Leveraging and strengthening local systems to increase first-time mothers’ use of postpartum family planning in Tanzania: A cluster randomized control trial of Connect-Tanzania

Last registered on August 07, 2023

Pre-Trial

Trial Information

General Information

Title
Leveraging and strengthening local systems to increase first-time mothers’ use of postpartum family planning in Tanzania: A cluster randomized control trial of Connect-Tanzania
RCT ID
AEARCTR-0011333
Initial registration date
April 25, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 03, 2023, 4:15 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
August 07, 2023, 9:04 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Primary Investigator

Affiliation
George Washington University

Other Primary Investigator(s)

PI Affiliation
George Washington University

Additional Trial Information

Status
On going
Start date
2023-02-22
End date
2025-12-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
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. We will evaluate Connect's approach through a cluster randomized control trial.

Registration Citation

Citation
Baird, Sarah and Jennifer Seager. 2023. "Leveraging and strengthening local systems to increase first-time mothers’ use of postpartum family planning in Tanzania: A cluster randomized control trial of Connect-Tanzania." AEA RCT Registry. August 07. https://doi.org/10.1257/rct.11333-1.2
Experimental Details

Interventions

Intervention(s)
The Connect project designed light-touch interventions, called “enhancements,” that could be layered onto larger host projects working with the CHW cadre in Tanzania. Specifically, the initial enhancements leveraged a larger USAID-funded “host” project, called Lishe Endelevu. Lishe Endelevu (meaning “sustainable nutrition” in Kiswahili) operates in 493 wards and 1,755 villages in 23 districts of Dodoma, Iringa, Rukwa, and Morogoro regions and aims to achieve a 15% reduction in stunting in children under five and increase the minimal acceptable diet in women of reproductive age and children 6-23 months by 15 percent. Lishe Endelevu reaches breastfeeding and young mothers and their household and community influencers through community-based outreach activities. With the aim of leveraging Lishe Endelevu’s reach to improve use of PPFP among FTMs ages 15-24, Connect introduced light-touch, scalable enhancements to Lishe Endelevu’s community activities in two districts of Dodoma Region.

The Connect Community Level Enhancements include:
Community Support Groups (CSGs)*: Connect enhances Lishe Endelevu’s CSGs of pregnant and lactating mothers ages 15-49. The CSGs use a toolkit to provide information about nutrition over the course of six months. Once completing the group-based toolkit, group members graduate to other community activities (i.e., model farmer activities, village savings and loan associations). Women are recruited into CSGs by CHWs. CHWs aim to recruit 15 women per group, including 8 FTMs. Over the next four months after recruitment, the CSGs meet two times. After four months, the groups end and CHWs recruit new women to form new groups.
CSGs formed by Lishe Endelevu prior to 2021 had limited and varied enrolment of FTMs, with some CSGs not having any enrolled FTMs. Connect enhances Lishe Endelevu’s Standard Operating Procedures to require at least four FTMs to be recruited into each CSG established. In addition, Connect enhances the CSG toolkit to include FTM focused content, including information on birth spacing and PPFP.

Home visits*: As part of the Connect package of enhancements, the CHWs who facilitate the community support groups also conduct home visits to FTMs. CHWs are provided a job aid to counsel FTMs and their families on PPFP. Counseling addresses myths about FP, norms around fertility and spacing, and includes prompts to engage family and male partners when present. Counseling also integrates timely nutrition information from the support groups (i.e., exclusive breastfeeding, introduction of complementary foods) with PPFP information (i.e., discussing lactation amenorrhea method (LAM) and providing information on lactation-safe FP methods for FTMs who are breastfeeding, discussing transition to another modern method when complementary foods are introduced). CHWs can provide non-clinical FP methods (pills, condoms) and provide referrals for services at public health facilities.

In addition to the community level enhancements, which will be randomized at the village level, there are also facility level enhancements that will be implemented across all public facilities (both those in control and treatment).

Respectful care on-the-job training: A light-touch respectful care activity will complement planned Lishe Endelevu efforts that aims to strengthen interpersonal communication skills for facility-based health providers. Connect supported the Ministry of Health to introduce a three- to four-day on-the-job training approach on respectful care, which includes provider reflection to increase self-awareness on specific biases related to FTPs and PPFP.

Through a cascading training approach, national trainers are trained using Lishe Endelevu and Connect materials. These national trainers then go to public health facilities and train the lead provider. That provider then trains all other providers in that facility. The government provides supportive supervision to monitor the dissemination of the training.
Intervention Start Date
2023-03-20
Intervention End Date
2024-03-20

Primary Outcomes

Primary Outcomes (end points)
Adoption and continuation of Postpartum Family Planning (PPFP): 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:

1. Indicator for adopted a modern contraceptive method within 12 months after giving birth (among women who have given birth).
2. Currently using a modern contraceptive method (among women who have given birth)
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
See protocol/pre-analysis plan
Secondary Outcomes (explanation)
See protocol/pre-analysis plan

Experimental Design

Experimental Design
Two districts were selected by the President’s Office for Regional and Local Government (PO-RALG) through discussions with Save the Children.

We conducted village-level (cluster) randomization to reduce the possibility of crossover from treatment and control FTMs. We stratified randomization by district and urbanization to achieve sample balance across location and urbanization.

Out of the 143 total villages in Dodoma Region (87 villages in Kongwa and 56 in Bahi), 111 villages were available for randomization (56 in Kongwa and 55 in Bahi). The other villages were either used in the pilot (16), used in some initial testing during Phase II (14), prior to the baseline survey, or were excluded due to many other ongoing interventions. We purposely selected all urban and peri-urban villages for inclusion in the sample. We then randomly selected 31 rural villages from Kongwa and 33 rural villages in Bahi to get a total of 38 villages in each district.

The villages selected into the sample were then randomized into treatment and control by strata.

Subsequently, 4 villages had to be dropped from the sample because they did not have CHWs (n=3) or they were inaccessible (n=1). The final sample included 36 villages in Bahi (18 treatment, 18 control) and 36 villages in Kongwa (19 treatment, 17 control).
Experimental Design Details
Not available
Randomization Method
Randomization was done using Stata. We generated a random variable for each village using the runiform() function, and ordered the villages within designated strata. Within strata, the first village was assigned to treatment, the second assigned to control, third treatment, continuing until all villages have been assigned to either treatment or control.
Randomization Unit
Village
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
76
Sample size: planned number of observations
1900 first time mothers
Sample size (or number of clusters) by treatment arms
38 treatment villages, 38 control villages
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
While the target was 76 clusters and 1900 first time mothers, in reality we ended up with 72 clusters and 1129 first time mothers. Given this sample, and using the following assumptions (alpha=0.05; ICC=.04; coefficient of variation of 0.5; 12% attrition;PPFP adoption in control group is 35%) the minimum detectable effect is 12 percentage points. For more detailed power calculations see the protocol/pre-analysis plans.
IRB

Institutional Review Boards (IRBs)

IRB Name
George Washington University Committee on Human Resource
IRB Approval Date
2022-10-04
IRB Approval Number
NCR203091
IRB Name
National Institute for Medical Research
IRB Approval Date
2022-12-19
IRB Approval Number
NIMR/HQ/R.8a/Vol.IX/4174
IRB Name
Tanzania Commission for Science and Technology
IRB Approval Date
2023-02-15
IRB Approval Number
N/A
Analysis Plan

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