HIV
Conditions
Brief summary
Gender norms embedded in the health-system and broader community shape patient-provider relationships in ways that may undermine the provision of antiretroviral treatment (ART) counseling for men and women in Uganda. This study seeks to develop and evaluate the acceptability, feasibility, and preliminary efficacy of an innovative gender transformative implementation strategy to improve HIV provider capacity for equitable HIV care and ART adherence counseling.
Detailed description
Antiretroviral treatment (ART) is the single most effective clinical intervention in the fight against HIV. However, in Uganda only 56% of people living with HIV were virally suppressed in 2017 with significant disparities between men and women, suggesting problems with implementation. While gender norms are a known driver of HIV disparities in sub-Saharan Africa, and patient-provider relationships are a key factor in HIV care engagement, little research has focused on the role that gender norms have in shaping the equitable provision of treatment and quality of ART counseling. The overall research objective is to develop and pilot test an implementation strategy to increase providers' capacity to provide equitable and gender-tailored treatment and counseling to HIV-infected men and women. Delivered to HIV providers, this group training integrates a gender transformative approach with adapted evidence-based strategies to reduce biases and increase gender equitable attitudes. The pilot trial will assess the implementation strategy's effectiveness by comparing changes in provider (competence for gender sensitive care) and in patient outcomes (clinic attendance, ART adherence, viral load) between the training intervention and usual care through 12-months. The implementation strategy will be assessed through a quasi-experimental pre/post design. Clinics will be randomly assigned to either the intervention or control condition. Providers in the intervention condition will receive a series of group training sessions. All participants in the provider cohort will complete interviewer administered questionnaires at baseline, 6-, and 12- month follow-up. In addition to the assessment of the cohort of HIV providers, the study will obtain additional data on the impact of the provider training on patient outcomes. Patient participants will complete an interviewer administered questionnaire at baseline, 6-, and 12- month follow-up, and will provide permission for the study team to review and extract relevant data from their clinic records related to engagement in HIV care. The total N and primary outcomes reflected in the clinicaltrials.gov database reflects the patient cohort (N=240, 120 per treatment arm). Secondary outcomes are obtained from the provider cohort (n=20-35 providers per clinic).
Interventions
BEHAVIORALTraining for HIV care providers (effect on provider outcomes)
This training program integrates evidence-based strategies to reduce provider bias, adapted to address gender bias in the context of HIV care in Uganda. The content aims to increase providers' knowledge, motivation, skills, and empathy to equitably deliver Ugandan Ministry of Health ART program guidelines to male and female patients (e.g., increasing awareness of HIV gender disparities, increasing empathy/skills to counsel men and women's gendered barriers to care, promoting shared decision-making). The intervention is delivered in a series of group training sessions with HIV providers.
Sponsors
Makerere University
National Institute of Mental Health (NIMH)
The University of Texas at San Antonio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Intervention model description
Clinics will be randomly assigned to intervention or control via coin toss. Two cohorts of participants will be recruited from both the intervention arm and control arm. The total number of participants (N=240) represents the patient cohort, for which change in patient HIV engagement outcomes are the primary outcomes of the study. A second cohort of HIV providers will also be recruited (n\ 80-140) depending on the number of HIV providers per clinic, who will provide secondary outcomes related to change in provider knowledge, attitudes, and skills.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Provider Cohort: Inclusion Criteria: * HIV care provider at the selected clinics, including HIV medical and clinical officers, nurses, midwives, linkage facilitators, counselors. * 18 years of age or older * Fluent in English or Luganda Patient Cohort: Inclusion Criteria: * HIV-infected * Enrolled in care at the clinic of recruitment * pre-ART (newly diagnosed) or newly initiated on ART (within 3 months-1 year) or struggling with treatment adherence, defined in two ways: (1) most recent viral load results unsuppressed as assessed through clinic records; (2) or self-reported non-adherence as by the Adult AIDS Clinical Trials Group (AACTG) scale 4-day adherence recall questions. This scale has demonstrated good construct validity in Uganda and strong correlations with viral load; * 18 years of age or an emancipated minor * Fluent in Luganda or English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Proportion of Missed Antiretroviral (ARV) Doses From Baseline Among Clients | Baseline, 6-months, and 12-months | AACTG Adherence Instruments, self-reported questionnaire on medication adherence from the Adult AIDS Clinical Trials Group (AACTG); operationalized as a proportion of total missed doses (missed doses/total doses) (continuous measure, range =0.0-1.0) |
| Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care) | Baseline, 6-months, and 12-months | Proportion of kept visits/scheduled visits (kept + missed visits) (continuous measure, range =0.0-1.0) |
| Change in Competence for Gender-sensitive Care From Baseline Among Providers | Baseline, 6-months, and 12-months | Adapted from the Nijmegen Gender Awareness in Medicine Scale (N-GAMS); collected from provider cohort; 9 items, total possible score using mean scoring: 1-5 (high score = better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients | Baseline, 6-months, and 12-months | Patient's perceptions of the quality of communication with their HIV care providers was measured through two scales that were combined for a total score continuous score. Wilson et al. was developed for HIV populations, including items measuring the perceived quality of general health communication from HIV care providers, asking patients to rate the quality of their HIV care providers in communicating general health information and in providing HIV specific information. In addition, patients' perceived quality of provider communication specific to ART adherence was be measured from items adapted from Schneider and colleagues. 14 items, total possible score using mean scoring: 0-4 (high score = better outcome) |
| Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients | Baseline, 6-months, and 12-months | Participatory decision-making style of HIV care providers, or how active of a role patients perceive they have in their health care decisions, was measured with Kaplan's 7-item scale. Total possible score using mean scoring: 0-4 (high score = better outcome) |
| Change in Satisfaction With HIV Care From Baseline Among Clients | Baseline, 6-months, and 12-months | The GHAA Consumer Satisfaction Survey measures overall satisfaction with care; we adapted these items to focus specifically on HIV care to measure patient satisfaction with HIV care. 6 items, total possible score using mean scoring: 0-4 (high score = better outcome) |
| Change in Self-efficacy for Client-centered Communication From Baseline Among Providers | Baseline, 6-months, and 12-months | An adapted version of the Self-Efficacy Questionnaire (SE-12) for Provider Communication was used to assess communication self-efficacy, adapted to be gender specific. 5 items. Total possible score using mean scoring: 0-4 (high score = better outcome) |
| Change in Anticipated HIV Stigma Among Clients | Baseline, 6-months, and 12-months | HIV stigma was measured using Earnshaw's HIV stigma framework scale , which measures anticipated (the degree of HIV stigma one expects to encounter from others), enacted (the degree of HIV stigma one has encountered from others), and internalized HIV stigma (the degree to which one internalized negative beliefs about people living with HIV about themselves). This outcome reports the mean for the anticipated scale. 7 items, total possible score using mean scoring: 0-4 (high score = worse outcome). |
| Change in Enacted HIV Stigma Among Clients | Baseline, 6-months, and 12-months | HIV stigma was measured using Earnshaw's HIV stigma framework scale , which measures anticipated (the degree of HIV stigma one expects to encounter from others), enacted (the degree of HIV stigma one has encountered from others), and internalized HIV stigma (the degree to which one internalized negative beliefs about people living with HIV about themselves). This outcome reports the mean for the enacted scale. 7 items, total possible score using mean scoring: 0-4 (high score = worse outcome). |
| Change in Internalized HIV Stigma Among Clients | Baseline, 6-months, and 12-months | HIV stigma was measured using Earnshaw's HIV stigma framework scale , which measures anticipated (the degree of HIV stigma one expects to encounter from others), enacted (the degree of HIV stigma one has encountered from others), and internalized HIV stigma (the degree to which one internalized negative beliefs about people living with HIV about themselves). This outcome reports the mean for the internalized scale. 7 items, total possible score using mean scoring: 0-4 (high score = worse outcome). |
| Change in Total HIV Stigma Score Among Clients | Baseline, 6-months, and 12-months | HIV stigma was measured using Earnshaw's HIV stigma framework scale , which measures anticipated (the degree of HIV stigma one expects to encounter from others), enacted (the degree of HIV stigma one has encountered from others), and internalized HIV stigma (the degree to which one internalized negative beliefs about people living with HIV about themselves). This outcome reports the mean for the entire scale. 21 items, total possible score using mean scoring: 0-4 (high score = worse outcome). |
| Change in Empathy Towards Clients From Baseline Among Providers | Baseline, 6-months, and 12-months | Provider empathy for clients' experiences was measured from an adapted version of the Jefferson Scale of Physician Empathy, which has been adapted for HIV care previously. 9 items, total possible score using mean scoring: 1-5 (high score = better outcome) |
| Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers | Baseline, 6-months, and 12-months | Providers' use of emotional regulation and stress reduction techniques, such as breathing exercises, sense soothing, tension release, attention shifting, and positive reframing, were measured through items adapted from the Mindful Self-Care Scale (MSCS) and the Brief COPE. 7-items, total possible score using mean scoring: 0-4 (high score = better outcome) |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Providers HIV care providers and staff receiving the training intervention.
The intervention arm will receive 4 sessions of training. Trained intervention facilitator experienced in health professional trainings will lead the training. The intervention content delivered is aimed to increase HIV providers' knowledge, motivation, skills, and empathy to: 1) equitably deliver ART program guidelines (i.e., quality of care) and 2) provide gender sensitive counseling to address ART patients' gendered barriers to HIV care engagement, increasing patient satisfaction, retention, and ART adherence, and reducing gender disparities in HIV outcomes.
Training: This training program integrates evidence-based strategies to reduce provider bias, adapted to address gender bias in the context of HIV care in Uganda. The content aims to increase providers' knowledge, motivation, skills, and empathy to equitably deliver Ugandan Ministry of Health ART program guidelines to male and female patients (e.g., increasing awareness of HIV gender disparities, increasing empathy/skills to counsel men and women's gendered barriers to care, promoting shared decision-making). The intervention is delivered in a series of group training sessions with HIV providers. | 61 |
| Intervention Clients Clients receiving HIV care in the intervention arm clinics. | 119 |
| Control Providers HIV care providers and staff in the control arm clinics (no intervention). | 83 |
| Control Clients Clients receiving HIV care in the control arm clinics (no intervention). | 119 |
| Total | 382 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Death | 0 | 5 | 0 | 3 |
| Overall Study | Lost to Follow-up | 1 | 8 | 3 | 8 |
Baseline characteristics
| Characteristic | Intervention Providers | Total | Control Clients | Control Providers | Intervention Clients |
|---|---|---|---|---|---|
| Age, Continuous | 31.80 years STANDARD_DEVIATION 10.8 | 36.16 years STANDARD_DEVIATION 11.05 | 39.58 years STANDARD_DEVIATION 11.05 | 34.9 years STANDARD_DEVIATION 10.7 | 38.36 years STANDARD_DEVIATION 11.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 61 Participants | 382 Participants | 119 Participants | 83 Participants | 119 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Uganda | 61 participants | 382 participants | 119 participants | 83 participants | 119 participants |
| Sex: Female, Male Female | 45 Participants | 223 Participants | 59 Participants | 59 Participants | 60 Participants |
| Sex: Female, Male Male | 16 Participants | 159 Participants | 60 Participants | 24 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 5 / 119 | 0 / 83 | 3 / 119 |
| other Total, other adverse events | 0 / 61 | 0 / 119 | 0 / 83 | 0 / 119 |
| serious Total, serious adverse events | 0 / 61 | 1 / 119 | 0 / 83 | 0 / 119 |
Outcome results
Primary
Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care)
Proportion of kept visits/scheduled visits (kept + missed visits) (continuous measure, range =0.0-1.0)
Time frame: Baseline, 6-months, and 12-months
Population: The client cohort only is analyzed for this outcome
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care) | Baseline | 0.96 percentage of total missed visits | Standard Deviation 0.11 |
| Intervention Clients | Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care) | 6-months | 0.99 percentage of total missed visits | Standard Deviation 0.06 |
| Intervention Clients | Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care) | 12-months | 0.99 percentage of total missed visits | Standard Deviation 0.07 |
| Control Clients | Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care) | Baseline | 0.95 percentage of total missed visits | Standard Deviation 0.12 |
| Control Clients | Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care) | 6-months | 0.98 percentage of total missed visits | Standard Deviation 0.08 |
| Control Clients | Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care) | 12-months | 1.00 percentage of total missed visits | Standard Deviation 0 |
p-value: 0.37Regression, Linear
Comparison: Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.p-value: 0.18Regression, Linear
Comparison: Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.p-value: 0.19Regression, Linear
Primary
Change in Competence for Gender-sensitive Care From Baseline Among Providers
Adapted from the Nijmegen Gender Awareness in Medicine Scale (N-GAMS); collected from provider cohort; 9 items, total possible score using mean scoring: 1-5 (high score = better outcome)
Time frame: Baseline, 6-months, and 12-months
Population: The provider cohort only is analyzed for this outcome
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Competence for Gender-sensitive Care From Baseline Among Providers | Baseline | 3.78 score on a scale | Standard Deviation 0.4 |
| Intervention Clients | Change in Competence for Gender-sensitive Care From Baseline Among Providers | 6-month | 3.95 score on a scale | Standard Deviation 0.35 |
| Intervention Clients | Change in Competence for Gender-sensitive Care From Baseline Among Providers | 12-month | 3.82 score on a scale | Standard Deviation 0.31 |
| Control Clients | Change in Competence for Gender-sensitive Care From Baseline Among Providers | Baseline | 3.55 score on a scale | Standard Deviation 0.24 |
| Control Clients | Change in Competence for Gender-sensitive Care From Baseline Among Providers | 6-month | 3.48 score on a scale | Standard Deviation 0.25 |
| Control Clients | Change in Competence for Gender-sensitive Care From Baseline Among Providers | 12-month | 3.61 score on a scale | Standard Deviation 0.31 |
p-value: 0.004Regression, Linear
p-value: <0.001Regression, Linear
p-value: 0.86Regression, Linear
Primary
Change in Proportion of Missed Antiretroviral (ARV) Doses From Baseline Among Clients
AACTG Adherence Instruments, self-reported questionnaire on medication adherence from the Adult AIDS Clinical Trials Group (AACTG); operationalized as a proportion of total missed doses (missed doses/total doses) (continuous measure, range =0.0-1.0)
Time frame: Baseline, 6-months, and 12-months
Population: The client cohort only is analyzed for this outcome
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Proportion of Missed Antiretroviral (ARV) Doses From Baseline Among Clients | Baseline | 90.14 percentage of total missed ARV doses | Standard Deviation 19.51 |
| Intervention Clients | Change in Proportion of Missed Antiretroviral (ARV) Doses From Baseline Among Clients | 6-months | 95.64 percentage of total missed ARV doses | Standard Deviation 14.35 |
| Intervention Clients | Change in Proportion of Missed Antiretroviral (ARV) Doses From Baseline Among Clients | 12-months | 95.45 percentage of total missed ARV doses | Standard Deviation 19.51 |
| Control Clients | Change in Proportion of Missed Antiretroviral (ARV) Doses From Baseline Among Clients | Baseline | 91.68 percentage of total missed ARV doses | Standard Deviation 22.4 |
| Control Clients | Change in Proportion of Missed Antiretroviral (ARV) Doses From Baseline Among Clients | 6-months | 96.73 percentage of total missed ARV doses | Standard Deviation 13.33 |
| Control Clients | Change in Proportion of Missed Antiretroviral (ARV) Doses From Baseline Among Clients | 12-months | 100.00 percentage of total missed ARV doses | Standard Deviation 0 |
p-value: 0.38Regression, Linear
Comparison: Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.p-value: 0.84Regression, Linear
Comparison: Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.p-value: 0.5Regression, Linear
Secondary
Change in Anticipated HIV Stigma Among Clients
HIV stigma was measured using Earnshaw's HIV stigma framework scale , which measures anticipated (the degree of HIV stigma one expects to encounter from others), enacted (the degree of HIV stigma one has encountered from others), and internalized HIV stigma (the degree to which one internalized negative beliefs about people living with HIV about themselves). This outcome reports the mean for the anticipated scale. 7 items, total possible score using mean scoring: 0-4 (high score = worse outcome).
Time frame: Baseline, 6-months, and 12-months
Population: The client cohort only is analyzed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Anticipated HIV Stigma Among Clients | Baseline | 0.79 score on a scale | Standard Deviation 0.89 |
| Intervention Clients | Change in Anticipated HIV Stigma Among Clients | 6-month | 0.80 score on a scale | Standard Deviation 0.88 |
| Intervention Clients | Change in Anticipated HIV Stigma Among Clients | 12-month | 0.59 score on a scale | Standard Deviation 0.88 |
| Control Clients | Change in Anticipated HIV Stigma Among Clients | Baseline | 0.67 score on a scale | Standard Deviation 0.89 |
| Control Clients | Change in Anticipated HIV Stigma Among Clients | 6-month | 0.57 score on a scale | Standard Deviation 0.73 |
| Control Clients | Change in Anticipated HIV Stigma Among Clients | 12-month | 0.90 score on a scale | Standard Deviation 0.63 |
p-value: <0.001Regression, Linear
p-value: 0.45Regression, Linear
p-value: 0.02Regression, Linear
Secondary
Change in Empathy Towards Clients From Baseline Among Providers
Provider empathy for clients' experiences was measured from an adapted version of the Jefferson Scale of Physician Empathy, which has been adapted for HIV care previously. 9 items, total possible score using mean scoring: 1-5 (high score = better outcome)
Time frame: Baseline, 6-months, and 12-months
Population: The provider cohort only is analyzed for this outcome
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Empathy Towards Clients From Baseline Among Providers | Baseline | 3.77 score on a scale | Standard Deviation 0.38 |
| Intervention Clients | Change in Empathy Towards Clients From Baseline Among Providers | 6-month | 3.86 score on a scale | Standard Deviation 0.45 |
| Intervention Clients | Change in Empathy Towards Clients From Baseline Among Providers | 12-month | 3.91 score on a scale | Standard Deviation 0.3 |
| Control Clients | Change in Empathy Towards Clients From Baseline Among Providers | Baseline | 3.62 score on a scale | Standard Deviation 0.38 |
| Control Clients | Change in Empathy Towards Clients From Baseline Among Providers | 6-month | 3.54 score on a scale | Standard Deviation 0.32 |
| Control Clients | Change in Empathy Towards Clients From Baseline Among Providers | 12-month | 3.63 score on a scale | Standard Deviation 0.44 |
p-value: <0.001Regression, Linear
p-value: 0.002Regression, Linear
p-value: 0.03Regression, Linear
Secondary
Change in Enacted HIV Stigma Among Clients
HIV stigma was measured using Earnshaw's HIV stigma framework scale , which measures anticipated (the degree of HIV stigma one expects to encounter from others), enacted (the degree of HIV stigma one has encountered from others), and internalized HIV stigma (the degree to which one internalized negative beliefs about people living with HIV about themselves). This outcome reports the mean for the enacted scale. 7 items, total possible score using mean scoring: 0-4 (high score = worse outcome).
Time frame: Baseline, 6-months, and 12-months
Population: The client cohort only is analyzed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Enacted HIV Stigma Among Clients | Baseline | 0.21 score on a scale | Standard Deviation 0.52 |
| Intervention Clients | Change in Enacted HIV Stigma Among Clients | 6-month | 0.16 score on a scale | Standard Deviation 0.46 |
| Intervention Clients | Change in Enacted HIV Stigma Among Clients | 12-month | 0.12 score on a scale | Standard Deviation 0.39 |
| Control Clients | Change in Enacted HIV Stigma Among Clients | Baseline | 0.14 score on a scale | Standard Deviation 0.43 |
| Control Clients | Change in Enacted HIV Stigma Among Clients | 6-month | 0.14 score on a scale | Standard Deviation 0.42 |
| Control Clients | Change in Enacted HIV Stigma Among Clients | 12-month | 0.17 score on a scale | Standard Deviation 0.47 |
p-value: 0.004Regression, Linear
p-value: 0.35Regression, Linear
p-value: 0.04Regression, Linear
Secondary
Change in Internalized HIV Stigma Among Clients
HIV stigma was measured using Earnshaw's HIV stigma framework scale , which measures anticipated (the degree of HIV stigma one expects to encounter from others), enacted (the degree of HIV stigma one has encountered from others), and internalized HIV stigma (the degree to which one internalized negative beliefs about people living with HIV about themselves). This outcome reports the mean for the internalized scale. 7 items, total possible score using mean scoring: 0-4 (high score = worse outcome).
Time frame: Baseline, 6-months, and 12-months
Population: The client cohort only is analyzed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Internalized HIV Stigma Among Clients | Baseline | 0.78 score on a scale | Standard Deviation 1.13 |
| Intervention Clients | Change in Internalized HIV Stigma Among Clients | 6-month | 0.82 score on a scale | Standard Deviation 1.14 |
| Intervention Clients | Change in Internalized HIV Stigma Among Clients | 12-month | 0.62 score on a scale | Standard Deviation 0.99 |
| Control Clients | Change in Internalized HIV Stigma Among Clients | Baseline | 0.99 score on a scale | Standard Deviation 0.85 |
| Control Clients | Change in Internalized HIV Stigma Among Clients | 6-month | 1.01 score on a scale | Standard Deviation 0.95 |
| Control Clients | Change in Internalized HIV Stigma Among Clients | 12-month | 1.04 score on a scale | Standard Deviation 0.61 |
p-value: 0.24Regression, Linear
p-value: 0.92Regression, Linear
p-value: 0.21Regression, Linear
Secondary
Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients
Participatory decision-making style of HIV care providers, or how active of a role patients perceive they have in their health care decisions, was measured with Kaplan's 7-item scale. Total possible score using mean scoring: 0-4 (high score = better outcome)
Time frame: Baseline, 6-months, and 12-months
Population: The client cohort only is analyzed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients | Baseline | 1.86 score on a scale | Standard Deviation 1.04 |
| Intervention Clients | Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients | 6-month | 2.11 score on a scale | Standard Deviation 0.9 |
| Intervention Clients | Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients | 12-month | 2.52 score on a scale | Standard Deviation 0.93 |
| Control Clients | Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients | Baseline | 2.19 score on a scale | Standard Deviation 0.97 |
| Control Clients | Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients | 6-month | 2.69 score on a scale | Standard Deviation 0.79 |
| Control Clients | Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients | 12-month | 2.75 score on a scale | Standard Deviation 0.39 |
p-value: <0.001Regression, Linear
p-value: 0.1Regression, Linear
p-value: 0.54Regression, Linear
Secondary
Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients
Patient's perceptions of the quality of communication with their HIV care providers was measured through two scales that were combined for a total score continuous score. Wilson et al. was developed for HIV populations, including items measuring the perceived quality of general health communication from HIV care providers, asking patients to rate the quality of their HIV care providers in communicating general health information and in providing HIV specific information. In addition, patients' perceived quality of provider communication specific to ART adherence was be measured from items adapted from Schneider and colleagues. 14 items, total possible score using mean scoring: 0-4 (high score = better outcome)
Time frame: Baseline, 6-months, and 12-months
Population: The client cohort only is analyzed for this outcome
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients | Baseline | 2.33 score on a scale | Standard Deviation 0.86 |
| Intervention Clients | Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients | 6-month | 2.53 score on a scale | Standard Deviation 1.04 |
| Intervention Clients | Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients | 12-month | 2.14 score on a scale | Standard Deviation 0.87 |
| Control Clients | Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients | Baseline | 2.25 score on a scale | Standard Deviation 0.69 |
| Control Clients | Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients | 6-month | 2.32 score on a scale | Standard Deviation 0.62 |
| Control Clients | Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients | 12-month | 2.88 score on a scale | Standard Deviation 0.43 |
p-value: <0.001Regression, Linear
p-value: 0.68Regression, Linear
p-value: <0.001Regression, Linear
Secondary
Change in Satisfaction With HIV Care From Baseline Among Clients
The GHAA Consumer Satisfaction Survey measures overall satisfaction with care; we adapted these items to focus specifically on HIV care to measure patient satisfaction with HIV care. 6 items, total possible score using mean scoring: 0-4 (high score = better outcome)
Time frame: Baseline, 6-months, and 12-months
Population: The client cohort only is analyzed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Satisfaction With HIV Care From Baseline Among Clients | Baseline | 3.38 score on a scale | Standard Deviation 0.55 |
| Intervention Clients | Change in Satisfaction With HIV Care From Baseline Among Clients | 6-month | 3.29 score on a scale | Standard Deviation 0.6 |
| Intervention Clients | Change in Satisfaction With HIV Care From Baseline Among Clients | 12-month | 3.09 score on a scale | Standard Deviation 0.59 |
| Control Clients | Change in Satisfaction With HIV Care From Baseline Among Clients | Baseline | 3.26 score on a scale | Standard Deviation 0.35 |
| Control Clients | Change in Satisfaction With HIV Care From Baseline Among Clients | 6-month | 3.19 score on a scale | Standard Deviation 0.4 |
| Control Clients | Change in Satisfaction With HIV Care From Baseline Among Clients | 12-month | 3.27 score on a scale | Standard Deviation 0.33 |
p-value: <0.001Regression, Linear
p-value: 0.97Regression, Linear
p-value: <0.001Regression, Linear
Secondary
Change in Self-efficacy for Client-centered Communication From Baseline Among Providers
An adapted version of the Self-Efficacy Questionnaire (SE-12) for Provider Communication was used to assess communication self-efficacy, adapted to be gender specific. 5 items. Total possible score using mean scoring: 0-4 (high score = better outcome)
Time frame: Baseline, 6-months, and 12-months
Population: The provider cohort only is analyzed for this outcome
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Self-efficacy for Client-centered Communication From Baseline Among Providers | Baseline | 3.08 score on a scale | Standard Deviation 0.75 |
| Intervention Clients | Change in Self-efficacy for Client-centered Communication From Baseline Among Providers | 6-month | 3.24 score on a scale | Standard Deviation 0.54 |
| Intervention Clients | Change in Self-efficacy for Client-centered Communication From Baseline Among Providers | 12-month | 2.98 score on a scale | Standard Deviation 0.53 |
| Control Clients | Change in Self-efficacy for Client-centered Communication From Baseline Among Providers | Baseline | 3.15 score on a scale | Standard Deviation 0.4 |
| Control Clients | Change in Self-efficacy for Client-centered Communication From Baseline Among Providers | 6-month | 3.26 score on a scale | Standard Deviation 0.43 |
| Control Clients | Change in Self-efficacy for Client-centered Communication From Baseline Among Providers | 12-month | 3.28 score on a scale | Standard Deviation 0.49 |
p-value: <0.001Regression, Logistic
Comparison: updatep-value: 0.81Regression, Linear
Comparison: updatep-value: <0.001Regression, Linear
Secondary
Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers
Providers' use of emotional regulation and stress reduction techniques, such as breathing exercises, sense soothing, tension release, attention shifting, and positive reframing, were measured through items adapted from the Mindful Self-Care Scale (MSCS) and the Brief COPE. 7-items, total possible score using mean scoring: 0-4 (high score = better outcome)
Time frame: Baseline, 6-months, and 12-months
Population: The provider cohort only is analyzed for this outcome
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers | Baseline | 1.64 score on a scale | Standard Deviation 0.91 |
| Intervention Clients | Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers | 6-month | 1.93 score on a scale | Standard Deviation 0.8 |
| Intervention Clients | Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers | 12-month | 2.03 score on a scale | Standard Deviation 0.97 |
| Control Clients | Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers | Baseline | 1.99 score on a scale | Standard Deviation 0.62 |
| Control Clients | Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers | 6-month | 1.86 score on a scale | Standard Deviation 0.75 |
| Control Clients | Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers | 12-month | 2.06 score on a scale | Standard Deviation 0.81 |
p-value: 0.01Regression, Linear
p-value: 0.15Regression, Linear
p-value: 0.008Regression, Linear
Secondary
Change in Total HIV Stigma Score Among Clients
HIV stigma was measured using Earnshaw's HIV stigma framework scale , which measures anticipated (the degree of HIV stigma one expects to encounter from others), enacted (the degree of HIV stigma one has encountered from others), and internalized HIV stigma (the degree to which one internalized negative beliefs about people living with HIV about themselves). This outcome reports the mean for the entire scale. 21 items, total possible score using mean scoring: 0-4 (high score = worse outcome).
Time frame: Baseline, 6-months, and 12-months
Population: The client cohort only is analyzed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Clients | Change in Total HIV Stigma Score Among Clients | Baseline | 0.60 score on a scale | Standard Deviation 0.65 |
| Intervention Clients | Change in Total HIV Stigma Score Among Clients | 6-month | 0.59 score on a scale | Standard Deviation 0.66 |
| Intervention Clients | Change in Total HIV Stigma Score Among Clients | 12-month | 0.45 score on a scale | Standard Deviation 0.64 |
| Control Clients | Change in Total HIV Stigma Score Among Clients | Baseline | 0.60 score on a scale | Standard Deviation 0.57 |
| Control Clients | Change in Total HIV Stigma Score Among Clients | 6-month | 0.58 score on a scale | Standard Deviation 0.55 |
| Control Clients | Change in Total HIV Stigma Score Among Clients | 12-month | 0.71 score on a scale | Standard Deviation 0.5 |
p-value: 0.01Regression, Linear
p-value: 0.81Regression, Linear
p-value: 0.04Regression, Linear