ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03376217
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Ministry of Health, Malawi
Peace Corps
Management Sciences for Health
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
University of Malawi College of Medicine

Brief 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 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.

Condition or disease Intervention/treatment Phase
Malaria in Pregnancy Other: IPTp delivered by HSAs Not Applicable

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

  1. 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
  2. Document the level of service delivery by HSAs
  3. Assess women's knowledge of HSAs and attitudes about receiving IPTp from a HSA
  4. Assess the feasibility of scaling-up community delivery of IPTp from the perspective of health facility staff, and HSAs..
  5. Assess the acceptability of community delivery of IPTp from health facility staff, HSAs, and women.
  6. Assess the factors which may affect the scale-up of community delivery of IPTp from the perspective of health facility staff, HSAs, and women.
  7. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2744 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
Drug Information available for: Altretamine

Arm Intervention/treatment
No Intervention: Control
IPTp delivered at antenatal clinic
Experimental: Intervention
IPTp delivered by HSAs
Other: IPTp delivered by HSAs
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 Name: community IPTp (cIPTp)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. IPTp doses received [ Time Frame: through study completion, 18 months ]
    Proportion of women who received 1, 2, or 4 or more dose of IPT

  2. IPTp doses delivered by ANC [ Time Frame: through study completion, 18 months ]
    Proportion of doses delivered by the HSA vs at the ANC

  3. Total ANC visits [ Time Frame: through study completion, 18 months ]
    proportion of women who made 1, 2, 3, 4, or more ANC visits

  4. Gestational age at first IPTp [ Time Frame: through study completion, 18 months ]
    gestational age at the time of first ANC and at 1st dose of IPTp



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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
  • 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.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376217


Contacts
Contact: Julie Gutman, MD MSc 404-718-4730 fff2@cdc.gov
Contact: Jobiba Chinkhumba, MBBS PhD jchinkhumba@mac.medcol.mw

Locations
Malawi
Malaria Alert Center, University of Malawi College of Medicine Recruiting
Liwonde, Malawi
Contact: Jobiba Chinkhumba, MBBS PhD    +011265999775520    jchinkhumba@mac.medcol.mw   
Principal Investigator: Jobiba Chinkhumba, MBBS PhD         
Sponsors and Collaborators
University of Malawi College of Medicine
Centers for Disease Control and Prevention
Ministry of Health, Malawi
Peace Corps
Management Sciences for Health
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Jobiba Chinkhumba, MBBS PhD Malaria Alert Center, Malawi College of Medicine
Principal Investigator: Julie Gutman, MD MSc Centers for Disease Control and Prevention

Publications:
Responsible Party: University of Malawi College of Medicine
ClinicalTrials.gov Identifier: NCT03376217     History of Changes
Other Study ID Numbers: P.08/17/2232
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Malawi College of Medicine:
malaria
malaria in pregnancy
intermittent preventive treatment in pregnancy (IPTp)
community health workers
Sulfadoxine-pyrimethamine (SP)

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases