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Contraceptive UsageConnect TZNCT06261970

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

A study testing Connect in people with Contraceptive Usage, run by George Washington University at 2 sites in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraceptive Usage
What is being tested?
Connect
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,134 participants
Where
2 sitesTanzania
Study dates
22 Feb 2023to 2 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Pregnant or has child under 9 months
  • Aged 14-25

Who cannot join

  • Younger than 14 or over 25
  • Has more than one child or is pregnant and has a child

Trial locations and contacts

2 sites in 1 country.

Tanzania2 sites

  • EDI

    Bahi, Dodoma

  • EDI

    Kongwa, Dodoma

Other trials in Tanzania

About this study

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

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.

Read the detailed 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).
Being tested
Connect
Medical subject headings
Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ConnectBehavioural

    Community level enhancements

Study groups in NCT06261970
Study groupRoleWhat they receive
Connect Community Level EnhancementsExperimentalCommunity Support Groups (CSGs)*: Connect enhances Lishe Endelevu's to require at least four FTMs to be recruited into each CSG established. Connect enhances the CSG toolkit to include FTM focused content, including information on birth spacing and PPFP. Home visits*: 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 with PPFP information. CHWs can provide non-clinical FP methods (pills, condoms) and provide referrals for services at public health facilities
Receives: Behavioral: Connect
ControlNo interventionNo additional Connect intervention. Lishe Endelevu Community Support Groups Operate per usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    Measured: 12 months

  2. 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)).

    Measured: At time of 12 month survey

Secondary outcomes (7)

  1. 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

    Measured: 12 months

  2. Average Satisfaction with PPFP methods

    1. Indicator for FTM believes advantages outweigh disadvantages, average across methods used, among those who have given birth
    • Methods: male condom, pill, injectable, implant, IUD

    Measured: 12 months

  3. Contraceptive Preferences

    1. Contraceptive preferences for modern methods, among all FTMs
    • 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.).

    Measured: 12 Months

  4. 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

    Measured: 12 months

  5. Communication and Agency

    1. Indicator for FTM discussed FP with husband/partner or other family member, among all FTMs

    Measured: 12 months

  6. 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.

    • 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

    Measured: 12 months

  7. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start22 Feb 2023
  3. Primary completion2 Feb 2025
  4. Study completion2 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06261970
Sponsor's protocol ID
999002684
Acronym
Connect TZ
Status last verified
Feb 2026
First submitted
8 Feb 2024
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified data will be made publicly available

Questions about this trial

What is this clinical trial studying?

A study testing Connect in people with Contraceptive Usage, run by George Washington University at 2 sites in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adoption of of Postpartum Family Planning (PPFP): (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06261970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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