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

Family Planning Clinical Trial

— CHARM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593943
• Other study ID #: R01HD061115
• Status: Completed
• Phase: Phase 3
• First received: May 4, 2012
• Last updated: December 3, 2014
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Institutional Review BoardIndia: Indian Council of Medical ResearchIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2162
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Family Planning

Intervention

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.

Locations

Country	Name	City	State
India	NIRRH	Mumbai	Maharashtra

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Diego	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Indian Council of Medical Research, Population Council

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	contraception	female reports of contraceptive use (any and consistent) in the past 3 months	past 3 months	No