Clinical Trials Logo

Clinical Trial Summary

While a growing body of programs have shown promise to increase use of contraception among first time mothers (FTMs), difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. 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 postpartum Family Planning (PPFP) adoption among FTMs. The investigators will evaluate Connect's approach through a cluster randomized control trial.


Clinical Trial Description

While a growing body of programs have shown promise to increase use of contraception among first time mothers (FTMs), difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. 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 postpartum Family Planning (PPFP) adoption 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 uptake 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 interventions-or "enhancements"-on adoption and continued use of modern PPFP methods among adolescent (ages 15-19 years) and young (ages 20-24 years) FTMs. These interventions are community support groups (CSGs) with PPFP-specific content and enhanced training for community health workers (CHWs) around PPFP for delivery during home visits. Alongside the wider-scale implementation of these enhancements, Connect will support the Ministry of Health as well as local and international non governmental organizations (NGOs) to sustain the enhancements beyond the donor-funded project. There are four specific aims for understanding the efficacy for Connects packages: 1. To estimate the causal impact and cost-effectiveness of Connect's community-level interventions (compared to a control) on the primary outcomes of adoption and continuation of modern PPFP methods among FTMs ages 15-24 in two districts in Tanzania. 2. To examine the causal impact of Connect's community-level interventions (compared to a control) on secondary outcomes (specified below) among FTMs ages15-24 in two districts in Tanzania. 3. To compare the impacts of Connect's community-level interventions on adolescent FTMs (ages 15-19) versus young FTMs (ages 20-24). 4. To use mixed-methods research to unpack the mechanisms by which the various interventions work, as well as understand for whom they work and why (exploratory analysis). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06261970
Study type Interventional
Source George Washington University
Contact
Status Active, not recruiting
Phase N/A
Start date February 22, 2023
Completion date December 2025

See also
  Status Clinical Trial Phase
Completed NCT03279120 - Safety, PK, and PD Study of IVRs Releasing TFV and LNG Phase 1
Withdrawn NCT03725358 - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon. N/A
Completed NCT01170390 - Oral Contraceptives and Body Mass Index Phase 4
Recruiting NCT05932537 - Ablation of Subcutaneous Contraceptive Implants in the Operating Room
Withdrawn NCT04882137 - Barriers to Referring Adolescent Women for Etonogestrel Implant. N/A
Completed NCT02613039 - Oral Contraceptive Therapy and Sexuality Phase 4
Completed NCT01425060 - Improving Effective Contraceptive Use Among Opioid-maintained Women Phase 1
Completed NCT03626597 - Community-based Provision of Urine Pregnancy Tests as Linkage to Reproductive Health Services N/A
Recruiting NCT04558229 - RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users Phase 4
Recruiting NCT05644886 - Pilot Study on Engaging Family Physicians in Family Planning in Pakistan N/A
Completed NCT03253783 - The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program N/A
Completed NCT04043130 - The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program N/A
Completed NCT03571932 - Assessment of Family Planning and Immunization Service Integration in Liberia
Completed NCT03336346 - Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
Active, not recruiting NCT03984695 - Sexual Health Empowerment for Women's Health N/A
Completed NCT02411357 - Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II N/A
Completed NCT05806463 - Efficacy of Mother's Time in Ethiopia N/A
Recruiting NCT05328648 - Randomized Controlled Trial to Address Unintended Pregnancy Rates in Low Resource Settings N/A
Active, not recruiting NCT05061472 - A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity
Not yet recruiting NCT05988983 - The Over The Counter Pill National Study