Child DevelopmentMalezi IINCT05244161
A Quasi-experimental Evaluation of the Malezi Program in Tanzania
A study testing RMV-ECD in people with Child Development and Father-Child Relations, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Tanzania.
Trial summary
The quality of caregiving and the parent-child relationship is critical for early child development (ECD) and has been shown to be modifiable. This study evaluated an ECD project in Tanzania, assessing the effectiveness of radio messaging (RM) alone and a combined radio messaging/video job aids/ECD (RMV-ECD)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Development, Father-Child Relations, Knowledge, Attitudes, Practice
- What is being tested?
- RMV-ECD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,248 participants
- Where
- 1 siteTanzania
- Study dates
- 13 Oct 2019to 30 Jun 2021
- 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
Who may be able to join
- resident adult (>18 years) primary caregiver of a child aged 0-24 months, and had the
- intention to remain in the same area for at least one year,
- willingness to be home-visited by a Community Health Worker.
Who cannot join
- unable or unwilling to give informed consent
- CHW eligibility criteria:
- assigned to a Malezi II study health facility/catchment community
- working as a Malezi II project CHW (i.e. attended Malezi (I or II) training, or capacitated for Malezi II project through on-job training and mentoring)
- able to understand and willing to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Early Child Development Multi-Media Communication on Caregiver and Community Health Worker Behaviors: Evaluation of the Malezi II Program
The quality of caregiving and the parent-child relationship is critical for early child development (ECD) and has been shown to be modifiable. This study evaluated an ECD project in Tanzania, assessing the effectiveness of radio messaging (RM) alone and a combined radio messaging/video job aids/ECD (RMV-ECD) intervention, using a two-arm pre-post design study, which enrolled a cohort of caregivers of children 0-24 months in four districts of Tabora region, following them for nine months. ECD radio messages were broadcast on popular stations at least 10 times/day reaching all study districts. In two districts, community health workers (CHW) trained in UNICEF's Care for Child Development package and used ECD videos in home- and facility-based sessions with caregivers. Five outcomes were used to assess the intervention effects: ECD knowledge, early stimulation, father engagement, responsive care, and environment safety. Additionally the effect of the training and video job aids on the quality of CHWs' counseling support was evaluated primarily using structured observation checklists of household visits and facility group counseling sessions with caregivers and their children. Qualitative data was collected from a subset of caregivers and CHW participating in the study to assess acceptability and other perceptions of the project.
Read the detailed description
Standardized interventions aimed at supporting child development are successful in a variety of cultural and socio-economic contexts, particularly in low to middle income countries. Integrated community and facility-based interventions can improve parenting behaviors. Mass media radio messaging campaigns can increase caregiver and community knowledge, and caregiver motivation to seek appropriate health care through reaching a broader audience such as family/household influencers such as fathers or grandparents.
Study design and setting:
This was a two-arm quasi-experimental pre-post evaluation study, comparing different 9-month intervention packages to establish their relative impact on parenting skills and environment among a cohort of caregivers of children under age three years in Tabora region, located in central-western Tanzania and home to a predominantly rural (87%) population. The study included four districts divided into two intervention groups. The first group (Kaliua, Uyui districts) was exposed to the minimal intervention package, composed of radio messaging (RM) only. The second group (Nzega, Igunga districts) was exposed to the Malezi II full intervention package, composed of radio messaging, the introduction of short video job aids primarily for community health worker (CHW) use, and the UNICEF Care for Childhood Development (CCD) program (RMV-ECD).
Sample and sampling procedures:
As the comprehensive program intervention was primarily delivered by CHW who were affiliated with health facilities, 31 health facilities were purposefully selected located in 29 administrative units called wards (6-8/district). From these wards, 75 National Bureau of Statistics census enumeration areas (EA) were randomly sampled proportional to population size. The study team aimed to enumerate all households in sampled EAs, listing potentially eligible households if there was a resident adult (>18 years) primary caregiver of a child aged 0-24 months who intended to remain in the same area for at least one year, and was willing to be home-visited by a CHW. From these listed households, only one caregiver per household was recruited. Caregivers who were not able to provide written informed consent due to a cognitive impairment or language barrier; or who were the primary caregiver of an index child with a congenital anomaly or other disability; or who worked as a CHW or medical provider, were excluded from the study.
The study team estimated that a completed sample size of 430 caregivers per intervention group would provide 90% power to detect a 15% difference between the RM and RMV-ECD intervention groups at endline, and >80% power to detect at least a 5% change in each t intervention group between baseline and endline, at a 5% significance level. Of 8880 households enumerated, 1248 caregivers were recruited into the study and interviewed at baseline (October-December 2019). Of these, 1051 were eligible for follow-up; 1004 (96%) were successfully traced and interviewed at endline (January-March 2021). Almost all (n=985; 98%) caregivers interviewed at endline remained the primary caregiver of the index child from baseline. Of the 19 caregivers whose index child had died or moved from the household, eight nominated an eligible "replacement" child under three years and 11 completed a partial interview skipping questions that were no longer applicable.
A cohort of 120 CHWs was also enrolled from the two intervention districts, who were assigned to caregiver-cohort enrolled households in the RMV-ECD arm.
Data collection and study variables Structured questionnaires were administered in a private place in or near the consenting caregiver's home in the national language (Swahili). Five outcome variables were defined reflecting caregiver knowledge, stimulation practices, father engagement, responsive care, and household environment risk. Continuous scores for each variable were dichotomized at the median for analysis. Some scores, where the number of items differed by age of the child (early stimulation) or sub-group (environment risk), were standardized to a 0-1 scale by dividing the raw score by the number of items. The quality of CHWs counseling support was evaluated using a structured evaluation checklist, targeting two home and two clinic observations for each CHW in each round; pre and post intervention. The checklist had 23 items across 6 dimensions; introduce, educate, ask, plan/problem solve, interact/encourage, and responsive care. Under the qualitative process evaluation, 25 in-depth interviews (IDI) were completed with caregivers enrolled in the cohort, and four focus group discussions (FGD) were held among those in the CHW cohort.
- Being tested
- RMV-ECD
- Keywords
- Early child development, Parenting, Media intervention, Community health workers, Program evaluation, Caregiver
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RMV-ECDBehavioural
Combined radio messaging, video job aids (primarily for CHWs), Care for Childhood Development package
| Study group | Role | What they receive |
|---|---|---|
| Radio messaging (RM) | No intervention | Radio messaging only (RM) |
| RM, Video job aids, Early Childhood Development program (RMV-ECD) | Active comparator | Radio messaging, short video job aids primarily for CHW use, and the UNICEF Care for Childhood Development program (RMV-ECD) Receives: Behavioral: RMV-ECD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver age appropriate early childhood development knowledge as assessed by responses to interview-administered questions
Proportion of respondents scoring <2 (poor knowledge) or 2-6 (good knowledge) to six questions (scoring 0-6 points) asking the caregiver to describe one specific way that a "caregiver can support a child's mental, emotional or physical development…" during pregnancy, from birth to six months, from 6-9, 9-12, and 12-24 months and 2-5 years of age. Caregiver responses coded correct or incorrect.
Measured: 9 months
Caregiver early childhood stimulation practices as assessed by responses to interview-administered questions adapted from UNICEF's Multiple Indicator Cluster Surveys
Proportion of respondents scoring poor (<50%) or good (equal or >50%) to questions on stimulation. Caregivers of children under seven months could score up to three points for reporting that the mother, father, or other adult engaged the child in singing songs, taking the child outside, or playing with the child in the past week. Caregivers of children over seven months were asked three additional items (read books, told stories, name/count things with child) for a total of six points. The sum of the items for these two measures were then standardized to a 0-1 scale.
Measured: 9 months
Father engagement with the child as assessed by caregiver responses to interview-administered questions adapted from UNICEF's Multiple Indicator Cluster Surveys
Proportion of respondents scoring <2 (poor engagement) or 2-6 (good engagement) to questions on father engagement. Caregivers of children under seven months could score up to three points for reporting that the father engaged the child in singing songs, taking the child outside, or playing with the child in the past week. Caregivers of children over seven months were asked three additional items (read books, told stories, name/count things with child) for a total of six points. The sum of the items for these two measures were then standardized to a 0-1 scale.
Measured: 9 months
Responsive care as assessed by interviewer observations of how the caregiver engaged with the child during the interview using questions from the interview guide
Proportion of respondents scoring <5 (poor responsive care) or 5-6 (good responsive care) by observed by interviewers of how the caregiver engaged with the child during the interview. Observations consisted of four items totaling up to six points which included helping the child keep busy (0, 1), pointing out objects/naming things (scored as 0, 1), recognizing when the child needs help with something (0,1,2), and keeping the child in view at all times (0,1,2).
Measured: 9 months
Household environment risk as assessed by interviewer observation of the inner and outer household areas using questions from interview guide
Proportion of respondent households scoring equal or <0.3 (poor) or >0.3 (good) to interviewer observations of household and neighborhood environment safety from risks of community (nearby road, bar/market, ditches); outside compound (open water source, unpenned animals, accessible sharp tools, chemicals or flammable materials, and unprotected cooking area); and inside household (accessible electric, medicine or cleaning chemicals, inappropriate toys). The environment risk outcome was standardized (0-1) to adjust for the different number of items in each group.
Measured: 9 months
Quality of CHWs counseling assessed by independent observations of home and clinic counseling sessions against a checklist
Proportion of CHWs scoring <15 or (poor) equal or >16 (good) on quality of home and clinic counseling at baseline and endline from video observations based on a 23-item checklist assessing how CHW 1) introduce topic/session, 2) educate on appropriate activities, 3) ask caregivers about behaviors, 4) plan and problem-solve, 5) interact with and encourage caregivers, and 6) discuss responsive care. Items with yes" or "no" response options were scored as "1" or "0", and items with "well done," "partly" or "not done" responses were scored "1," "0.5" or "0" points, respectively. Raw scores were then standardized to a 0-1 scale. Clinic and home observations scored separately and subsequently combined for an overall score.
Measured: 12-18 months
Secondary outcomes (1)
Acceptability of ECD intervention activities as assessed through open-ended responses recorded in in-depth interviews with caregivers and focus group discussions with CHW.
Among CHW, perceptions and experiences receiving project training and implementing ECD intervention activities (home visits, videos, group counseling, radio). Among caregivers, perceptions and experiences of CHW support and receiving the ECD intervention.
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start13 Oct 2019
- Primary completion31 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Community Development, Gender, Elderly and Children, President's Office, Regional Administration and Local Government, Development Media International, Aga Khan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244161
- Sponsor's protocol ID
- EG0227
- Acronym
- Malezi II
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antelman G, Ferla J, Gill MM, Hoffman HJ, Komba T, Abubakar A, Remes P, Jahanpour O, Mariki M, Mang'enya MA, van de Ven R. Effectiveness of an integrated multilevel early child development intervention on caregiver knowledge and behavior: a quasi-experimental evaluation of the Malezi program in Tanzania. BMC Public Health. 2023 Jan 4;23(1):19. doi: 10.1186/s12889-022-14956-2.
PubMed 36600280
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Early Child Development Multi-Media Communication on Caregiver and Community Health Worker Behaviors: Evaluation of the Malezi II Program
- ClinicalTrials.gov ID
- NCT05244161
- Acronym / sponsor ID
- Malezi II / EG0227
- Keywords
- Early child development, Parenting, Media intervention, Community health workers, Program evaluation, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,248 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Ministry of Health, Community Development, Gender, Elderly and Children, President's Office, Regional Administration and Local Government, Development Media International, Aga Khan University
- Study start
- 13 Oct 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The quality of caregiving and the parent-child relationship is critical for early child development (ECD) and has been shown to be modifiable. This study evaluated an ECD project in Tanzania, assessing the effectiveness of radio messaging (RM) alone and a combined radio messaging/video job aids/ECD (RMV-ECD) intervention, using a two-arm pre-post design study, which enrolled a cohort of caregivers of children 0-24 months in four districts of Tabora region, following them for nine months. ECD radio messages were broadcast on popular stations at least 10 times/day reaching all study districts. In two districts, community health workers (CHW) trained in UNICEF's Care for Child Development package and used ECD videos in home- and facility-based sessions with caregivers. Five outcomes were used to assess the intervention effects: ECD knowledge, early stimulation, father engagement, responsive care, and environment safety. Additionally the effect of the training and video job aids on the quality of CHWs' counseling support was evaluated primarily using structured observation checklists of household visits and facility group counseling sessions with caregivers and their children. Qualitative data was collected from a subset of caregivers and CHW participating in the study to assess acceptability and other perceptions of the project.
Detailed description
Standardized interventions aimed at supporting child development are successful in a variety of cultural and socio-economic contexts, particularly in low to middle income countries. Integrated community and facility-based interventions can improve parenting behaviors. Mass media radio messaging campaigns can increase caregiver and community knowledge, and caregiver motivation to seek appropriate health care through reaching a broader audience such as family/household influencers such as fathers or grandparents.
Study design and setting:
This was a two-arm quasi-experimental pre-post evaluation study, comparing different 9-month intervention packages to establish their relative impact on parenting skills and environment among a cohort of caregivers of children under age three years in Tabora region, located in central-western Tanzania and home to a predominantly rural (87%) population. The study included four districts divided into two intervention groups. The first group (Kaliua, Uyui districts) was exposed to the minimal intervention package, composed of radio messaging (RM) only. The second group (Nzega, Igunga districts) was exposed to the Malezi II full intervention package, composed of radio messaging, the introduction of short video job aids primarily for community health worker (CHW) use, and the UNICEF Care for Childhood Development (CCD) program (RMV-ECD).
Sample and sampling procedures:
As the comprehensive program intervention was primarily delivered by CHW who were affiliated with health facilities, 31 health facilities were purposefully selected located in 29 administrative units called wards (6-8/district). From these wards, 75 National Bureau of Statistics census enumeration areas (EA) were randomly sampled proportional to population size. The study team aimed to enumerate all households in sampled EAs, listing potentially eligible households if there was a resident adult (>18 years) primary caregiver of a child aged 0-24 months who intended to remain in the same area for at least one year, and was willing to be home-visited by a CHW. From these listed households, only one caregiver per household was recruited. Caregivers who were not able to provide written informed consent due to a cognitive impairment or language barrier; or who were the primary caregiver of an index child with a congenital anomaly or other disability; or who worked as a CHW or medical provider, were excluded from the study.
The study team estimated that a completed sample size of 430 caregivers per intervention group would provide 90% power to detect a 15% difference between the RM and RMV-ECD intervention groups at endline, and >80% power to detect at least a 5% change in each t intervention group between baseline and endline, at a 5% significance level. Of 8880 households enumerated, 1248 caregivers were recruited into the study and interviewed at baseline (October-December 2019). Of these, 1051 were eligible for follow-up; 1004 (96%) were successfully traced and interviewed at endline (January-March 2021). Almost all (n=985; 98%) caregivers interviewed at endline remained the primary caregiver of the index child from baseline. Of the 19 caregivers whose index child had died or moved from the household, eight nominated an eligible "replacement" child under three years and 11 completed a partial interview skipping questions that were no longer applicable.
A cohort of 120 CHWs was also enrolled from the two intervention districts, who were assigned to caregiver-cohort enrolled households in the RMV-ECD arm.
Data collection and study variables Structured questionnaires were administered in a private place in or near the consenting caregiver's home in the national language (Swahili). Five outcome variables were defined reflecting caregiver knowledge, stimulation practices, father engagement, responsive care, and household environment risk. Continuous scores for each variable were dichotomized at the median for analysis. Some scores, where the number of items differed by age of the child (early stimulation) or sub-group (environment risk), were standardized to a 0-1 scale by dividing the raw score by the number of items. The quality of CHWs counseling support was evaluated using a structured evaluation checklist, targeting two home and two clinic observations for each CHW in each round; pre and post intervention. The checklist had 23 items across 6 dimensions; introduce, educate, ask, plan/problem solve, interact/encourage, and responsive care. Under the qualitative process evaluation, 25 in-depth interviews (IDI) were completed with caregivers enrolled in the cohort, and four focus group discussions (FGD) were held among those in the CHW cohort.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radio messaging (RM) | No intervention | –Radio messaging only (RM) |
| RM, Video job aids, Early Childhood Development program (RMV-ECD) | Active comparator | Behavioral: RMV-ECDRadio messaging, short video job aids primarily for CHW use, and the UNICEF Care for Childhood Development program (RMV-ECD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- resident adult (>18 years) primary caregiver of a child aged 0-24 months, and had the
- intention to remain in the same area for at least one year,
- willingness to be home-visited by a Community Health Worker.
Key exclusion criteria (5 listed)
- unable or unwilling to give informed consent
- assigned to a Malezi II study health facility/catchment community
- working as a Malezi II project CHW (i.e. attended Malezi (I or II) training, or capacitated for Malezi II project through on-job training and mentoring)
- able to understand and willing to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RMV-ECDCombined radio messaging, video job aids (primarily for CHWs), Care for Childhood Development package | Behavioural | RM, Video job aids, Early Childhood Development program (RMV-ECD) |
Primary outcome
Caregiver age appropriate early childhood development knowledge as assessed by responses to interview-administered questions
Time frame: 9 months
Proportion of respondents scoring <2 (poor knowledge) or 2-6 (good knowledge) to six questions (scoring 0-6 points) asking the caregiver to describe one specific way that a "caregiver can support a child's mental, emotional or physical development…" during pregnancy, from birth to six months, from 6-9, 9-12, and 12-24 months and 2-5 years of age. Caregiver responses coded correct or incorrect.
Caregiver early childhood stimulation practices as assessed by responses to interview-administered questions adapted from UNICEF's Multiple Indicator Cluster Surveys
Time frame: 9 months
Proportion of respondents scoring poor (<50%) or good (equal or >50%) to questions on stimulation. Caregivers of children under seven months could score up to three points for reporting that the mother, father, or other adult engaged the child in singing songs, taking the child outside, or playing with the child in the past week. Caregivers of children over seven months were asked three additional items (read books, told stories, name/count things with child) for a total of six points. The sum of the items for these two measures were then standardized to a 0-1 scale.
Father engagement with the child as assessed by caregiver responses to interview-administered questions adapted from UNICEF's Multiple Indicator Cluster Surveys
Time frame: 9 months
Proportion of respondents scoring <2 (poor engagement) or 2-6 (good engagement) to questions on father engagement. Caregivers of children under seven months could score up to three points for reporting that the father engaged the child in singing songs, taking the child outside, or playing with the child in the past week. Caregivers of children over seven months were asked three additional items (read books, told stories, name/count things with child) for a total of six points. The sum of the items for these two measures were then standardized to a 0-1 scale.
Responsive care as assessed by interviewer observations of how the caregiver engaged with the child during the interview using questions from the interview guide
Time frame: 9 months
Proportion of respondents scoring <5 (poor responsive care) or 5-6 (good responsive care) by observed by interviewers of how the caregiver engaged with the child during the interview. Observations consisted of four items totaling up to six points which included helping the child keep busy (0, 1), pointing out objects/naming things (scored as 0, 1), recognizing when the child needs help with something (0,1,2), and keeping the child in view at all times (0,1,2).
Household environment risk as assessed by interviewer observation of the inner and outer household areas using questions from interview guide
Time frame: 9 months
Proportion of respondent households scoring equal or <0.3 (poor) or >0.3 (good) to interviewer observations of household and neighborhood environment safety from risks of community (nearby road, bar/market, ditches); outside compound (open water source, unpenned animals, accessible sharp tools, chemicals or flammable materials, and unprotected cooking area); and inside household (accessible electric, medicine or cleaning chemicals, inappropriate toys). The environment risk outcome was standardized (0-1) to adjust for the different number of items in each group.
Quality of CHWs counseling assessed by independent observations of home and clinic counseling sessions against a checklist
Time frame: 12-18 months
Proportion of CHWs scoring <15 or (poor) equal or >16 (good) on quality of home and clinic counseling at baseline and endline from video observations based on a 23-item checklist assessing how CHW 1) introduce topic/session, 2) educate on appropriate activities, 3) ask caregivers about behaviors, 4) plan and problem-solve, 5) interact with and encourage caregivers, and 6) discuss responsive care. Items with yes" or "no" response options were scored as "1" or "0", and items with "well done," "partly" or "not done" responses were scored "1," "0.5" or "0" points, respectively. Raw scores were then standardized to a 0-1 scale. Clinic and home observations scored separately and subsequently combined for an overall score.
1 secondary outcome
Acceptability of ECD intervention activities as assessed through open-ended responses recorded in in-depth interviews with caregivers and focus group discussions with CHW.
Time frame: 9-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 36600280Antelman G, Ferla J, Gill MM, Hoffman HJ, Komba T, Abubakar A, Remes P, Jahanpour O, Mariki M, Mang'enya MA, van de Ven R. Effectiveness of an integrated multilevel early child development intervention on caregiver knowledge and behavior: a quasi-experimental evaluation of the Malezi program in Tanzania. BMC Public Health. 2023 Jan 4;23(1):19. doi: 10.1186/s12889-022-14956-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RMV-ECD in people with Child Development and Father-Child Relations, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 4 Mar 2022. 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 Tanzania. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Caregiver age appropriate early childhood development knowledge as assessed by responses to interview-administered questions (time frame: 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244161, which also lists 1 linked publication.
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 4 Mar 2022.