Increase First-time Mothers' Use of Postpartum Family Planning in Tanzania: The Connect Project

Contraceptive Usage Clinical Trial

— Connect TZ  

Official title:

Leveraging and Strengthening Local Systems to Increase First-time Mothers' Use of Postpartum Family Planning in Tanzania: A Cluster Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06261970
• Other study ID #: 999002684
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1134
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 25 Years

Eligibility

Inclusion Criteria:

• Pregnant or has child under 9 months

• Aged 14-25

Exclusion Criteria:

• Younger than 14 or over 25

• Has more than one child or is pregnant and has a child

Related Conditions & MeSH terms

• Contraceptive Usage

Intervention

Behavioral:
• Connect
Community level enhancements

Locations

Country	Name	City	State
Tanzania	EDI	Bahi	Dodoma
Tanzania	EDI	Kongwa	Dodoma

Sponsors (4)

Lead Sponsor	Collaborator
George Washington University	Bill and Melinda Gates Foundation, Save the Children, Save the Children International Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adoption of 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)). We will use the following indicators to measure adoption and continuation of PPFP:	12 months
Primary	Currently Using PPFP	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)).	At time of 12 month survey
Secondary	Adopted or Intention to adopt PPFP	1. 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	12 months
Secondary	Average Satisfaction with PPFP methods	2. Indicator for FTM believes advantages outweigh disadvantages, average across methods used, among those who have given birth; o Methods: male condom, pill, injectable, implant, IUD	12 months
Secondary	Contraceptive Preferences	3. Contraceptive preferences for modern methods, among all FTMs; o 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.).	12 Months
Secondary	Quality of Family Planning Counseling	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	12 months
Secondary	Communication and Agency	5. Indicator for FTM discussed FP with husband/partner or other family member, among all FTMs	12 months
Secondary	PPFP Attitudes	PPFP attitudes index of nine 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 45. Higher scores will indicate less restrictive attitudes with regard to family planning.; o A set of 9 questions using a 5-point likert scale (1=strongly agree, 5=strongly disagree) adapted from EMERGE and PMA 2020 asked in a random order: o	12 months
Secondary	PPFP Knowledge	PPFP knowledge index of eight 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 8, with 8 indicating that all questions were answered correctly.	12 months