Documentation:An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: Study Protocol for the Insika Yomama Cluster Randomised Controlled Trial
DDI.InsikaYomama.COVID.19.QualitativeDataset
Cecilia Ambrosius Hoegfeldt
Alan Stein
Sweetness H Dube
Africa Health Research Institute
Nesstar Publisher
An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: Study Protocol for the Insika Yomama Cluster Randomised Controlled Trial
AHRI.InsikaYomama.COVID.19.QualitativeDataset
Tamsen Rochat
Alan Stein
Samukelisiwe Dube
Kobus Herbst
Cecilia A. Hoegfeldt
Stephanie Redinger
Thandeka Khoza
Ruth Margret Bland
Linda Richter
Louise Linsell
Chris Desmond
Aisha K. Yousafzai
Michelle Craske
Ed Juszczak
Melanie Abas
Taygen Edwards
David Ekers
Joint Global Health Trials (MRC(UK)/DFID/Wellcome)
Oxford Health Biomedical Research Centre (BRC)
Africa Health Research Insittute
Nesstar Publisher
v1.0.0
South Africa
The trial is being conducted at the Africa Health Research Institute (AHRI) Somkhele Research Campus in rural Northern KwaZulu-Natal, South Africa, within AHRI's Population Intervention Platform demographic surveillance area. The study area covers 845km2 and the community is predominantly rural but contains an urban township and informal peri-urban settlements (54,55). The resident population is approximately 100,000 people (~20,000 households) of which the majority are isiZulu-speaking. The area includes one district-level hospital and 17 primary healthcare facilities. The unit of randomisation is the cluster using the geospatial location of the participant's home. There are approximately 300 neighbourhoods in the region included in this trial; these are defined by geographical area as well as population density so that they are equivalent in terms of sample size. The distinct neighbourhoods have been merged into 48-60 clusters to ensure comparable clusters in terms of key indicators, including population size.
Multiple records (assessments at different time points) for each study participant (n = 320).
Survey data, clinical data, psychological test data, program sourcce codes, observation data, textual data.
The first primary outcome is the cognitive subscale on the BSID-III at 24 months of age. To achieve a power of over 90% (two-sided t-test with a significance level of 0.05), and assuming an estimated difference of 6 points (SD 15), a total sample size of 396 women (198 per arm) is required. This calculation takes into account geospatial clustering (28 clusters per arm with an intra-cluster correlation coefficient (ICC) of 0.05) and 'counsellor effect' in the intervention arm (4 lay counsellors with an ICC of 0.05). To take account of attrition of up to 25% a total sample size of 528 women is being recruited (264 per arm, 48-60 geospatial clusters, 9-11 women per cluster). Using the EPDS assessment with a standard deviation of 5, with the same assumptions of clustering as above, a difference of 2 points between trial arms (not adjusting for baseline or repeated measurements) could be detected with 90% power and a 5% two-sided significance level. Analysis using repeated measures, taking into account within-participant correlation over time, would allow smaller differences to be detected with the same power.
Access to the data requires accurate completion of the online data access application form accessible on the AHRI Data repository(<https://data.ahri.org/>). Data users are required to abide by the data use conditions stipulated on the application for access to the data. Failure to do so may result in their data access privileges being revoked by the Data Custodian. In order to recognise the effort and intellectual contributions of AHRI investigators in producing and curating the data, users of AHRI data must acknowledge the source of the data and abide by the terms and conditions under which the data is accessed and must cite the dataset in publication using the citation provided as part of this documentation. All analytical datasets published on the AHRI Data Repository are assigned digital object identifier (DOIs) and the DOIs can be found on the Data Repository under Study Description tab - Access policy. AHRI data users are required to always cite the dataset using the relevant DOI.
AHRI.InsikaYomama.COVID_19.QualitativeDataset.NSDstat
20
98
Nesstar 200801
Participant Screening Identifier
20
0
1352
5897
4511.3
1403.623
Session Number
20
0
1
1
0
2
2
0
3
3
0
4
4
0
5
5
0
6
6
0
7
7
0
8
8
0
9
9
1
10
10
0
11
11
19
Therapy sessions in total at interview
6
14
Telephonic Therapy sessions in total at interview
6
14
In-Person Therapy sessions in total at interview
6
14
Does the participant consent to having this call audio-recording for the purpose
18
2
0
No
0
1
Yes
18
Sysmiss
2
Date of Interview
18
2021-05-03
2021-08-25
Has the consent form been successfully explained?
18
2
0
No
0
1
Yes
18
Sysmiss
2
Fill in for the participant "I agree to take part in the interview"
18
2
0
No
0
1
Yes
18
Sysmiss
2
Fill in for the participant "I consent to being audio-recorded"
18
2
0
No
0
1
Yes
18
Sysmiss
2
Date of Interview
20
2021-05-06
2021-09-01
Did the participant consent to have the interview audio-recorded?
18
2
0
No
0
1
Yes
18
Sysmiss
2
Select participant mood rating (out of 10)
17
3
1
0
0
2
1
1
3
2
0
4
3
0
5
4
0
6
5
5
7
6
0
8
7
1
9
8
3
10
9
1
11
10
6
Sysmiss
3
On a scale from 1 to 5, how good did you think the telephonic therapy was? (5 be
17
3
0
1 - Not very good
2
1
2 - Not so good
0
2
3 - OK
7
3
4 - Good
0
4
5 - Very good
8
Sysmiss
3
On a scale from 1 to 5, how did telephonic therapy make you feel? (5 being makin
17
3
0
1 - Not very good
1
1
2 - Not so good
1
2
3 - OK
5
3
4 - Good
1
4
5 - Very good
9
Sysmiss
3
On a scale from 1 to 5, how much would you recommend the therapy package to a fr
17
3
0
1 - Not very likely to recommend
3
1
2 - Not so likely to recommend
0
2
3 - OK likely to recommend
2
3
4 - Likely to recommend
3
4
5 - Very likely to recommend
9
Sysmiss
3
Select participant mood rating (out of 10)
17
3
1
0
1
2
1
0
3
2
0
4
3
1
5
4
0
6
5
0
7
6
0
8
7
2
9
8
1
10
9
2
11
10
10
Sysmiss
3
On a scale from 1 to 5, how good did you think the telephonic therapy was? (5 be
17
3
0
1 - Not very good
0
1
2 - Not so good
0
2
3 - OK
3
3
4 - Good
1
4
5 - Very good
13
Sysmiss
3
On a scale from 1 to 5, how did telephonic therapy make you feel? (5 being makin
17
3
0
1 - Not very good
1
1
2 - Not so good
0
2
3 - OK
2
3
4 - Good
0
4
5 - Very good
14
Sysmiss
3
On a scale from 1 to 5, how much would you recommend the therapy package to a fr
17
3
0
1 - Not very likely to recommend
3
1
2 - Not so likely to recommend
0
2
3 - OK likely to recommend
2
3
4 - Likely to recommend
0
4
5 - Very likely to recommend
12
Sysmiss
3
Was this transcript back-translated?
12
8
0
No
6
1
Yes
6
Sysmiss
8
Was this transcript checked by someone?
12
8
0
No
9
1
Yes
3
Sysmiss
8
Please delete the audio-recording from your laptop when you have finished the tr
12
8
0
No
4
1
Yes
8
Sysmiss
8
Enrolment Date
20
2019-02-26
2021-03-31
Date of Birth of the Mother
20
1980-05-05
1997-09-01
Date of Birth of Child
20
2019-06-26
2021-07-11
Total EPDS score
20
0
Total EPDS score
19
1
Total EPDS score
20
0
Total EPDS score
17
3
Total EPDS score
20
0
Clinic recruited from
20
0
1
KwaMsane
0
2
Somkhele
2
3
Hlabisa
0
4
Mtubatuba
4
5
Hlabisa (Gateway clinic)
1
6
Sipho Zungu (Khula)
1
7
Ezwenelisha
0
8
Nkundusi
3
9
Madwaleni
2
10
Mpukunyoni
4
11
Esiyembeni
0
12
Machibini
0
13
Gunjaneni
1
14
Ntondweni
0
15
Macabuzela
0
16
Makhowe
0
17
Inhlwathi
0
18
Mpembeni
1
19
Hluhluwe
1
Was this a planned pregnancy?
20
0
0
No
18
1
Yes
2
How many times have you been pregnant?
20
0
1
1
0
2
2
7
3
3
6
4
4
4
5
5
3
6
6
0
7
7
0
8
8 or more
0
How many living children do you have?
15
5
Are you currently on HIV treatment?
20
0
1
Yes
20
2
No
0
3
Don?t Know
0
Have there been days in the past 4 weeks where there has not been enough food fo
20
0
0
No
14
1
Yes
6
Have you been diagnosed with gestational diabetes in this pregnancy?
20
0
1
Yes
1
2
No
14
3
Don?t Know
5
Have you been diagnosed with anemia in this pregnancy?
20
0
1
Yes
5
2
No
15
3
Don?t Know
0
Have you been diagnosed with high blood pressure in this pregnancy?
20
0
1
Yes
3
2
No
17
3
Don?t Know
0
Since discovering you were pregnant, have you smoked?
20
0
0
No
18
1
Yes
2
Since you discovered you were pregnant, have you had any alcohol to drink?
20
0
0
No
17
1
Yes
3
Thinking about how to manage food with your current resources, have there been d
20
0
0
No
12
1
Yes
8
What is the highest educational level you have completed?
20
0
0
None
1
1
Some primary
0
2
Primary completed
1
3
Grade 10 (Standard 8)
10
4
Matriculation
7
5
Post-matriculation
1
Do you have paid employment?
20
0
0
No
15
1
Yes
5
If yes, is this employment:
5
15
1
Part-time
4
2
Full-time
1
Sysmiss
15
Who is the main provider of income for your household?
20
0
1
Mother (self)
6
2
Other family member
14
3
Non-family member
0
Does anyone in this household have access to a support grant?
20
0
1
Yes
19
2
No
1
3
Don?t Know
0
Does this household own a fridge?
20
0
0
No
17
1
Yes
3
How would this household classify its financial situation these days?
20
0
1
Very comfortable
0
2
Comfortable
1
3
Just getting by
12
4
Poor
5
5
Extremely poor
2
6
Don't know
0
7
Refused
0
During the last 6 months have you or your family had too little money for basics
20
0
1
Yes
12
2
No
8
3
Don?t Know
0
If you had a really big problem and needed help with, for example money, the chi
20
0
1
Nobody
12
2
Maybe/unsure
5
3
A number of people
3
Do you have a confidante, someone you can talk to about almost anything?
20
0
0
No
5
1
Yes
15
Have you experienced any negative life events in the last year (bereavement, acc
20
0
0
No
11
1
Yes
9
Your family get on well together
20
0
1
Strongly agree
5
2
Agree
10
3
Disagree
0
4
Strongly Disagree
5
That your family have frequent conflicts
20
0
1
Strongly agree
3
2
Agree
9
3
Disagree
5
4
Strongly Disagree
3
That your family often resolve conflict by talking about the problem?
20
0
1
Strongly agree
6
2
Agree
11
3
Disagree
1
4
Strongly Disagree
2
That your family try to find solutions that are acceptable to all of you
20
0
1
Strongly agree
5
2
Agree
9
3
Disagree
4
4
Strongly Disagree
2
That your current family makes your life harder?
20
0
1
Strongly agree
5
2
Agree
5
3
Disagree
8
4
Strongly Disagree
2
What best describes your current relationship?
20
0
1
Not in a relationship
2
2
In relationship with father of the baby
18
3
In relationship with new partner
0
Is the father of the baby supportive of the pregnancy?
2
18
1
Yes
0
2
No
2
3
Don?t Know
0
Sysmiss
18
Does the father of the baby contribute financially?
2
18
1
Yes
0
2
No
2
3
Don?t Know
0
Sysmiss
18
Have you disclosed your HIV status to the father of the baby?
2
18
0
No
0
1
Yes
2
Sysmiss
18
Baseline GAD Total
20
0
Form completion date
19
2020-07-01
2022-07-27
Visit
4
16
1
12 Month
4
2
24 Month
0
Sysmiss
16
What is the date of birth for your child
19
2019-06-26
2021-07-11
Is it correct your enrolled child is these many months old?
19
1
Has the care you have received helped you with your mood/depression?
19
1
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
1
4
Improved quite a lot
1
5
Improved a great deal
17
Sysmiss
1
Has the care you have received helped you feel better about yourself (increased
19
1
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
1
5
Improved a great deal
18
Sysmiss
1
Has the care you have received helped you with practical issues (for example, co
19
1
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
1
4
Improved quite a lot
1
5
Improved a great deal
17
Sysmiss
1
Has the care you have received helped you with your relationship with your baby?
19
1
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
1
5
Improved a great deal
18
Sysmiss
1
Has the care you have received helped you know what you could do to help your ba
19
1
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
1
4
Improved quite a lot
0
5
Improved a great deal
18
Sysmiss
1
Has care you have received helped you with understanding your baby's communicati
19
1
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
1
4
Improved quite a lot
1
5
Improved a great deal
17
Sysmiss
1
Has the care you have received helped you with being able to feel relaxed?
19
1
1
No, it has made it worse
0
2
No difference
1
3
Improved a bit
1
4
Improved quite a lot
4
5
Improved a great deal
13
Sysmiss
1
Has the care you have received helped you cope with stressful situations?
19
1
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
1
4
Improved quite a lot
3
5
Improved a great deal
15
Sysmiss
1
Do you have a partner?
19
1
0
No
5
1
Yes
14
Sysmiss
1
Has the care you have received helped you with your relationship with your partn
14
6
1
No, it has made it worse
0
2
No difference
1
3
Improved a bit
1
4
Improved quite a lot
0
5
Improved a great deal
12
Sysmiss
6
Has the care you have received helped you with your relationship with other peop
19
1
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
4
5
Improved a great deal
15
Sysmiss
1
AE or SAE reported during session?
19
1
0
No
19
1
Yes
0
Sysmiss
1
If yes, please describe
0
0
Form completion date
1
2022-07-27
2022-07-27
Visit
0
20
1
12 Month
0
2
24 Month
0
Sysmiss
20
What is the date of birth for your child (enrolled child)?
1
2021-02-12
2021-02-12
Is it correct your enrolled child is these many months old?
1
19
Has the care you have received helped you with your mood/depression?
1
19
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
0
5
Improved a great deal
1
Sysmiss
19
Has the care you have received helped you feel better about yourself (increased
1
19
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
0
5
Improved a great deal
1
Sysmiss
19
Has the care you have received helped you with practical issues (for example, co
1
19
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
0
5
Improved a great deal
1
Sysmiss
19
Has the care you have received helped you with your relationship with your baby?
1
19
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
0
5
Improved a great deal
1
Sysmiss
19
Has the care you have received helped you know what you could do to help your ba
1
19
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
0
5
Improved a great deal
1
Sysmiss
19
Has care you have received helped you with understanding your baby's communicati
1
19
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
0
5
Improved a great deal
1
Sysmiss
19
Has the care you have received helped you with being able to feel relaxed?
1
19
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
0
5
Improved a great deal
1
Sysmiss
19
Has the care you have received helped you cope with stressful situations?
1
19
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
0
5
Improved a great deal
1
Sysmiss
19
Do you have a partner?
1
19
0
No
0
1
Yes
1
Sysmiss
19
Has the care you have received helped you with your relationship with your partn
0
20
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
0
5
Improved a great deal
0
Sysmiss
20
Has the care you have received helped you with your relationship with other peop
1
19
1
No, it has made it worse
0
2
No difference
0
3
Improved a bit
0
4
Improved quite a lot
0
5
Improved a great deal
1
Sysmiss
19
AE or SAE reported during session?
1
19
0
No
1
1
Yes
0
Sysmiss
19
If yes, please describe
0
0