data will be collected at 3-months post-intervention. Data at each time point will be collected via a 30-minute audio computer-assisted self-interview (ACASI) in Spanish. Data will also be collected to assess qualities of program implementation (i.e., process evaluation) to ensure implementation of the program as intended as well as unforeseen barriers to implementation. Creation of procedures for data collection, review of quality control data, and interpretation of findings will occur in collaboration with the entire mentoring/training committee. In-depth interviews (IDIs) with female adolescent FP clients ages 16-20 with a recent IPV/RC (n= 20), and focus groups (FGs) (n=2; 6-8 participants per group) with FP counselors in 2 comparable urban community health centers to identify perceptions of prevalence and impact of IPV and RC among adolescent clients and barriers to identifying IPV and RC. FGs with FP counselors from the participating community health centers will be conducted (n=2; 6-8 participants per group). FP counselors from these community health centers will be purposely selected to participate based on having provided FP services for at least 10 female adolescent clients in the past 6 months. At intervention sites, FP counselors will deliver the intervention integrated into standard-of-care practice; at control sites FP counselors will deliver solely standard-of-care services. Analyses specific to participants ages 16-20 will provide findings to guide consideration of ARCHES as an effective strategy to improve the reproductive health and reduce GBV among adolescents in this region.

Registry
clinicaltrials.gov
Start Date
September 15, 2018
End Date
January 22, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Argentina Servin, MD, MPH

Assistant Professor

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • a) Client seeking voluntary FP services at community health centers; b)Aged 16-20 years; c) Biologically female; d) Willing to complete baseline, exit, and 3-month follow-up survey; e) Able to provide informed consent; f) Literate in Spanish; g) Screened positive for recent RC; h) Reside in Tijuana and have no plans to move in the next 12 months; i) Having no cognitive impairment that may interfere with their decisions to participate in the project (using Folstein Mini-Mental Exam); j) Not have participated in the IDIs (qualitative phase).

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Recent RC

Time Frame: Change from prior 3 months (baseline) and 3-month follow-up

RC consisted of two elements, pregnancy coercion and birth control sabotage. Pregnancy coercion was assessed using via 5 dichotomous items. Birth control sabotage was assessed via 5 dichotomous items measuring experiences of partner interference with contraception to promote pregnancy.

Secondary Outcomes

  • Contraception self-efficacy(Baseline and 3-month follow-up)
  • Biased and coercive FP provider practices(Immediate post-intervention)
  • Contraception discontinuation(Prior 6 months and 12 months)
  • Knowledge of IPV services(Present, assessed at baseline, 3-month follow-up)
  • Intimate Partner Violence (IPV)(Prior 3 months and prior 12 months)
  • Contraception delivery(Immediate post-intervention)
  • Utilization of IPV services among those reporting IPV(Prior 3 months and 6 months)

Study Sites (3)

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