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Jovenes Sanos: Preventing IPV and RC

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ClinicalTrials.gov Identifier: NCT03660514
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : July 5, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Comision de Salud Fronteriza Mexico - Estados Unidos
Secretaria de Salud de Baja California
Information provided by (Responsible Party):
Argentina Servin, MD, MPH, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Unintended Pregnancy Family Planning Intimate Partner Violence (IPV) Behavioral: Jovenes Sanos Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Jovenes Sanos: Preventing IPV and Reproductive Coercion Among Underserved Adolescents
Actual Study Start Date : September 15, 2018
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
No Intervention: Standard Family Planning
Counseling Clients receive standard FP counseling services.
Experimental: Jovenes Sanos Intervention in FP Counseling
Clients receive the Jovenes Sanos intervention in addition to standard FP counseling services.
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.
Other Name: ARCHES




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Intimate Partner Violence (IPV) [ Time Frame: Prior 3 months and prior 12 months ]
    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?".

  2. Contraception discontinuation [ Time Frame: Prior 6 months and 12 months ]
    Items assessing discontinuation of use of method of contraception that participant reported using during prior 6 months or 12 months

  3. Contraception self-efficacy [ Time Frame: Baseline and 3-month follow-up ]
    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.

  4. Contraception delivery [ Time Frame: Immediate post-intervention ]
    Report of receiving modern contraception method during clinic visit immediately preceding survey.

  5. Biased and coercive FP provider practices [ Time Frame: Immediate post-intervention ]
    Items to assess whether specified coercive or discriminatory behaviors were experienced from a FP provider during clinic visit immediately preceding survey.

  6. Knowledge of IPV services [ Time Frame: Present, assessed at baseline, 3-month follow-up ]
    Items assessing reported knowledge of listed local services for women and girls experiencing IPV

  7. Utilization of IPV services among those reporting IPV [ Time Frame: Prior 3 months and 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biologically Female seeking family planning services
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660514


Contacts
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Contact: Argentina E Servin, MD, MPH (858) 822-4630 arservin@ucsd.edu
Contact: Cassandra Cyr, BS (858)534-7979 clcyr@ucsd.edu

Locations
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United States, California
Division of Infectious Diseases and Global Public Health, University of California, San Diego Not yet recruiting
La Jolla, California, United States, 92093
Contact: Argenta E Servin, MD, MPH    858-822-4630    arservin@ucsd.edu   
Contact: Christina J Catabay, MPH    (619) 884-7253    cjcatabay@ucsd.edu   
Principal Investigator: Argentina E Servin, MD, MPH         
Mexico
Centro de Salud Florido Morita Recruiting
Tijuana, Baja California, Mexico, 22245
Contact: Alejandra Padilla-Mercado, MD    +52 664 102 8113    alejandrapadillamd@gmail.com   
Contact: Frida Lameiro, MD    +52 16644453588    frida.lameiro@hotmail.com   
Centro de Salud Fransisco Villa Recruiting
Tijuana, Baja California, Mexico
Contact: Raquel Rocha, MD    6644278600    raquelrx3.88@gmail.com   
Contact: Diana Huerta, MD    6651275058      
Sponsors and Collaborators
University of California, San Diego
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Comision de Salud Fronteriza Mexico - Estados Unidos
Secretaria de Salud de Baja California
Investigators
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Principal Investigator: Argentina E Servin, MD, MPH Division of Infectious Diseases and Global Public Health, University of California, San Diego

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Responsible Party: Argentina Servin, MD, MPH, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03660514    
Other Study ID Numbers: 161741
K23HD084756-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Argentina Servin, MD, MPH, University of California, San Diego:
Reproductive Coercion
Gender-based violence
Contraception
Clinic-based screening for IPV
Clinic-based counseling