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Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy (CHARM2)

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ClinicalTrials.gov Identifier: NCT03514914
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Population Council
Information provided by (Responsible Party):
Anita Raj, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE April 10, 2018
First Posted Date  ICMJE May 3, 2018
Last Update Posted Date May 17, 2019
Actual Study Start Date  ICMJE June 7, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
Modern Contraceptive Use in past 3 months [ Time Frame: 18 months ]
Based on self-report in survey on item assessing form of contraceptive used in pst 3 months, with all types of traditional and modern contraceptives included as options. Variable will be constructed by dichotomizing data as yes/no for use of modern contraceptives. This measure was taken from the Demographic and Health Survey (DHS) and has been used in India's DHS for decades
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • Marital Sexual Violence [ Time Frame: 18 months ]
    Marital Sexual VIolence will be assessed via two items on forced or pressured sexual activity from husband in the past six months, dichotomized based on a yes response to either item. These items were taken from the Demographic and Health Survey. Prior research from India documents a Cronbach's alpha for this two item measure of 0.97.
  • Unintended Pregnancy [ Time Frame: 18 months ]
    This variable will be constructed from a survey item on whether the participant would like to be pregnancy now, not now or in future, or not at all. If participants indicate that they did not want a pregnancy now and holds a positive pregnancy test result, they will be identified as having an unintended pregnancy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy
Official Title  ICMJE Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy
Brief Summary

Globally, 41% of all pregnancies are unintended, increasing risk for maternal and infant morbidity and mortality. Most unintended pregnancies occur in the context of contraceptive non-use or failure. Women with husbands who are not supportive of contraception are more likely to report contraceptive non-use, and women with sexually abusive husbands are more likely to report contraceptive failure. This highlights the need for family planning (FP) interventions that engage both women and men, focus on eliminating marital sexual violence (MSV) and promote use of effective contraceptives including long-acting reversible contraception (LARC). Rural India, with some of the lowest rates of contraception and highest rates of marital violence globally, offers an important context to test such interventions, with global implications. Prior research from this team documents promise of the original CHARM intervention, a gender equity (GE) FP intervention engaging men and delivered by male health providers over 3 months. This intervention improved contraceptive use and reduced likelihood of MSV, but demonstrated no reduction in unintended pregnancy; additionally, it demonstrated high participation from men (91%) but less from couples (51%), largely due to women's discomfort with a male provider. Poor reach to women and provision of only short-acting contraceptives, more vulnerable to contraceptive failure, may have compromised an effect on unintended pregnancy outcomes. Based on these findings, CHARM2 includes CHARM sessions for men AND parallel women-focused GE+FP sessions delivered by a female provider and inclusive of broader contraceptive options, including LARC. This study seeks a) to implement CHARM2, b) to evaluate its impact on contraceptive use, unintended pregnancy, and MSV with rural couples in India, and c) to assess its potential for sustainability in rural India, using implementation science methods.

To evaluate the impact of CHARM2, a 2-armed cluster randomized controlled trial will be conducted with up to N=1200 married couples from 20 geographic clusters (n=50-60 couples per cluster) in rural India. Participants will receive CHARM2 or the standard of care, which will involve community health workers offering pills/condoms and linking women to public health clinics. Outcomes will be assessed via pregnancy testing and surveys at baseline, 9 & 18-month follow-ups. Implementation science methods will assess the quality, scalability, and replicability of CHARM2 for uptake by rural health care systems (i.e., sustainability).

Detailed Description

Overview: This study will involve 3 phases: Phase 1- the Preparatory Phase to map the project area and prepare communities for the planned research. Phase 2- Implementation and Evaluation of CHARM 2 (Aims 1&2), using a two-armed cluster randomized controlled trial (RCT) in 20 geographic clusters mapped in Phase 1. To assess treatment impact on contraceptive use, MSV and unintended pregnancy, clusters will be randomized to receive CHARM2 or the control program, which includes standard of care public health FP services. Intervention effects will be assessed via surveys and pregnancy testing at baseline and 9 &18-month follow-up with n=1000-1200 couples (wife aged 18-29 years). Phase 3- Implementation Science Assessments will include in-depth interviews with CHARM2 providers (n=20), select CHARM2 couples (n=50) and key Indian stakeholders in FP & public health (n=50). Interviews with providers and couples will explore intervention delivery and perceived impact. Interviews with FP & public health stakeholders will obtain feedback on perceived feasibility to sustain and scale up CHARM2. A cost-effectiveness analysis will also be done to support considerations of sustainability.

Intervention: The CHARM2 intervention will involve gender, culture and contextually-tailored FP+GE counseling sessions delivered individually to husbands by a trained male health provider (2 sessions), and, in parallel, delivered individually to wives by a trained female provider (2 session2). CHARM2 differs from the original CHARM intervention by 1.) eliminating the couple session 2.) adding a parallel component for wives, delivered by a female and inclusive of reproductive coercion counseling 3.) including LARC counseling for husbands and wives and LARC provision via the public health system.

Standard of Care (Control): Under India's public health system, frontline health workers, including nurses, provide household visits to women to increase awareness and use of FP services but they rarely providing contraceptives. For those women or couples that reach the health center, standard of care FP counseling and services are delivered by a physician; free contraceptives are then offered.

Timeline: Phase 1 of the study preparation will take approximately 3 months. Phase 2 will be in month 4 to month 60, including enrollment and intervention start at month 4, 9 month follow up at month 13, and a 18 month follow up at month 22. The outcome analysis will also be carried out in this phase at month 40. Phase 3, on sustaining the intervention will overlap from month 7 to month 60.

Plan for Data Collection: All survey data will be collected using mobile devices (tablets) with an ODK-based software system for e-data collection and web-based data management. The ODK application with CHARM2 survey questionnaire will be loaded onto the tablets, displaying questions simultaneously in English and Marathi.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
To evaluate the impact of CHARM2 on reversible contraceptive use (including LARC), unintended pregnancy, and MSV via a two armed cluster RCT with N=1000-1200 married couples from 20 geographic clusters (n=50-60 couples per cluster) in rural India. The control arm will receive standard of care in the form of community health workers offering pills/condoms and linking women to public health clinics.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Contraception
Intervention  ICMJE Behavioral: The CHARM2 Intervention
CHARM2 intervention will involve gender, culture & contextually-tailored family planning and gender equity counseling.
Study Arms  ICMJE
  • Experimental: CHARM2 Intervention
    CHARM2 intervention will involve gender, culture & contextually-tailored family planning and gender equity counseling for married couples. Two sessions for men delivered by male health providers and two sessions for women delivered by female providers.
    Intervention: Behavioral: The CHARM2 Intervention
  • No Intervention: Control
    Control clusters will receive standard of care.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2018)
2070
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Young wives (aged 18 - 29 years) and their husbands
  • Couples fluent in Marathi and both willing to participate
  • No sterilization or infertility (infertility is defined as having no pregnancy for 1+ years despite non-use of traditional or modern contraception)
  • No pregnancy or female/male surgical sterilization planned for the next 18 months
  • Residing in the village for at least 2 years and residing together for at least 3 months, to facilitate follow-up tracking

Exclusion Criteria

- If either member of the couple appears to be cognitively impaired or of too poor health to be able to respond to the screening assessment across 2 visits one week apart, the couple will be excluded from the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anita Raj, PhD 8588220229 anitaraj@ucsd.edu
Contact: Jennifer Yore, MPH 8588222152 jyore@ucsd.edu
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03514914
Other Study ID Numbers  ICMJE 1R01HD084453-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anita Raj, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Population Council
Investigators  ICMJE
Principal Investigator: Anita Raj, PhD University of California, San Diego
PRS Account University of California, San Diego
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP