Jovenes Sanos: Preventing IPV and RC

NCT03660514 | Completed

• 2 other identifiers: 161741K23HD084756-01A1
• Study Type: interventional
• Target: 124
• Locations: 2 countries
• Sites: 3

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.

Conditions

Unintended Pregnancy; Family Planning; Intimate Partner Violence (IPV)

Keywords

Reproductive Coercion; Gender-based violence; Contraception; Clinic-based screening for IPV; Clinic-based counseling

Outcome Measures

Primary Outcomes (1)

• Recent RC

  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.

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

Secondary Outcomes (7)

• Intimate Partner Violence (IPV)

  Prior 3 months and prior 12 months

• Contraception discontinuation

  Prior 6 months and 12 months

• Contraception self-efficacy

  Baseline and 3-month follow-up

• Contraception delivery

  Immediate post-intervention

• Biased and coercive FP provider practices

  Immediate post-intervention

Study Arms (2)

Standard Family Planning

NO INTERVENTION

Counseling Clients receive standard FP counseling services.

Jovenes Sanos Intervention in FP Counseling

EXPERIMENTAL

Clients receive the Jovenes Sanos intervention in addition to standard FP counseling services.

Behavioral: Jovenes Sanos

Interventions

Jovenes Sanos BEHAVIORAL

FP counselors in intervention clinics will a) provide counseling and education regarding risk of partner detection of FP methods, and women's and girls' strategies to use FP methods to minimize partner detection risk integrated into standard FP counseling, b) make brief inquiries to allow clients the opportunity to disclose experiences of RC and IPC (i.e., screening), c) provide method-specific counseling based on this information and the method chosen by the client, d) provide supported linkage of IPV survivors to local IPV support services (i.e. warm referral), and e) distribute palm-sized educational materials on RC and IPV, as well as IPV services.

Also known as: ARCHES

Jovenes Sanos Intervention in FP Counseling

Eligibility Criteria

• Age: 16 Years - 20 Years
• Gender Eligibility Details: Biologically Female seeking family planning services
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• University of California, San Diego: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Comision de Salud Fronteriza Mexico - Estados Unidos: collaborator
• Secretaria de Salud de Baja California: collaborator

Study Sites (3)

Division of Infectious Diseases and Global Public Health, University of California, San Diego

La Jolla, California, 92093, United States

Location

Centro de Salud Florido Morita

Tijuana, Estado de Baja California, 22245, Mexico

Location

Centro de Salud Fransisco Villa

Tijuana, Estado de Baja California, Mexico

Location

Related Publications (1)

• 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.

  PMID: 33183147 RESULT

MeSH Terms

Interventions

cpsf4 protein, zebrafish

Study Officials

• Argentina E Servin, MD, MPH

  Division of Infectious Diseases and Global Public Health, University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 6, 2018
• Study Start: September 15, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2); US (1)