Jovenes Sanos: Preventing IPV and RC

Family Planning Clinical Trial

Official title:

Jovenes Sanos: Preventing IPV and Reproductive Coercion Among Underserved Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660514
• Other study ID #: 161741
• Secondary ID: K23HD084756-01A1
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: January 22, 2020

Study information

• Verified date: August 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 20 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Jovenes Sanos
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.

Locations

Country	Name	City	State
Mexico	Centro de Salud Florido Morita	Tijuana	Baja California
Mexico	Centro de Salud Fransisco Villa	Tijuana	Baja California
United States	Division of Infectious Diseases and Global Public Health, University of California, San Diego	La Jolla	California

Sponsors (4)

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

Countries where clinical trial is conducted

United States,  Mexico, 

References & 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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intimate Partner Violence (IPV)	Recent IPV is defined as violence in the past 3 months and Past IPV as violence in the past 12 months with participant's primary partner. a) Physical IPV: "pushed, pulled, slapped, held you down; punched you with fist or something that could hurt you; kicked or dragged you; tried to strangle or burn you; threatened you with a knife, gun, other weapon; attacked you with knife, gun, other weapon?" b) Sexual IPV: "used verbal threats to force you to have sex; physically forced you to have sex; or coerced you to perform other sexual acts when you did not want to?".	Prior 3 months and prior 12 months
Secondary	Contraception discontinuation	Items assessing discontinuation of use of method of contraception that participant reported using during prior 6 months or 12 months	Prior 6 months and 12 months
Secondary	Contraception self-efficacy	Modified HIV risk reduction self-efficacy scale, which measures participants' reports of belief that she can enact certain contraceptive behaviors. This is a 4-item scale where each item has a 3-point measure from 0-2 with a score of 2 being very confident, 1 being somewhat confident, and 0 being not at all confident, for a total score range of 0-8.	Baseline and 3-month follow-up
Secondary	Contraception delivery	Report of receiving modern contraception method during clinic visit immediately preceding survey.	Immediate post-intervention
Secondary	Biased and coercive FP provider practices	Items to assess whether specified coercive or discriminatory behaviors were experienced from a FP provider during clinic visit immediately preceding survey.	Immediate post-intervention
Secondary	Knowledge of IPV services	Items assessing reported knowledge of listed local services for women and girls experiencing IPV	Present, assessed at baseline, 3-month follow-up
Secondary	Utilization of IPV services among those reporting IPV	Items assessing whether participant called or visited a listed local service for women or girls experiencing IPV- only assessed for participants reporting history of IPV.	Prior 3 months and 6 months