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Table 1 Overview of measures

From: ‘Mothers moving towards empowerment’ intervention to reduce stigma and improve treatment adherence in pregnant women living with HIV in Botswana: study protocol for a pragmatic clinical trial

Assessment measure

Baseline (< 28 weeks gestational age)

Post-MME

Follow-up (16 weeks postpartum)

Comparison metric

Stigma outcomes

 Berger HIV Stigma Scale

ALL

MME

ALL

1,2,3,4,5

 WMM HIV Cultural Stigma Scale in Botswana (HCSS-B)

ALL

MME

ALL

1,2,3,4,5

 Botho (3 items)

ALL

MME

ALL

1,2,3,4,5

Psychosocial outcomes

 Quality of life (PROMIS-8)

ALL

MME

ALL

1,2,3,4,5

 Depressive symptoms (CES-D)

ALL

MME

ALL

1,2,3,4,5

 Post-traumatic stress symptoms (PCL-5)

ALL

MME

ALL

1,2,3,4,5

 Social functioning (WHODAS-12)

ALL

MME

ALL

1,2,3,4,5

 Social support (6 items)

ALL

MME

ALL

1,2,3,4,5

Treatment adherence

 Antenatal adherence

ALL

MME

ALL

1,2,3,4,5

 ART adherence (ACTG questionnaire)

ALL

MME

ALL

1,2,3,4,5

Covariates

 Demographic measures

ALL

MME

ALL

N/A

 Alcohol use (AUDIT)

ALL

MME

ALL

N/A

 Sexual behavior (5 items)

ALL

MME

ALL

N/A

 Intimate partner violence (WAST)

ALL

MME

ALL

N/A

Qualitative (open-ended; differs at each time points)

MME

MME

MME

N/A

HIV metrics: CD4 count and viral load

(IDCC records/electronic medical record system)

  

ALL

1

Birth outcomes: birth weight, gestational age, APGAR scores

(Delivery Summary Sheet)

  

ALL

1

Infant health: infant mortality, infant HIV status, feeding method, vaccinations, hospitalizations (dates, diagnosis)

(“Under 5 Card”: asked from mother at 4 month follow-up)

  

ALL

1

  1. 1 Bivariate comparison of mean (median) scores at 16-week follow-up between intervention and control group
  2. 2 Bivariate comparison of change in mean (median) scores from baseline to 16-week follow-up between intervention and control groups
  3. 3 Bivariate comparison of mean (median) scores at baseline and post-MME within intervention group
  4. 4 Bivariate comparison of mean (median) scores at baseline and 16-week follow-up within intervention group
  5. 5 Bivariate comparison of mean (median) scores at post-MME and 16-week follow-up within intervention group
  6. ALL all participants
  7. MME only intervention participants