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

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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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Apr 10, 2026

Last modified

Apr 13, 2026

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Data file: AHRI.InsikaYomama.AssessmentWithoutVaccine.20241117

Cases:	320
Variables:	1246

Variables

wk_twin

Is the infant a twin?

wk_disability_birth

Is there any disability (including birth defects)?

weight_12w_missing

Birth weight missing ?

birth_weight_final

Birth weight final

length_12w_missing

Birth length missing ?

birth_length_final

Birth length final

headcircum_12w_missing

Head circumference at birth missing ?

birth_circum_final

Birth head circumference

gestational_age_delivery_final

Gestational age at delivery in weeks

rthc_46

Did the mother receive infant feeding counselling at birth?

post_12w_breastmilk

Have you ever given breastmilk to your child?

post_12w_ever_breastfed

Did you ever breastfeed?

post_12w_milk_only

Skip this section if the mother did not breastfeed her baby: For how long did yo

post_12w_ebf_stop

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

post_12w_breastfeed_stop

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

post_12w_still_bm

Are you still giving breastmilk to your child?

post_12w_age_stop_bm

If no, when did you stop breastfeeding altogether?

post_12w_confirm_hivtreatment

Are you currently on HIV treatment?

post_12w_maternal_hosp

Since the birth of your baby, have you been hospitalised overnight?

post_12w_maternal_hosp_times

If yes, how many times have you been hospitalised?

post_12w_maternal_hosp_date

Date of hospitalisation

post_12w_maternal_hosp_length

wk_episode2_date

Date of hospitalisation

wk_episode2_diag

wk_episode2_length

wk_episode3_date

Date of hospitalisation

wk_episode3_diag

wk_episode3_length

wk_episode4_date

Date of hospitalisation

wk_episode4_diag

wk_episode4_length

wk_hiv_pcr

Was the HIV PCR test done?

wk_pcr_when

wk_pcr_result

If the result is available, is the PCR negative or positive?

wk_cotrimoxazole

If the baby tested positive, has cotrimoxazole started?

wk_nevirapine

Has your baby received nevirapine?

wk_other_med

If your baby is PCR positive, is he/she receiving any other medication?

wk_infant_feeding

Infant feeding discussed at 6 weeks?

post_12w_diarrhoea

wk_diar_days

If yes, many days of diarrhoea did your child have over the past 14 days?

wk_hosp_baby

Since your baby was born, has he/she ever been hospitalised overnight?

wk_hosp_times

If yes, how many times has he/she been hospitalised?

wk_hosp1_reason

Reason for hospitalisation

post_12w_baby_hosp_date

Date of hospitalisation

post_12w_baby_hosp_length

wk_hosp2_reason

Reason for hospitalisation

wk_hosp2_other

If other, please specify

wk_hosp2_date

Date of hospitalisation

wk_hosp2_length

wk_hosp3_reason

Reason for hospitalisation

wk_hosp3_other

If other, please specify

wk_hosp3_date

Date of hospitalisation

wk_hosp3_length

wk_hosp4_reason

Reason for hospitalisation

wk_hosp4_other

If other, please specify

wk_hosp4_date

Date of hospitalisation

wk_hosp4_length

wk_hosp5_reason

Reason for hospitalisation

mnth12_hosp5_other

If other, please specify

wk_hosp5_date

Date of hospitalisation

wk_hosp5_length

post_12w_living_changed

Previously you stated: [baseline_living]. Has this situation changed since we la

post_12w_living

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

post_12w_hh_gender

What is the gender of the head of the household?

post_12w_hh_number

How many residents are there in this household?

post_12w_res_adults

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

post_12w_res_adolescents

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

post_12w_res_children

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

post_12w_fam_geton

Your family get on well together

post_12w_fam_conflict

That your family have frequent conflicts

post_12w_conf_resolve

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

post_12w_fam_solutions

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

post_12w_fam_life_harder

That your current family makes your life harder?

post_12w_relationship_changed

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

post_12w_relationship

If yes, what best describes your the change?

post_12w_part_live

Does this new partner live with you in this household?

post_12w_part_hivstat

Do you know your new partner's HIV status?

post_12w_new_part_hivstat2

If yes, what is his HIV status?

post_12w_new_part_disc

Have you disclosed your HIV status to your new partner?

post_12w_new_part_disc_level

If yes, what level of disclosure?

post_12w_new_part_geton

You and your partner get on well together

post_12w_new_part_conflict

That you and your current partner have frequent conflicts?

post_12w_new_part_resolve_conf

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

post_12w_new_part_solutions

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

post_12w_new_part_life

That your current partner makes your life harder?

post_12w_rel_father_live

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

post_12w_rel_father_support

Is the father of the baby supportive of the pregnancy?

post_12w_rel_father_finance

Does the father of the baby contribute financially?

post_12w_rel_father_hivstat

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

post_12w_rel_father_hivstat2

If yes, what is his HIV status?

post_12wk_rel_father_disc

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

post_12w_rel_fath_disc_level

If yes, what level of disclosure?

post_12w_rel_fath_geton

You and your partner get on well together

post_12w_rel_fath_conflict

That you and your partner have frequent conflicts?

post_12w_rel_fath_conf_res

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

post_12w_rel_fath_sol

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

post_12w_rel_fath_harder

That your current partner makes your life harder?

post_12w_fath_supp

Even though you are no longer together, has the father been supportive of the ba

post_12w_fath_fin

Even though you are no longer together, since the baby was born has the father b

post_12w_epds_1

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

post_12w_epds_2

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

post_12w_epds_3

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

post_12w_epds_4

Have you been anxious or worried for no good reason?

post_12w_epds_5

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

post_12w_epds_6

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

post_12w_epds_7

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

post_12w_epds_8

Have you been feeling sad or miserable?

post_12w_epds_9

Have you been so unhappy that you have been crying?

post_12w_epds_10

Has the thought of harming yourself occurred to you?

post_12w_suicidal

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

post_12w_suicidal_today

Do you feel this way today?

post_12w_suicidal_plans

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

post_12w_rumination_1

How much do you think about how alone you feel?

post_12w_rumination_2

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

post_12w_rumination_3

How much do you think about how sad you feel?

post_12w_rumination_4

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

post_12w_rumination_5

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

post_12w_unblinded

I became unblinded:

psma_completion_date

Form Completion Date

post_6m_assesment_setting

Is this assessment done

post_6m_assesment_session

Is this assessment session done

post_6m_assesment_session_o

Please explain where the assessment was done

post_6m_1

Note whether baby is alive

post_6m_child_living

Can you confirm whether the baby is still living in the same household with you?

post_6m_ever_breastfed

Did you ever breastfeed?

post_6m_ebf_stop

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

post_6m_other_period

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

post_6m_breastfeed_stop

How old was your child when you stopped breastfeeding completely?

post_6m_bf_other_period

If other period, how long did the mother breastfeed for (specify number and unit

post_6m_solid

Have you started your baby on solids

post_6m_solid1

When did you introduce solids?

post_6m_milk

What milk are you giving your baby?

post_6m_milk_other

post_6m_exclusive_stop

At what age did you stop giving breastmilk only?

post_6m_breast_stop

At what age did you stop breastfeeding altogether?

post_6m_exclusive

If still breastfeeding, exclusive or otherwise, when do you intend to stop breas

post_6m_still_bm

When we interviewed you at 12 weeks postnatal you indicated that you were breast

post_6m_age_stop_bm

If no, when did you stop breastfeeding all together?

post_6m_7

How long did you give breastmilk only?

post_6m_8

In the past 24 hours how have you fed your child?

post_6m_9

In the past week how have you fed your child?

mnth_feeding_stop

If still breastfeeding, exclusive or otherwise, when do you intend to stop breas

post_6m_diarrhoea

mth_diarr_length

If yes, how many days of diarrhoea did your baby have over the past 14 days?

post_6m_still_number

Has your contact number changed?

post_6m_address_confirm

Has your address changed?

post_6m_unblinded

I became unblinded

post_6m_unblinded_des

If yes, details of what happened?

ptma_completion_date

Form Completion date

post_12m_cs_date

post_12m_covid_type

Staff member type

post_12m_enrol_bfr_lockdown

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

post_12m_assesment_setting

Is this assessment done

post_12m_assesment_session

Is this assessment session done

post_12m_assesment_session_o

Please explain where the assessment was done

post_12m_vital_status

For Fieldworker: Note whether baby is alive

post_12m_living_child

Are you currently living with your child?

post_12m_new_pregnancy

Have you become pregnant since we interviewed you at the 12 week postnatal asses

post_12m_new_pregnancy2

If yes, are you currently pregnant?

post_12m_pregnancy_ended

If no, what is the reason why you are no longer pregnant?

post_12m_delivery

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

post_12m_pregnancy_ended_gest

Gestation at time of termination or miscarriage

post_12m_pregnancy_ended_date

Date of termination or miscarriage

post_12m_new_pregnancy_gest

If currently pregnant, how may weeks pregnant are you currently?

post_12m_smoked

In the last 12 months, have you smoked?

post_12m_smoked_nu

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

post_12m_alcohol1

In the last 12 months, have you had any alcohol to drink?

post_12m_alcohol

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

post_12m_traditional

Have you used traditional medicines on either yourself or your child?

post_12m_trad_meds

If using traditional medicines, do you use:

post_12m_confirm_hivtreatment

Are you currently on HIV treatment?

mnth_arv

If yes, are you still taking ARVs?

post_12m_arv_visits

In the last 12 months since your baby was born, have you been able to attend all

post_12m_arv_adherence

In the last 12 months since your baby was born, have you managed to adhere to ta

post_12m_arv_complication

Have you had any ART treatment complications (but not hospitalisation) in the la

post_12m_illness

In the last 12 months, have you been diagnosed with a serious illness? (besides

post_12m_illness_descr_2

Have you been diagnosed with TB in the last 12 months?

post_12m_illness_descr_3

If yes, was it drug resistant TB (MDR-TB)?

post_12m_illness_descr_4

If yes, when did you start taking treatment?

post_12m_illness_descr_5

If yes, have you completed treatment?

mth_hosp

Since we last interviewed you when your child was 12 weeks old, have you been ho

post_12m_maternal_hosp_times

If yes, how many times have you been hospitalised?

post_12m_maternal_hosp_date

Date of hospitalisation

post_12m_maternal_hosp_length

mnth_12_ep2_date

Date of hospitalisation

mnth12_ep2_length

mnth12_ep3_date

Date of hospitalisation

mnth12_ep3

mnth12_ep3_length

mnth12_ep4_date

Date of hospitalisation

mnth12_ep4_diagnosis

mnth12_ep4_length

post_12m_diarrhoea2

mnth12_diar_days

If yes, how many days of diarrhoea did your child have over the past 14 days?

mnth12_ever_hosp

At the 12 week visit, you reported that your child had been hospitalised [wk_hos

mnth12_hosp_times

If yes, how many times has he/she been hospitalised?

mnth12_hosp1_reason

Reason for hospitalisation

mnth12_hosp1_other

If other, please specify

post_12m_baby_hosp_date

Date of hospitalisation

post_12m_baby_hosp_length

mnth12_wk_hosp2_reason

Reason for hospitalisation

mnth12_wk_hosp2_other

If other, please specify

mnth12_wk_hosp2_date

Date of hospitalisation

mnth12_wk_hosp2_length

mnth12_wk_hosp3_reason

Reason for hospitalisation

mnth12_wk_hosp3_other

If other, please specify

mnth12_wk_hosp3_date

Date of hospitalisation

mnth12_wk_hosp3_length

mnth12_wk_hosp4_reason

Reason for hospitalisation

mnth12_wk_hosp4_other

If other, please specify

mnth12_wk_hosp4_date

Date of hospitalisation

mnth12_wk_hosp4_length

mnth12_wk_hosp5_reason

Reason for hospitalisation

mnth12_wk_hosp5_other

If other, please specify

mnth12_wk_hosp5_date

Date of hospitalisation

mnth12_wk_hosp5_length

mnth_child_hiv_test

How many HIV tests has the child had to date?

mnth_child_test1_date

Date of HIV test

mnth_child_test1_result

Result of HIV test

mnth_child_test2_date

Date of HIV test

mnth_child_test2_result

Result of HIV test

mnth_child_test3_date

Date of HIV test

mnth_child_test3_result

Result of HIV test

mnth_child_test4_date

Date of HIV test

mnth_child_test4_result

Result of HIV test

mnth_child_test5_date

Date of HIV test

mnth_child_test5_result

Result of HIV test

mnth_child_viral_date

Date of viral load test

mnth_child_viral1_result

Result of viral load test

mnth_child_viral2_date

Date of viral load test

mnth_child_viral2_result

Result of viral load test

mnth_child_cd42_date

Date of CD4 count test

mnth_child_cd4_1_result

Result of CD4 count test

mnth_child_cd4_2_date

Date of CD4 count test

mnth_cd4_2_result

Result of CD4 count test

mnth_child_arv

Has the child started taking ARV treatment?

post_12m_ever_breastfed

Did you ever breastfeed?

post_12m_ebf_stop

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

post_12m_breastfeed_stop

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

post_12m_baby_hiv16

Since we last spoke to you when your child was 6 months old, are you still givin

post_12m_baby_hiv17

If no, when did you stop?

post_12m_baby_hiv18

Are you giving any other milk to your baby?

mnth_feeding_solids

When did you introduce solids?

post_12m_food_security

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

post_12m_adult_wk

If yes, does this happen every week?

post_12m_child_food

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

post_12m_child_wk

If yes, does this happen every week?

measles1_received_final

Measles 1 received

measles1_received_date_final

Measles 1 received date

measles2_received_final

Measles 2 received

measles2_received_date_final

Measles 2 received date

post_12m_paid_empl

Do you have paid employment?

post_12m_full_part

If yes, is this employment:

post_12m_who_income

Who is the main provider of income for your household?

post_12m_income_type

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

post_12m_grant_type

If yes, is it a:

post_12m_fridge

Does this household own a fridge?

post_12m_hh_finance

How would this household classify its financial situation these days?

post_12m_debt_6m

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

post_12m_money

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

post_12m_support

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

post_12m_confidante_y_n

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

post_12m_confidante_who

What is the relationship of this person to you?

post_12m_living_change

Has your living situation changed since the last interview when your baby was 12

post_12m_living

How would you describe your current family situation?

post_12m_gend_head

What is the gender of the head of the household?

post_12m_res_hh

How many residents are there in this household?

post_12m_res_adults_2

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

post_12m_res_adolescents

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

post_12m_res_child

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

post_12m_crim_past12m

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

post_12m_life_events

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

post_12m_fam_geton

Your family get on well together

post_12m_rpcs_20

That your family have frequent conflicts

post_12m_rpcs_adult_2

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

post_12m_rpcs_adult_1

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

post_12m_s1000_fam

That your current family makes your life harder?

post_12m_relationship

What best describes your current relationship?

post_12m_fath_supp

Has the father of your child been supportive of the child in the last 12 months?

post_12m_fath_fin

Does the father of the your child contribute financially?

post_12m_new_live

Does this new partner live with you in this household?

post_12m_hiv_new

Do you know your new partner's HIV status?

post_12m_hiv_new2

If yes, what is his HIV status?

post_12m_fath_disc_3

Have you disclosed your HIV status to your new partner?

post_12m_hiv_disc_3

If yes, what level of disclosure?

post_12m_part_geton2

You and your partner get on well together

post_12m_coonflict

That you and your current partner have frequent conflicts?

post_12m_rpcs_4

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

post_12m_rpcs_3

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

post_12m_s1001

That your current partner makes your life harder?

post_12m_epds_1

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

post_12m_epds_2

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

post_12m_epds_3

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

post_12m_epds_4

Have you been anxious or worried for no good reason?

post_12m_epds_5

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

post_12m_epds_6

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

post_12m_epds_7

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

post_12m_epds_8

Have you been feeling sad or miserable?

post_12m_epds_9

Have you been so unhappy that you have been crying?

post_12m_epds_10

Has the thought of harming yourself occurred to you?

Total: 1246

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