N/A
N=2,402
Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT03514914 ↗Enrolled (actual)
2,402
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months — 265; 295 Couple
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The CHARM2 Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months |
265; 295 | — |
| SECONDARY Number of Couples Reporting Marital Sexual Violence |
7; 5 | — |
| SECONDARY Number of Couples Reporting Unintended Pregnancy During Follow-up Time Period |
58; 69 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03514914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.