Maternal and Child Health Clinical Trial
Official title:
Impact Evaluation of Super Abbu: A Speech Based MNCH Platform in Pakistan
NCT number | NCT04008199 |
Other study ID # | 1255578 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | July 31, 2023 |
Verified date | November 2023 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 276 |
Est. completion date | July 31, 2023 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Lahore University of Management Sciences | Lahore | Lahore/Punjab |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | Lahore University of Management Sciences, University of California, Riverside, University of Michigan |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | How many times did she receive antenatal care during this pregnancy? | Language taken from Pakistan DHS. | From childbirth through study completion, an average of 3 months | |
Primary | 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] | From childbirth through study completion, an average of 3 months | |
Primary | When [NAME] was born, was [NAME] very large, larger than average, average, smaller than average, or very small? | Language taken from the Pakistan DHS. | From childbirth through study completion, an average of 3 months | |
Primary | For how much time in total do you plan to breastfeed [NAME] for? | [DAYS/WEEKS/MONTHS/YEARS] | From childbirth through study completion, an average of 3 months |
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