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

HIV Clinical Trial

Official title:

A Gender Transformative Implementation Strategy With Providers to Improve HIV

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05178979
• Other study ID #: K01MH121663-01A1
• Secondary ID: 1K01MH121663-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: The University of Texas at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 383
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Uganda	Luwero Health HCIV	Luwero
Uganda	Namayumba Health HCIV	Namayumba

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas at San Antonio	Makerere University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion of missed antiretroviral (ARV) doses from baseline among patients	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)	6-months
Primary	Change in proportion of missed ARV doses from baseline among patients	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)	12-months
Primary	Change in antiretroviral treatment (ART) adherence (90% of doses taken as prescribed) from baseline among patients	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)	6-months
Primary	Change in ART adherence (90% of doses taken as prescribed) from baseline among patients	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)	12-months
Primary	Change in number of missed visits accrued (count measure) from baseline among patients	Number of missed visits accrued based on scheduled visits determined by Ministry of Health clinical guidelines, collected through clinic records	6-months
Primary	Change in number of missed visits accrued (count measure) from baseline among patients	Number of missed visits accrued based on scheduled visits determined by Ministry of Health clinical guidelines, collected through clinic records	12-months
Primary	Change in clinic visit adherence from baseline among patients	Proportion of kept visits/scheduled visits (kept + missed visits) (continuous measure, range =0.0-1.0)	6-months
Primary	Change in clinic visit adherence from baseline among patients	Proportion of kept visits/scheduled visits (kept + missed visits) (continuous measure, range =0.0-1.0)	12-months
Secondary	Change in viral load from baseline to 12 months follow-up among patients	Viral load	12-months
Secondary	Change in overall satisfaction with HIV clinical care from baseline among patients	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)	6-months
Secondary	Change in overall satisfaction with HIV clinical care from baseline among patients	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)	12-months
Secondary	Change in gender awareness 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)	6-months
Secondary	Change in gender awareness 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)	12-months
Secondary	Change in awareness of gender disparities in HIV care from baseline among providers	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)	6-months
Secondary	Change in awareness of gender inequities from baseline among providers	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)	12-months
Secondary	Change in perceived importance of gender sensitive counseling from baseline among providers	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)	6-months
Secondary	Change in perceived importance of gender sensitive counseling from baseline among providers	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)	12-months
Secondary	Change in gender sensitive counseling skills from baseline among providers	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)	6-months
Secondary	Change in gender sensitive counseling skills from baseline among providers	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)	12-months
Secondary	Change in self-efficacy for gender specific provider communication from baseline among providers	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)	6-months
Secondary	Change in self-efficacy for gender specific provider communication from baseline among providers	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)	12-months
Secondary	Change in Gender Equitable Norms from baseline among providers	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)	6-months
Secondary	Change in Gender Equitable Norms from baseline among providers	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)	12-months