HIV (Human Immunodeficiency Virus)NCT07881575
Testing a Multi-Level Approach to Reduce Stigma for Women Living With HIV
A study testing Labda Siku Moja and Total Facility Approach in people with HIV (Human Immunodeficiency Virus), run by RTI International at 1 site in Tanzania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- What is being tested?
- Labda Siku Moja and Total Facility Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 1 siteTanzania
- Study dates
- Mar 2027to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, living with HIV and receiving services at one of the 20 selected HCF/CTCs
- Age 18 years old and above
- Evidence of care engagement challenge, defined as either:
- Missed a scheduled clinic visit in the past 12 months, or
- Attended the most recent clinic visit 14 or more days late
- Routinely receiving services at the HCF where recruited
Show all 9Show fewer
- Not anticipating changing HCF in the next 12 months
- Willing to provide whole-blood samples for viral load testing (baseline and 12 months)
- Willing and able to provide informed consent.
Who cannot join
- Unable to visit the facility during recruitment period
- Too medically unwell at recruitment to safely complete study procedures (e.g., severe weakness, high fever, severe pain, vomiting/dehydration, shortness of breath, confusion).
- Severe mental health condition, acute distress, intoxication, or cognitive impairment that prevents informed consent or reliable participation. (This criterion is applied observationally by the research assistant at the point of contact and does not involve a screening instrument, a standardized assessment or a review of the client's mental health diagnoses. It is a judgement about capacity to engage with the consent conversation on that day, not a judgement about whether the woman has a mental health condition.)
- Psychiatric emergency at recruitment (e.g., active suicidal intent/plan, severe agitation/psychosis) requiring urgent care.
- Communication barrier that makes consent or data collection not feasible with available accommodations.
- Refuses to provide minimum locator/tracing information needed for follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tanzania1 site
RTI International Study Office
Dar es Salaam
Jessie K Mwambo, MD, +255 754-333-9747, jessiekilonzo@gmail.com
Jacqueline Ndirangu, MSc, +254-791-814-973, jndirangu@rti.org
About this study
Official title: A Hierarchical Factorial Cluster-randomized Controlled Trial to Evaluate a Multi-level Intervention to Address Stigma for Women Living With HIV.
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.
Read the detailed description
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 women living with HIV (WLWH) through ethnodrama-based group sessions guided by motivational interviewing techniques.
Using a hybrid type 1 effectiveness-implementation design, a hierarchical 2×2 factorial cluster-randomized controlled trial will be conducted 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.
- Conditions
- HIV (Human Immunodeficiency Virus)
- Being tested
- Labda Siku Moja, Total Facility Approach
- Keywords
- HIV, Stigma, Women, Tanzania, Quality of Life, Viral Suppression, Multilevel intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labda Siku MojaBehavioural
An internalized stigma reduction intervention using ethnodrama videos and guided group discussion with motivational interviewing techniques.
Total Facility ApproachBehavioural
Facility-level stigma reduction intervention using participatory training plus follow-on action planning led by facility champions
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | No intervention | Standard of care HIV (usual) HIV treatment and care services only |
| SOC + Labda Siku Moja Intervention (LSM) | Experimental | Standard of care HIV (usual) HIV treatment and care services only + internalized stigma reduction intervention for women living with HIV Receives: Behavioral: Labda Siku Moja |
| SOC + Total Facility Approach (TFA) | Experimental | Standard of care HIV (usual) HIV treatment and care services only + facility-level stigma reduction intervention Receives: Behavioral: Total Facility Approach |
| TFA + LSM | Experimental | Facility-level stigma reduction intervention + internalized stigma reduction intervention for women living with HIV Receives: Behavioral: Labda Siku Moja; Behavioral: Total Facility Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months after intervention
HIV Viral Load Suppression
Percentage of participants with HIV viral load <50 copies/mL
Measured: Baseline to 12 months after intervention
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: Baseline to 3 and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startMar 2027 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The Interventional Study Model is Factorial Assignment using a hierarchical 2 × 2 factorial cluster-randomized design.
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Laura Nyblade, RTI International
- Investigators
- Laura W Nyblade, PhD, Principal investigator, RTI InternationalJessie K Mwambo, MD, Principal investigator, Muhimbili National Hospital/MUHAS/RTI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881575
- Sponsor's protocol ID
- MNH/IRB/VOL.I/2025/127
- Other IDs
- R01MH142180, STUDY00023403
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hierarchical Factorial Cluster-randomized Controlled Trial to Evaluate a Multi-level Intervention to Address Stigma for Women Living With HIV.
- ClinicalTrials.gov ID
- NCT07881575
- Acronym / sponsor ID
- MNH/IRB/VOL.I/2025/127
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- HIV, Stigma, Women, Tanzania, Quality of Life, Viral Suppression, Multilevel intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 women living with HIV (WLWH) through ethnodrama-based group sessions guided by motivational interviewing techniques.
Using a hybrid type 1 effectiveness-implementation design, a hierarchical 2×2 factorial cluster-randomized controlled trial will be conducted 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The Interventional Study Model is Factorial Assignment using a hierarchical 2 × 2 factorial cluster-randomized design.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | No intervention | –Standard of care HIV (usual) HIV treatment and care services only |
| SOC + Labda Siku Moja Intervention (LSM) | Experimental | Behavioral: Labda Siku MojaStandard of care HIV (usual) HIV treatment and care services only + internalized stigma reduction intervention for women living with HIV |
| SOC + Total Facility Approach (TFA) | Experimental | Behavioral: Total Facility ApproachStandard of care HIV (usual) HIV treatment and care services only + facility-level stigma reduction intervention |
| TFA + LSM | Experimental | Behavioral: Labda Siku Moja, Behavioral: Total Facility ApproachFacility-level stigma reduction intervention + internalized stigma reduction intervention for women living with HIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female, living with HIV and receiving services at one of the 20 selected HCF/CTCs
- Age 18 years old and above
- Evidence of care engagement challenge, defined as either:
- Missed a scheduled clinic visit in the past 12 months, or
- Attended the most recent clinic visit 14 or more days late
Key exclusion criteria (6 listed)
- Unable to visit the facility during recruitment period
- Too medically unwell at recruitment to safely complete study procedures (e.g., severe weakness, high fever, severe pain, vomiting/dehydration, shortness of breath, confusion).
- Severe mental health condition, acute distress, intoxication, or cognitive impairment that prevents informed consent or reliable participation. (This criterion is applied observationally by the research assistant at the point of contact and does not involve a screening instrument, a standardized assessment or a review of the client's mental health diagnoses. It is a judgement about capacity to engage with the consent conversation on that day, not a judgement about whether the woman has a mental health condition.)
- Psychiatric emergency at recruitment (e.g., active suicidal intent/plan, severe agitation/psychosis) requiring urgent care.
- Communication barrier that makes consent or data collection not feasible with available accommodations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labda Siku MojaAn internalized stigma reduction intervention using ethnodrama videos and guided group discussion with motivational interviewing techniques. | Behavioural | SOC + Labda Siku Moja Intervention (LSM), TFA + LSM |
| Total Facility ApproachFacility-level stigma reduction intervention using participatory training plus follow-on action planning led by facility champions | Behavioural | SOC + Total Facility Approach (TFA), TFA + LSM |
Primary outcome
Change in quality of life among women living with HIV (participants), measured using the WHO Quality of Life-Brief (WHOQOL-BREF).
Time frame: Baseline to 12 months after intervention
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.
HIV Viral Load Suppression
Time frame: Baseline to 12 months after intervention
Percentage of participants with HIV viral load <50 copies/mL
3 secondary outcomes
Change in self-esteem, as measured by the Swahili version of the Rosenberg Self-Esteem Scale
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)
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).
Time frame: Baseline to 3 and 6 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura W Nyblade, PhD principal investigator
RTI International
Jessie K Mwambo, MD principal investigator
Muhimbili National Hospital/MUHAS/RTI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labda Siku Moja and Total Facility Approach in people with HIV (Human Immunodeficiency Virus), run by RTI International at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Nyblade Nyblade, PhD (+1 202 641 2388, lynblade@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life among women living with HIV (participants), measured using the WHO Quality of Life-Brief (WHOQOL-BREF). (time frame: Baseline to 12 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.