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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Indian Council of Medical Research
Population Council
Information provided by (Responsible Party):
Anita Raj, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01593943
First received: May 4, 2012
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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=1500 couples, 30 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.


Condition Intervention Phase
Family Planning
Behavioral: CHARM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Gender Equity-Focused, Male-Centered Family Planning for Rural India

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • contraception [ Time Frame: past 3 months ] [ Designated as safety issue: No ]
    female reports of contraceptive use (any and consistent) in the past 3 months


Estimated Enrollment: 3000
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Condition
None
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.

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593943

Contacts
Contact: Donta Balaiah, PhD bdonta2007@yahoo.co.in

Locations
India
NIRRH Recruiting
Mumbai, Maharashtra, India
Principal Investigator: Donta Balaiah, PhD         
Sponsors and Collaborators
University of California, San Diego
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
  More Information

No publications provided

Responsible Party: Anita Raj, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01593943     History of Changes
Other Study ID Numbers: R01HD061115
Study First Received: May 4, 2012
Last Updated: September 12, 2012
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board
India: Indian Council of Medical Research
India: Institutional Review Board

Keywords provided by University of California, San Diego:
contraception
india
rural

ClinicalTrials.gov processed this record on October 29, 2014