Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy

NCT03514914 | Completed Results DMC

• 1 other identifier: 1R01HD084453-01A1
• Study Type: interventional
• Target: 2,402
• Locations: 1 country
• Sites: 1

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).

Conditions

Contraception

Keywords

LARC, contraception, family planning, India, male engagement

Outcome Measures

Primary Outcomes (1)

• Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months

  Based on self-report in survey on item assessing form of contraceptive used in past 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. This outcome excludes currently pregnant couples.

  18 months

Secondary Outcomes (2)

• Number of Couples Reporting Marital Sexual Violence

  18 months

• Number of Couples Reporting Unintended Pregnancy During Follow-up Time Period

  18 months

Study Arms (2)

CHARM2 Intervention

EXPERIMENTAL

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.

Behavioral: The CHARM2 Intervention

Control

NO INTERVENTION

Control clusters will receive standard of care.

Interventions

The CHARM2 Intervention BEHAVIORAL

CHARM2 intervention will involve gender, culture \& contextually-tailored family planning and gender equity counseling.

CHARM2 Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Population Council: collaborator

Study Sites (1)

Junnar Taluka

Pune District, Maharashtra, India

Location

Related Publications (10)

• Raj A, Ghule M, Ritter J, Battala M, Gajanan V, Nair S, Dasgupta A, Silverman JG, Balaiah D, Saggurti N. Cluster Randomized Controlled Trial Evaluation of a Gender Equity and Family Planning Intervention for Married Men and Couples in Rural India. PLoS One. 2016 May 11;11(5):e0153190. doi: 10.1371/journal.pone.0153190. eCollection 2016.

  PMID: 27167981 BACKGROUND

• Yore J, Dasgupta A, Ghule M, Battala M, Nair S, Silverman J, Saggurti N, Balaiah D, Raj A. CHARM, a gender equity and family planning intervention for men and couples in rural India: protocol for the cluster randomized controlled trial evaluation. Reprod Health. 2016 Feb 20;13:14. doi: 10.1186/s12978-016-0122-3.

  PMID: 26897656 BACKGROUND

• Dixit A, Averbach S, Yore J, Kully G, Ghule M, Battala M, Begum S, Johns NE, Vaida F, Bharadwaj P, Wyss N, Saggurti N, Silverman J, Raj A. A gender synchronized family planning intervention for married couples in rural India: study protocol for the CHARM2 cluster randomized controlled trial evaluation. Reprod Health. 2019 Jun 25;16(1):88. doi: 10.1186/s12978-019-0744-3.

  PMID: 31238954 BACKGROUND

• Johns NE, Dixit A, Ghule M, Begum S, Battala M, Kully G, Silverman J, Dehlendorf C, Raj A, Averbach S. Validation of the Interpersonal Quality of Family Planning Scale in a rural Indian setting. Contracept X. 2020 Jul 26;2:100035. doi: 10.1016/j.conx.2020.100035. eCollection 2020.

  PMID: 32793878 RESULT

• Chen GL, Silverman JG, Dixit A, Begum S, Ghule M, Battala M, Johns NE, Raj A, Averbach S. A cross-sectional analysis of intimate partner violence and family planning use in rural India. EClinicalMedicine. 2020 Apr 18;21:100318. doi: 10.1016/j.eclinm.2020.100318. eCollection 2020 Apr.

  PMID: 32322807 RESULT

• Raj A, Ghule M, Johns NE, Battala M, Begum S, Dixit A, Vaida F, Saggurti N, Silverman JG, Averbach S. Evaluation of a gender synchronized family planning intervention for married couples in rural India: The CHARM2 cluster randomized control trial. EClinicalMedicine. 2022 Mar 5;45:101334. doi: 10.1016/j.eclinm.2022.101334. eCollection 2022 Mar.

  PMID: 35274093 RESULT

• Averbach S, Johns NE, Tomar S, Meurice ME, Rao N, Ghule M, Raj A. Psychometric evaluation of the desire to avoid pregnancy scale in India. Contraception. 2025 Aug;148:110940. doi: 10.1016/j.contraception.2025.110940. Epub 2025 May 8.

  PMID: 40348316 DERIVED

• Raj A, Johns N, Vaida F, Ghule M, Rao N, Silverman JG. Four-year follow-up of CHARM2, an effective family planning intervention, on number and sex of births: Findings from an RCT in rural India. Dialogues Health. 2025 Apr 19;6:100218. doi: 10.1016/j.dialog.2025.100218. eCollection 2025 Jun.

  PMID: 40342544 DERIVED

• Averbach S, Johns NE, Ghule M, Dixit A, Begum S, Battala M, Saggurti N, Silverman J, Raj A. Understanding quality of contraceptive counseling in the CHARM2 gender-equity focused family planning intervention: Findings from a cluster randomized controlled trial among couples in rural India. Contraception. 2023 Feb;118:109907. doi: 10.1016/j.contraception.2022.10.009. Epub 2022 Nov 1.

  PMID: 36328094 DERIVED

• Dixit A, Johns NE, Ghule M, Battala M, Begum S, Yore J, Saggurti N, Silverman JG, Reed E, Benmarhnia T, Averbach S, Raj A. Male-female concordance in reported involvement of women in contraceptive decision-making and its association with modern contraceptive use among couples in rural Maharashtra, India. Reprod Health. 2021 Jun 30;18(1):139. doi: 10.1186/s12978-021-01187-8.

  PMID: 34193214 DERIVED

Results Point of Contact

• Title: Dr. Anita Raj
• Organization: University of California San Diego

anitaraj@health.ucsd.edu

(858) 246-0066

Study Officials

• Anita Raj, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 3, 2018
• Study Start: June 7, 2018
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: September 6, 2022
• Results First Posted: September 6, 2022

Record last verified: 2022-08

Locations

IN (1)