Trial · NCT03514914
Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy
NCT03514914, Not applicable, Completed, University of California, San Diego; results first posted 2022-09-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy. Trials, record NCT03514914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03514914
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy
- NCT number
- NCT03514914
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,402 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Contraception
- Interventions
- The CHARM2 Intervention
- First posted
- 2018-05-03
- Last updated
- 2022-09-06
- Results first posted
- 2022-09-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months | 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. |
| Secondary | Number of Couples Reporting Marital Sexual Violence | 18 months | 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. |
| Secondary | Number of Couples Reporting Unintended Pregnancy During Follow-up Time Period | 18 months | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months | 18 months | 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) | Couple | COUNT_OF_UNITS |
| SECONDARY | Number of Couples Reporting Marital Sexual Violence | 18 months | 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). | Couples | COUNT_OF_UNITS |
| SECONDARY | Number of Couples Reporting Unintended Pregnancy During Follow-up Time Period | 18 months | 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. | Couple | COUNT_OF_UNITS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months | CHARM2 Intervention | 265 | Couple | ||
| Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months | Control | 295 | Couple | ||
| Number of Couples Reporting Marital Sexual Violence | CHARM2 Intervention | 7 | Couples | ||
| Number of Couples Reporting Marital Sexual Violence | Control | 5 | Couples | ||
| Number of Couples Reporting Unintended Pregnancy During Follow-up Time Period | CHARM2 Intervention | 58 | Couple | ||
| Number of Couples Reporting Unintended Pregnancy During Follow-up Time Period | Control | 69 | Couple |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CHARM2 Intervention | 1,200 | 10 |
| Overall Study | STARTED | Control | 1,202 | 10 |
| Overall Study | 9 Month Follow-up | CHARM2 Intervention | 1,091 | 10 |
| Overall Study | 9 Month Follow-up | Control | 1,114 | 10 |
| Overall Study | COMPLETED | CHARM2 Intervention | 1,080 | 10 |
| Overall Study | COMPLETED | Control | 1,110 | 10 |
| Overall Study | NOT COMPLETED | CHARM2 Intervention | 120 | 0 |
| Overall Study | NOT COMPLETED | Control | 92 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CHARM2 Intervention | 3 | 1,200 |
| Total, all-cause mortality | Control | 3 | 1,202 |
| Total, other adverse events | CHARM2 Intervention | 0 | 1,200 |
| Total, other adverse events | Control | 0 | 1,202 |
| Total, serious adverse events | CHARM2 Intervention | 0 | 1,200 |
| Total, serious adverse events | Control | 0 | 1,202 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD084453 | Enhancing male participation in interventions to prevent unintended pregnancy | RAJ, ANITA | UNIVERSITY OF CALIFORNIA, SAN DIEGO | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2017 to 2021 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CHARM2 Intervention vs Control: deaths from any cause | Trial comparisons |
| CHARM2 Intervention vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03514914
GET https://conductscience.org/api/trials/v1/NCT03514914/registered