HIVNCT06269081
Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV
A study testing Supportive-Expressive Peer Social Support Group Intervention and Individual Strengths-Based Case Management Intervention in people with HIV, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Supportive-Expressive Peer Social Support Group Intervention and Individual Strengths-Based Case Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 31 Jan 2028
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50 years or greater
- Living in a county with a score of .4 or higher on the index of relative rurality (IRR)
- Living in Alabama, Arkansas, Delaware, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, Missouri, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia
- Living with HIV
- Has a telephone at home
- Able to provide informed consent
Who cannot join
- Not meeting eligibility criteria described above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for AIDS Intervention Research, Medical College of Wisconsin
Milwaukee, Wisconsin, 53202
Jennifer Walsh, 4149557710, jwalsh@mcw.edu
About this study
Official title: Testing the Efficacy of Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV
Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV.
- Conditions
- HIV
- Being tested
- Supportive-Expressive Peer Social Support Group Intervention, Individual Strengths-Based Case Management Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive-Expressive Peer Social Support Group InterventionBehavioural
The social support group intervention involves weekly virtual support group meetings for 8 consecutive weeks. The groups, facilitated by trained research staff, will last approximately 90 minutes each week and include 5-12 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Facilitators will encourage mutual support among group members, promote greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy.
Individual Strengths-Based Case Management InterventionBehavioural
The strengths-based case management (SBCM) intervention helps participants address the multiple structural barriers faced by rural older people living with HIV. This intervention, delivered by trained research staff, includes two 60-minute telephone- or video-based SBCM counseling sessions, with shorter follow-up sessions to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
| Study group | Role | What they receive |
|---|---|---|
| Supportive-Expressive Peer Social Support Group + Individual Strengths-Based Case Management | Experimental | Not described Receives: Behavioral: Supportive-Expressive Peer Social Support Group Intervention; Behavioral: Individual Strengths-Based Case Management Intervention |
| Supportive-Expressive Peer Social Support Group | Experimental | Not described Receives: Behavioral: Supportive-Expressive Peer Social Support Group Intervention |
| Individual Strengths-Based Case Management | Experimental | Not described Receives: Behavioral: Individual Strengths-Based Case Management Intervention |
| HIV Information Only | No intervention | This arm will not receive either of the interventions but will receive information on successfully aging with HIV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
HIV viral load will be assessed using self-collected dried blood spot (DBS) samples, with samples collecting using HemaSpot devices. Viral suppression will be defined as a measured viral load less than or equal to 839 copies/mL.
Measured: 4 and 12 month follow-ups
Antiretroviral Treatment Medication Adherence
Recent (past 30 day) antiretroviral treatment adherence will be self-reported using the 3-item Wilson Medication Adherence Scale. The calculated scale range is 0-100, with higher scores indicating more consistent medication adherence.
Measured: 4, 8, and 12 month follow-ups
Health-Related Quality of Life
Health-related quality of life will be self-reported using the 31-item World Health Organization Quality of Life Brief Assessment for PLH (WHOQOL-HIV BREF). The calculated scale range is 0-100, with higher scores indicating better quality of life. Composite scores will be calculated in line with Walsh et al., 2024.
Measured: 4, 8, and 12 month follow-ups
Depressive Symptoms
Depressive symptoms during the past 2 weeks will be self-reported via completion of the 9-item Patient Health Questionnaire-9 (PHQ-9). The calculated scale range is 0-27, with higher scores indicating more depressive symptoms.
Measured: 4, 8, and 12 month follow-ups
Secondary outcomes (7)
Social Support
Social support will be self-reported using the 19-item Medical Outcomes Study (MOS) Social Support Scale. Scale scores range from 1-5, with higher scores indicating more social support.
Measured: 4, 8, and 12 month follow-ups
Loneliness
Loneliness will be self-reported using the 5-item Loneliness survey from the National Institutes of Health (NIH) Toolbox. Scale scores range from 1-5, with higher scores indicating greater loneliness.
Measured: 4, 8, and 12 month follow-ups
Internalized HIV Stigma
Internalized HIV stigma will be self-reported using the 6-item internalized stigma subscale of the HIV Stigma Mechanisms scale. Scale scores range from 1-5, with higher scores indicating more internalized stigma.
Measured: 4, 8, and 12 month follow-ups
General Self-Efficacy
General self-efficacy will be self-reported using the 8-item New General Self-Efficacy Scale. Scale scores range from 1-5, with higher scores indicating greater self-efficacy.
Measured: 4, 8, and 12 month follow-ups
HIV Treatment Adherence Self-Efficacy
HIV treatment adherence self-efficacy will be self-reported using the 8-item HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). Scale scores range from 0-4, with higher scores indicating greater self-efficacy.
Measured: 4, 8, and 12 month follow-ups
Accessing Needed Social and Medical Services
Participants will self-report which of 12 HIV-related social and medical services they have needed during the previous 3 months, and which of these needed services they were able to obtain. A composite variable will indicate whether participants successfully accessed at least one needed service (0 = no, 1 = yes).
Measured: 4, 8, and 12 month follow-ups
Structural Barriers
Participants will self-report structural barriers they have faced in the past 3 months, with items assessing the following barriers: not having current health insurance, transportation as a barrier to health care, finances as a barrier to health care, not having enough food to eat, not having stable housing, and lacking eHealth literacy. Participants will be coded as having faced or not having faced each barrier, and barriers will be summed to indicate a score from 0-6, with higher scores indicating more structural barriers.
Measured: 4, 8, and 12 month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start10 Apr 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jennifer Walsh, Medical College of Wisconsin
- Investigators
- Jennifer Walsh, PhD, Principal investigator, Center for AIDS Intervention Research, Medical College of WisconsinAndrew Petroll, MD, Principal investigator, Center for AIDS Intervention Research, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269081
- Sponsor's protocol ID
- R01NR020770
- Other IDs
- R01NR020770
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.
PubMed 27098408Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941O'Connell KA, Skevington SM. An international quality of life instrument to assess wellbeing in adults who are HIV-positive: a short form of the WHOQOL-HIV (31 items). AIDS Behav. 2012 Feb;16(2):452-60. doi: 10.1007/s10461-010-9863-0.
PubMed 21181253Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
PubMed 2035047Earnshaw VA, Smith LR, Chaudoir SR, Amico KR, Copenhaver MM. HIV stigma mechanisms and well-being among PLWH: a test of the HIV stigma framework. AIDS Behav. 2013 Jun;17(5):1785-95. doi: 10.1007/s10461-013-0437-9.
PubMed 23456594Salsman JM, Butt Z, Pilkonis PA, Cyranowski JM, Zill N, Hendrie HC, Kupst MJ, Kelly MA, Bode RK, Choi SW, Lai JS, Griffith JW, Stoney CM, Brouwers P, Knox SS, Cella D. Emotion assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S76-86. doi: 10.1212/WNL.0b013e3182872e11.
PubMed 23479549Kidder DP, Wolitski RJ, Campsmith ML, Nakamura GV. Health status, health care use, medication use, and medication adherence among homeless and housed people living with HIV/AIDS. Am J Public Health. 2007 Dec;97(12):2238-45. doi: 10.2105/AJPH.2006.090209. Epub 2007 Oct 30.
PubMed 17971562Johnson MO, Neilands TB, Dilworth SE, Morin SF, Remien RH, Chesney MA. The role of self-efficacy in HIV treatment adherence: validation of the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). J Behav Med. 2007 Oct;30(5):359-70. doi: 10.1007/s10865-007-9118-3. Epub 2007 Jun 23.
PubMed 17588200Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a new general self-efficacy scale. Organizational research methods, 4, 62-83.
Heckman TG, Heckman BD, Anderson T, Lovejoy TI, Mohr D, Sutton M, Bianco JA, Gau JT. Supportive-expressive and coping group teletherapies for HIV-infected older adults: a randomized clinical trial. AIDS Behav. 2013 Nov;17(9):3034-44. doi: 10.1007/s10461-013-0441-0.
PubMed 23474642Petroll AE, Hirshfield S, Quinn KG, John SA, Algiers OH, Randall L, Wyley Long D, McAuliffe T, Walsh JL. Testing the Efficacy of 2 Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 17;14:e71429. doi: 10.2196/71429.
PubMed 41105943
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV
- ClinicalTrials.gov ID
- NCT06269081
- Acronym / sponsor ID
- R01NR020770
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 21 Feb 2024 (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.
Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supportive-Expressive Peer Social Support Group + Individual Strengths-Based Case Management | Experimental | Behavioral: Supportive-Expressive Peer Social Support Group Intervention, Behavioral: Individual Strengths-Based Case Management Intervention |
| Supportive-Expressive Peer Social Support Group | Experimental | Behavioral: Supportive-Expressive Peer Social Support Group Intervention |
| Individual Strengths-Based Case Management | Experimental | Behavioral: Individual Strengths-Based Case Management Intervention |
| HIV Information Only | No intervention | –This arm will not receive either of the interventions but will receive information on successfully aging with HIV. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 50 years or greater
- Living in a county with a score of .4 or higher on the index of relative rurality (IRR)
- Living in Alabama, Arkansas, Delaware, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, Missouri, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia
- Living with HIV
- Has a telephone at home
Key exclusion criteria (1 listed)
- Not meeting eligibility criteria described above
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 |
|---|---|---|
| Supportive-Expressive Peer Social Support Group InterventionThe social support group intervention involves weekly virtual support group meetings for 8 consecutive weeks. The groups, facilitated by trained research staff, will last approximately 90 minutes each week and include 5-12 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Facilitators will encourage mutual support among group members, promote greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy. | Behavioural | Supportive-Expressive Peer Social Support Group, Supportive-Expressive Peer Social Support Group + Individual Strengths-Based Case Management |
| Individual Strengths-Based Case Management InterventionThe strengths-based case management (SBCM) intervention helps participants address the multiple structural barriers faced by rural older people living with HIV. This intervention, delivered by trained research staff, includes two 60-minute telephone- or video-based SBCM counseling sessions, with shorter follow-up sessions to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs. | Behavioural | Individual Strengths-Based Case Management, Supportive-Expressive Peer Social Support Group + Individual Strengths-Based Case Management |
Primary outcome
Viral Suppression
Time frame: 4 and 12 month follow-ups
HIV viral load will be assessed using self-collected dried blood spot (DBS) samples, with samples collecting using HemaSpot devices. Viral suppression will be defined as a measured viral load less than or equal to 839 copies/mL.
Antiretroviral Treatment Medication Adherence
Time frame: 4, 8, and 12 month follow-ups
Recent (past 30 day) antiretroviral treatment adherence will be self-reported using the 3-item Wilson Medication Adherence Scale. The calculated scale range is 0-100, with higher scores indicating more consistent medication adherence.
Health-Related Quality of Life
Time frame: 4, 8, and 12 month follow-ups
Health-related quality of life will be self-reported using the 31-item World Health Organization Quality of Life Brief Assessment for PLH (WHOQOL-HIV BREF). The calculated scale range is 0-100, with higher scores indicating better quality of life. Composite scores will be calculated in line with Walsh et al., 2024.
Depressive Symptoms
Time frame: 4, 8, and 12 month follow-ups
Depressive symptoms during the past 2 weeks will be self-reported via completion of the 9-item Patient Health Questionnaire-9 (PHQ-9). The calculated scale range is 0-27, with higher scores indicating more depressive symptoms.
7 secondary outcomes
Social Support
Time frame: 4, 8, and 12 month follow-ups
Loneliness
Time frame: 4, 8, and 12 month follow-ups
Internalized HIV Stigma
Time frame: 4, 8, and 12 month follow-ups
General Self-Efficacy
Time frame: 4, 8, and 12 month follow-ups
HIV Treatment Adherence Self-Efficacy
Time frame: 4, 8, and 12 month follow-ups
Accessing Needed Social and Medical Services
Time frame: 4, 8, and 12 month follow-ups
Structural Barriers
Time frame: 4, 8, and 12 month follow-ups
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 6 Oct 2026.
- Background: PubMed 27098408Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 21181253O'Connell KA, Skevington SM. An international quality of life instrument to assess wellbeing in adults who are HIV-positive: a short form of the WHOQOL-HIV (31 items). AIDS Behav. 2012 Feb;16(2):452-60. doi: 10.1007/s10461-010-9863-0.
- Background: PubMed 2035047Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
- Background: PubMed 23456594Earnshaw VA, Smith LR, Chaudoir SR, Amico KR, Copenhaver MM. HIV stigma mechanisms and well-being among PLWH: a test of the HIV stigma framework. AIDS Behav. 2013 Jun;17(5):1785-95. doi: 10.1007/s10461-013-0437-9.
- Background: PubMed 23479549Salsman JM, Butt Z, Pilkonis PA, Cyranowski JM, Zill N, Hendrie HC, Kupst MJ, Kelly MA, Bode RK, Choi SW, Lai JS, Griffith JW, Stoney CM, Brouwers P, Knox SS, Cella D. Emotion assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S76-86. doi: 10.1212/WNL.0b013e3182872e11.
- Background: PubMed 17971562Kidder DP, Wolitski RJ, Campsmith ML, Nakamura GV. Health status, health care use, medication use, and medication adherence among homeless and housed people living with HIV/AIDS. Am J Public Health. 2007 Dec;97(12):2238-45. doi: 10.2105/AJPH.2006.090209. Epub 2007 Oct 30.
- Background: PubMed 17588200Johnson MO, Neilands TB, Dilworth SE, Morin SF, Remien RH, Chesney MA. The role of self-efficacy in HIV treatment adherence: validation of the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). J Behav Med. 2007 Oct;30(5):359-70. doi: 10.1007/s10865-007-9118-3. Epub 2007 Jun 23.
- BackgroundChen, G., Gully, S. M., & Eden, D. (2001). Validation of a new general self-efficacy scale. Organizational research methods, 4, 62-83.
- Background: PubMed 23474642Heckman TG, Heckman BD, Anderson T, Lovejoy TI, Mohr D, Sutton M, Bianco JA, Gau JT. Supportive-expressive and coping group teletherapies for HIV-infected older adults: a randomized clinical trial. AIDS Behav. 2013 Nov;17(9):3034-44. doi: 10.1007/s10461-013-0441-0.
- Derived from this study: PubMed 41105943Petroll AE, Hirshfield S, Quinn KG, John SA, Algiers OH, Randall L, Wyley Long D, McAuliffe T, Walsh JL. Testing the Efficacy of 2 Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 17;14:e71429. doi: 10.2196/71429.
- Individual participant dataSharing planned: No
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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.
Jennifer Walsh, PhD principal investigator
Center for AIDS Intervention Research, Medical College of Wisconsin
Andrew Petroll, MD principal investigator
Center for AIDS Intervention Research, Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive-Expressive Peer Social Support Group Intervention and Individual Strengths-Based Case Management Intervention in people with HIV, run by Medical College of Wisconsin at 1 site in United States.
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 6 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: looking for participants now, as of the sponsor's last update on 6 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 United States. 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 Jennifer Walsh, PhD (414-955-7710, jwalsh@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression (time frame: 4 and 12 month follow-ups). The study lists 4 primary outcomes in all. 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 NCT06269081, which also lists 11 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 6 Oct 2026.