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

NCT05178979 | Completed Results

• 2 other identifiers: K01MH121663-01A11K01MH121663-01A1
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Change in Self-efficacy for Client-centered Communication From Baseline Among Providers

  Baseline, 6-months, and 12-months

• Change in Empathy Towards Clients From Baseline Among Providers

  Baseline, 6-months, and 12-months

• Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers

  Baseline, 6-months, and 12-months

• Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients

  Baseline, 6-months, and 12-months

• Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients

  Baseline, 6-months, and 12-months

Study Arms (4)

Intervention Providers

EXPERIMENTAL

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)

Intervention Clients

EXPERIMENTAL

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)

Control Providers

NO INTERVENTION

The control arm will receive no training. This cohort is of HIV care providers and staff at clinics receiving no intervention.

Control Clients

NO INTERVENTION

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.

Interventions

Training for HIV care providers (effect on provider outcomes) BEHAVIORAL

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; Intervention Providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV care provider at the selected clinics, including HIV medical and clinical officers, nurses, midwives, linkage facilitators, counselors.
• years of age or older
• Fluent in English or Luganda
• Patient Cohort:
• 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;
• years of age or an emancipated minor
• Fluent in Luganda or English

Sponsors & Collaborators

• The University of Texas at San Antonio: lead
• Makerere University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Luwero Health HCIV

Luwero, Uganda

Location

Namayumba Health HCIV

Namayumba, Uganda

Location

Related Publications (2)

• Sileo KM, Wanyenze RK, Anecho A, Luttinen RL, Weston K, Mukasa B, Mukama SC, Vermund SH, Dworkin SL, Dovidio JF, Taylor BS, Kershaw TS. Acceptability, feasibility, and factors affecting implementation of a gender-sensitivity training for HIV providers and staff in Uganda: a mixed methods, quasi-experimental controlled pilot trial. BMC Public Health. 2025 May 24;25(1):1925. doi: 10.1186/s12889-025-23008-4.

  PMID: 40413446 DERIVED

• Sileo KM, Wanyenze RK, Anecho A, Luttinen R, Semei C, Mukasa B, Musoke W, Vermund SH, Dworkin SL, Dovidio JF, Taylor BS, Kershaw TS. Protocol for the pilot quasi-experimental controlled trial of a gender-responsive implementation strategy with providers to improve HIV outcomes in Uganda. Pilot Feasibility Stud. 2022 Dec 23;8(1):264. doi: 10.1186/s40814-022-01202-0.

  PMID: 36564795 DERIVED

Limitations and Caveats

This study is a pilot trial. Therefore, the results reported are exploratory because they are underpowered. A full-scale efficacy trial is needed to replicate these results.

Results Point of Contact

• Title: Katelyn Sileo
• Organization: Boston College

sileoka@bc.edu

617-552-3205

Study Officials

• Katelyn M Sileo, PhD, MPH

  University of Texas at San Antonio

  PRINCIPAL INVESTIGATOR

• Rhoda K. Wanyenze, MBChB, MPH, PhD

  Makerere School of Pubic Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: January 5, 2022
• Study Start: December 31, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• Access Criteria: Upon request from the PI

Locations

UG (2)