This Trial Aims to Evaluate the Effect of Two HIV Stigma Reduction Interventions at the Health Facility Level and the Individual Level for People Struggling to Access and Remain in Care in Uganda.

NCT07708519 | Active Not Recruiting

• 2 other identifiers: IDI-REC-2024-92R01TW012672
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of the Ssinga Nze study ("Ssinga Nze" means "If it were me" in Luganda, the local language) is to reduce HIV-related stigma and improve access to HIV care, including antiretroviral treatment (ART) and HIV pre-exposure prophylaxis (PrEP), as well as increase linkage to care among people affected by HIV in Uganda. The HIV pandemic has a disproportionate impact on populations at risk of HIV, or living with HIV, who struggle to access and remain in HIV prevention or treatment. Stigma is 'a behavioral manifestation of self or societal disapproval of a condition affecting those who are stigmatized.' HIV-associated stigma is 'negative attitudes and beliefs about people with HIV.' The National Institutes of Health recognizes it as a critical and complex barrier to the uptake and use of PrEP and ART. Much work remains in addressing HIV-related stigma and scaling up treatment and prevention coverage for people affected by HIV. Two evidence-based HIV stigma reduction interventions are available -- (1) Health Policy Plus (HP+) Total Facility Approach (TFA) to Stigma Reduction (a clinic-level intervention) and (2) HIV Education, Empathy and Empowerment (HIVE3) (an individual-level intervention) -- but these have not been adapted and implemented for people affected by HIV in sub-Saharan Africa. HP+ and HIVE3 are complementary interventions that could be combined to reduce stigma at the health facility and individual levels. However, research is needed to determine if the adapted multi-level HP+/HIVE3 intervention, Ssinga Nze (which means "If it was me" in Luganda), reduces HIV-related stigma and improves HIV outcomes for people affected by HIV. To explore these questions, we will conduct a randomized wait-list controlled trial to evaluate the preliminary effectiveness of Ssinga Nze on PrEP adherence and viral suppression, compared to the standard of care, using a status-neutral approach-that is, engagement in care regardless of HIV status. We will also employ qualitative methods to examine the mechanisms of intervention delivery. By leveraging the interdisciplinary expertise of our multi-national research team and working at four health facilities in Central Uganda (Entebbe Regional Referral Hospital, Kisenyi Health Center IV, Kitebi Health Center III and Nsangi Health Center III), we will implement the following Specific Aims: Aim 1: Adapt the multilevel PRISM stigma reduction intervention to address HIV-related stigma for populations struggling to access and remain in HIV prevention and treatment in Uganda (intervention adaptation). Aim 2: Conduct a pilot hybrid type 1 effectiveness-implementation trial to test the preliminary effectiveness of the adapted multilevel Ssinga Nze HIV-related stigma reduction intervention on (a) HIV pre-exposure prophylaxis (PrEP) adherence or (b) viral suppression among people with HIV who struggle to remain on treatment using a status-neutral approach (intervention implementation). Aim 3: Evaluate the implementation of Ssinga Nze using qualitative methods (intervention evaluation). Clinic-level implementation outcomes include adoption, fidelity, and sustainability, assessed through key informant interviews, training attendance sheets, observation checklists, and rapid feedback surveys. Individual-level outcomes include: (1) PrEP adherence at 3 months post-intervention, assessed by urine tenofovir levels (primary outcome), (2) viral suppression defined as HIV viral load below 50 copies/mL, and (3) stigma reduction at 3 months post-intervention (secondary outcomes). This multi-level approach to implementing stigma reduction interventions will improve PrEP and antiretroviral treatment (ART) adherence outcomes among people affected by HIV, build stigma research capacity in Uganda, and generate actionable data for scale-up and program implementation in Uganda and sub-Saharan Africa.

Conditions

HIV; Stigma

Keywords

Stigma reduction; Multi-level intervention; HIV prevention; HIV treatment

Outcome Measures

Primary Outcomes (1)

• PrEP adherence

  PrEP adherence, measured by urine tenofovir detection (≥1,500 ng/ml), will be compared between intervention and wait-list control groups using a generalized estimating equations (GEE) model with identity link, exchangeable correlation structure and robust variance estimates.

  Three months

Secondary Outcomes (2)

• HIV viral suppression

  Three months

• HIV-related stigma reduction in health facilities

  Three months post-intervention

Study Arms (2)

Ssinga Nze - a multi-level stigma reduction intervention

ACTIVE COMPARATOR

Two health facilities in Central Uganda (Entebbe Regional Referral Hospital and Kisenyi Health Center IV) were randomly assigned to receive the intervention, which comprises two complementary stigma reduction interventions. They are (1) Health Policy Plus (HP+) Total Facility Approach (TFA) to Stigma Reduction (a clinic-level intervention), and (2) HIV Education, Empathy and Empowerment (HIVE3) (an individual-level intervention). They were combined to reduce health facility- and individual-level stigma and improve PrEP adherence and viral suppression, compared with standard of care, using a status-neutral approach. Trained study peers will recruit research volunteers from the catchment areas of intervention facilities. After providing informed consent, basic sociodemographic data will be collected, and a behavioral HIV risk assessment will be conducted to determine study eligibility. HIVE3/HP+ and ART/PrEP will be provided at intervention clinics at no cost.

Behavioral: Health Policy Plus (HP+) Total Facility Approach (TFA) to Stigma Reduction, a clinic-level intervention and HIV Education, Empathy and Empowerment (HIVE3), an individual-level intervention.

Wait-list control

PLACEBO COMPARATOR

Standard of care services, including counselling, addressing stigma and discrimination, condom use, prevention and management of sexually transmitted infections, responsible alcohol consumption, and gender-based violence, in addition to the provision of ART and PrEP at clinics not yet implementing the intervention.

Behavioral: Health Policy Plus (HP+) Total Facility Approach (TFA) to Stigma Reduction, a clinic-level intervention and HIV Education, Empathy and Empowerment (HIVE3), an individual-level intervention.

Interventions

Health Policy Plus (HP+) Total Facility Approach (TFA) to Stigma Reduction, a clinic-level intervention and HIV Education, Empathy and Empowerment (HIVE3), an individual-level intervention. BEHAVIORAL

The HP+ HIV stigma-reduction "Total Facility" Approach (TFA) is grounded in behavior change informed by social cognitive theory principles. It focuses on improving HCF staff capacity through participatory ISD-reduction training workshops for all staff and by integrating a stigma-reduction focus into institutional processes and structures. HP+ addresses immediately actionable drivers of ISD in health facilities, including lack of awareness of stigma, fear, attitudes, beliefs, and myths and misconceptions through participatory training and facility-developed stigma-reduction activities. The HIV Empathy, Empowerment, and Education (HIVE3) aims to increase peer support, decrease social isolation, and reduce the effects of HIV-related stigma on HIV self-care and healthcare-seeking behaviors, using the tenets of peer support defined by the Dennis Peer Support model, including emotional, appraisal, and informational support.

Ssinga Nze - a multi-level stigma reduction intervention; Wait-list control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Self-identification as a sex worker
• Able and willing to provide written informed consent

You may not qualify if:

• unwilling to provide written informed consent for study procedures
• have a physical or mental condition that prohibits informed consent and participation in study procedures.

Sponsors & Collaborators

• Makerere University: lead
• Fogarty International Center of the National Institute of Health: collaborator
• RTI International: collaborator

Study Sites (1)

Infectious Diseases Institute, Makerere University

Kampala, Uganda

Location

MeSH Terms

Conditions

Social Stigma

Interventions

Health Policy

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Public Policy; Social Control Policies; Policy; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid type 1 effectiveness-implementation trial

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: November 27, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years
• Access Criteria: The data generated through this project can be shared upon request in accordance with Makerere University policies. Depending on these policies, data may be transferred to other researchers or institutions under the terms of a data-sharing agreement.

Locations

UG (1)