Trial Outcomes & Findings for A Gender Transformative Implementation Strategy With Providers to Improve HIV Outcomes in Uganda (NCT NCT05178979)

NCT ID: NCT05178979

Last Updated: 2025-04-25

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

382 participants

Primary outcome timeframe

Baseline, 6-months, and 12-months

Results posted on

2025-04-25

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention Providers
Intervention arm providers receiving the training. 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.
Intervention Clients
Clients receiving HIV care at the intervention arm clinics.
Control Providers
HIV care providers and staff at the control arm clinics.
Control Clients
Clients receiving HIV care at the control arm clinics.
Overall Study
STARTED
61
119
83
119
Overall Study
6-month Follow-up
60
97
78
91
Overall Study
COMPLETED
60
105
80
108
Overall Study
NOT COMPLETED
1
14
3
11

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention Providers
Intervention arm providers receiving the training. 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.
Intervention Clients
Clients receiving HIV care at the intervention arm clinics.
Control Providers
HIV care providers and staff at the control arm clinics.
Control Clients
Clients receiving HIV care at the control arm clinics.
Overall Study
Death
0
5
0
3
Overall Study
Adverse Event
0
1
0
0
Overall Study
Lost to Follow-up
1
8
3
8

Baseline Characteristics

A Gender Transformative Implementation Strategy With Providers to Improve HIV Outcomes in Uganda

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Providers
n=61 Participants
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.
Intervention Clients
n=119 Participants
Clients receiving HIV care in the intervention arm clinics.
Control Providers
n=83 Participants
HIV care providers and staff in the control arm clinics (no intervention).
Control Clients
n=119 Participants
Clients receiving HIV care in the control arm clinics (no intervention).
Total
n=382 Participants
Total of all reporting groups
Age, Continuous
31.80 years
STANDARD_DEVIATION 10.8 • n=5 Participants
38.36 years
STANDARD_DEVIATION 11.66 • n=7 Participants
34.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
39.58 years
STANDARD_DEVIATION 11.05 • n=4 Participants
36.16 years
STANDARD_DEVIATION 11.05 • n=21 Participants
Sex: Female, Male
Female
45 Participants
n=5 Participants
60 Participants
n=7 Participants
59 Participants
n=5 Participants
59 Participants
n=4 Participants
223 Participants
n=21 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
59 Participants
n=7 Participants
24 Participants
n=5 Participants
60 Participants
n=4 Participants
159 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
61 Participants
n=5 Participants
119 Participants
n=7 Participants
83 Participants
n=5 Participants
119 Participants
n=4 Participants
382 Participants
n=21 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Region of Enrollment
Uganda
61 participants
n=5 Participants
119 participants
n=7 Participants
83 participants
n=5 Participants
119 participants
n=4 Participants
382 participants
n=21 Participants

PRIMARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The client cohort only is analyzed for this outcome

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)

Outcome measures

Outcome measures
Measure
Intervention Clients
n=105 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=108 Participants
Clients receiving HIV care at the control clinics.
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
91.68 percentage of total missed ARV doses
Standard Deviation 22.40
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
96.73 percentage of total missed ARV doses
Standard Deviation 13.33
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
100.00 percentage of total missed ARV doses
Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The client cohort only is analyzed for this outcome

Proportion of kept visits/scheduled visits (kept + missed visits) (continuous measure, range =0.0-1.0)

Outcome measures

Outcome measures
Measure
Intervention Clients
n=105 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=108 Participants
Clients receiving HIV care at the control clinics.
Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care)
Baseline
0.96 percentage of total missed visits
Standard Deviation 0.11
0.95 percentage of total missed visits
Standard Deviation 0.12
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
0.98 percentage of total missed visits
Standard Deviation 0.08
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
1.00 percentage of total missed visits
Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The provider cohort only is analyzed for this outcome

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)

Outcome measures

Outcome measures
Measure
Intervention Clients
n=60 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=78 Participants
Clients receiving HIV care at the control clinics.
Change in Competence for Gender-sensitive Care From Baseline Among Providers
Baseline
3.78 score on a scale
Standard Deviation 0.40
3.55 score on a scale
Standard Deviation 0.24
Change in Competence for Gender-sensitive Care From Baseline Among Providers
6-month
3.95 score on a scale
Standard Deviation 0.35
3.48 score on a scale
Standard Deviation 0.25
Change in Competence for Gender-sensitive Care From Baseline Among Providers
12-month
3.82 score on a scale
Standard Deviation 0.31
3.61 score on a scale
Standard Deviation 0.31

SECONDARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The provider cohort only is analyzed for this outcome

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)

Outcome measures

Outcome measures
Measure
Intervention Clients
n=60 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=78 Participants
Clients receiving HIV care at the control clinics.
Change in Self-efficacy for Client-centered Communication From Baseline Among Providers
Baseline
3.08 score on a scale
Standard Deviation 0.75
3.15 score on a scale
Standard Deviation 0.40
Change in Self-efficacy for Client-centered Communication From Baseline Among Providers
6-month
3.24 score on a scale
Standard Deviation 0.54
3.26 score on a scale
Standard Deviation 0.43
Change in Self-efficacy for Client-centered Communication From Baseline Among Providers
12-month
2.98 score on a scale
Standard Deviation 0.53
3.28 score on a scale
Standard Deviation 0.49

SECONDARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The provider cohort only is analyzed for this outcome

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)

Outcome measures

Outcome measures
Measure
Intervention Clients
n=60 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=78 Participants
Clients receiving HIV care at the control clinics.
Change in Empathy Towards Clients From Baseline Among Providers
Baseline
3.77 score on a scale
Standard Deviation 0.38
3.62 score on a scale
Standard Deviation 0.38
Change in Empathy Towards Clients From Baseline Among Providers
6-month
3.86 score on a scale
Standard Deviation 0.45
3.54 score on a scale
Standard Deviation 0.32
Change in Empathy Towards Clients From Baseline Among Providers
12-month
3.91 score on a scale
Standard Deviation 0.30
3.63 score on a scale
Standard Deviation 0.44

SECONDARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The provider cohort only is analyzed for this outcome

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)

Outcome measures

Outcome measures
Measure
Intervention Clients
n=60 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=78 Participants
Clients receiving HIV care at the control clinics.
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
1.99 score on a scale
Standard Deviation 0.62
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 0.80
1.86 score on a scale
Standard Deviation 0.75
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
2.06 score on a scale
Standard Deviation 0.81

SECONDARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The client cohort only is analyzed for this outcome

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)

Outcome measures

Outcome measures
Measure
Intervention Clients
n=105 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=108 Participants
Clients receiving HIV care at the control clinics.
Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients
Baseline
2.33 score on a scale
Standard Deviation 0.86
2.25 score on a scale
Standard Deviation 0.69
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
2.32 score on a scale
Standard Deviation 0.62
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
2.88 score on a scale
Standard Deviation 0.43

SECONDARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The client cohort only is analyzed for this outcome.

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)

Outcome measures

Outcome measures
Measure
Intervention Clients
n=105 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=108 Participants
Clients receiving HIV care at the control clinics.
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
2.19 score on a scale
Standard Deviation 0.97
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 0.90
2.69 score on a scale
Standard Deviation 0.79
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
2.75 score on a scale
Standard Deviation 0.39

SECONDARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The client cohort only is analyzed for this outcome.

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)

Outcome measures

Outcome measures
Measure
Intervention Clients
n=105 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=108 Participants
Clients receiving HIV care at the control clinics.
Change in Satisfaction With HIV Care From Baseline Among Clients
Baseline
3.38 score on a scale
Standard Deviation 0.55
3.26 score on a scale
Standard Deviation 0.35
Change in Satisfaction With HIV Care From Baseline Among Clients
6-month
3.29 score on a scale
Standard Deviation 0.60
3.19 score on a scale
Standard Deviation 0.40
Change in Satisfaction With HIV Care From Baseline Among Clients
12-month
3.09 score on a scale
Standard Deviation 0.59
3.27 score on a scale
Standard Deviation 0.33

SECONDARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The client cohort only is analyzed for this outcome.

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).

Outcome measures

Outcome measures
Measure
Intervention Clients
n=105 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=108 Participants
Clients receiving HIV care at the control clinics.
Change in Total HIV Stigma Score Among Clients
Baseline
0.60 score on a scale
Standard Deviation 0.65
0.60 score on a scale
Standard Deviation 0.57
Change in Total HIV Stigma Score Among Clients
6-month
0.59 score on a scale
Standard Deviation 0.66
0.58 score on a scale
Standard Deviation 0.55
Change in Total HIV Stigma Score Among Clients
12-month
0.45 score on a scale
Standard Deviation 0.64
0.71 score on a scale
Standard Deviation 0.50

SECONDARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The client cohort only is analyzed for this outcome.

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).

Outcome measures

Outcome measures
Measure
Intervention Clients
n=105 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=108 Participants
Clients receiving HIV care at the control clinics.
Change in Anticipated HIV Stigma Among Clients
Baseline
0.79 score on a scale
Standard Deviation 0.89
0.67 score on a scale
Standard Deviation 0.89
Change in Anticipated HIV Stigma Among Clients
6-month
0.80 score on a scale
Standard Deviation 0.88
0.57 score on a scale
Standard Deviation 0.73
Change in Anticipated HIV Stigma Among Clients
12-month
0.59 score on a scale
Standard Deviation 0.88
0.90 score on a scale
Standard Deviation 0.63

SECONDARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The client cohort only is analyzed for this outcome.

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).

Outcome measures

Outcome measures
Measure
Intervention Clients
n=105 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=108 Participants
Clients receiving HIV care at the control clinics.
Change in Enacted HIV Stigma Among Clients
Baseline
0.21 score on a scale
Standard Deviation 0.52
0.14 score on a scale
Standard Deviation 0.43
Change in Enacted HIV Stigma Among Clients
6-month
0.16 score on a scale
Standard Deviation 0.46
0.14 score on a scale
Standard Deviation 0.42
Change in Enacted HIV Stigma Among Clients
12-month
0.12 score on a scale
Standard Deviation 0.39
0.17 score on a scale
Standard Deviation 0.47

SECONDARY outcome

Timeframe: Baseline, 6-months, and 12-months

Population: The client cohort only is analyzed for this outcome.

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).

Outcome measures

Outcome measures
Measure
Intervention Clients
n=105 Participants
Clients receiving HIV care at the intervention clinics. 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.
Control Clients
n=108 Participants
Clients receiving HIV care at the control clinics.
Change in Internalized HIV Stigma Among Clients
Baseline
0.78 score on a scale
Standard Deviation 1.13
0.99 score on a scale
Standard Deviation 0.85
Change in Internalized HIV Stigma Among Clients
6-month
0.82 score on a scale
Standard Deviation 1.14
1.01 score on a scale
Standard Deviation 0.95
Change in Internalized HIV Stigma Among Clients
12-month
0.62 score on a scale
Standard Deviation 0.99
1.04 score on a scale
Standard Deviation 0.61

Adverse Events

Intervention Providers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention Clients

Serious events: 1 serious events
Other events: 0 other events
Deaths: 5 deaths

Control Providers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Clients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure
Intervention Providers
n=61 participants at risk
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.
Intervention Clients
n=119 participants at risk
Clients receiving HIV care at the intervention arm clinics.
Control Providers
n=83 participants at risk
HIV care providers and staff at the control clinics (no intervention).
Control Clients
n=119 participants at risk
Clients receiving HIV care at the control clinics (no intervention).
Psychiatric disorders
Mental health
0.00%
0/61 • 12 months
0.84%
1/119 • Number of events 1 • 12 months
0.00%
0/83 • 12 months
0.00%
0/119 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Katelyn Sileo

Boston College

Phone: 617-552-3205

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place