Gender Equity-Focused, Male-Centered Family Planning for Rural India (CHARM)

December 3, 2014 updated by: Anita Raj, University of California, San Diego
The major barrier to India meeting its national goal of replacement fertility is the huge discrepancy between urban and rural family planning, with rural young women at highest risk for unplanned and unspaced pregnancies. These concerns are considered to drive the persistent and unacceptably high rates of maternal and infant mortality in India. Major impediments to these young wives' acquisition of family planning services include high male partner control over reproductive decision-making, low mobility, and very low access to family planning services in villages. Such findings document the need for male-centered family planning efforts available at the village level, to better meet the needs of rural young wives. These male-centered efforts must address male gender role and gender inequity ideologies and norms (e.g., son preference, wife abuse) and marital communication, as these factors are associated with lower likelihood of contraceptive use in rural young Indian couples. Hence, the proposed study involves development and testing of the CHARM Program, a gender equity (GE)-focused, male-centered family planning (FP) program delivered by village health providers (VHPs), via a public-private partnership with primary health centers (PHCs) and private providers serving rural India. In Phase 1 the investigators will conduct formative research including health care resource mapping of Vasai within the Thane district of Maharashtra to identify villages and VHPs for inclusion in subsequent research and intervention. The investigators will also conduct in-depth interviews with rural young husbands (n=30), rural young wives (n=20), and health care providers (n=12), as well as focus groups with mothers' of rural young husbands (n=40). These data will be used to develop the CHARM program and efficacy trial. Phase 2 will involve development and pilot testing of CHARM protocols and training of VHPs for their role in the intervention trial (Phase 3). The CHARM intervention will involve VHP-delivered GE and FP counseling. It is delivered via a single session with 2 optional additional sessions one of which would include their wife. Phase 3 will involve evaluation of CHARM, using a two-armed randomized controlled trial design. Villages (N=50) will be randomized to receive either CHARM or the control program (standard FP referral to government public health centers [PHCs] located outside of villages), to assess treatment impact on spacing contraceptive use, pregnancy, and unmet family planning need. Intervention effects will be assessed via behavioral surveys with rural young husbands (18-30 years) and their wives (N=1000 couples, 20 couples per village) at baseline and 9 and 18 month follow-up, as well as pregnancy tests from wives, conducted at baseline and 18 month follow-up. A process evaluation will be undertaken via interviews with study participants and VHPs, as well as through VHP interviews and clinical record review, to assess program adherence, participation rates, response to program, and ease of delivery. In-depth interviews will also be conducted with key informants from the village and public and rural health systems to assess sustainability and institutionalization of the model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2162

Phase

  • Phase 3

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

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India
        • NIRRH

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

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Primary study participants for intervention evaluation are rural young men (n=1500) and their wives (n=1500). Inclusion and exclusion criteria for these men are as follows:

INCLUSION CRITERIA

  • Age 18-30 years and Fluent in Marathi
  • Willing to Have Wife Included in the Study
  • Residing in the village for the past 2 years and residing with wife in village for past 3 months

EXCLUSION CRITERIA

  • Sterile or Wife is Sterile
  • Cognitive Impairment (husband or wife)
  • Intend to move in next 18 months

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Condition
Experimental: CHARM Intervention
CHARM will be conducted via three 30-minute counseling sessions delivered in a rural setting, with the first session being required and the subsequent sessions being optional. The first two CHARM sessions will be for men only to build family planning (FP) and gender equity (GE) awareness and investment, and the third session will be for the couple with an emphasis on FP services, shared decision-making and marital communication. The three sessions can occur anytime within a 3 month timeframe but with a minimum of 1 week between sessions. All sessions and FP services (pill, condom, EC) will be provided at no cost to patients.
Behavioral: CHARM
CHARM will be conducted via three 30-minute counseling sessions delivered in the rural setting, with the first session required and the 2nd and 3rd sessions optional. The first two CHARM sessions will be for men only to build family planning (FP) and gender equity (GE) awareness and investment, and the third session will be for the couple with an emphasis on FP services, shared decision-making and marital communication. The three sessions can occur anytime within a 3 month timeframe but with a minimum of 1 week between sessions. All sessions and FP services (pill, condom, EC) will be provided at no cost to patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
contraception
Time Frame: past 3 months
female reports of contraceptive use (any and consistent) in the past 3 months
past 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Indian Council of Medical Research
Population Council

Investigators

  • Principal Investigator: Anita Raj, PhD, UCSD
  • Principal Investigator: Niranjan Saggurti, PhD, Population Council
  • Principal Investigator: Donta Balaiah, PhD, NIRRH

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.

General Publications

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

March 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01HD061115 (U.S. NIH Grant/Contract)

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.

Clinical Trials on Family Planning

Clinical Trials on CHARM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe