Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03404284
Other study ID # IRB00007595
Secondary ID
Status Completed
Phase N/A
First received January 11, 2018
Last updated January 11, 2018
Start date June 2016
Est. completion date September 2017

Study information

Verified date January 2018
Source Jhpiego
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a mixed methods process evaluation of a programmatic intervention to integrate family planning and immunization services at health facilities and through outreach services in Dowa and Ntchisi districts of Malawi. The study involved qualitative methods (in depth interviews and focus group discussions with service providers, mothers and fathers of infants <1 year, and supervisors and program managers) as well as secondary analysis of service statistics for family planning and immunization services and of supervision reports.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All health facilities and associated outreach sites in Ntchisi and Dowa districts implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program

Exclusion Criteria:

- All health facilities and associated outreach sites not implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program

Study Design


Intervention

Behavioral:
Family planning and infant immunization service integration
The approach involved integration of services through health surveillance assistant (HSA) outreach as well as through the health facility platform. The HSAs provided door to door FP services in their designated communities as well as provided integrated FP and Immunisation services at village clinics and outreach sessions. At outreach sessions, mothers were offered both routine infant immunization and family planning services (pills, condoms, injectables plus referrals for other methods). At health facilities, mothers who sought routine infant immunization services were offered same-day family planning services and those who seek family planning services are also screened for infant immunization schedule completion / need for infant immunization services. HSAs and health facility providers were trained on FP-immunization service integration and were monitored through regular supportive supervision visits.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Jhpiego John Snow, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Number of modern family planning users June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
Primary Number of Penta 1 doses administered June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
Primary Number of Penta 3 doses administered June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
See also
  Status Clinical Trial Phase
Completed NCT02577601 - Impact of Combined Hormonal Contraceptives on UPA Phase 4
Completed NCT03153644 - Improving Contraceptive Care for Women With Medical Conditions
Completed NCT04112095 - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use Phase 3
Recruiting NCT05521646 - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative N/A
Active, not recruiting NCT04291001 - Ovarian Function With ENG Implant and UPA Use Early Phase 1
Completed NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed NCT03438682 - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting NCT01948882 - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women N/A
Enrolling by invitation NCT04997499 - Adolescent Subcutaneous (SQ) Injection Video Validation N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2
Completed NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03154125 - Sayana® Press Extension Study Phase 3
Withdrawn NCT03725358 - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon. N/A
Completed NCT02957630 - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" Phase 1/Phase 2
Completed NCT02718222 - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services N/A
Completed NCT02456584 - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods Phase 1
Recruiting NCT02121067 - LNG-IUS at 2 Weeks Postpartum Phase 4
Terminated NCT02169869 - Immediate Postplacental IUD Insertion N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Withdrawn NCT01930994 - Kenya Sino-implant (II) PK Study N/A