Clinical trial NCT05178979: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: The University of Texas at San Antonio
Sponsor class: OTHER
Collaborators: name: Makerere University
name: National Institute of Mental Health (NIMH)
First posted: 2022-01-05
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Change in Proportion of Missed Antiretroviral (ARV) Doses From Baseline Among Clients
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care)
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Competence for Gender-sensitive Care From Baseline Among Providers
timeFrame: Baseline, 6-months, and 12-months
Secondary outcomes:
measure: Change in Self-efficacy for Client-centered Communication From Baseline Among Providers
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Empathy Towards Clients From Baseline Among Providers
timeFrame: Baseline, 6-months, and 12-months
measure: Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Satisfaction With HIV Care From Baseline Among Clients
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Total HIV Stigma Score Among Clients
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Anticipated HIV Stigma Among Clients
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Enacted HIV Stigma Among Clients
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Internalized HIV Stigma Among Clients
timeFrame: Baseline, 6-months, and 12-months
Other outcomes:
Locations:
city: Luwero
country: Uganda
facility: Luwero Health HCIV
city: Namayumba
country: Uganda
facility: Namayumba Health HCIV
Study officials:
affiliation: University of Texas at San Antonio
name: Katelyn M Sileo, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere School of Pubic Health
name: Rhoda K. Wanyenze, MBChB, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: