Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy

Contraception Clinical Trial

— CHARM2  

Official title:

Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514914
• Other study ID #: 1R01HD084453-01A1
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: December 16, 2020

Study information

• Verified date: August 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2402
• Est. completion date: December 16, 2020
• Est. primary completion date: December 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• The CHARM2 Intervention
CHARM2 intervention will involve gender, culture & contextually-tailored family planning and gender equity counseling.

Locations

Country	Name	City	State
India	Junnar Taluka	Pune District	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Population Council

Country where clinical trial is conducted

India, 

References & Publications (6)

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. — View Citation

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. — View Citation

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 — View Citation

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. EClinic — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Couples Reporting Marital Sexual Violence	Marital Sexual Violence will be assessed via two items asked of wives 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.	18 months
Secondary	Number of Couples Reporting Unintended Pregnancy During Follow-up Time Period	This outcome will be constructed based on reported pregnancy during the 18-month follow up time period, and a question asked of the female participant in reference to each pregnancy whether they had wanted the pregnancy at that time, not at that time but in the future, or not at all. If participants indicate that they did not want at least one pregnancy during the follow-up time period at that time or at all, they were be identified as having an unintended pregnancy.	18 months

External Links

•   Brief description of the original CHARM study