An interventional study of Labda Siku Moja and Total Facility Approach in HIV (Human Immunodeficiency Virus), sponsored by RTI International. Not yet recruiting at 1 site in Tanzania. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by RTI International · Not applicable, Interventional, and Treatment
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.
This study will evaluate the effectiveness and implementation of a multilevel HIV stigma reduction intervention that integrates two evidence-based, culturally tailored components previously adapted for Tanzania: the Total Facility Approach (TFA) to reduce health care facility (HCF) stigma among clinical and nonclinical staff, and Labda Siku Moja (LSM) to reduce internalized stigma among WLWH through ethnodrama-based group sessions guided by motivational interviewing techniques.
Using a hybrid type 1 effectiveness-implementation design, we will conduct a hierarchical 2×2 factorial cluster-randomized controlled trial in 20 Ministry of Health and non-profit faith-based HCF offering ART in Dar es Salaam region. Facilities will be randomized to TFA or standard of care (SOC). Within each facility, 34 WLWH who have missed clinic visits or attended the most recent clinic visit 14 or more days late (N=680) will be individually randomized to receive LSM or SOC. Primary outcomes are QoL (WHOQOL-BREF) and viral suppression (\<50 copies/ml) measured over 12 months.
A prospective mixed methods process evaluation will assess implementation fidelity, mechanisms and mediators of change (including stigma and psychosocial constructs), contextual influences on outcomes, and preliminary intervention costs using programmatic data, surveys, qualitative focus groups, and micro-costing methods. A Study Advisory Group (SAG) comprising WLWH, community partners, providers, and Ministry of Health representatives will guide intervention refinement, interpret findings, and develop recommendations to optimize the study for broader implementation. If effective, the study will provide scalable evidence to improve QoL and viral suppression among WLWH and advance Tanzania's and global goals for ending the HIV epidemic.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's planned enrollment of 680 is above the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →RTI International is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
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
Behavioral: Labda Siku Moja
Standard of care HIV (usual) HIV treatment and care services only + facility-level stigma reduction intervention
Behavioral: Total Facility Approach
Facility-level stigma reduction intervention + internalized stigma reduction intervention for women living with HIV
Behavioral: Labda Siku Moja · Behavioral: Total Facility Approach
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
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.
Time frame: Baseline to 12 months after intervention
HIV Viral Load Suppression
Percentage of participants with HIV viral load \<50 copies/mL
Time frame: Baseline to 12 months after intervention
Change in self-esteem, as measured by the Swahili version of the Rosenberg Self-Esteem Scale
Scores range from 10 to 40, with lower scores indicating lower self-esteem and higher scores indicating higher self-esteem
Time frame: 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)
Scores range from 0 to 27, with lower scores indicating less depressive symptoms and higher scores indicating more depressive symptoms
Time frame: 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).
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.
Time frame: Baseline to 3 and 6 months after intervention
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome →
RTI International