Clinical trial NCT03660514: Jovenes Sanos: Preventing IPV and RC
Official title: Jovenes Sanos: Preventing IPV and Reproductive Coercion Among Underserved Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unintended Pregnancy
Family Planning
Intimate Partner Violence (IPV)
Keywords: Reproductive Coercion
Gender-based violence
Contraception
Clinic-based screening for IPV
Clinic-based counseling
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Comision de Salud Fronteriza Mexico - Estados Unidos
name: Secretaria de Salud de Baja California
First posted: 2018-09-06
Enrollment: 124
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Jovenes Sanos study will take place in two urban clinics in Tijuana, Mexico for all clients receiving voluntary FP counseling. The intervention study will involve a matched cluster control trial. Two clinics will serve as the intervention sites.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Primary outcomes:
measure: Recent RC
timeFrame: Change from prior 3 months (baseline) and 3-month follow-up
Secondary outcomes:
measure: Intimate Partner Violence (IPV)
timeFrame: Prior 3 months and prior 12 months
measure: Contraception discontinuation
timeFrame: Prior 6 months and 12 months
measure: Contraception self-efficacy
timeFrame: Baseline and 3-month follow-up
measure: Contraception delivery
timeFrame: Immediate post-intervention
measure: Biased and coercive FP provider practices
timeFrame: Immediate post-intervention
measure: Knowledge of IPV services
timeFrame: Present, assessed at baseline, 3-month follow-up
measure: Utilization of IPV services among those reporting IPV
timeFrame: Prior 3 months and 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Division of Infectious Diseases and Global Public Health, University of California, San Diego
state: California
city: Tijuana
country: Mexico
facility: Centro de Salud Florido Morita
state: Baja California
city: Tijuana
country: Mexico
facility: Centro de Salud Fransisco Villa
state: Baja California
Study officials:
affiliation: Division of Infectious Diseases and Global Public Health, University of California, San Diego
name: Argentina E Servin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uysal J, Stockman JK, Miller E, Rocha-Jimenez T, Rangel GM, Mercado AP, Servin AE. "At Least I Didn't Get Raped": A Qualitative Exploration of IPV and Reproductive Coercion among Adolescent Girls Seeking Family Planning in Mexico. J Interpers Violence. 2022 Apr;37(7-8):NP4740-NP4761. doi: 10.1177/0886260520959571. Epub 2020 Nov 12.