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

A Gender Transformative Implementation Strategy With Providers to Improve HIV

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Training for HIV care providers (effect on provider outcomes)

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).

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Luwero, Uganda
    • Luwero Health HCIV
  • Namayumba, Uganda
    • Namayumba Health HCIV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Providers; HIV care providers and staff in the intervention arm will receive up to 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.	Behavioral: Training 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.
Experimental: Intervention Clients; In the intervention arm clinics, we will enroll a cohort of people living with HIV receiving HIV treatment at the clinics. While they do not receive a direct intervention, we measure change in their outcomes to assess if the provider training intervention has effects on client outcomes.	Behavioral: Training 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.
No Intervention: Control Providers; The control arm will receive no training. This cohort is of HIV care providers and staff at clinics receiving no intervention.
No Intervention: Control Clients; The control arm will receive no training. This cohort is of people living with HIV receiving HIV treatment at the control clinics, receiving no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline, 6-months, and 12-months
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)	Baseline, 6-months, and 12-months
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)	Baseline, 6-months, and 12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline, 6-months, and 12-months
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)	Baseline, 6-months, and 12-months
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)	Baseline, 6-months, and 12-months
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)	Baseline, 6-months, and 12-months
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)	Baseline, 6-months, and 12-months
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)	Baseline, 6-months, and 12-months
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).	Baseline, 6-months, and 12-months
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).	Baseline, 6-months, and 12-months
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).	Baseline, 6-months, and 12-months
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).	Baseline, 6-months, and 12-months

Collaborators and Investigators

• Sponsor: The University of Texas at San Antonio
• Collaborators: National Institute of Mental Health (NIMH); Makerere University
• Investigators: Principal Investigator: Katelyn M Sileo, PhD, MPH, University of Texas at San Antonio; Principal Investigator: Rhoda K. Wanyenze, MBChB, MPH, PhD, Makerere School of Pubic Health

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: K01MH121663-01A1 (U.S. NIH Grant/Contract); 1K01MH121663-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Quantitative data collected in this trial (baseline, follow-up assessments) will be made available, under the following provisions: (1)The data will be fully de-identified; (2) Access to the data will be made available first to researchers and their students at the two collaborating institutions (within 3 years of study completion): The University of Texas at San Antonio and the Makerere University School of Public Health (MakSPH); 3) 5 years after study completion, data will be made available to those requesting access outside of the collaborating institutions. Qualitative data collected as part of this trial will not be made available, as it is difficult to fully de-identify and to interpret without knowledge of the context.
• IPD Sharing Time Frame: 3 years after study completion for researchers and students within the collaborating institutions and 5 years after study completion for those outside of the collaborating institutions upon request
• IPD Sharing Access Criteria: Upon request from the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No