Family Planning Clinical Trial
Official title:
Jovenes Sanos: Preventing IPV and Reproductive Coercion Among Underserved Adolescents
Verified date | August 2021 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
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 |
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 |
United States, Mexico,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00928538 -
Nurse Family Partnership (NFP) Contraceptive Study
|
Phase 4 | |
Not yet recruiting |
NCT04521517 -
Effect of Pamphlet Supported Counseling During Child Immunization on the Initiation of Post-partum Family Planning
|
N/A | |
Completed |
NCT02866643 -
Labor and Delivery Implant Insertion: A Randomized Controlled Trial
|
Phase 3 | |
Completed |
NCT05503992 -
Evaluating the Efficacy of Using a Digital Consumption Management Tool for Family Planning in Zambia
|
N/A | |
Recruiting |
NCT04558229 -
RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users
|
Phase 4 | |
Completed |
NCT03973593 -
Evaluation of Dynamics of Contraceptive Use, Discontinuation and Method Switching in Migori and Kitui Counties, Kenya
|
||
Completed |
NCT02714231 -
Oral Diclofenac Sodium Versus Oral Hyoscine Butyl Bromide During Intrauterine Device Insertion
|
Phase 4 | |
Completed |
NCT02711358 -
Indomethacin Use in Pain Relief During Intrauterine Device Insertion
|
Phase 4 | |
Completed |
NCT01593943 -
Gender Equity-Focused, Male-Centered Family Planning for Rural India
|
Phase 3 | |
Completed |
NCT03106727 -
Evaluating the Impact of a Community Health Worker Program in Neno, Malawi
|
N/A | |
Completed |
NCT01288274 -
Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia
|
N/A | |
Completed |
NCT03534401 -
Addressing Reproductive Coercion in HEalth Settings - Kenya
|
N/A | |
Completed |
NCT03576157 -
Kilkari Impact Evaluation
|
N/A | |
Not yet recruiting |
NCT04970420 -
Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks).
|
N/A | |
Completed |
NCT01894126 -
Mobile Phone Messaging to Improve Women's and Children's Health (Mobile WACh) in Kenya
|
N/A | |
Completed |
NCT03490617 -
Misoprostol Prior to IUD Insertion in Nullipara
|
Phase 3 | |
Completed |
NCT06320964 -
The TARANG Intervention
|
N/A | |
Completed |
NCT03135288 -
Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives
|
N/A | |
Completed |
NCT02633631 -
Contraceptive Choice Center
|
||
Completed |
NCT06450756 -
Effect of Male Involvement in Family Planning Education on Contraceptive Use
|
N/A |