HIV/AIDSNCT05307250
M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma
A study testing Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE and Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR). in people with HIV/AIDS, run by Washington University School of Medicine at 1 site in Uganda.
Trial summary
M-Suubi, a three arm cluster randomized study will examine the effects and cost-effectiveness of a multi-level intervention on HIV viral suppression among 840 adolescents living with HIV (ALHIV) enrolled in 42 secondary schools with a boarding section. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE and Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,851 participants
- Where
- 1 siteUganda
- Study dates
- 15 Mar 2022to 31 Jul 2026
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- HIV-positive adolescents confirmed by medical report
- Prescribed antiretroviral therapy
- Enrolled in primary and secondary schools in a boarding section
- Caregivers of ALHIV who agree to participate in the study
- Teachers, school nurses, and administrators in the target schools who agree to participate in the study
Who cannot join
- A significant cognitive impairment that interferes with the participant's understanding of the informed consent process, or inability/unwillingness to commit to completing the study
Trial locations and contacts
1 site in 1 country.
Uganda1 site
International Center for Child Health and Development Field Office
Masaka
About this study
Official title: M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes Among Adolescents Living With HIV in Uganda
M-Suubi, a three arm cluster randomized study will examine the effects and cost-effectiveness of a multi-level intervention on HIV viral suppression among 840 adolescents living with HIV (ALHIV) enrolled in 42 secondary schools with a boarding section. The investigators will test the effects of a group-based HIV stigma reduction intervention for educators (GED-HIVSR), over and above the effects of multiple family groups with HIV stigma reduction combined with family economic empowerment (MFG-HIVSR plus FEE), relative to Bolstered Standard of Care (BSOC). ALHIV will be randomized at the school level to one of three study arms
Read the detailed description
HIV stigma remains a formidable barrier to HIV treatment adherence among adolescents in Uganda, contributing to low rates of medication adherence and viral suppression (less than 50%) and high attrition from HIV treatment services. ALHIV experience HIV stigma (internalized, anticipated and enacted) in various settings, including families and schools, the most important developmental contexts that should otherwise be supportive of their development and wellbeing. One of the unique features about education in Uganda and other countries in Sub-Saharan Africa is the high proportion (over 60%) of school-going adolescents enrolled in boarding secondary schools - which represent a form of parental opt-in institutionalized care. ALHIV in schools are more disadvantaged and have lower levels of HIV treatment adherence due to high levels of HIV stigma within schools, rigid school structures and routines, lack of adherence support and food insecurity. Within families, HIV stigma is perpetuated in various forms including discrimination and violence, often due to unfounded fears of infection-hence undermining the quality of family relations and supports for ALHIV. Building on our research and current evidence on HIV stigma reduction, the investigators propose a multi-level three-arm cluster randomized study (M-Suubi) with the following specific aims: Aim 1: Examine the impact of M-Suubi on HIV viral suppression (primary outcome); and adherence to HIV treatment (keeping appointments, pharmacy refills, pill counts), and retention in care (secondary outcome); Aim 2: Examine the effect of M-Suubi on HIV stigma (internalized, anticipated and enacted), with secondary analyses to explore hypothesized mechanisms of change (e.g. depression) and intervention mediation; Aim 3: Assess the cost and cost-effectiveness of each intervention condition; and Aim 4: Qualitatively examine: a) participants' experiences with HIV stigma, HIV treatment adherence, and the intervention; and 2) educators' attitudes towards ALHIV, experiences with GED-HIVSR, and program/policy implementation post-training. The study will enroll 840 ALHIV recruited from 42 schools located within the greater Masaka region, heavily affected by HIV (prevalence 12% vs 7.3% national average). M-Suubi will be provided for 20 months, with assessments at baseline, 12, 24 and 36 months. Findings may inform combination intervention efforts to optimize HIV treatment outcomes and engagements in care among ALHIV.
- Conditions
- HIV/AIDS
- Being tested
- Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE, Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR)., Bolstered Standard of Care (BSOC)
- Keywords
- AIDS PREVENTION, ADOLESCENT, ADHERENCE, AIDS/HIV PROBLEM
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEEBehavioural
In addition to the BSOC, ALHIV and their caregivers will participate in a family strengthening intervention plus a family economic empowerment intervention.
MFG is an evidence-based family-centered, group-delivered, evidence-informed, strength-based 10-session (weekly) intervention for children whose families struggle with poverty. Six additional sessions covering HIV stigma stigma-related issues will be added.
ALHIV will receive a YDA with a 1:1 matched savings program at a financial institution accredited by the Bank of Uganda. Each YDA will be opened in the name of the adolescent, with their primary caregiver as a co-signer, until the adolescent turns 18 years. The account will then be matched with money from the program on 1:1 rate.
Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR).Behavioural
In addition to BSOC and MFG-HIVSR+FEE, ALHIV in this arm will receive the school-level HIV stigma reduction intervention targeting teachers, school nurses, matrons, and administrators (headteachers, director of studies) in their schools. GED-HIVSR seeks to impart educators in the intervention schools with HIV related knowledge, provide a safe space for educators to explore their personal values and bias that may promote or hinder their role of supportive individuals and systems for ALHIV, and empower them with knowledge and skills to act as change agents within their schools.
Bolstered Standard of Care (BSOC)Other
All participants (in control and treatment arms) will receive medical and psychosocial support as part of the BSOC. 1) Medical SOC: All public clinics, including our study sites, follow procedures for pediatric ART initiation and monitoring, as outlined in the National Department of Health Guidelines for pediatric HIV care in Uganda. Specifically, immediately after initiation, or if clinically unstable, ALHIV are seen more frequently (weekly to monthly). Laboratory data (VL and CD4 counts) are collected every six months until the patient is stabilized and then annually, using the National Health Laboratory Service standardized protocol. A
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE Receives: Behavioral: Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE; Other: Bolstered Standard of Care (BSOC) |
| Treatment Arm 2 | Experimental | Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR) Receives: Behavioral: Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR).; Other: Bolstered Standard of Care (BSOC) |
| Control Arm | Other | Bolstered Standard of Care (BSOC) Receives: Other: Bolstered Standard of Care (BSOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change HIV viral suppression
Change in viral suppression will be assessed using viral load (VL) data collected from health clinic records. VL will be dichotomized between undetectable /suppression (VL< 40 copies/ml) and detectable/failed viral suppression (VL > =40 copies/ml) levels at each assessment time.
Measured: Baseline 12, 24 and 36 month follow-up
Secondary outcomes (3)
Change in Adherence and retention in care
Change in adolescent Self reported medication adherence. This will be measured using the Adherence and retention in care questionnaire focusing on the pharmacy refills, pill counts and missed appointments at each assessment time.
Measured: Baseline 12, 24 and 36 month follow-up
HIV Stigma Measure for Children
HIV-associated stigma for children will be measured using the HIV Stigma Measure. We will measure the mean score over time. The total score range between 40- 160 with a high score indicating higher levels of perceived HIV-associated stigma.
Measured: Baseline 12, 24 and 36 month follow-up
The Shame Questionnaire for Children
Shame related to living with HIV will be measured using the Shame Questionnaire. We will measure the mean score over time. The total score range between 0 and 16 with a higher score indicating higher levels of HIV-associated shame.
Measured: Baseline 12, 24 and 36 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start15 Mar 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Fred Ssewamala, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307250
- Sponsor's protocol ID
- R01MH126892
- Status last verified
- Aug 2025
- First submitted
- 21 Dec 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per Code of Federal Regulations Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.
Publications
Mutumba M, Ssewamala FM, Nabunya P, Matovu F, Namatovu P, Nattabi J. Stigma, Mental Health, and HIV Adherence: A Cross-sectional Structural Equation Modeling Study Exploring Direct and Indirect Effects Among School-Engaged Ugandan Adolescents Living With HIV. J Assoc Nurses AIDS Care. 2026 Jul-Aug 01;37(4):434-446. doi: 10.1097/JNC.0000000000000645. Epub 2026 May 4.
PubMed 42080911Mutumba M, Ssewamala FM, Nabunya P, Nattabi J, Namirembe R, Matovu F, Namatovu P, Mwebembezi A. HIV-related stigma and academic outcomes: the mediating role of mental health among adolescents living with HIV in Uganda. AIDS Care. 2026 Mar;38(3):571-582. doi: 10.1080/09540121.2025.2606202. Epub 2025 Dec 29.
PubMed 41457981Mutumba M, Ssewamala F, Namirembe R, Sensoy Bahar O, Nabunya P, Neilands T, Tozan Y, Namuwonge F, Nattabi J, Acayo Laker P, Mukasa B, Mwebembezi A. A Multilevel Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes Among Adolescents Living With HIV in Uganda: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 5;11(10):e40101. doi: 10.2196/40101.
PubMed 36197706
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes Among Adolescents Living With HIV in Uganda
- ClinicalTrials.gov ID
- NCT05307250
- Acronym / sponsor ID
- R01MH126892
- Conditions
- HIV/AIDS
- Keywords
- AIDS PREVENTION, ADOLESCENT, ADHERENCE, AIDS/HIV PROBLEM
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,851 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 1 Apr 2022 (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.
M-Suubi, a three arm cluster randomized study will examine the effects and cost-effectiveness of a multi-level intervention on HIV viral suppression among 840 adolescents living with HIV (ALHIV) enrolled in 42 secondary schools with a boarding section. The investigators will test the effects of a group-based HIV stigma reduction intervention for educators (GED-HIVSR), over and above the effects of multiple family groups with HIV stigma reduction combined with family economic empowerment (MFG-HIVSR plus FEE), relative to Bolstered Standard of Care (BSOC). ALHIV will be randomized at the school level to one of three study arms
Detailed description
HIV stigma remains a formidable barrier to HIV treatment adherence among adolescents in Uganda, contributing to low rates of medication adherence and viral suppression (less than 50%) and high attrition from HIV treatment services. ALHIV experience HIV stigma (internalized, anticipated and enacted) in various settings, including families and schools, the most important developmental contexts that should otherwise be supportive of their development and wellbeing. One of the unique features about education in Uganda and other countries in Sub-Saharan Africa is the high proportion (over 60%) of school-going adolescents enrolled in boarding secondary schools - which represent a form of parental opt-in institutionalized care. ALHIV in schools are more disadvantaged and have lower levels of HIV treatment adherence due to high levels of HIV stigma within schools, rigid school structures and routines, lack of adherence support and food insecurity. Within families, HIV stigma is perpetuated in various forms including discrimination and violence, often due to unfounded fears of infection-hence undermining the quality of family relations and supports for ALHIV. Building on our research and current evidence on HIV stigma reduction, the investigators propose a multi-level three-arm cluster randomized study (M-Suubi) with the following specific aims: Aim 1: Examine the impact of M-Suubi on HIV viral suppression (primary outcome); and adherence to HIV treatment (keeping appointments, pharmacy refills, pill counts), and retention in care (secondary outcome); Aim 2: Examine the effect of M-Suubi on HIV stigma (internalized, anticipated and enacted), with secondary analyses to explore hypothesized mechanisms of change (e.g. depression) and intervention mediation; Aim 3: Assess the cost and cost-effectiveness of each intervention condition; and Aim 4: Qualitatively examine: a) participants' experiences with HIV stigma, HIV treatment adherence, and the intervention; and 2) educators' attitudes towards ALHIV, experiences with GED-HIVSR, and program/policy implementation post-training. The study will enroll 840 ALHIV recruited from 42 schools located within the greater Masaka region, heavily affected by HIV (prevalence 12% vs 7.3% national average). M-Suubi will be provided for 20 months, with assessments at baseline, 12, 24 and 36 months. Findings may inform combination intervention efforts to optimize HIV treatment outcomes and engagements in care among ALHIV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Behavioral: Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE, Other: Bolstered Standard of Care (BSOC)Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE |
| Treatment Arm 2 | Experimental | Behavioral: Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR)., Other: Bolstered Standard of Care (BSOC)Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR) |
| Control Arm | Other | Other: Bolstered Standard of Care (BSOC)Bolstered Standard of Care (BSOC) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- HIV-positive adolescents confirmed by medical report
- Prescribed antiretroviral therapy
- Enrolled in primary and secondary schools in a boarding section
- Caregivers of ALHIV who agree to participate in the study
- Teachers, school nurses, and administrators in the target schools who agree to participate in the study
Key exclusion criteria (1 listed)
- A significant cognitive impairment that interferes with the participant's understanding of the informed consent process, or inability/unwillingness to commit to completing the study
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 |
|---|---|---|
| Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEEIn addition to the BSOC, ALHIV and their caregivers will participate in a family strengthening intervention plus a family economic empowerment intervention. MFG is an evidence-based family-centered, group-delivered, evidence-informed, strength-based 10-session (weekly) intervention for children whose families struggle with poverty. Six additional sessions covering HIV stigma stigma-related issues will be added. ALHIV will receive a YDA with a 1:1 matched savings program at a financial institution accredited by the Bank of Uganda. Each YDA will be opened in the name of the adolescent, with their primary caregiver as a co-signer, until the adolescent turns 18 years. The account will then be matched with money from the program on 1:1 rate. | Behavioural | Treatment Arm 1 |
| Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR).In addition to BSOC and MFG-HIVSR+FEE, ALHIV in this arm will receive the school-level HIV stigma reduction intervention targeting teachers, school nurses, matrons, and administrators (headteachers, director of studies) in their schools. GED-HIVSR seeks to impart educators in the intervention schools with HIV related knowledge, provide a safe space for educators to explore their personal values and bias that may promote or hinder their role of supportive individuals and systems for ALHIV, and empower them with knowledge and skills to act as change agents within their schools. | Behavioural | Treatment Arm 2 |
| Bolstered Standard of Care (BSOC)All participants (in control and treatment arms) will receive medical and psychosocial support as part of the BSOC. 1) Medical SOC: All public clinics, including our study sites, follow procedures for pediatric ART initiation and monitoring, as outlined in the National Department of Health Guidelines for pediatric HIV care in Uganda. Specifically, immediately after initiation, or if clinically unstable, ALHIV are seen more frequently (weekly to monthly). Laboratory data (VL and CD4 counts) are collected every six months until the patient is stabilized and then annually, using the National Health Laboratory Service standardized protocol. A | Other | Control Arm, Treatment Arm 1, Treatment Arm 2 |
Primary outcome
Change HIV viral suppression
Time frame: Baseline 12, 24 and 36 month follow-up
Change in viral suppression will be assessed using viral load (VL) data collected from health clinic records. VL will be dichotomized between undetectable /suppression (VL< 40 copies/ml) and detectable/failed viral suppression (VL > =40 copies/ml) levels at each assessment time.
3 secondary outcomes
Change in Adherence and retention in care
Time frame: Baseline 12, 24 and 36 month follow-up
HIV Stigma Measure for Children
Time frame: Baseline 12, 24 and 36 month follow-up
The Shame Questionnaire for Children
Time frame: Baseline 12, 24 and 36 month follow-up
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 14 Aug 2025.
- Derived from this study: PubMed 42080911Mutumba M, Ssewamala FM, Nabunya P, Matovu F, Namatovu P, Nattabi J. Stigma, Mental Health, and HIV Adherence: A Cross-sectional Structural Equation Modeling Study Exploring Direct and Indirect Effects Among School-Engaged Ugandan Adolescents Living With HIV. J Assoc Nurses AIDS Care. 2026 Jul-Aug 01;37(4):434-446. doi: 10.1097/JNC.0000000000000645. Epub 2026 May 4.
- Derived from this study: PubMed 41457981Mutumba M, Ssewamala FM, Nabunya P, Nattabi J, Namirembe R, Matovu F, Namatovu P, Mwebembezi A. HIV-related stigma and academic outcomes: the mediating role of mental health among adolescents living with HIV in Uganda. AIDS Care. 2026 Mar;38(3):571-582. doi: 10.1080/09540121.2025.2606202. Epub 2025 Dec 29.
- Derived from this study: PubMed 36197706Mutumba M, Ssewamala F, Namirembe R, Sensoy Bahar O, Nabunya P, Neilands T, Tozan Y, Namuwonge F, Nattabi J, Acayo Laker P, Mukasa B, Mwebembezi A. A Multilevel Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes Among Adolescents Living With HIV in Uganda: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 5;11(10):e40101. doi: 10.2196/40101.
- Individual participant dataSharing planned: Yes. Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per Code of Federal Regulations Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE and Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR). in people with HIV/AIDS, run by Washington University School of Medicine at 1 site in Uganda.
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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. 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 Uganda. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change HIV viral suppression (time frame: Baseline 12, 24 and 36 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307250, which also lists 3 linked publications.
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 14 Aug 2025.