Trial Outcomes & Findings for Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy (NCT NCT03514914)
NCT ID: NCT03514914
Last Updated: 2022-09-06
Results Overview
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.
COMPLETED
NA
2402 participants
18 months
2022-09-06
Participant Flow
This study involves randomization at the geographic cluster level. Clusters were created based on geographic boundaries surrounding a subcenter health facility. Clusters were randomized to intervention or control conditions using computer-generated random numbers. Households within each cluster were screened sequentially for eligibility. The required number of couples per cluster (n=60) were selected through systematic random sampling (selecting every nth participant).
Unit of analysis: Subcenters (geographic catchment areas)
Participant milestones
| Measure |
CHARM2 Intervention
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.
The CHARM2 Intervention: CHARM2 intervention will involve gender, culture \& contextually-tailored family planning and gender equity counseling.
|
Control
Control clusters will receive standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
1200 10
|
1202 10
|
|
Overall Study
9 Month Follow-up
|
1091 10
|
1114 10
|
|
Overall Study
COMPLETED
|
1080 10
|
1110 10
|
|
Overall Study
NOT COMPLETED
|
120 0
|
92 0
|
Reasons for withdrawal
| Measure |
CHARM2 Intervention
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.
The CHARM2 Intervention: CHARM2 intervention will involve gender, culture \& contextually-tailored family planning and gender equity counseling.
|
Control
Control clusters will receive standard of care.
|
|---|---|---|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
117
|
89
|
Baseline Characteristics
Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy
Baseline characteristics by cohort
| Measure |
CHARM2 Intervention
n=1200 Participants
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.
The CHARM2 Intervention: CHARM2 intervention will involve gender, culture \& contextually-tailored family planning and gender equity counseling.
|
Control
n=1202 Participants
Control clusters will receive standard of care.
|
Total
n=2402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1200 Participants
n=99 Participants
|
1202 Participants
n=107 Participants
|
2402 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
600 Participants
n=99 Participants
|
601 Participants
n=107 Participants
|
1201 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
600 Participants
n=99 Participants
|
601 Participants
n=107 Participants
|
1201 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1200 Participants
n=99 Participants
|
1202 Participants
n=107 Participants
|
2402 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
India
|
1200 participants
n=99 Participants
|
1202 participants
n=107 Participants
|
2402 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: This outcome is analyzed at the couple level, based on wife report (wife report has been shown to be most reliable). This outcome includes only non-pregnant couples. Pregnant couples are excluded from this outcome. The outcome is also missing if only husband provided survey data at 18 months (N=9 intervention, N=6 control)
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.
Outcome measures
| Measure |
CHARM2 Intervention
n=499 Couple
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.
The CHARM2 Intervention: CHARM2 intervention will involve gender, culture \& contextually-tailored family planning and gender equity counseling.
|
Control
n=506 Couple
Control clusters will receive standard of care.
|
|---|---|---|
|
Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months
|
265 Couple
|
295 Couple
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: This outcome is analyzed at the couple level as it relies on wife's report. The outcome is missing if only the husband provided 18-month survey data (N=9 intervention, N=6 control).
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.
Outcome measures
| Measure |
CHARM2 Intervention
n=536 Couples
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.
The CHARM2 Intervention: CHARM2 intervention will involve gender, culture \& contextually-tailored family planning and gender equity counseling.
|
Control
n=552 Couples
Control clusters will receive standard of care.
|
|---|---|---|
|
Number of Couples Reporting Marital Sexual Violence
|
7 Couples
|
5 Couples
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: This outcome is analyzed at the couple level as it relies on wife's report. It includes N=11 intervention couples and N=7 control couples where the wife provided information at 9-month follow-up but not 18-month follow-up. It is missing for N=25 intervention couples and N=25 control couples where the wife declined or was missing information on pregnancy intendedness.
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.
Outcome measures
| Measure |
CHARM2 Intervention
n=522 Couple
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.
The CHARM2 Intervention: CHARM2 intervention will involve gender, culture \& contextually-tailored family planning and gender equity counseling.
|
Control
n=534 Couple
Control clusters will receive standard of care.
|
|---|---|---|
|
Number of Couples Reporting Unintended Pregnancy During Follow-up Time Period
|
58 Couple
|
69 Couple
|
Adverse Events
CHARM2 Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place