- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03660514
Jovenes Sanos: Preventing IPV and RC
August 5, 2021 updated by: Argentina Servin, MD, MPH, University of California, San Diego
Jovenes Sanos: Preventing IPV and Reproductive Coercion Among Underserved Adolescents
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
124
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Baja California
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Tijuana, Baja California, Mexico, 22245
- Centro de Salud Florido Morita
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Tijuana, Baja California, Mexico
- Centro de Salud Fransisco Villa
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California
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La Jolla, California, United States, 92093
- Division of Infectious Diseases and Global Public Health, University of California, San Diego
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 20 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Standard Family Planning
Counseling Clients receive standard FP counseling services.
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EXPERIMENTAL: Jovenes Sanos Intervention in FP Counseling
Clients receive the Jovenes Sanos intervention in addition to standard FP counseling services.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recent RC
Time Frame: Change from prior 3 months (baseline) and 3-month follow-up
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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.
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Change from prior 3 months (baseline) and 3-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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?".
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Prior 3 months and prior 12 months
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Contraception discontinuation
Time Frame: Prior 6 months and 12 months
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Items assessing discontinuation of use of method of contraception that participant reported using during prior 6 months or 12 months
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Prior 6 months and 12 months
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Contraception self-efficacy
Time Frame: Baseline and 3-month follow-up
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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.
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Baseline and 3-month follow-up
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Contraception delivery
Time Frame: Immediate post-intervention
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Report of receiving modern contraception method during clinic visit immediately preceding survey.
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Immediate post-intervention
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Biased and coercive FP provider practices
Time Frame: Immediate post-intervention
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Items to assess whether specified coercive or discriminatory behaviors were experienced from a FP provider during clinic visit immediately preceding survey.
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Immediate post-intervention
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Knowledge of IPV services
Time Frame: Present, assessed at baseline, 3-month follow-up
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Items assessing reported knowledge of listed local services for women and girls experiencing IPV
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Present, assessed at baseline, 3-month follow-up
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Utilization of IPV services among those reporting IPV
Time Frame: Prior 3 months and 6 months
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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.
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Prior 3 months and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Argentina E Servin, MD, MPH, Division of Infectious Diseases and Global Public Health, University of California, San Diego
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 15, 2018
Primary Completion (ACTUAL)
January 22, 2020
Study Completion (ACTUAL)
January 22, 2020
Study Registration Dates
First Submitted
August 28, 2018
First Submitted That Met QC Criteria
September 4, 2018
First Posted (ACTUAL)
September 6, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 9, 2021
Last Update Submitted That Met QC Criteria
August 5, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 161741
- K23HD084756-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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