Jovenes Sanos: Preventing IPV and RC

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT03660514
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Comision de Salud Fronteriza Mexico - Estados Unidos (Other), Secretaria de Salud de Baja California (Other)
124
Enrollment
3
Locations
2
Arms
16.2
Actual Duration (Months)
41.3
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Behavioral: Jovenes Sanos
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
124 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.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 :
Sep 15, 2018
Actual Primary Completion Date :
Jan 22, 2020
Actual Study Completion Date :
Jan 22, 2020

Arms and Interventions

ArmIntervention/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 Names:
  • ARCHES
  • Outcome Measures

    Primary Outcome Measures

    1. Recent RC [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) [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 [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 [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 [Immediate post-intervention]

      Report of receiving modern contraception method during clinic visit immediately preceding survey.

    5. Biased and coercive FP provider practices [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 20 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    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).

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Division of Infectious Diseases and Global Public Health, University of California, San DiegoLa JollaCaliforniaUnited States92093
    2Centro de Salud Florido MoritaTijuanaBaja CaliforniaMexico22245
    3Centro de Salud Fransisco VillaTijuanaBaja CaliforniaMexico

    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

    • Principal Investigator: Argentina E Servin, MD, MPH, Division of Infectious Diseases and Global Public Health, University of California, San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Argentina Servin, MD, MPH, Assistant Professor, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT03660514
    Other Study ID Numbers:
    • 161741
    • K23HD084756-01A1
    First Posted:
    Sep 6, 2018
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Assistant Professor, University of California, San Diego

    Study Results

    No Results Posted as of Aug 9, 2021