Contraceptive Usage Clinical Trial
— Connect TZOfficial title:
Leveraging and Strengthening Local Systems to Increase First-time Mothers' Use of Postpartum Family Planning in Tanzania: A Cluster Randomized Control Trial
Verified date | February 2024 |
Source | George Washington University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Tanzania | EDI | Bahi | Dodoma |
Tanzania | EDI | Kongwa | Dodoma |
Lead Sponsor | Collaborator |
---|---|
George Washington University | Bill and Melinda Gates Foundation, Save the Children, Save the Children International Tanzania |
Tanzania,
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 |
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