Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405487752509 Date of Approval: 02/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessing the Impact of Group ANC on IPTp uptake in Benin and the Feasibility and Acceptability of Pregnant Women as a Sentinel Surveillance Population
Official scientific title Assessing the Impact of Group ANC on IPTp uptake in Benin and the Feasibility and Acceptability of Pregnant Women as a Sentinel Surveillance Population
Brief summary describing the background and objectives of the trial Group antenatal care (GANC) is a service delivery model where women with pregnancies of similar gestational age are brought together for antenatal care (ANC), incorporating information sharing and peer support. This model provides selected aspects of clinical care to women in the group at the same time during group visits, as well as creating a support group of women at a similar stage in pregnancy, to improve the quality of care and engagement of women in the ANC process, ultimately leading to better retention in care. Initial studies have suggested that this improves uptake of intermittent preventive treatment in pregnancy (IPTp) among women who participate, but have not evaluated the effect at community level. We propose to assess whether use of the GANC model in Benin can improve the quality of ANC as compared to standard individual ANC, by measuring uptake of recommended interventions, primarily IPTp. Benin has been selected as coverage of early ANC is high, with 83% of women receiving ANC from a trained provider, with a median age of initiation of four months. Coverage of 4 ANC visits (ANC4), however, is sub-optimal: just 63% in Atlantique in Benin. Despite the relatively early initiation of ANC, only 34.2% and 13.7% received 2 and 3 doses of IPTp (IPTp2 and IPTp3), respectively. Recent data from Tanzania and Kenya suggest that malaria parasitemia prevalence among pregnant women correlates with the prevalence among children under five, and could be used to track trends over time. The very high coverage of ANC (>80% attending at least one ANC contact), suggests that pregnant women could be a good sentinel population that could be readily tracked over time. However, pregnant women represent only about 5% of the overall population, thus, it is important to demonstrate that the trends in malaria prevalence and household level coverage of interventions reported by pregnant women attending ANC is representative of coverage among the general population. If validat
Type of trial RCT
Acronym (If the trial has an acronym then please provide) GANC
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/03/2021
Actual trial start date 24/03/2021
Anticipated date of last follow up 28/02/2023
Actual Last follow-up date 31/03/2023
Anticipated target sample size (number of participants) 2539
Actual target sample size (number of participants) 2539
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Routine Antenatal care routine ANC visits duration of pregnancy Women attend standard, individual, antenatal care visits 1267 Active-Treatment of Control Group
Experimental Group Group Antenatal Care monthly 5 months Facilitated group meetings to provide antenatal care 1272
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Facility selection criteria 1. Facility characteristics • High enough ANC census to form groups o Approximately 30-120 first ANC visits per month o > 15 ANC1 visits/month with women <20 weeks gestational age • >1 provider/staff working at a time so that 1–2 can facilitate group meeting while others are available to see to other clients (e.g., deliveries) • Space for group meeting • Public or non-profit facility • Interest in offering GANC at the facility and district level • Facilities are easily accessible throughout majority of the year 2. Population characteristics • Women likely to stay in catchment area throughout pregnancy – e.g., they are not visiting from another place; it is not a cultural norm for women to move back to parent’s house in third trimester or postpartum • If area has a large number of women working outside the home, may need higher ANC census to form groups and/or enroll more women/cohort – attendance in this population may be lower due to difficulty getting off work. Pregnant women for GANC: • Pregnant women who present for initial ANC visit prior to 24 completed weeks • Intend to remain in the area for the duration of the pregnancy • Agree to participate in GANC. Recently pregnant women (for cross sectional household surveys) • Women between the ages of 15-49 years • Have been pregnant/delivered in the previous 12 months • Consent to participation Pregnant women: • Women will be excluded from participation in GANC if they initiate ANC care >24 weeks gestation • if there are no available groups that they can join • if they do not intend to remain in the facility catchment area for the duration of the study • if they are not available during the times the group intends to meet Recently pregnant women (cross sectional survey): • Women <15 or >49 years will be excluded • Women who last delivered a child over twelve months ago will be excluded For qualitative research, the same criteria will be used. Immediate pre- or postpartum women (for the facility-based survey): • Women will be excluded if they initiated ANC care >24 weeks gestation • < 15 or >49 years old • Unable or unwilling to provide consent • Suffered a fetal/ neonatal loss or miscarriage during the current pregnancy. Adult: 19 Year-44 Year 15 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/04/2020 Comite National Pour LEthique de la Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
08 BP 882 Cotonou 08 BP 882 Benin
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/03/2022 Comite National D Ethique pour la Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
08 BP 882, Benin Cotonou 08 BP 882 Benin
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/06/2022 COMITE NATIONAL DETHIQUE POUR LA RECHERCHE EN SANTE
Ethics Committee Address
Street address City Postal code Country
08 BP 882 Cotonou 08 BP 882 Benin
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome proportion of pregnant women receiving IPTp3+ Delivery, beginning of study, end of study
Secondary Outcome Mean number of antenatal care visits delivery, study baseline, study endline
Secondary Outcome Mean gestational age at first antenatal care visit delivery, beginning and end of study
Secondary Outcome Increased proportion of women with facility-based delivery Study baseline and endline
Secondary Outcome Greater proportion of women completing the full antenatal care package, composed of blood pressure, urine test, blood test, tetanus, IFA, albendazole, LLIN, IPTp Study baseline and endline
Secondary Outcome feasibility and acceptability of group antenatal care study baseline and endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CS Adjan not available Atlantique Benin
CS Agon NA Atlantique Benin
CS Agonkanme NA Atlantique Benin
CS AhomeyLokpo NA Atlantique Benin
CS AHOUANNONZOUN NA Atlantique Benin
CS Attogon na Atlantique Benin
CS Avame NA Atlantique Benin
CS Ayou NA ATLANTIQUE Benin
CS COUSSI NA ATLANTIQUE Benin
CS DAME NA ATLANTIQUE Benin
CS DODJI BATA NA ATLANTIQUE Benin
CS DEKOUNGBE NA ATLANTIQUE Benin
CS GANVIE NA ATLANTIQUE Benin
CS GOLODJIGBE NA ATLANTIQUE Benin
CS HINVI NA ATLANTIQUE Benin
CS HOUEGBO NA ATLANTIQUE Benin
CS HOUEDO AGUEKON NA ATLANTIQUE Benin
CS KPANROUN NA ATLANTIQUE Benin
CS KPOMASSE NA ATLANTIQUE Benin
CS LISSEGAZOUN NA ATLANTIQUE Benin
CS MARIA GLETA NA ATLANTIQUE Benin
CS MI HOUNDJAVA NA ATLANTIQUE Benin
MI KPOVE NA ATLANTIQUE Benin
CS OUEDO NA ATLANTIQUE Benin
CS SAVI NA ATLANTIQUE Benin
CS SE NA ATLANTIQUE Benin
CS SEDJE DENOU NA ATLANTIQUE Benin
CS SEHOUE NA ATLANTIQUE Benin
CS SEKOU NA ATLANTIQUE Benin
CS SO AVA NA ATLANTIQUE Benin
CA TANGBO DJEVIE NA ATLANTIQUE Benin
CS TOFFO NA ATLANTIQUE Benin
CS TOGOUDO NA ATLANTIQUE Benin
CS TOKPA DOME BA ATLANTIQUE Benin
CS TORI GARE NA ATLANTIQUE Benin
CS TORI BOSSITO NA ATLANTIQUE Benin
CS TORI CADA NA ATLANTIQUE Benin
CS ZE NA ATLANTIQUE Benin
CS ZINVIE NA ATLANTIQUE Benin
FUNDING SOURCES
Name of source Street address City Postal code Country
Presidents Malaria Initiative 1300 Pennsylvania Avenue NW Washington DC 20004 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor USAID 1300 Pennsylvania Avenue NW Washington DC 20004 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Julie Gutman fff2@cdc.gov 14047184730 1600 Clifton Rd
City Postal code Country Position/Affiliation
Atlanta 30029 United States of America Centers for Disease Control and Prevention
Role Name Email Phone Street address
Public Enquiries Julie Gutman fff2@cdc.gov 14047184730 1600 Clifton Rd
City Postal code Country Position/Affiliation
Atlanta 30029 United States of America Centers for Disease Control and Prevention
Role Name Email Phone Street address
Scientific Enquiries Julie Gutman fff2@cd.gov 14047184730 1600 Clifton Rd
City Postal code Country Position/Affiliation
Atlanta United States of America Centers for Disease Control and Prevention
Role Name Email Phone Street address
Principal Investigator Aurore OgouyemiHounto aurorefel@yahoo.fr 22997684645 BP 526 Universite dAbomey Calavi
City Postal code Country Position/Affiliation
Cotonou Benin Universite dAbomey Calavi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymous individual level data will be available from participants enrolled in the cross sectional surveys; interested persons should contact the study PI, Dr. Julie Gutman at fff2@cdc.gov with a proposal and permission will be sought from the Beninese Ministry of Health prior to sharing the data. Study Protocol 24 months from completion of trial Individuals may contact the PIs with reasonable requests for data and will be granted upon approval of the Benin Ministry of Health
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information