An interventional study of Connect in Contraceptive Usage, sponsored by George Washington University. Completed at 1 site in Bangladesh. Open to female participants aged 14 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by George Washington University · Not applicable, Interventional, and Health services research
While a growing body of programs have shown promise to increase uptake of contraception among FTMs, difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Despite the importance of PNC it remains a neglected area within the maternal and newborn health continuum of care in many areas around the world. Programs working to improve coverage of PNC and PNHVs have faced difficulties with insufficient human resources and health systems, suggesting a need for prioritization of care in settings with limited human resources. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing PPFP and PNC uptake among FTMs. The investigators will evaluate Connect\'s approach through a cluster randomized control trial.
While a growing body of programs have shown promise to increase uptake of contraception among FTMs, difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Despite the importance of PNC it remains a neglected area within the maternal and newborn health continuum of care in many areas around the world. Programs working to improve coverage of PNC and PNHVs have faced difficulties with insufficient human resources and health systems, suggesting a need for prioritization of care in settings with limited human resources. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing PPFP and PNC uptake among FTMs. The investigators will evaluate Connect\'s approach through a cluster randomized control trial.
The overall goal of this study is to add to the evidence base on scalable and efficacious approaches for increasing PPFP adoption and improving timing and uptake of PNC among adolescent and young FTMs in order to increase spacing before subsequent births and improve maternal and neonatal outcomes.
Specifically, this protocol outlines the parameters for the evaluation of the impact of Connect's package of community-level interventions-or "enhancements"-on adoption and continued use of modern PPFP methods and uptake of PNC among adolescent (ages 15-19 years) and young (ages 20-24 years) FTMs. These interventions are enhanced home visits by family welfare assistants (FWA) and FWA-led enhanced courtyard meetings.
FWA enhanced home visits are targeted based on identification of at-risk mother-baby dyads through a risk-stratification algorithm to ensure home visits to all FTMs who give birth at home and to at-risk mothers, including first time mothers. FWAs performing the enhanced home visits have undergone additional training emphasizing the importance of referring mothers to facility-based providers, encouraging facility delivery, encouraging attendance of courtyard meetings, involving other family members during the visit, and on the specific needs of first-time parents. Invitation cards to go to the nearest facility and mother-baby booklets within formaiton on ANC, PNC, AND PPFP are also provided.
Enhanced courtyard meetings include standard content provided across all locations but Connect reinforces the regularity of these meetings and the FWAs running them will be more sensitized to first-time parents.
Alongside the wider-scale implementation of these enhancements, Connect will support the Ministry of Health as well as local and international NGOs to sustain the enhancements beyond the donor-funded project.
There are four specific aims for understanding the efficacy for Connect's packages:
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's enrollment of 2,308 is above the median of 382 across 106 interventional studies indexed under Contraception Behavior.
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Exclusion Criteria:
At the community level, Connect enhancements build on standard community health worker (CHW) home visits implemented by the government and pre-existing courtyard meetings implemented by the Government of Bangladesh. Courtyard meetings are led by CHWs and convened monthly for new mothers and their families. CHWs sensitize participants to postpartum family planning (PPFP) and share the importance of available services from facilities. Connect reinforces the regularity of these meetings. CHWs receive additional training to be sensitized to the needs of first time parents and engage first-time mothers to attend. Home Visits: CHWs conduct home visits to women who are pregnant or recently gave birth in their catchment areas. During these visits CHWs provide basic care, information on ANC, PNC and PPFP, and provide access to FP methods. Connect targets home visits to first time mothers and those who gave birth at home. They provide print materials to support PPFP and PNC care.
Behavioral: Connect
No additional Connect intervention. Pre-existing institutionalized services for expecting and new mothers.
Community level enhancements
Adoption of Postpartum Family Planning (PPFP):
1\. Indicator for adopted a modern contraceptive method within 12 months after giving birth (among women who have given birth). Adoption of a modern contraceptive method in the first year after giving birth, among FTMs who have given birth-modern methods are defined here as male condoms, oral contraceptive pills, injectables, and long-active reversible contraception (LARC) methods (implants and intrauterine device (IUD)).
Time frame: 12 months
Currently using PPFP
2\. Currently using a modern contraceptive method (among women who have given birth). Modern methods are defined here as male condoms, oral contraceptive pills, injectables, and long-active reversible contraception (LARC) methods (implants and intrauterine device (IUD)).
Time frame: 12 months
Postnatal Care uptake
3\. Indicator for received any PNC, among FTMs who have given birth. Uptake of facility-based PNC for mother and baby. Care that is reported to be a PNC visit but occurs outside of a health facility is not considered a PNC visit for these indicators.
Time frame: 12 months
Timing of Postnatal Care (PNC)
4\. FTM received PNC within 72 hours of delivery, among FTMs who have given birth more than 72 hours ago. Care that is reported to be a PNC visit but occurs outside of a health facility is not considered a PNC visit for these indicators.
Time frame: 12 months
Adopted or Intention to adopt PPFP
Indicator for adopt or intention to adopt modern PPFP with 12 months after birth: Using or planning to use a modern contraceptive method to delay or avoid pregnancy within first year of child's life, among all FTMs who have given birth within the past 12 months. Modern methods included in this indicator are: male condoms, oral contraceptive pills, injectables, implants, IUDs
Time frame: 12 months
Quality of additional PNC
We measure quality in two ways: (1) Using an indicator for quality of any of an FTM's PNC contact that occurred more than 24 hours after delivery, among FTMs who received a PNC contact. The indicator is equal to one if received all 17 content areas measured; (2) using a scale (0-17) of the total number of content areas covered out of 17 during any PNC contact that the FTM received more than 24 hours after birth. this score will be calculated by generating an indicator for each content area equal to one if the content was covered and summing the indicators.
Time frame: 12 months
Quality of early PNC
This will be measured in two ways: 1. Indicator for quality of early PNC contact (within 24 hours of delivery) for FTM, among FTMs who received an early PNC contact 2. Scale (0-10) indicating the total number of content areas covered out of 10 during an early PNC contact, among FTMs who received an early PNC contact. This score is calculated by generating an indicator for each content area equal to one if it was covered, sum the indicators to generate the overall scale.
Time frame: 12 months
Contraceptive Preferences
Contraceptive preferences for modern methods, among all FTMs, measured with an indicator equal to one if the FTM names a modern method (male condom, pill, injectable, implant, IUD) as preferred family planning method if there were no constraints (e.g., cost, access, opinions of others, etc.).
Time frame: 12 months
Quality of Family Planning Counselling
Quality score (0-100), among all FTMs who received family planning counseling. A 22-item quality of care index, adapted from Jain et al. (2019) is combined into a weighted additive index where each of 4 domains have equal weight (1) respectful care, (2) method selection, (3) effective use of method selected, and (4) continuity of contraceptive use and care. For each domain, we will construct an indicator equal to one of the care is of \"high quality\", defined as having a score that is greater than the mean score plus half of the standard deviation
Time frame: 12 months
Communication and agency
Indicator for FTM discussed FP with husband/partner or other family member, among all FTMs
Time frame: 12 months
PPFP knowledge
PPFP knowledge index of six true/false statements, standardized to the mean and standard deviation of the control group, among all FTMs. The raw index will be the sum of the responses to each individual true/false statement. Raw scores range from 0 to 6, with 6 indicating that all questions were answered correctly. A set of 5 true/false questions adapted from MOMENTUM asked in a random order.
Time frame: 12 months
PPFP Attitudes
PPFP attitudes index of eight attitudes, standardized to the mean and standard deviation of the control group, among all FTMs. The raw index will be the sum of the responses to each individual attitude (score ranging from 1 to 5), with a possible maximum score of 40. Higher scores will indicate less restrictive attitudes with regard to family planning.
Time frame: 12 months
PNC attitudes
PNC attitudes index of four attitudes, standardized to the mean and standard deviation of the control group, among all FTMs. The raw index will be the sum of the responses to each individual attitude (score ranging from 1 to 5), with a possible maximum score of 20. Higher scores will indicate less restrictive attitudes with regard to PNC.
Time frame: 12 months
Plan to share: Yes — Deidentified data will be made publicly available
Supporting information: Study protocol, Statistical analysis plan
Time frame: 2025
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