Malaria in PregnancyNCT03376217
Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi
A study testing IPTp delivered by HSAs in people with Malaria in Pregnancy, run by Kamuzu University of Health Sciences at 1 site in Malawi.
Trial summary
The overall aim of the study is to learn whether utilization of Health Surveillance Assistants (HSAs) for delivery of intermittent preventive treatment of malaria in pregnant women (IPTp) can increase coverage of three or more IPTp doses compared to IPTp delivery only at antenatal clinics (ANC), while at the same time… Read more about this study
- Who is it for?
- Ages 16 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria in Pregnancy
- What is being tested?
- IPTp delivered by HSAs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,447 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Dec 2017to 30 Aug 2020
- 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 16 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women:
- All pregnant women residing in study catchment area are eligible to receive SP from HSAs, with the exception of HIV positive women.
- To be included in the women's question portion of the baseline and end line household surveys, women must be between the ages of 16-49 years, have been pregnant/delivered in the previous 12 months, consent to participation, and will be eligible for inclusion in surveys regardless of where the woman gave birth (i.e., whether at home or in facility). All pregnant/recently pregnant women will be included in the cross sectional survey, but the sample size is calculated in order to identify those who have completed pregnancies in the past 12 months. There were be a very short subset of demographic and knowledge questions which will be asked of all households during the baseline and end line surveys, regardless of whether there are any recently pregnant women in the household.
- Providers:
- At each facility we will randomly select one ANC provider who has had at least six months of work experience
- HSA supervisor
Show all 9Show fewer
- Health facility in-charge
- HSAs:
- All HSAs working in the study areas will be eligible; we will select at least 36 at random to be participate in interviews and focus groups discussions.
Who cannot join
- Pregnant women: Women who experienced a delivery in the past 12 months, but are <16 or >49 years will be excluded. Those who last delivered a child over twelve months ago will be excluded from survey questions specific to recently pregnant women, but may answer questions related to community perception or general demographics. For qualitative research, the same criteria will be used.
- Health facility providers: Those who have been working in the health service for less than six months will not be interviewed due to low levels of relevant experience or exposure to the intervention.
- HSAs: All HSAs are eligible to participate.
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Malaria Alert Center, University of Malawi College of Medicine
Liwonde
About this study
The overall aim of the study is to learn whether utilization of Health Surveillance Assistants (HSAs) for delivery of intermittent preventive treatment of malaria in pregnant women (IPTp) can increase coverage of three or more IPTp doses compared to IPTp delivery only at antenatal clinics (ANC), while at the same time improve or maintain ANC attendance. This will be a cluster randomized trial, including a total of 20 health facilities (HF) which will be randomly assigned to either the intervention (10) or non-intervention group (10); all HSAs affiliated with a HF will be in the same group.
Read the detailed description
Project Background WHO recommends the use of intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) to prevent the adverse effects of malaria in pregnancy. In 2012, in an effort to boost uptake, the World Health Organization (WHO) updated its policy promoting initiation of IPTp-SP as early as possible during the second trimester and at every scheduled antenatal clinic (ANC) visit thereafter, as long as the visits were at least one month apart. Despite this recommendation, progress has been slow, and no sub-Saharan African country has achieved the 85% coverage target set by the President's Malaria Initiative (PMI). Malawi was the first country to adopt IPTp-SP, and though it had early gains, these have remained stagnant. Coverage of 2 doses of IPTp-SP was 42.9% in 2004 (DHS), 53.8% in 2010 (DHS), and remained only 63% as of 2014 (MIS), despite the fact that >95% of women make 2 or more visits to the ANC, with 44% making four or more visits, and despite the fact that the median gestational age at the first visit is 5.6 months. Clearly, a novel approach to ensure earlier presentation at ANC and increase IPTp delivery is needed to boost coverage to the 85% target. Community delivery of IPTp has been suggested as a means to improve coverage, however, there is concern that this could also lead to reduced antenatal care (ANC) visits. Thus, it is relevant to assess whether there is a benefit of community delivery of IPTp-SP under the current policy advocating IPTp at each ANC visit, whether this approach is feasible, both from the standpoint of service delivery as well as data collection, and ensure that there is no adverse effect on ANC attendance prior to large scale roll-out.
Study Aims Broad objective: The overall aim of the study is to learn whether utilization of Health Surveillance Assistants (HSAs) for delivery of intermittent preventive treatment of malaria in pregnant women (IPTp) can increase coverage of three or more IPTp doses compared to IPTp delivery only at antenatal clinics (ANC), while at the same time improve or maintain ANC attendance
Specific objectives Primary objective
- Determine the effect of community-based IPTp delivery by HSAs compared with facility-based IPTp delivery on IPTp coverage (including 1, 2, 3, and 4 doses) and ANC coverage (including 1, 2, 3, and 4 visits) Secondary objectives
- Document the level of service delivery by HSAs
- Assess women's knowledge of HSAs and attitudes about receiving IPTp from a HSA
- Assess the feasibility of scaling-up community delivery of IPTp from the perspective of health facility staff, and HSAs..
- Assess the acceptability of community delivery of IPTp from health facility staff, HSAs, and women.
- Assess the factors which may affect the scale-up of community delivery of IPTp from the perspective of health facility staff, HSAs, and women.
- Assess incremental costs of community-based IPTp delivery compared to HF based IPTp delivery from both provider and household perspectives.
Methodology Study design: This will be a cluster randomized trial, including a total of 20 health facilities (HF) which will be randomly assigned to either the intervention (10) or non-intervention group (10); all HSAs affiliated with a HF will be in the same group.
The study will use baseline and end line cross sectional household surveys, midline and post-intervention in-depth interviews with health facility staff and HSAs, pre- and post-intervention in-depth interviews with women, and focus group discussions with HSAs to achieve the objectives.
- Conditions
- Malaria in Pregnancy
- Being tested
- IPTp delivered by HSAs
- Keywords
- malaria, malaria in pregnancy, intermittent preventive treatment in pregnancy (IPTp), community health workers, Sulfadoxine-pyrimethamine (SP)
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPTp delivered by HSAsOther
Also called community IPTp (cIPTp)
Pregnant women will have the option to receive IPTp-SP from Health surveillance assistants (HSAs). SP is recommended in Malawi for prevention of malaria during pregnancy, but currently it is only available at antenatal clinics.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | IPTp delivered at antenatal clinic |
| Intervention | Experimental | IPTp delivered by HSAs Receives: Other: IPTp delivered by HSAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 or more doses of IPTp (IPTp3+)
Proportion of recently pregnant women who received at least 3 doses of IPTp
Measured: through study completion, 18 months
Secondary outcomes (4)
IPTp doses received
Proportion of women who received 1, 2, or 4 or more dose of IPT
Measured: through study completion, 18 months
IPTp doses delivered by ANC
Proportion of doses delivered by the HSA vs at the ANC
Measured: through study completion, 18 months
Total ANC visits
proportion of women who made 1, 2, 3, 4, or more ANC visits
Measured: through study completion, 18 months
Gestational age at first IPTp
gestational age at the time of first ANC and at 1st dose of IPTp
Measured: through study completion, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Dec 2017
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malaria in PregnancyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamuzu University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Health, Malawi, Peace Corps, Management Sciences for Health, United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Julie Gutman, Kamuzu University of Health Sciences
- Investigators
- Jobiba Chinkhumba, MBBS PhD, Principal investigator, Malaria Alert Center, Malawi College of MedicineJulie Gutman, MD MSc, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376217
- Sponsor's protocol ID
- P.08/17/2232
- Status last verified
- Jul 2021
- First submitted
- 6 Dec 2017
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Okeibunor JC, Orji BC, Brieger W, Ishola G, Otolorin E', Rawlins B, Ndekhedehe EU, Onyeneho N, Fink G. Preventing malaria in pregnancy through community-directed interventions: evidence from Akwa Ibom State, Nigeria. Malar J. 2011 Aug 5;10:227. doi: 10.1186/1475-2875-10-227.
PubMed 21819579Ndyomugyenyi R, Tukesiga E, Katamanywa J. Intermittent preventive treatment of malaria in pregnancy (IPTp): participation of community-directed distributors of ivermectin for onchocerciasis improves IPTp access in Ugandan rural communities. Trans R Soc Trop Med Hyg. 2009 Dec;103(12):1221-8. doi: 10.1016/j.trstmh.2009.03.006. Epub 2009 May 20.
PubMed 19467686Mbonye AK, Magnussen P, Bygbjerg IB. Intermittent preventive treatment of malaria in pregnancy: the effect of new delivery approaches on access and compliance rates in Uganda. Trop Med Int Health. 2007 Apr;12(4):519-31. doi: 10.1111/j.1365-3156.2007.01819.x.
PubMed 17445143Msyamboza KP, Savage EJ, Kazembe PN, Gies S, Kalanda G, D'Alessandro U, Brabin BJ. Community-based distribution of sulfadoxine-pyrimethamine for intermittent preventive treatment of malaria during pregnancy improved coverage but reduced antenatal attendance in southern Malawi. Trop Med Int Health. 2009 Feb;14(2):183-9. doi: 10.1111/j.1365-3156.2008.02197.x. Epub 2009 Jan 15.
PubMed 19207178Gies S, Coulibaly SO, Ky C, Ouattara FT, Brabin BJ, D'Alessandro U. Community-based promotional campaign to improve uptake of intermittent preventive antimalarial treatment in pregnancy in Burkina Faso. Am J Trop Med Hyg. 2009 Mar;80(3):460-9.
PubMed 19270299Rubenstein BL, Chinkhumba J, Chilima E, Kwizombe C, Malpass A, Cash S, Wright K, Troell P, Nsona H, Kachale F, Ali D, Kaunda E, Lankhulani S, Kayange M, Mathanga DP, Munthali J, Gutman JR. A cluster randomized trial of delivery of intermittent preventive treatment of malaria in pregnancy at the community level in Malawi. Malar J. 2022 Jun 21;21(1):195. doi: 10.1186/s12936-022-04216-4.
PubMed 35729612
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi
- ClinicalTrials.gov ID
- NCT03376217
- Acronym / sponsor ID
- P.08/17/2232
- Conditions
- Malaria in Pregnancy
- Keywords
- malaria, malaria in pregnancy, intermittent preventive treatment in pregnancy (IPTp), community health workers, Sulfadoxine-pyrimethamine (SP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,447 participants (actual)
- Lead sponsor
- Kamuzu University of Health SciencesUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Health, Malawi, Peace Corps, Management Sciences for Health, United States Agency for International Development (USAID)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 18 Dec 2017 (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.
The overall aim of the study is to learn whether utilization of Health Surveillance Assistants (HSAs) for delivery of intermittent preventive treatment of malaria in pregnant women (IPTp) can increase coverage of three or more IPTp doses compared to IPTp delivery only at antenatal clinics (ANC), while at the same time improve or maintain ANC attendance. This will be a cluster randomized trial, including a total of 20 health facilities (HF) which will be randomly assigned to either the intervention (10) or non-intervention group (10); all HSAs affiliated with a HF will be in the same group.
Detailed description
Project Background WHO recommends the use of intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) to prevent the adverse effects of malaria in pregnancy. In 2012, in an effort to boost uptake, the World Health Organization (WHO) updated its policy promoting initiation of IPTp-SP as early as possible during the second trimester and at every scheduled antenatal clinic (ANC) visit thereafter, as long as the visits were at least one month apart. Despite this recommendation, progress has been slow, and no sub-Saharan African country has achieved the 85% coverage target set by the President's Malaria Initiative (PMI). Malawi was the first country to adopt IPTp-SP, and though it had early gains, these have remained stagnant. Coverage of 2 doses of IPTp-SP was 42.9% in 2004 (DHS), 53.8% in 2010 (DHS), and remained only 63% as of 2014 (MIS), despite the fact that >95% of women make 2 or more visits to the ANC, with 44% making four or more visits, and despite the fact that the median gestational age at the first visit is 5.6 months. Clearly, a novel approach to ensure earlier presentation at ANC and increase IPTp delivery is needed to boost coverage to the 85% target. Community delivery of IPTp has been suggested as a means to improve coverage, however, there is concern that this could also lead to reduced antenatal care (ANC) visits. Thus, it is relevant to assess whether there is a benefit of community delivery of IPTp-SP under the current policy advocating IPTp at each ANC visit, whether this approach is feasible, both from the standpoint of service delivery as well as data collection, and ensure that there is no adverse effect on ANC attendance prior to large scale roll-out.
Study Aims Broad objective: The overall aim of the study is to learn whether utilization of Health Surveillance Assistants (HSAs) for delivery of intermittent preventive treatment of malaria in pregnant women (IPTp) can increase coverage of three or more IPTp doses compared to IPTp delivery only at antenatal clinics (ANC), while at the same time improve or maintain ANC attendance
Specific objectives Primary objective
- Determine the effect of community-based IPTp delivery by HSAs compared with facility-based IPTp delivery on IPTp coverage (including 1, 2, 3, and 4 doses) and ANC coverage (including 1, 2, 3, and 4 visits) Secondary objectives
- Document the level of service delivery by HSAs
- Assess women's knowledge of HSAs and attitudes about receiving IPTp from a HSA
- Assess the feasibility of scaling-up community delivery of IPTp from the perspective of health facility staff, and HSAs..
- Assess the acceptability of community delivery of IPTp from health facility staff, HSAs, and women.
- Assess the factors which may affect the scale-up of community delivery of IPTp from the perspective of health facility staff, HSAs, and women.
- Assess incremental costs of community-based IPTp delivery compared to HF based IPTp delivery from both provider and household perspectives.
Methodology Study design: This will be a cluster randomized trial, including a total of 20 health facilities (HF) which will be randomly assigned to either the intervention (10) or non-intervention group (10); all HSAs affiliated with a HF will be in the same group.
The study will use baseline and end line cross sectional household surveys, midline and post-intervention in-depth interviews with health facility staff and HSAs, pre- and post-intervention in-depth interviews with women, and focus group discussions with HSAs to achieve the objectives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –IPTp delivered at antenatal clinic |
| Intervention | Experimental | Other: IPTp delivered by HSAsIPTp delivered by HSAs |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- All pregnant women residing in study catchment area are eligible to receive SP from HSAs, with the exception of HIV positive women.
- To be included in the women's question portion of the baseline and end line household surveys, women must be between the ages of 16-49 years, have been pregnant/delivered in the previous 12 months, consent to participation, and will be eligible for inclusion in surveys regardless of where the woman gave birth (i.e., whether at home or in facility). All pregnant/recently pregnant women will be included in the cross sectional survey, but the sample size is calculated in order to identify those who have completed pregnancies in the past 12 months. There were be a very short subset of demographic and knowledge questions which will be asked of all households during the baseline and end line surveys, regardless of whether there are any recently pregnant women in the household.
- At each facility we will randomly select one ANC provider who has had at least six months of work experience
- HSA supervisor
- Health facility in-charge
Key exclusion criteria (3 listed)
- Pregnant women: Women who experienced a delivery in the past 12 months, but are <16 or >49 years will be excluded. Those who last delivered a child over twelve months ago will be excluded from survey questions specific to recently pregnant women, but may answer questions related to community perception or general demographics. For qualitative research, the same criteria will be used.
- Health facility providers: Those who have been working in the health service for less than six months will not be interviewed due to low levels of relevant experience or exposure to the intervention.
- HSAs: All HSAs are eligible to participate.
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 |
|---|---|---|
| IPTp delivered by HSAsAlso: community IPTp (cIPTp)Pregnant women will have the option to receive IPTp-SP from Health surveillance assistants (HSAs). SP is recommended in Malawi for prevention of malaria during pregnancy, but currently it is only available at antenatal clinics. | Other | Intervention |
Primary outcome
3 or more doses of IPTp (IPTp3+)
Time frame: through study completion, 18 months
Proportion of recently pregnant women who received at least 3 doses of IPTp
4 secondary outcomes
IPTp doses received
Time frame: through study completion, 18 months
IPTp doses delivered by ANC
Time frame: through study completion, 18 months
Total ANC visits
Time frame: through study completion, 18 months
Gestational age at first IPTp
Time frame: through study completion, 18 months
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 26 Jul 2021.
- Background: PubMed 21819579Okeibunor JC, Orji BC, Brieger W, Ishola G, Otolorin E', Rawlins B, Ndekhedehe EU, Onyeneho N, Fink G. Preventing malaria in pregnancy through community-directed interventions: evidence from Akwa Ibom State, Nigeria. Malar J. 2011 Aug 5;10:227. doi: 10.1186/1475-2875-10-227.
- Background: PubMed 19467686Ndyomugyenyi R, Tukesiga E, Katamanywa J. Intermittent preventive treatment of malaria in pregnancy (IPTp): participation of community-directed distributors of ivermectin for onchocerciasis improves IPTp access in Ugandan rural communities. Trans R Soc Trop Med Hyg. 2009 Dec;103(12):1221-8. doi: 10.1016/j.trstmh.2009.03.006. Epub 2009 May 20.
- Background: PubMed 17445143Mbonye AK, Magnussen P, Bygbjerg IB. Intermittent preventive treatment of malaria in pregnancy: the effect of new delivery approaches on access and compliance rates in Uganda. Trop Med Int Health. 2007 Apr;12(4):519-31. doi: 10.1111/j.1365-3156.2007.01819.x.
- Background: PubMed 19207178Msyamboza KP, Savage EJ, Kazembe PN, Gies S, Kalanda G, D'Alessandro U, Brabin BJ. Community-based distribution of sulfadoxine-pyrimethamine for intermittent preventive treatment of malaria during pregnancy improved coverage but reduced antenatal attendance in southern Malawi. Trop Med Int Health. 2009 Feb;14(2):183-9. doi: 10.1111/j.1365-3156.2008.02197.x. Epub 2009 Jan 15.
- Background: PubMed 19270299Gies S, Coulibaly SO, Ky C, Ouattara FT, Brabin BJ, D'Alessandro U. Community-based promotional campaign to improve uptake of intermittent preventive antimalarial treatment in pregnancy in Burkina Faso. Am J Trop Med Hyg. 2009 Mar;80(3):460-9.
- Derived from this study: PubMed 35729612Rubenstein BL, Chinkhumba J, Chilima E, Kwizombe C, Malpass A, Cash S, Wright K, Troell P, Nsona H, Kachale F, Ali D, Kaunda E, Lankhulani S, Kayange M, Mathanga DP, Munthali J, Gutman JR. A cluster randomized trial of delivery of intermittent preventive treatment of malaria in pregnancy at the community level in Malawi. Malar J. 2022 Jun 21;21(1):195. doi: 10.1186/s12936-022-04216-4.
- 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.
Jobiba Chinkhumba, MBBS PhD principal investigator
Malaria Alert Center, Malawi College of Medicine
Julie Gutman, MD MSc principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPTp delivered by HSAs in people with Malaria in Pregnancy, run by Kamuzu University of Health Sciences at 1 site in Malawi.
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 9 inclusion and 3 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 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. 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?
3 or more doses of IPTp (IPTp3+) (time frame: through study completion, 18 months). 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 NCT03376217, which also lists 6 linked publications.
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 26 Jul 2021.