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

South Africa, 2018 - 2023

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AHRI.Insika.Yomama.dataset

Producer(s)

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

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Created on

Apr 10, 2026

Last modified

Apr 13, 2026

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119

Data file: AHRI.InsikaYomama.AssessmentWithoutVaccine.20241117

Cases:	320
Variables:	1246

Variables

Id

Individual Identifier

prescreen_fcd

Form Completion Date

contact_clinic

Clinic recruited from:

prescreen_dob

What is your date of birth?

prescreen_age

Could you tell me your age?

prescreen_agecat

If between 16 and 17 years of age: Would you agree for your parent or guardian t

prescreen_gest_age

You were referred to us by the nurse because you are pregnant. How far along are

prescreen_due_date

When is your due date?

prescreen_anc_visit

When is your next antenatal appointment?

prescreen_gest_contact

If < 23 weeks: It is a little early in your pregnancy to be screened for this st

prescreen_screen

If between >=23 and <=33 weeks: You are eligible to be screened to participate i

prescreen_hiv_status

As part of your screening we need you to confirm your HIV status

prescreen_hivstatus

Are you on HIV treatment?

elig_form_comp_date

Form Completion Date

eligibility_study_boundary

Participant lives in study boundary area?

eligibility_live_dsa

Do you plan to live with your baby in the study area for at least 9 months after

eligibility_illness

During this pregnancy, have you been diagnosed with a serious illness? (Note to

eligibility_disabilities

Do you have any disabilities?

eligibility_excl2

Is this an illness or disability that prevents the person from participating in

eligibility_disability_type___1

eligibility_disability_type___2

eligibility_disability_type___3

Hearing problem

eligibility_disability_type___4

eligibility_disability_type___5

eligibility_disability_type___6

eligibility_disability_other

If other, please describe

eligibility_psych_treatment

Are you currently receiving a psychological treatment from a psychologist or psy

eligibility_psych_therapy

If yes, can you describe the type of treatment?

elig_symp

Have you ever been hospitalised for more than 3 days for a serious mental disord

elig_psych_hospital

If yes, do you know what you received treatment for while in hospital? Was it fo

sa

Have you ever been diagnosed with a substance or alcohol use disorder?

remission

If yes, is this current/remission?

screeningerollment_date

Form Completion Date

screen_gestation

How many weeks pregnant are you?

enrollment_due_date

When is your due date?

screening_hiv_treatment

Are you on HIV treatment?

screening_suicidal

You stated on item on the EPDS that the thought of harming yourself has occurred

suicidal_today

Do you feel this way today?

suicidal_plans

Have you thought about how you might go about harming yourself or have you made

screen_eligible_yes_no

Screened eligible

epds_1_final_screening

Have you been able to laugh and see the funny side of things - how does this com

epds_2_final_screening

Have you been able to look forward to things with enjoyment - how does this comp

epds_3_final_screening

Have you been feeling guilty about things that you have done?

epds_4_final_screening

Have you been anxious or worried for no good reason?

epds_5_final_screening

Have you been feeling scared or panicky for no good reason?

epds_6_final_screening

Have you been feeling that things were getting on top of you?

epds_7_final_screening

Have you been so unhappy that you have been having difficulty sleeping?

epds_8_final_screening

Have you been feeling sad or miserable?

epds_9_final_screening

Have you been so unhappy that you have been crying?

epds_10_final_screening

Has the thought of harming yourself occurred to you?

epds_total_final_screening

Total EPDS score

enrolment_date

Form completion date:

assesment_setting

Is this assessment done

assesment_session

Is this assessment session done

assesment_session_o

Please explain where the assessment was done

enrolment_in_area

Homestead in study boundary area:

enroll_consent

Does the participant still consent to take part in the study?

enroll_enrolled

enrolment_changes_reason

Reason for making changes

bq_completiondate

Form Completion Date

bq_assesment_setting

Is this assessment done

bq_assesment_session

Is this assessment session done

bq_assesment_session_o

Please explain where the assessment was done

confirm_hivtreatment

Are you currently on HIV treatment?

prev_pregnancies_no_final

Gravida/Previous pregnancies - How many times have the mother been pregnant befo

primagravida_final

Gravida - Is this the first time the mother is ever pregnant (regardless of the

previous_non_live_births

Previous miscarriages/stillbirth - how many times did the previous pregnancies (

living_children_no_final

Living children - how many living children does this mother have?

parity_final

Nulliparous or Multiparous - has the mother ever delivered a live baby before?

baseline_anc_visit

How many antenatal visits have you had during this pregnancy?

planned_pregnancy

Was this a planned pregnancy?

confirm_gestatation

At the last interview you said that you were [screen_gestation] weeks pregnant.

baseline_duedate_change

The last time we spoke you said that your due date was [enrollment_due_date], ha

baseline_new_duedate

If yes, when is your new due date?

comorbidities_diabetes

Have you been diagnosed with gestational diabetes in this pregnancy?

comorbid_anemia

Have you been diagnosed with anemia in this pregnancy?

comorbid_preeclampsia

Have you been diagnosed with high blood pressure in this pregnancy?

baseline_smoked

Since discovering you were pregnant, have you smoked?

baseline_alcohol1

Since you discovered you were pregnant, have you had any alcohol to drink?

baseline_alcohol

If yes, on average, how many units of alcohol per week have you had?

baseline_traditional

Do you intend to use traditional medicines either during this pregnancy or once

baseline_trad_meds

If yes, do you intend to use:

prior_feed

Skip if woman has no previous children) Did you breastfeed any of your children?

feed_intent

What milk do you intend to give your new baby during the first 4 weeks?

feed_months

If you plan to breastfeed only, for how long do you intend to exclusively breast

feed_discuss

Have you discussed your feeding intention decision with anyone?

feed_who

feed_dec

Is there anyone in your household who disagrees with your decision to feed your

feed_support

Is there anyone at home who will be able to support you with feeding your baby?

food_you

Thinking about how to manage food with your current resources, have there been d

baseline_adult_wk

If yes, does this happen every week?

baseline_child_food

Have there been days in the past 4 weeks where there has not been enough food fo

baseline_child_wk

If yes, does this happen every week?

baseline_mother_ed

What is the highest educational level you have completed?

baseline_paid_empl

Do you have paid employment?

baseline_full_part

If yes, is this employment:

baseline_who_income

Who is the main provider of income for your household?

income_type

Does anyone in this household have access to a support grant?

baseline_grant_type

If yes, is it a

baseline_fridge

Does this household own a fridge?

hh_finance

How would this household classify its financial situation these days?

baseline_debt_6m

During the last 6 months, have you found that you are in so much debt that you d

baseline_money

During the last 6 months have you or your family had too little money for basics

baseline_support

If you had a really big problem and needed help with, for example money, the chi

baseline_confidante_y_n

Do you have a confidante, someone you can talk to about almost anything?

baseline_confidante_who

If yes, what is the relationship of this person to you?

baseline_living

How would you describe your current family situation?

baseline_gend_head

What is the gender of the head of the household?

baseline_res_hh

How many residents are there in this household?

baseline_res_adults_2

How many resident adults (i.e .>18 years) are there in this household?

baseline_res_adolescents

How many resident adolescents (i.e. 11 to 18 years) are there in this household?

baseline_res_child

How many resident children (i.e. 0 to 10 years) are there in this household?

baseline_crim_past12m

Has anyone in this family been a victim of crime in the last 12 months?

baseline_life_events

Have you experienced any negative life events in the last year (bereavement, acc

baseline_famtogether

Your family get on well together

baseline_freqconflicts

That your family have frequent conflicts

baseline_resconflict

That your family often resolve conflict by talking about the problem?

baseline_accsolutions

That your family try to find solutions that are acceptable to all of you

baseline_lifeharder

That your current family makes your life harder?

baseline_relationship

What best describes your current relationship?

baseline_fath_supp

Is the father of the baby supportive of the pregnancy?

baseline_fath_fin

Does the father of the baby contribute financially?

baseline_fath_hiv

Do you know the father of the baby's HIV status?

baseline_fath_status

If yes, what is his HIV status?

baseline_fath_disc

Have you disclosed your HIV status to the father of the baby?

baseline_hiv_disclevel

If yes, what level of disclosure?

baseline_fath_live

Does the father of the baby live with you in this household?

baseline_fath_supp2

Is the father of the baby supportive of the pregnancy?

baseline_fath_fin2

Does the father of the baby contribute financially?

baseline_fath_hiv2

Do you know the father of the baby's HIV status?

baseline_fath_hivstatus

If yes, what is his HIV status?

baseline_fath_disc2

Have you disclosed your HIV status to the father of the baby?

baseline_hiv_disclevel2

If yes, what level of disclosure?

baseline_parttogether

You and your partner get on well together

baseline_partfreqconflict

That you and your partner have frequent conflicts?

baseline_partresconflict

That you both often resolve conflict by talking about the problem?

baseline_partaccsolution

That you try to find solutions that are acceptable to both of you?

baseline_partlifeharder

That your current partner makes your life harder?

basline_newpartlive

Does this new partner live with you in this household?

baseline_hiv_newpart

Do you know your new partner's HIV status?

baseline_newpartstatus

If yes, what is his HIV status?

baseline_newpartdiscl

Have you disclosed your HIV status to your new partner?

baseline_newpartdiscllevel

If yes, what level of disclosure?

baseline_parttogether2

You and your partner get on well together

baseline_partfreqconflict2

That you and your current partner have frequent conflicts?

baseline_partresconflict2

That you both often resolve conflict by talking about the problem?

baseline_partaccsolution2

That you try to find solutions that are acceptable to both of you?

baseline_partlifeharder2

That your current partner makes your life harder?

baseline_gad_1

Feeling nervous, anxious, or on edge

baseline_gad_2

Not being able to stop or control worrying

baseline_gad_3

Worrying too much about different things

baseline_gad_4

Trouble relaxing

baseline_gad_5

Being so restless that it's hard to sit still

baseline_gad_6

Becoming easily annoyed or irritable

baseline_gad_7

Feeling afraid as if something awful might happen

baseline_gad_difficult

If you checked off any problems, how difficult have these made it for you to do

baseline_rumination_1

How much do you think about how alone you feel?

baseline_rumination_2

How much do you think about your feelings of fatigue and achiness?

baseline_rumination_3

How much do you think about how sad you feel?

baseline_rumination_4

How much do you think about all your mistakes and failures?

baseline_rumination_5

How much do you think about how angry you are with yourself?

baseline_vf_task

Did the participant complete the baby voices and faces task on the tablet?

baseline_changes_reason

Reason for making changes

pa_completiondate

Form Completion Date

pregnancy_cs_date

pregnancy_covid_type

Staff member type:

pregnancy_enrol_bfr_lockdown

Was the participant enrolled before the lockdown (i.e. PID will be ranging from

pregnancy_notice

I would just like to find out how are you and the pregnancy going?

preg_assesment_setting

Is this assessment done

preg_assesment_session

Is this assessment session done

preg_assesment_session_o

Please explain where the assessment was done

pregnancy_confirm_hivtreatment

Are you currently on HIV treatment?

pregnancy_anc

How many antenatal visits have you been to during this pregnancy?

pregnancy_confirm_gestatation

At the last interview you said that you were [baseline_arm_1][confirm_gestatatio

pregnancy_due_date

The last time we spoke you said your due date was [baseline_arm_1][enrollment_du

pregnancy_duedate_new

If yes, when is your new due date?

pregnancy_comorbid_diabetes

Since I last saw you, have you been diagnosed with gestational diabetes?

pregnancy_comorbid_anemia

Since I last saw you, have you been diagnosed with anemia?

pregnancy_comorbid_preeclampsia

Since I last saw you, have you been diagnosed with pre-eclampsia or high blood p

pregnancy_smoked

Since I last saw you, have you smoked?

pregnancy_smoked_nu

If yes, can you tell me the maximum number of cigarettes you smoked on any one d

pregnancy_alcohol1

Since I last saw you, have you had any alcohol to drink?

pregnancy_alcohol

If yes, on average, how many units of alcohol per week have you had?

pregnancy_traditional

Since I last saw you, do you intend to use traditional medicines either during t

pregnancy_trad_meds

If yes, do you use

pregnancy_feed_change

Previously you said that you intended to feed your baby with [baseline_arm_1][fe

pregnancy_feed_intent

If no, what do you now intend to feed your new baby during the first 4 weeks?

pregnancy_feed_months

If you plan to breastfeed only, for how long do you intend to exclusively breast

pregnancy_feed_discuss

If feeding intentions have changed, have you discussed this with anyone?

pregnancy_feed_who

pregnancy_feed_dec

Is there anyone in your household who disagrees with your decision to feed your

pregnancy_feed_support

Is there anyone at home who will be able to support you with feeding your baby?

pregnancy_food_you

Thinking about how to manage food with your current resources, have there been d

pregnancy_adult_wk

If yes, does this happen every week?

pregnancy_child_food

Have there been days in the past 4 weeks where there has not been enough food fo

pregnancy_child_wk

If yes, does this happen every week?

pregnancy_living_changed

Previously you stated: [baseline_arm_1][baseline_living]. Has this situation cha

pregnancy_living

If yes, how would you describe your current family situation?

pregnancy_gend_head

What is the gender of the head of the household?

pregnancy_res_hh

How many residents are there in this household?

pregnancy_res_adults_2

How many resident adults (i.e .>18 years) are there in this household?

pregnancy_res_adolescents

How many resident adolescents (i.e. 11 to 18 years) are there in this household?

pregnancy_res_child

How many resident children (i.e. 0 to 10 years) are there in this household?

pregnancy_crim_past12m

Has anyone in this family been a victim of crime in the last 12 months?

pregnancy_life_events

Have you experienced any negative life events in the last year (bereavement, acc

pregnancy_fam_geton

Your family get on well together

pregnancy_rpcs_20

That your family have frequent conflicts

pregnancy_rpcs_adult_2

That your family often resolve conflict by talking about the problem?

pregnancy_rpcs_adult_1

That your family try to find solutions that are acceptable to all of you?

pregnancy_s1000_fam

That your current family makes your life harder?

pregnancy_relationship_changed

Previously you said that you were [baseline_relationship]. Has your partnership

pregnancy_relationship

If yes, what best describes your the change?

preg_part_live

Does this new partner live with you in this household?

preg_part_hiv

Do you know your new partner's HIV status?

preg_new_part_status

If yes, what is his HIV status?

preg_part_discl

Have you disclosed your HIV status to your new partner?

preg_part_level_disclosure

If yes, what level of disclosure?

preg_part_geton

You and your partner get on well together

preg_part_conflict

That you and your current partner have frequent conflicts?

preg_part_resolve_conflict

That you both often resolve conflict by talking about the problem?

preg_part_solutions

That you try to find solutions that are acceptable to both of you?

preg_part_life_harder

That your current partner makes your life harder?

preg_father_live

Does the father of the baby live with you in this household?

preg_father_supp

Is the father of the baby supportive of the pregnancy?

preg_father_financ

Does the father of the baby contribute financially?

preg_father_hiv_stat

Do you know the father of the baby's HIV status?

preg_father_hiv_status

If yes, what is his HIV status?

preg_father_disc

Have you disclosed your HIV status to the father of the baby?

preg_father_disc_type

If yes, what level of disclosure?

preg_father_geton

You and your partner get on well together

preg_father_conflict

That you and your partner have frequent conflicts?

preg_father_resolve

That you both often resolve conflict by talking about the problem?

preg_father_solutions

That you try to find solutions that are acceptable to both of you?

preg_father_life_harder

That your current partner makes your life harder?

pregnancy_fath_supp

Even though you are no longer together, is the father of the baby supportive of

pregnancy_fath_fin

Even though you are no longer together, does the father of the baby contribute f

pregnancy_fath_hiv

At the previous assessment, you mentioned that you did not know the father of yo

pregnancy_fath_hiv2

If yes, what is his HIV status?

pregnancy_fath_disc

At the last assessment, you mentioned that you had not disclosed your HIV status

pregnancy_hiv_disc

If yes, what level of disclosure?

pregnancy_fath_disc_4

At the last assessment, you mentioned that you had partially disclosed your HIV

pregnancy_epds_1

Have you been able to laugh and see the funny side of things - how does this com

pregnancy_epds_2

Have you been able to look forward to things with enjoyment - how does this comp

pregnancy_epds_3

Have you been feeling guilty about things that you have done?

pregnancy_epds_4

Have you been anxious or worried for no good reason?

pregnancy_epds_5

Have you been feeling scared or panicky for no good reason?

pregnancy_epds_6

Have you been feeling that things were getting on top of you?

pregnancy_epds_7

Have you been so unhappy that you have been having difficulty sleeping?

pregnancy_epds_8

Have you been feeling sad or miserable?

pregnancy_epds_9

Have you been so unhappy that you have been crying?

pregnancy_epds_10

Has the thought of harming yourself occurred to you?

pregnancy_suicidal

You stated on item on the EPDS that the thought of harming yourself has occurred

pregnancy_suicidal_today

Do you feel this way today?

pregnancy_suicidal_plans

Have you thought about how you might go about harming yourself or have you made

pregnancy_gad_1

Feeling nervous, anxious, or on edge

pregnancy_gad_2

Not being able to stop or control worrying

pregnancy_gad_3

Worrying too much about different things

pregnancy_gad_4

Trouble relaxing

pregnancy_gad_5

Being so restless that it's hard to sit still

pregnancy_gad_6

Becoming easily annoyed or irritable

pregnancy_gad_7

Feeling afraid as if something awful might happen

pregnancy_gad_diff

If you checked off any problems, how difficult have these made it for you to do

pregnancy_rumination_1

How much do you think about how alone you feel

pregnancy_rumination_2

How much do you think about your feelings of fatigue and achiness?

pregnancy_rumination_3

How much do you think about how sad you feel?

pregnancy_rumination_4

How much do you think about all your mistakes and failures?

pregnancy_rumination_5

How much do you think about how angry you are with yourself?

pregnancy_unblinded

I became unblinded

pregnancy_changes_reason

Reason for making changes

psds_completion_date

Form Completion Date

post_6d_assesment_setting

Is this assessment done

post_6d_assesment_session

Is this assessment session done

post_6d_assesment_session_o

Please explain where the assessment was done

post_6d_1

Can you confirm that you delivered your baby?

post_6day_early_delivery

If delivered baby, say: Congratulations on the birth of your baby. May I ask w

day_child_mortality

If the child has passed away, please follow SAE protocol.

day_gender

What is the gender of your baby?

post_6d_birth_comp

If baby has been born, were there any complications during delivery:

day_neonatal

Did your baby stay overnight in the neonatal (nursary) unit?

day_neonatal_time

If yes, for how many nights?

day_feeding

How is your baby being fed?

post_6d_9

Did you get a Road to Health Card for your baby?

day_ever_breastfed

Did you ever breastfeed?

day_ebf_stop

How long did you give your baby breastmilk ONLY when feeding?

day_ebf_other_period

If other period, how long did the mother exclusively breastfeed for (specify num

day_breastfeed_stop

How old was your child when you stopped breastfeeding completely? (This includes

post_6d_still_number

Has your contact number changed?

post_6d_address_confirm

We will be visiting you at home when your baby is 3 months old. Do you still pla

post_6d_blind

I became unblinded

post_6d_changes_reason

Reason for making changes

ptwa_completion_date

Form Completion Date

post_12w_assesment_setting

Is this assessment done

post_12w_assesment_session

Is this assessment session done

post_12w_assesment_session_o

Please explain where the assessment was done

wk_fieldworker_note

For fieldworker: Note whether baby is alive

wk_delivery_date

I would just like to confirm that the date of delivery of your baby was [enrollm

wk_birth_date

If no, on what date was your baby born?

wk_type_birth

How was your baby born?

post_12w_confirm_residence

I am visiting you here today because you previously told us that this is your pr

child_dob_final

Child dob final

Total: 1246

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