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Table 6 Exploratory outcome measures used to pilot the acceptability and feasibility of measurement tools and procedures and the intervention’s preliminary effect on provider and patient outcomes (exploratory aim 3)

From: Protocol for the pilot quasi-experimental controlled trial of a gender-responsive implementation strategy with providers to improve HIV outcomes in Uganda

Provider cohort

Exploratory primary outcome measures

Data collection procedures/measures

Time frame

Gender awareness

Gender awareness is measured with the Adapted Nijmegen Gender Awareness in Medicine Scale (N-GAMS) [108], developed for medical personnel. The sub-scales have good content validity and reliability (Cronbach’s α = 0.73–0.86) in developed settings [108]. Two subscales will be adapted for the present study to measure:

• Attitudes towards gender sensitivity: This scale measures attitudes towards gender sensitivity in healthcare, with items that measure agreement on the perceived importance and perceived outcomes of gender-sensitive care, adapted by the study team to be HIV specific

• Gender stereotypes towards patients: Items originally developed to measure gender stereotypes about patients in healthcare settings will be adapted by the study team to be specific to the cultural context of Uganda, including common stereotypes and bias specific to gender and HIV

Baseline, 6 and 12 months

Competence for gender-responsive care

Competence for gender-sensitive care will be measured through an adaption of Saha et al.’s Self-Rated Cultural Competence Instrument for Primary Care Providers that assesses awareness, perceived importance, motivation, and skills to provide culturally competent care [109]. For the current study, the scale is adapted to be specific to competence for gender-responsive HIV care. The original scale has items mapping onto specific domains, adapted for our study, including the following:

• Awareness of societal gender inequities: The original scale included items to assess the provider attitudes on disparities in health and healthcare. For the present study, items will be adapted to assess providers’ agreement with statements on societal-level gender inequities that favor men and disadvantage women

• Awareness of gender disparities in HIV care: Within the original scale’s domain of disparities in health and healthcare, items will be adapted to measure providers’ knowledge of HIV gender disparities

• Gender-sensitive care/counseling skills and behavior: The original items developed to assess the level in which providers engage in gender-responsive care behavior and their perceived self-efficacy or skill for delivering gender-responsive care will be adapted to be HIV specific

Baseline, 6 and 12 months

Exploratory secondary outcome measures

Data collection procedures/measures

Time frame

Communication self-efficacy

An adapted version of the self-efficacy questionnaire (SE-12) for provider communication will be used to assess communication self-efficacy, adapted to be gender specific

Baseline, 6 and 12 months

Gender equitable attitudes

Gender equitable attitudes will be measured with the Gender Equitable Men scale [110] validated in Tanzania and Ghana [111], with a Cronbach’s α = 0.79–0.88 in African settings [111,112,113,114]

Baseline, 6 and 12 months

Empathy

Provider empathy for patient experiences will be measured from an adapted version of the Jefferson scale of physician empathy, which has been adapted for HIV care previously [115, 116]

Baseline, 6 and 12 months

Emotional regulation and stress reduction techniques

Providers’ use of emotional regulation and stress reduction techniques, such as breathing exercises, sense soothing, tension release, attention shifting, and positive reframing, will be measured through items adapted from the Mindful Self-Care Scale (MSCS) and the Brief COPE [117, 118]

Baseline, 6 and 12 months

Exploratory primary outcome measures

Data collection procedures/measures

Time frame

ART adherence

Measured by self-report, through the Adult AIDS Clinical Trials Group (AACTG) scale’s [119] 4-day adherence recall questions; demonstrated good construct validity in Uganda [120], strong correlations with viral load [121], and moderate correlations with electronic adherence monitoring [122]

Baseline, 6 and 12 months

Patient Cohort

Exploratory secondary outcome measures

Data collection procedures/measures

Time frame

Short-term retention in care

Operationalized in two ways, collected through patient clinic records, and triangulated with self-report

• Missed visit count: Number of missed visits accrued (count measure) based on scheduled visits determined by MOH clinical guidelines

• Visit adherence: Proportion of kept visits/scheduled visits (kept + missed visits) (continuous measure, range = 0.0–1.0)

Baseline, 6 and 12 months

Viral load

Collected from patient clinic records* and confirmed with self-report, viral load will be operationalized in two ways

• Change in viral load: Change in viral load will be measured with statistically significant reductions defined as a threefold, or a 0.5 log10 copies/mL, change [123]

• Viral load suppression: Viral load suppression will be defined as HIV RNA < 200 copies/mL

Baseline, 12 months

Quality of communication

Patient’s perceptions of the quality of communication with their HIV providers will be measured through two scales

• Quality of communication: Developed by Wilson et al. [124] for HIV populations, items measure the perceived quality of general health communication from HIV providers, asking patients to rate the quality of their HIV providers in communicating general health information and in providing HIV-specific information

• Quality of adherence dialogue: Patients’ perceived quality of provider communication specific to ART adherence will be measured from items adapted from Schneider and colleagues [125]

Baseline, 6 and 12 months

Participatory decision-making

Participatory decision-making style of HIV providers, or how active of a role patients perceive they have in their healthcare decisions, will be measured with Kaplan’s 7-item scale [126]

Baseline, 6 and 12 months

Exploratory secondary outcome measures

Data collection procedures/measures

Time frame

Overall satisfaction with care

The GHAA Consumer Satisfaction Survey to measure overall satisfaction with care adapted to focus specifically on HIV care will measure patient satisfaction with HIV care [127]

Baseline, 6 and 12 months

Provider trust

Provider trust will be measured with items from the Primary Care Assessment Survey by Safran and colleagues [128]

Baseline, 6 and 12 months

HIV stigma

General HIV stigma and HIV stigma from healthcare providers will be measured using Earnshaw’s HIV stigma framework scale [129], which measures anticipated, enacted, and internalized HIV stigma

Baseline, 6 and 12 months

  1. Notes: *Clinics follow MOH guidelines for routine viral load testing; viral loads are taken as part of routine care after 6 months of ART and every 12 months thereafter (or 6 months if detectable). Since patients will be newly initiated on treatment or unsuppressed, they should have had a viral load recently taken or will be eligible for viral load at baseline or 6 months and 12 months later