Contraceptive UsageNCT03585361
Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) in Ethiopia
A study testing Health centers provide PPFP counseling and services, HEWs provide PPFP counseling and services and Volunteers (Development Army) promote PPFP in people with Contraceptive Usage and Postpartum Family Planning, run by Jhpiego at 6 sites in Ethiopia.
Trial summary
This study is investigating whether use of postpartum family planning (PPFP) increases if messages on PPFP and, if desired, PPFP services are integrated into as many contacts as possible between women/couples and the health system during pregnancy and the first year after birth. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Contraceptive Usage, Postpartum Family Planning, Contraception
- What is being tested?
- Health centers provide PPFP counseling and services, HEWs provide PPFP counseling and services and Volunteers (Development Army) promote PPFP
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 6 sitesEthiopia
- Study dates
- 20 Feb 2017to 30 May 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women
- Pregnant at time of enrollment
- Willing to give informed consent
- Provider interviews
- Providers providing PPFP messages or services in study area
- Willing to give informed consent
Who cannot join
- Women
- Not pregnant at time of enrollment
- Living outside study area
- Provider interviews
- Not working in antenatal, labor \& delivery, postnatal, or immunization care
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Ethiopia6 sites
Boru PHCU
Hitosa, Oromiya
Sibu PHCU
Hitosa, Oromiya
Aleko PHCU
Lode Hitosa, Oromiya
Huruta PHCU
Lode Hitosa, Oromiya
Ligaba PHCU
Lode Hitosa, Oromiya
Lode Jimata
Lode Hitosa, Oromiya
About this study
Official title: Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) to Pregnant Women and Women Within Twelve Months Postpartum in Ethiopia
This study is investigating whether use of postpartum family planning (PPFP) increases if messages on PPFP and, if desired, PPFP services are integrated into as many contacts as possible between women/couples and the health system during pregnancy and the first year after birth. Health system contacts may be at health facilities (including antenatal, labor and delivery, postnatal, and child immunization visits) or, with Ethiopia's Health Extension Program, at households or health posts in the community.
Read the detailed description
This implementation research study used a quasi-experimental, mixed method design with two arms. Two districts in Arsi Zone in Ethiopia's Oromia Region (Hitosa and Lode Hitosa) were selected for the study. In each district, one primary health care unit (PHCU) - a public health center and its satellite health posts - was randomly assigned to the intervention arm and one to the comparison arm.
PPFP counseling, services, and documentation were strengthened through training and supervision at health centers in both intervention and comparison PHCUs, consistent with Government of Ethiopia policies and guidelines. Only the intervention arm received the community-based intervention. The community-based intervention involved training Health Extension Workers (HEWs) who staff health posts, make outreach home visits, and support volunteers under the government's Development Army. HEWs were trained on PPFP with a refresher on implant insertion. The community invention also involved giving tools to HEWs and volunteers to help them track women's PPFP preferences and pregnancy risk.
The study objectives are to:
- Assess the effect of systematically integrating PPFP messages into contacts with the health system on uptake of PPFP through 12 months postpartum using a 'dose-response' analysis based on the number of contacts
- Estimate the added effect of the community-based intervention by comparing uptake of PPFP through 12 months postpartum in intervention and comparison sites
- Explore the acceptability and feasibility of tracking PPFP and reviewing data at health centers and HEWs and volunteers using record keeping and review processes to track women's decision-making and contraceptive use from pregnancy through 12 months postpartum
- Explore factors influencing women's/couples' adoption of PPFP during the first 12 months postpartum.
- Being tested
- Health centers provide PPFP counseling and services, HEWs provide PPFP counseling and services, Volunteers (Development Army) promote PPFP, Health centers conduct data reviews, HEWs and volunteers track PPFP
- Keywords
- Contraceptive Usage, Pregnancy, Postpartum Family Planning, Contraception, Prenatal Care, Postnatal Care, Postpartum Care, Family Planning, Ethiopia, Community Health Workers, Community Based Care, Health Extension Workers
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health centers provide PPFP counseling and servicesBehavioural
Providers trained on PPFP counseling skills and insertion technique for placing intrauterine devices (IUDs) immediately after birth with a refresher on insertion techniques for IUDs and implants. Training also included how to use tools to document PPFP services and referrals. Follow up supervision ensured skill mastery and retention.
HEWs provide PPFP counseling and servicesBehavioural
HEWs trained in PPFP counseling with a refresher on implant insertion skills. Training also included how to use tools to document PPFP services, method choice, and pregnancy risk at every contact during pregnancy and up to 12 months after birth. Follow up supervision ensured skill improvement and retention.
Volunteers (Development Army) promote PPFPBehavioural
HEWs orient volunteers on promoting PPFP and how to use a pictoral tool to remind women to access ANC, immunization, and PPFP services and to document women's method preferences and pregnancy risk at every contact during pregnancy and up to 12 months after birth.
Health centers conduct data reviewsBehavioural
Health center staff document PPFP counseling, provision, and referrals in registers and use a facility dashboard to display and track aggregate PPFP data.
HEWs and volunteers track PPFPBehavioural
HEWs and volunteers track PPFP counseling, choice of method, receipt of methods, and pregnancy risk starting in pregnancy through 12 months postpartum. HEWs and volunteers meet and review data.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Health centers provide PPFP counseling and services, implementing current Government of Ethiopia policy and standard of care (including still experimental screening and intra-facility referrals of women bringing infants for immunization). Also, health centers conduct data reviews of PPFP counseling, intra-facility referrals and uptake data. At community level, HEWs provide PPFP counseling and services throughout continuum of care, volunteers (Development Army) promote PPFP, and HEWs and volunteers track PPFP method choice and uptake. Receives: Behavioral: Health centers provide PPFP counseling and services; Behavioral: HEWs provide PPFP counseling and services; Behavioral: Volunteers (Development Army) promote PPFP; Behavioral: Health centers conduct data reviews; Behavioral: HEWs and volunteers track PPFP |
| Comparison | Active comparator | Health centers provide PPFP counseling and services, implementing current Government of Ethiopia policy and standard of care (including still experimental screening and intra-facility referrals of women bringing infants for immunization). Health centers conduct data reviews. Receives: Behavioral: Health centers provide PPFP counseling and services; Behavioral: Health centers conduct data reviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPFP uptake
Proportion of interviewed postpartum women who used a modern family planning method within 12 months after giving birth
Measured: 12 months after birth
Secondary outcomes (1)
Method choice
Proportion of interviewed postpartum women who chose a method prior to delivery
Measured: 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start20 Feb 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 776 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585361
- Sponsor's protocol ID
- IRB00007143
- Status last verified
- Jul 2018
- First submitted
- 29 Jun 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pfitzer A, Jima GH, Sitrin D, Ayalew F, Ahmed S. Effect of multiple counselling contacts along the continuum of care on use of postpartum family planning in a cohort of Ethiopian women: a dose-response analysis. BMJ Open. 2024 Dec 20;14(12):e084247. doi: 10.1136/bmjopen-2024-084247.
PubMed 39806635
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) to Pregnant Women and Women Within Twelve Months Postpartum in Ethiopia
- ClinicalTrials.gov ID
- NCT03585361
- Acronym / sponsor ID
- IRB00007143
- Keywords
- Contraceptive Usage, Pregnancy, Postpartum Family Planning, Contraception, Prenatal Care, Postnatal Care, Postpartum Care, Family Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 776 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Bill and Melinda Gates Foundation
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is investigating whether use of postpartum family planning (PPFP) increases if messages on PPFP and, if desired, PPFP services are integrated into as many contacts as possible between women/couples and the health system during pregnancy and the first year after birth. Health system contacts may be at health facilities (including antenatal, labor and delivery, postnatal, and child immunization visits) or, with Ethiopia's Health Extension Program, at households or health posts in the community.
Detailed description
This implementation research study used a quasi-experimental, mixed method design with two arms. Two districts in Arsi Zone in Ethiopia's Oromia Region (Hitosa and Lode Hitosa) were selected for the study. In each district, one primary health care unit (PHCU) - a public health center and its satellite health posts - was randomly assigned to the intervention arm and one to the comparison arm.
PPFP counseling, services, and documentation were strengthened through training and supervision at health centers in both intervention and comparison PHCUs, consistent with Government of Ethiopia policies and guidelines. Only the intervention arm received the community-based intervention. The community-based intervention involved training Health Extension Workers (HEWs) who staff health posts, make outreach home visits, and support volunteers under the government's Development Army. HEWs were trained on PPFP with a refresher on implant insertion. The community invention also involved giving tools to HEWs and volunteers to help them track women's PPFP preferences and pregnancy risk.
The study objectives are to:
- Assess the effect of systematically integrating PPFP messages into contacts with the health system on uptake of PPFP through 12 months postpartum using a 'dose-response' analysis based on the number of contacts
- Estimate the added effect of the community-based intervention by comparing uptake of PPFP through 12 months postpartum in intervention and comparison sites
- Explore the acceptability and feasibility of tracking PPFP and reviewing data at health centers and HEWs and volunteers using record keeping and review processes to track women's decision-making and contraceptive use from pregnancy through 12 months postpartum
- Explore factors influencing women's/couples' adoption of PPFP during the first 12 months postpartum.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health centers provide PPFP counseling and services, Behavioral: HEWs provide PPFP counseling and services, Behavioral: Volunteers (Development Army) promote PPFP, Behavioral: Health centers conduct data reviews, Behavioral: HEWs and volunteers track PPFPHealth centers provide PPFP counseling and services, implementing current Government of Ethiopia policy and standard of care (including still experimental screening and intra-facility referrals of women bringing infants for immunization). Also, health centers conduct data reviews of PPFP counseling, intra-facility referrals and uptake data. At community level, HEWs provide PPFP counseling and services throughout continuum of care, volunteers (Development Army) promote PPFP, and HEWs and volunteers track PPFP method choice and uptake. |
| Comparison | Active comparator | Behavioral: Health centers provide PPFP counseling and services, Behavioral: Health centers conduct data reviewsHealth centers provide PPFP counseling and services, implementing current Government of Ethiopia policy and standard of care (including still experimental screening and intra-facility referrals of women bringing infants for immunization). Health centers conduct data reviews. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Women
- Provider interviews
Key exclusion criteria (5 listed)
- Women
- Provider interviews
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health centers provide PPFP counseling and servicesProviders trained on PPFP counseling skills and insertion technique for placing intrauterine devices (IUDs) immediately after birth with a refresher on insertion techniques for IUDs and implants. Training also included how to use tools to document PPFP services and referrals. Follow up supervision ensured skill mastery and retention. | Behavioural | Comparison, Intervention |
| HEWs provide PPFP counseling and servicesHEWs trained in PPFP counseling with a refresher on implant insertion skills. Training also included how to use tools to document PPFP services, method choice, and pregnancy risk at every contact during pregnancy and up to 12 months after birth. Follow up supervision ensured skill improvement and retention. | Behavioural | Intervention |
| Volunteers (Development Army) promote PPFPHEWs orient volunteers on promoting PPFP and how to use a pictoral tool to remind women to access ANC, immunization, and PPFP services and to document women's method preferences and pregnancy risk at every contact during pregnancy and up to 12 months after birth. | Behavioural | Intervention |
| Health centers conduct data reviewsHealth center staff document PPFP counseling, provision, and referrals in registers and use a facility dashboard to display and track aggregate PPFP data. | Behavioural | Comparison, Intervention |
| HEWs and volunteers track PPFPHEWs and volunteers track PPFP counseling, choice of method, receipt of methods, and pregnancy risk starting in pregnancy through 12 months postpartum. HEWs and volunteers meet and review data. | Behavioural | Intervention |
Primary outcome
PPFP uptake
Time frame: 12 months after birth
Proportion of interviewed postpartum women who used a modern family planning method within 12 months after giving birth
1 secondary outcome
Method choice
Time frame: 12 months after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 39806635Pfitzer A, Jima GH, Sitrin D, Ayalew F, Ahmed S. Effect of multiple counselling contacts along the continuum of care on use of postpartum family planning in a cohort of Ethiopian women: a dose-response analysis. BMJ Open. 2024 Dec 20;14(12):e084247. doi: 10.1136/bmjopen-2024-084247.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health centers provide PPFP counseling and services, HEWs provide PPFP counseling and services and Volunteers (Development Army) promote PPFP in people with Contraceptive Usage and Postpartum Family Planning, run by Jhpiego at 6 sites in Ethiopia.
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 6 inclusion and 5 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Ethiopia. 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?
PPFP uptake (time frame: 12 months after birth). 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 NCT03585361, which also lists 1 linked publication.
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 18 Jul 2018.