A Hierarchical Factorial Cluster-randomized Controlled Trial to Evaluate a Multi-level Intervention to Address Stigma for Women Living With HIV.
Sponsor study identifier
Secondary identifiers
NIH
OTHER · RTI International Office of Research Protection
interventional
680
1 country
1
Study Start
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study will test two approaches to reduce HIV-related stigma and improve quality of life and viral suppression among women living with HIV in Dar es Salaam, Tanzania. Twenty health facilities will take part. One approach will help facility staff reduce stigma, while the other will use group sessions to help women manage internalized stigma. The study will include 680 women living with HIV who have missed clinic visits or attended the most recent clinic visit 14 or more days late and will follow them for 12 months. Researchers will assess quality of life and viral suppression as well as how well the approaches are delivered, what supports or limits their success, and their initial costs. A study advisory group-including women living with HIV, community partners, health care providers, and Ministry of Health representatives-will help refine the approaches, interpret the findings, and guide recommendations for wider use.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2026
Actual (reported)October 19, 2026
Actual (reported)March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in quality of life among women living with HIV (participants), measured using the WHO Quality of Life-Brief (WHOQOL-BREF).
The WHOQOL-BREF is a 26-item self-report questionnaire assessing four domains: Physical Health (7 items; e.g., pain, energy, sleep, mobility), Psychological Health (6 items; e.g., positive/negative feelings, self-esteem, thinking), Social Relationships (3 items; personal relationships, social support, sexual activity), and Environment (8 items; e.g., financial resources, safety, health access, physical environment). Two additional items assess overall quality of life and general health. Each item is rated on a 5-point Likert scale (1-5). Domain scores are calculated by summing item scores and transforming them to a 0-100 scale, with higher scores indicating better perceived quality of life.
Baseline to 12 months after intervention
HIV Viral Load Suppression
Percentage of participants with HIV viral load \<50 copies/mL
Baseline to 12 months after intervention
Change in self-esteem, as measured by the Swahili version of the Rosenberg Self-Esteem Scale
Baseline and 3, 6, and 12 months after intervention
Change in depressive symptoms, as measured by the Swahili version of the Patient Health Questionnaire 9 (PHQ-9)
Baseline and 3, 6, and 12 months after intervention
Intermediate Quality of Life (QoL) among women living with HIV (participants), measured using the WHO Quality of Life-Brief (WHOQOL-BREF).
Baseline to 3 and 6 months after intervention
Standard of care HIV (usual) HIV treatment and care services only
Standard of care HIV (usual) HIV treatment and care services only + internalized stigma reduction intervention for women living with HIV
Standard of care HIV (usual) HIV treatment and care services only + facility-level stigma reduction intervention
An internalized stigma reduction intervention using ethnodrama videos and guided group discussion with motivational interviewing techniques.
Facility-level stigma reduction intervention using participatory training plus follow-on action planning led by facility champions
RTI International Study Office
Dar es Salaam, Tanzania
Laura W Nyblade, PhD
RTI International
Jessie K Mwambo, MD
Muhimbili National Hospital/MUHAS/RTI
First Submitted
October 12, 2026
First Posted
October 19, 2026
Study Start
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Effect of Extra Virgin Olive Oil Consumption on the Occurrence of Cardiovascular Events in Population Living With HIV
Facility-level stigma reduction intervention + internalized stigma reduction intervention for women living with HIV
Contact the study team to confirm eligibility.
Primary Completion
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-10
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