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Table 3 Factors and measures to be assessed in data collection

From: Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial

 

Factors

Study measurements

Group and timing

Couple HIV testing (primary outcome)

Couple HIV testing

Couple HIV testing uptake during the observation period (Y/N)*

All participants at baseline and follow-ups

Other testing outcomes

HIV re-testing

Re-testing for HIV during pregnancy and postpartum*

All participants at follow-ups

New male HIV+ tests

Number of new HIV+ test results of male partners*

Discordant couples

Number of new serodiscordant couples identified

Transformation of couple motivation and couple coping

Couple relationship dynamics

Relationship satisfaction [48], dyadic trust [49], couple communication [50], interpersonal closeness [51], Sexual Relationship Power Scale [52], commitment [53]

All participants at baseline and follow-ups

Disclosure

Reports of disclosure to others from both partners [54]

 

HIV-related couple

Male partner support for MCH-specific social support [55], couple communal coping [56], Network of Relationships Social Provision Scale (ref)

 

Other potential moderators and mediators

Pregnancy intendedness

One item measure of the intendedness of the current pregnancy [57]

All participants at baseline and follow-ups

Perceptions of stigma

Anticipated stigma and perceived community HIV-related stigma scales [58, 59]

Stigma experience

Anticipated, enacted, and internalized HIV-related stigma [60]

HIV-positive participant

IPV

Dyadic version of WHO intimate partner violence measure [39]

All participants at baseline and follow-ups

HIV treatment beliefs

Adaptation of the Beliefs about Medications Questionnaire [61]

Depression

PHQ-8 [46]

Anxiety

GAD-7 [62]

Healthcare utilization

PMTCT practices

Mother’s use of ARVs for PMTCT*, prophylactic ARVs for the infant*, infant feeding practices

HIV-positive women at follow-ups

Use of MCH services

Number of ANC visits*, childbirth with a skilled attendant (Y/N), postnatal check-ups*

All participants at follow-ups

PREP uptake

Initiation of PrEP

Discordant partners at follow-ups

Woman’s HIV care linkage and engagement

Time to linkage in HIV care*, enrollment in HIV care (Y/N)*, self-reported ART adherence [63], number of HIV visits*

HIV-positive women at baseline and follow-ups

Man’s HIV care linkage

Time to linkage in HIV care*, enrollment in HIV care (Y/N)*, self-reported ART adherence [63], number of HIV visits*

HIV-positive men at baseline and follow-ups

Infant HIV testing

Date and result of infant HIV test*

Parents of HIV-exposed infants at follow-ups

Process measures

Intervention content

Topics covered, services delivered, referrals made during couple visits

All intervention participants at follow-ups

Participation

Number of couple home visits completed, number of HIV self-tests received/used

Social consequences

Positive and negative life event measures [47]

Acceptability

Satisfaction with intervention components, intervention content, and mode of delivery; attitudes toward PrEP and HIV self-testing

 

Secondary health outcomes

Viral suppression

Viral Load < 200 copies (undetectable)*

All HIV-positive participants at baseline and follow-ups

HIV-free child survival

Child alive and HIV-free at 18 months after the birth*

  1. Secondary outcome measures and assessment are listed in the table above:
  2. 1. HIV re-testing [time frame: baseline, 3 months postpartum, 12 months postpartum]. Re-testing for HIV during pregnancy and postpartum during observation period assessed in the questionnaire and confirmed through medical records, completed by all participants at baseline and each follow-up until 12 months postpartum
  3. 2. Number of new male HIV-positive diagnoses [time frame: baseline, 3 months postpartum, 12 months postpartum]. Number of new HIV-positive test results of male partners during the observation period, coded as Y/N. This is assessed for all male participants at baseline and each follow-up until 12 months postpartum in the questionnaires and confirmed through medical records
  4. 3. Number of new discordant couples [time frame: baseline, 3 months postpartum, 12 months postpartum]. Number of new HIV serodiscordant couples identified during the observation period. This is assessed for all couples at baseline and each follow-up until 12 months postpartum in the questionnaires and confirmed through medical records
  5. 4. Use of PMTCT interventions (for HIV-positive women only) [time frame: 3 months postpartum, 12 months postpartum, 18 months postpartum]. Composite variable including mothers use of antiretrovirals (ARVs) (Y/N), prophylactic ARVs given to the infant (Y/N), and appropriate infant feeding practices. These are assessed in the questionnaires completed at each follow-up up to 18 months postpartum
  6. 5. Utilization of maternal and child health (MCH) services (all couples in the study) [time frame: 3 months postpartum, 12 months postpartum, 18 months postpartum]. Composite variable including having completed at least four antenatal care (ANC) visits during pregnancy (Y/N), childbirth with a skilled attendant (Y/N), and postnatal check-ups for woman (Y/N) and infant (Y/N). These are assessed in the follow-up questionnaires completed up to 18 months postpartum
  7. 6. Pre-exposure prophylaxis (PrEP) uptake (discordant partners at follow-ups) [time frame: 3 months postpartum, 12 months postpartum, 18 months postpartum]. Initiation of PrEP by discordant partners assessed at each follow-up in the questionnaires and confirmed through medical records up to 18 months after the baby’s birth
  8. 7. Woman’s linkage to HIV care (HIV-positive women) [time frame: baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum]. Time to linkage to HIV care assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records
  9. 8. Woman’s enrollment in HIV care (HIV-positive women) [time frame: baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum]. Enrollment of HIV-positive women in HIV care (Y/N) assessed at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records
  10. 9. Woman’s adherence to HIV care (HIV-positive women) [time frame: baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum]. Self-reported adherence to HIV care assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records
  11. 10. Number of HIV care visits (HIV-positive women) [time frame: baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum]. Number of HIV care visits assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records
  12. 11. Man’s linkage to HIV care (HIV-positive men) [time frame: baseline, 3 months after baby’s birth, 12 months after baby’s birth, 18 months after baby’s birth]. Time to linkage to HIV care assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records
  13. 12. Man’s enrollment in HIV care (HIV-positive men) [time frame: baseline, 3 months after baby’s birth, 12 months after baby’s birth, 18 months after baby’s birth]. Enrollment of HIV-positive men in HIV care (Y/N) assessed at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records
  14. 13. Man’s adherence to HIV care (HIV-positive men) [time frame: baseline, 3 months after baby’s birth, 12 months after baby’s birth, 18 months after baby’s birth]. Self-reported adherence to HIV care assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records
  15. 14. Number of HIV care visits (HIV-positive men) [time frame: baseline, 3 months after baby’s birth, 12 months after baby’s birth, 18 months after baby’s birth]. Number of HIV care visits assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records
  16. 15. Maternal HIV viral suppression (HIV-positive women) [time frame: baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum]. Viral load < 200 copies (undetectable) for all HIV-positive women at baseline and 18 months postpartum through medical records
  17. 16. HIV-free child survival [time frame: 18 months after the birth]. Child alive and HIV-free at 18 months after the birth. This is assessed in a brief interview and confirmed through medical records
  18. 17. Result of infant HIV test [time frame: 3 months after birth, 12 months after birth, 18 months after birth]. Result of infant HIV test based on medical records
  19. 18. Date of infant HIV test [time frame: 3 months after birth, 12 months after birth, 18 months after birth]. Date of infant HIV test based on medical records
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