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Unintended PregnancyNCT03660514

Jovenes Sanos: Preventing IPV and RC

A study testing Jovenes Sanos in people with Unintended Pregnancy and Family Planning, run by University of California, San Diego at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 … Read more about this study

Who is it for?
Ages 16 to 20 years, women onlyHealthy volunteers can take part
What is being tested?
Jovenes Sanos
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
3 sitesin 2 countries
Study dates
15 Sep 2018to 22 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 20 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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).

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Mexico2 sites

  • Centro de Salud Florido Morita

    Tijuana, Estado de Baja California, 22245

  • Centro de Salud Fransisco Villa

    Tijuana, Estado de Baja California

Other trials in Mexico

United States1 site

  • Division of Infectious Diseases and Global Public Health, University of California, San Diego

    La Jolla, California, 92093

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Jovenes Sanos
Keywords
Reproductive Coercion, Gender-based violence, Contraception, Clinic-based screening for IPV, Clinic-based counseling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jovenes SanosBehavioural

    Also called ARCHES

    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.

Study groups in NCT03660514
Study groupRoleWhat they receive
Standard Family PlanningNo interventionCounseling Clients receive standard FP counseling services.
Jovenes Sanos Intervention in FP CounselingExperimentalClients receive the Jovenes Sanos intervention in addition to standard FP counseling services.
Receives: Behavioral: Jovenes Sanos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from prior 3 months (baseline) and 3-month follow-up

Secondary outcomes (7)

  1. 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?".

    Measured: Prior 3 months and prior 12 months

  2. Contraception discontinuation

    Items assessing discontinuation of use of method of contraception that participant reported using during prior 6 months or 12 months

    Measured: Prior 6 months and 12 months

  3. 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.

    Measured: Baseline and 3-month follow-up

  4. Contraception delivery

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

    Measured: Immediate post-intervention

  5. 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.

    Measured: Immediate post-intervention

  6. Knowledge of IPV services

    Items assessing reported knowledge of listed local services for women and girls experiencing IPV

    Measured: Present, assessed at baseline, 3-month follow-up

  7. 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.

    Measured: Prior 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2018
  2. Study start15 Sep 2018
  3. Primary completion22 Jan 2020
  4. Study completion22 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03660514
Sponsor's protocol ID
161741
Other IDs
K23HD084756-01A1
Status last verified
Aug 2021
First submitted
28 Aug 2018
Last updated
9 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2022 Apr;37(7-8):NP4740-NP4761. doi: 10.1177/0886260520959571. Epub 2020 Nov 12.

    PubMed 33183147

Questions about this trial

What is this clinical trial studying?

A study testing Jovenes Sanos in people with Unintended Pregnancy and Family Planning, run by University of California, San Diego at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Mexico, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recent RC (time frame: Change from prior 3 months (baseline) and 3-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03660514, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.

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