Family PlanningPhase 3CHARMNCT01593943
Gender Equity-Focused, Male-Centered Family Planning for Rural India
A Phase 3 study testing CHARM in people with Family Planning, run by University of California, San Diego at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Planning
- What is being tested?
- CHARM
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,162 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2012to Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Sterile or Wife is Sterile
- Cognitive Impairment (husband or wife)
- Intend to move in next 18 months
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Family Planning
- Being tested
- CHARM
- Keywords
- contraception, india, rural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHARMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | No intervention | Not described |
| CHARM Intervention | Experimental | 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. Receives: Behavioral: CHARM |
What is being measured
The primary outcome is the main question the study is designed to answer.
contraception
female reports of contraceptive use (any and consistent) in the past 3 months
Measured: past 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Family PlanningStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Indian Council of Medical Research, Population Council
- Responsible party
- Principal investigator, Anita Raj, University of California, San Diego
- Investigators
- Anita Raj, PhD, Principal investigator, UCSDNiranjan Saggurti, PhD, Principal investigator, Population CouncilDonta Balaiah, PhD, Principal investigator, NIRRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593943
- Sponsor's protocol ID
- R01HD061115
- Acronym
- CHARM
- Status last verified
- Dec 2014
- First submitted
- 4 May 2012
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nair S, Dixit A, Ghule M, Battala M, Gajanan V, Dasgupta A, Begum S, Averbach S, Donta B, Silverman J, Saggurti N, Raj A. Health care providers' perspectives on delivering gender equity focused family planning program for young married couples in a cluster randomized controlled trial in rural Maharashtra, India. Gates Open Res. 2019 Jul 17;3:1508. doi: 10.12688/gatesopenres.13026.1. eCollection 2019.
PubMed 32266327Shakya HB, Dasgupta A, Ghule M, Battala M, Saggurti N, Donta B, Nair S, Silverman J, Raj A. Spousal discordance on reports of contraceptive communication, contraceptive use, and ideal family size in rural India: a cross-sectional study. BMC Womens Health. 2018 Sep 4;18(1):147. doi: 10.1186/s12905-018-0636-7.
PubMed 30180845Raj 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 26897656
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Equity-Focused, Male-Centered Family Planning for Rural India
- ClinicalTrials.gov ID
- NCT01593943
- Acronym / sponsor ID
- CHARM / R01HD061115
- Conditions
- Family Planning
- Keywords
- contraception, india, rural
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,162 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Indian Council of Medical Research, Population Council
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Condition | No intervention | – |
| CHARM Intervention | Experimental | Behavioral: CHARMCHARM 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. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Sterile or Wife is Sterile
- Cognitive Impairment (husband or wife)
- Intend to move in next 18 months
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 |
|---|---|---|
| CHARMCHARM 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. | Behavioural | CHARM Intervention |
Primary outcome
contraception
Time frame: past 3 months
female reports of contraceptive use (any and consistent) in the past 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Derived from this study: PubMed 32266327Nair S, Dixit A, Ghule M, Battala M, Gajanan V, Dasgupta A, Begum S, Averbach S, Donta B, Silverman J, Saggurti N, Raj A. Health care providers' perspectives on delivering gender equity focused family planning program for young married couples in a cluster randomized controlled trial in rural Maharashtra, India. Gates Open Res. 2019 Jul 17;3:1508. doi: 10.12688/gatesopenres.13026.1. eCollection 2019.
- Derived from this study: PubMed 30180845Shakya HB, Dasgupta A, Ghule M, Battala M, Saggurti N, Donta B, Nair S, Silverman J, Raj A. Spousal discordance on reports of contraceptive communication, contraceptive use, and ideal family size in rural India: a cross-sectional study. BMC Womens Health. 2018 Sep 4;18(1):147. doi: 10.1186/s12905-018-0636-7.
- Derived from this study: 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.
- Derived from this study: 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.
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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
UCSD
Niranjan Saggurti, PhD principal investigator
Population Council
Donta Balaiah, PhD principal investigator
NIRRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHARM in people with Family Planning, 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 3 inclusion and 3 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 4 Dec 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
contraception (time frame: past 3 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 NCT01593943, which also lists 4 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 4 Dec 2014.