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
|Condition or disease||Intervention/treatment||Phase|
|Unintended Pregnancy Family Planning Intimate Partner Violence (IPV)||Behavioral: Jovenes Sanos||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
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
- 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.
- 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?".
- 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
- 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.
- Contraception delivery [ Time Frame: Immediate post-intervention ]Report of receiving modern contraception method during clinic visit immediately preceding survey.
- 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.
- 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
- 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.
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
|Contact: Argentina E Servin, MD, MPH||(858) firstname.lastname@example.org|
|Contact: Cassandra Cyr, BS||(858)email@example.com|
|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 firstname.lastname@example.org|
|Contact: Christina J Catabay, MPH (619) 884-7253 email@example.com|
|Principal Investigator: Argentina E Servin, MD, MPH|
|Centro de Salud Florido Morita||Recruiting|
|Tijuana, Baja California, Mexico, 22245|
|Contact: Alejandra Padilla-Mercado, MD +52 664 102 8113 firstname.lastname@example.org|
|Contact: Frida Lameiro, MD +52 16644453588 email@example.com|
|Centro de Salud Fransisco Villa||Recruiting|
|Tijuana, Baja California, Mexico|
|Contact: Raquel Rocha, MD 6644278600 firstname.lastname@example.org|
|Contact: Diana Huerta, MD 6651275058|
|Principal Investigator:||Argentina E Servin, MD, MPH||Division of Infectious Diseases and Global Public Health, University of California, San Diego|