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Maternal and Child HealthNCT04008199

Impact Evaluation of Super Abbu: A Speech Based MNCH Platform in Pakistan

A study testing Super Abbu in people with Maternal and Child Health, run by University of California, Davis at 1 site in Pakistan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The investigators have developed, piloted, and propose to expand and to experimentally evaluate a speech-based service that connects expectant fathers to doctors and to each other over a simple phone call. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Maternal and Child Health
What is being tested?
Super Abbu
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
1 sitePakistan
Study dates
1 Jun 2021to 31 Jul 2023
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Primary study subjects The target study population are households in Punjab, Pakistan, with a pregnant woman with a male spouse. The researchers will identify households that fit these criteria village-by-village, through community-based Lady Health Workers (LHWs) that, among other things, are charged with knowing which women are pregnant in her catchment area. LHWs are appointed by Punjab's Department of Health at the village level, and are supervised by Lady Health Supervisors (LHSs) at the sub-district level, who are in turn supervised by district coordinators and assistant district coordinators at the district level. The research team has relationships with LHSs and district coordinators in several districts in Punjab through prior work and it is these districts from which the study sample will be selected.

From all of the selected districts, the researchers will draw a random sample of 40 LHWs, stratified on sub-district. The team will then work with each of these 40 LHWs to identify all of the households in their catchment area that meet the study requirements. Note that these LHWs will share location and pregnancy status of households with the researchers, with permission of their supervisors, which the researchers have verified does not break any confidentiality rules within Pakistan, Punjab, and/or Punjab's Department of Health. It is discussed below how the researchers will maintain confidentiality of the research subjects once they are in the sample.

The researchers expect each LHW to have 1000 households in her catchment area on average. It is expected that four percent of households will have a pregnant woman at any given time. This implies that each LHW will have forty pregnant women in her catchment area. The researchers thus expect 1600 pregnant women across the sample catchment areas.

Once all of these 1600 households have been identified across 40 LHW's catchment areas, the researchers will randomly select 20 catchment areas for "treatment" and 20 to be "control". While all 1600 households will then be administered identical baseline and endline surveys, as described below, spouses in households in "treatment" catchments will also be invited to join Super Abbu at the conclusion of their baseline survey. What Super Abbu entails is described below.

Before enrolling households into the study during the baseline survey, the research team will verify that the household does in fact have a pregnant woman with a male spouse. The woman and her spouse will then be enrolled into the study. The only additional criteria will be that the subject is an adult who gives consent, where adult in this setting is 18 years or older.

There will be no other inclusion or exclusion criteria for primary study subjects.

Preliminary study subjects The researchers will conduct a preliminary study with approximately 100 subjects prior to beginning the primary study, to pilot the service and to test different versions of Super Abbu. These participants will be selected following the same procedure as with the primary study subjects, with one exception---they will all be invited to join Super Abbu. They will also be in a geographically distinct location from the primary study participants.

Focus group subjects The research team will also conduct focus groups prior to the primary study. Separate focus groups will be conducted with: gynecologists, LHWs, pregnant mothers, expectant fathers, fathers that were invited to be preliminary study subjects, fathers that were invited to be primary study subjects who were also invited to Super Abbu, and fathers that were invited to be primary study subjects who were not invited to Super Abbu. In all cases, the researchers will only include adults (18 years or older) who give consent. Selection criteria will be that subjects must match the group for which each given focus group is being conducted, with no additional criteria. Groups of 1-10, identified ad-hoc based on referrals, will be invited in-person to join a focus group at a central location. The researchers expect to conduct two focus groups per group, except four for preliminary study subjects, for a total of 16 focus groups and up to 160 participants. Note while the researchers expect discussion to differ based on the background and perspectives of those being focus grouped they plan to ask very similar questions of the group and, as such, only have one consent form for all focus group participants.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Lahore University of Management Sciences

    Lahore, Lahore/Punjab

Other trials in Pakistan

About this study

The investigators have developed, piloted, and propose to expand and to experimentally evaluate a speech-based service that connects expectant fathers to doctors and to each other over a simple phone call. This service, dubbed Super Abbu (Super Dad in English), addresses the challenges faced by existing efforts in several new and important ways:

  • The service targets fathers. Currently, the entire public health infrastructure in Punjab is geared towards providing information to women.
  • It supplements LHWs by providing information between LHW visits.
  • It does so in a manner appropriate for those who are illiterate and do not have smartphones.
  • It does not require synchronous phone calls. Expectant fathers can leave questions to be answered. And they can access past questions and answers asked by themselves and other users.
  • Through experience developing, publicizing, and driving adoption of speech-based services, the investigators believe they can overcome the slow adoption rate faced by the Punjab Health Line. Principal investigator Raza previously developed and launched Baang in Punjab, an entertainment speech-based social service, similar to Reddit, which accumulated 42,500 calls by 1,550 users within 71 days of its launch. These users listened to 393,448 speech posts.
Read the detailed description

Problem: Pakistan has the highest neonatal mortality rate in the world (44.2 per 1000 live births), accounting for 7% of the world's neonatal deaths, and among the worst maternal mortality rate in the region (178 per 100,000 live births). These indicators remain high despite the best efforts of the government and NGOs to leverage modern practices and technology to improve maternal, newborn, and child health (MNCH). To this end, the province of Punjab, Pakistan has hired 48,000 Lady Health Workers (LHWs), has introduced multiple information communication technology (ICT)-based health monitoring systems, and has launched the Punjab Health Line staffed by 150 doctors 24/7. LHW effectiveness has been limited, however, given the size of Punjab (100+ million people). LHWs are expected to visit nine homes per day and in 40 minutes cover a long syllabus and perform several tasks. Similarly, high deployment costs, low smartphone penetration, and low literacy rates in rural areas have limited the effectiveness of ICT-based interventions. The Punjab Health Line has been ineffective for more mundane reasons-its adoption has been very slow despite extensive publicity.

Research goals and expected outcomes: Super Abbu itself will generate useful information on frequently asked questions for public health professionals. In addition, the investigators seek to evaluate the effectiveness of Super Abbu at reducing maternal and infant mortality rates, and key drivers of these rates, in Punjab, Pakistan. In order to do so, the service must first be expanded to accommodate a new base of users. The investigators will then conduct a careful, large-scale randomized control trial of the service to understand its impacts on drivers of maternal and infant mortality rates, such as the number of antenatal visits, tetanus injections administered before birth, iron supplements consumed, and breastfeeding during neonatal days, and attitudes about vaccination, breastfeeding, and delivery.

Impact on research fields: Current speech-based health services in the developing world either depend on the functionality of a smartphone, involve synchronous contact with a healthcare provider, only target women, are costly, or are any combination of these. Super Abbu pushes the envelope. In addition, a careful evaluation of the service conducted by an interdisciplinary team would impact future research in public health, in computer science/language technologies, as well as in development economics.

Being tested
Super Abbu

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Super AbbuOther

    The investigators have developed, piloted, and propose to expand and to experimentally evaluate a speech-based service that connects expectant fathers to doctors and to each other over a simple phone call. This service is dubbed Super Abbu (Super Dad in English).

Study groups in NCT04008199
Study groupRoleWhat they receive
ControlNo interventionControl group will not receive any intervention. Households in this group will only be surveyed.
TreatmentExperimentalTreatment group will receive an invitation to join Super Abbu in addition to identical surveys to those in the control group.
Receives: Other: Super Abbu

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. How many times did she receive antenatal care during this pregnancy?

    Language taken from Pakistan DHS.

    Measured: From childbirth through study completion, an average of 3 months

  2. Where did you give birth to [NAME]?

    Language taken from Pakistan DHS; possible choices: [OWN HOME, OTHER HOME, GOVERNMENT HOSPITAL, GOVERNMENT CLINIC, OTHER GOVERNMENT, PRIVATE HOSPITAL, PRIVATE CLINIC, OTHER PRIVATE]

    Measured: From childbirth through study completion, an average of 3 months

  3. When [NAME] was born, was [NAME] very large, larger than average, average, smaller than average, or very small?

    Language taken from the Pakistan DHS.

    Measured: From childbirth through study completion, an average of 3 months

  4. For how much time in total do you plan to breastfeed [NAME] for?

    [DAYS/WEEKS/MONTHS/YEARS]

    Measured: From childbirth through study completion, an average of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start1 Jun 2021
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2023

Why it stopped: COVID-19 pandemic

Resources

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
Model description
The researchers are conducting a field experiment of the Super Abbu platform. Some households will be invited to participate and others will not, at random.
Masking
None (open label)
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04008199
Sponsor's protocol ID
1255578
Status last verified
Nov 2023
First submitted
28 Jun 2019
Last updated
30 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data collected for this study, including separately encrypted identifiers, will be kept indefinitely to support future research. The publicly shared content of Super Abbu, such as the public questions to doctors as well as the stories shared by parents will be kept beyond the duration of the project, and will be shared publicly on the hotline. The publicly shared content and focus group, baseline, and endline survey responses may also be shared with other researchers, however, personal identifiers will not be shared with anyone outside the research team.

Questions about this trial

What is this clinical trial studying?

A study testing Super Abbu in people with Maternal and Child Health, run by University of California, Davis at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 30 Nov 2023. 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 Pakistan. 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 was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.

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?

How many times did she receive antenatal care during this pregnancy? (time frame: From childbirth through study completion, an average of 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 30 Nov 2023.

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