Acceptability and Feasibility in the Context of the IMPROVE Trial in Kenya

Adherence, Treatment Clinical Trial

Official title:

Acceptability and Feasibility of IPTp With Dihydroartemisinin-piperaquine With or Without Azithromycin to Prevent Malaria, Sexually Transmitted and Reproductive Tract Infections in HIV-uninfected Pregnant Women (IMPROVE) in Kenya.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160026
• Other study ID #: 18-073
• Status: Completed
• Phase: Phase 4
• Start date: November 11, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2021
• Source: Liverpool School of Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multi-centre study will compare the acceptability, feasibility, cost and incremental cost-effectiveness of intermittent preventive treatment (IPTp) with dihydroartemisinin-piperaquine (DP) with or without azithromycin to the current strategy of IPTp with sulphadoxine-pyrimethamine (SP) to prevent malaria, sexually transmitted and reproductive tract infections in HIV-uninfected pregnant women (IMPROVE).

Description:

Primary objectives:

1. To assess the acceptability, costs and incremental cost-effectiveness of IPTp-DP, with or without AZ, compared to current policy of IPTp-SP in HIV-uninfected pregnant women.

2. To assess the feasibility of delivering IPTp-DP with or without a targeted information transfer intervention among HIV-uninfected pregnant women attending ANC in the routine health system i.e. non-trial settings.

Acceptability, costs and incremental cost-effectiveness will be assessed in the context of the IMPROVE clinical trial in Kenya, Malawi and Tanzania (see NCT02909712).

We will also conduct an 'implementation feasibility' study in the routine setting in adjacent sites to the IMPROVE trial site in Kenya (only), using a 3-arm cluster randomized design to assess systems effectiveness, implementation strength, scalability, and identify potential operational hurdles for scale up. Ministry of health nurses providing routine ANC services will be trained to provide IPTp-DP or given refresher training for current policy (IPTp-SP). The interventions will be implemented for a period of 10 months. Approximately 5-6 months after the start of implementation, delivery effectiveness will be assessed through exit interviews with pregnant women leaving ANC clinics. Women who receive the correct doses of the interventions will be followed up at home 4-5 days after their clinic visit (i.e. no more than 2 days after their 3-day regimen finished) and interviewed about adherence, including pill counts. The quantitative study will be supplemented by a qualitative study to explain the quantitative outcomes and to assess perceptions of scalability of the interventions tested.

Feasibility study Interventions:

Monthly IPTp regimens: Arm 1. Standard single-day stat course of quality-assured SP; Arm 2. Standard 3-day course of 3 to 5 tablets (40/320mg) of DP per day based on bodyweight (Eurartesim®, AlfaSigma, Italy); Arm 3. Same as 2, with additional job aids and IEC materials.

Outcome Measures

Feasibility study:

Primary Outcome - Adherence assessed through home visits: Proportion of pregnant women attending ANC who receive the first dose of IPTp by DOT and the correct number of tablets for subsequent doses (IPTp-DP) visited at home and who have verified they completed the treatment. Where IPTp-SP is given by DOT this is assumed as 100% adherence and that the correct dosage is given.

Secondary outcome - Delivery effectiveness assessed by exit interviews with pregnant women leaving ANC: Proportion of pregnant women attending ANC for their first and second visit in their second or third trimester who receive an appropriate dose with each drug/drug combination. For the IPTp-DP arm, women will be asked whether the first dose was given by DOT and the correct number of tablets for subsequent doses available on exit. For IPTp-SP the full dose should be given by DOT.

Sample sizes:

Feasibility exit interviews (delivery rate): 1,485 pregnant women Feasibility home visits (adherence rate): 744 pregnant women sampled from women enrolled in exit interviews Acceptability among pregnant women: approx. 90 Acceptability among health providers: approx.90

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Kenya Government owned health facilities, Level 3 or 4 health facilities

• Pregnant women attending ANC through non-trial health facilities for a scheduled antenatal care visit in the second or third trimester who receive one of the three study interventions depending on which arm is allocated to that health facility

Exclusion Criteria:

• Mission or private health facilities, Kenya government owned Level 2 or level 5 health facilities, health facilities included in the trial

• Pregnant women accessing private health facilities

• Health facilities, or pregnant women, involved in other malaria or HIV in pregnancy intervention trials or studies.

• Pregnant women in the first trimester, or pregnant women for who their last visit was less than one month ago

Related Conditions & MeSH terms

• Adherence, Treatment
• Malaria
• Malaria in Pregnancy

Intervention

Drug:
• Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine
Feasibility study to assess adherence among health providers in antenatal clinics delivering the study interventions in a routine setting and uptake and adherence among pregnant women.
• Monthly intermittent preventive treatment with sulfadoxine-pyrimethamine
Feasibility study to assess adherence among health providers in antenatal clinics delivering the study interventions in a routine setting and uptake and adherence among pregnant women.
• Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transfer
Feasibility study to assess adherence to guidelines among health providers in antenatal clinics delivering the study interventions in a routine setting and uptake and adherence among pregnant women.

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Kisumu

Sponsors (7)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	Kenya Medical Research Institute, Kilimanjaro Christian Medical Centre, Tanzania, London School of Hygiene and Tropical Medicine, National Institute for Medical Research, Tanzania, University of Bergen, University of Malawi College of Medicine

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence in pregnant women	Proportion of pregnant women attending ANC who receive the drug course correctly and who have verified they completed the treatment at home during a home visit.	Assessed 6-10 months after implementation commences
Secondary	Effectiveness of service delivery	Proportion of pregnant women attending ANC for their first and second visit in their second or third trimester who receive the drug course correctly on exit from ANC. For IPTp-SP the full dose should be given by DOT.	Assessed 6-10 months after implementation commences