ContraceptionCHARM2NCT03514914
Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy
A study testing The CHARM2 Intervention in people with Contraception, run by University of California, San Diego at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- The CHARM2 Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,402 participants
- Where
- 1 siteIndia
- Study dates
- 7 Jun 2018to 16 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed 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.
- Conditions
- Contraception
- Being tested
- The CHARM2 Intervention
- Keywords
- LARC, contraception, family planning, India, male engagement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The CHARM2 InterventionBehavioural
CHARM2 intervention will involve gender, culture \& contextually-tailored family planning and gender equity counseling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The CHARM2 Intervention |
| Control | No intervention | Control clusters will receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (2)
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.
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start7 Jun 2018
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,402 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Population Council
- Responsible party
- Principal investigator, Anita Raj, University of California, San Diego
- Investigators
- Anita Raj, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514914
- Sponsor's protocol ID
- 1R01HD084453-01A1
- Acronym
- CHARM2
- Status last verified
- Aug 2022
- First submitted
- 10 Apr 2018
- Last updated
- 6 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27167981Yore 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.
PubMed 26897656Dixit 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.
PubMed 31238954Johns 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.
PubMed 32793878Chen 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.
PubMed 32322807Raj 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.
PubMed 35274093Averbach 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.
PubMed 40348316Raj 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.
PubMed 40342544Averbach 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.
PubMed 36328094Dixit 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.
PubMed 34193214
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy
- ClinicalTrials.gov ID
- NCT03514914
- Acronym / sponsor ID
- CHARM2 / 1R01HD084453-01A1
- Conditions
- Contraception
- Keywords
- LARC, contraception, family planning, India, male engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,402 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Population Council
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Posted 6 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CHARM2 Intervention | Experimental | Behavioral: The CHARM2 InterventionCHARM2 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. |
| Control | No intervention | –Control clusters will receive standard of care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The CHARM2 InterventionCHARM2 intervention will involve gender, culture \& contextually-tailored family planning and gender equity counseling. | Behavioural | CHARM2 Intervention |
Primary outcome
Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months
Time frame: 18 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.
2 secondary outcomes
Number of Couples Reporting Marital Sexual Violence
Time frame: 18 months
Number of Couples Reporting Unintended Pregnancy During Follow-up Time Period
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27167981Raj 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.
- Background: PubMed 26897656Yore 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.
- Background: PubMed 31238954Dixit 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.
- Results publication: PubMed 32793878Johns 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.
- Results publication: PubMed 32322807Chen 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.
- Results publication: PubMed 35274093Raj 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.
- Derived from this study: PubMed 40348316Averbach 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.
- Derived from this study: PubMed 40342544Raj 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.
- Derived from this study: PubMed 36328094Averbach 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.
- Derived from this study: PubMed 34193214Dixit 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.
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Contraception
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Raj, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The CHARM2 Intervention in people with Contraception, run by University of California, San Diego at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03514914, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.