## Protocol Section
### Identification Module
**NCT ID:** NCT05178979

**Brief Title:** A Gender Transformative Implementation Strategy With Providers to Improve HIV Outcomes in Uganda

**Official Title:** A Gender Transformative Implementation Strategy With Providers to Improve HIV

#### Organization Study ID Info
**ID:** K01MH121663-01A1
**Link:** https://reporter.nih.gov/quickSearch/K01MH121663-01A1
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas at San Antonio
#### Secondary ID Infos
**ID:** 1K01MH121663-01A1
**Link:** https://reporter.nih.gov/quickSearch/1K01MH121663-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2023-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-05

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-04

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-12-31

**Type:** ACTUAL

**Status Verified Date:** 2023-01

#### Study First Post Date
**Date:** 2022-01-05
**Type:** ACTUAL
**Study First Submit Date:** 2021-11-15
**Study First Submit QC Date:** 2022-01-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Makerere University

**Class:** NIH

**Name:** National Institute of Mental Health (NIMH)

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Texas at San Antonio

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- HIV

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**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.

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 383

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Training

**Label:** Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control arm will receive no training.

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** 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.

**Name:** Training

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Change in proportion of missed antiretroviral (ARV) doses from baseline among patients

**Time Frame:** 6-months

**Description:** 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)

**Measure:** Change in proportion of missed ARV doses from baseline among patients

**Time Frame:** 12-months

**Description:** AACTG Adherence Instruments, self-reported questionnaire on medication adherence from the Adult AIDS Clinical Trials Group (AACTG); operationalized as having taken 90% of doses as prescribed in the reporting period (dichotomous measure: 0 not adherent; 1 adherent)

**Measure:** Change in antiretroviral treatment (ART) adherence (90% of doses taken as prescribed) from baseline among patients

**Time Frame:** 6-months

**Description:** AACTG Adherence Instruments, self-reported questionnaire on medication adherence from the Adult AIDS Clinical Trials Group (AACTG); operationalized as having taken 90% of doses as prescribed in the reporting period (dichotomous measure: 0 not adherent; 1 adherent)

**Measure:** Change in ART adherence (90% of doses taken as prescribed) from baseline among patients

**Time Frame:** 12-months

**Description:** Number of missed visits accrued based on scheduled visits determined by Ministry of Health clinical guidelines, collected through clinic records

**Measure:** Change in number of missed visits accrued (count measure) from baseline among patients

**Time Frame:** 6-months

**Description:** Number of missed visits accrued based on scheduled visits determined by Ministry of Health clinical guidelines, collected through clinic records

**Measure:** Change in number of missed visits accrued (count measure) from baseline among patients

**Time Frame:** 12-months

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

**Measure:** Change in clinic visit adherence from baseline among patients

**Time Frame:** 6-months

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

**Measure:** Change in clinic visit adherence from baseline among patients

**Time Frame:** 12-months

#### Secondary Outcomes

**Description:** Viral load

**Measure:** Change in viral load from baseline to 12 months follow-up among patients

**Time Frame:** 12-months

**Description:** Adapted from Consumer Satisfaction Survey and User's Manual, self-reported questionnaire, using version previously adapted for HIV populations - Total possible score using mean scoring: 0-4 (high score = better outcome)

**Measure:** Change in overall satisfaction with HIV clinical care from baseline among patients

**Time Frame:** 6-months

**Description:** Adapted from Consumer Satisfaction Survey and User's Manual, self-reported questionnaire, using version previously adapted for HIV populations - Total possible score using mean scoring: 0-4 (high score = better outcome)

**Measure:** Change in overall satisfaction with HIV clinical care from baseline among patients

**Time Frame:** 12-months

**Description:** 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)

**Measure:** Change in gender awareness from baseline among providers

**Time Frame:** 6-months

**Description:** 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)

**Measure:** Change in gender awareness from baseline among providers

**Time Frame:** 12-months

**Description:** Awareness of societal gender inequities in the provider cohort, adapted to be specific to gender from the Self-Rated Cultural Competence Instrument for Primary Care Providers Total possible score using mean scoring: 1-5 (high score = better outcome)

**Measure:** Change in awareness of gender disparities in HIV care from baseline among providers

**Time Frame:** 6-months

**Description:** Awareness of societal gender inequities in the provider cohort, adapted to be specific to gender from the Self-Rated Cultural Competence Instrument for Primary Care Providers

5-items; total possible score using mean scoring: 1-5 (high score = better outcome)

**Measure:** Change in awareness of gender inequities from baseline among providers

**Time Frame:** 12-months

**Description:** Perceived importance of providing gender sensitive counseling in the provider cohort, adapted to be specific to gender from the Self-Rated Cultural Competence Instrument for Primary Care Providers Total possible score using mean scoring: 1-5 (high score = better outcome)

**Measure:** Change in perceived importance of gender sensitive counseling from baseline among providers

**Time Frame:** 6-months

**Description:** Perceived importance of providing gender sensitive counseling in the provider cohort, adapted to be specific to gender from the Self-Rated Cultural Competence Instrument for Primary Care Providers Total possible score using mean scoring: 1-5 (high score = better outcome)

**Measure:** Change in perceived importance of gender sensitive counseling from baseline among providers

**Time Frame:** 12-months

**Description:** Self-reported change in gender sensitive counseling skills and behaviors in the provider cohort, adapted to be specific to gender from the Self-Rated Cultural Competence Instrument for Primary Care Providers

Total possible score using mean scoring: 1-5 (high score = better outcome)

**Measure:** Change in gender sensitive counseling skills from baseline among providers

**Time Frame:** 6-months

**Description:** Self-reported change in gender sensitive counseling skills and behaviors in the provider cohort, adapted to be specific to gender from the Self-Rated Cultural Competence Instrument for Primary Care Providers

Total possible score using mean scoring: 1-5 (high score = better outcome)

**Measure:** Change in gender sensitive counseling skills from baseline among providers

**Time Frame:** 12-months

**Description:** Self-reported change in self-efficacy to provide gender sensitive patient-centered communication in the provider cohort, adapted to be specific to gender from the Self Efficacy Questionnaire (SE-12)

Total possible score using mean scoring: 1-5 (high score = better outcome)

**Measure:** Change in self-efficacy for gender specific provider communication from baseline among providers

**Time Frame:** 6-months

**Description:** Self-reported change in self-efficacy to provide gender sensitive patient-centered communication in the provider cohort, adapted to be specific to gender from the Self Efficacy Questionnaire (SE-12)

Total possible score using mean scoring: 1-5 (high score = better outcome)

**Measure:** Change in self-efficacy for gender specific provider communication from baseline among providers

**Time Frame:** 12-months

**Description:** Self-reported attitudes towards gender equity measured with the Gender Equitable Men scale

Total possible score using mean scoring: 1-3 (high score = worse outcome)

**Measure:** Change in Gender Equitable Norms from baseline among providers

**Time Frame:** 6-months

**Description:** Self-reported attitudes towards gender equity measured with the Gender Equitable Men scale

Total possible score using mean scoring: 1-3 (high score = worse outcome)

**Measure:** Change in Gender Equitable Norms from baseline among providers

**Time Frame:** 12-months

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Luwero

**Country:** Uganda

**Facility:** Luwero Health HCIV

**Location 2:**

**City:** Namayumba

**Country:** Uganda

**Facility:** Namayumba Health HCIV

#### Overall Officials

**Official 1:**

**Affiliation:** University of Texas at San Antonio

**Name:** Katelyn M Sileo, PhD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Makerere School of Pubic Health

**Name:** Rhoda K. Wanyenze, MBChB, MPH, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Upon request from the PI

**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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**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

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
