HIV Pre-exposure ProphylaxisIMPACTNCT07379658
Long-Acting Injectable HIV PrEP PROs
An observational study of HIV Pre-exposure Prophylaxis, run by Anupama Raghuram MD at 3 sites in United States.
Trial summary
The goal of this observational study is to learn about the real world effectiveness, patient satisfaction and clinical outcomes of LAI PrEP with lenacapavir (LEN) versus cabotegravir (CAB) through surveys and interviews. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Pre-exposure Prophylaxis
- What is being tested?
- Interview and survey to evaluate patient reported outcomes between the two medications.
- How many people
- 128 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jan 2026to Jan 2028
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants receiving injectable PrEP in Louisville, KY.
Who may be able to join
- Adults aged 18 and older
- Deemed eligible for HIV PrEP per healthcare provider
- Receiving or initiating LAI PrEP, defined as:
- Current use of CAB or LEN LAI PrEP at study entry
- Initiation of either CAB or LEN LAI PrEP within 30 days of study enrollment
- Receiving PrEP services in Louisville, KY
- Able to provide informed consent and complete study assessments
Who cannot join
- HIV diagnosis prior to enrollment
- Currently on oral PrEP with no plans to switch to LAI PrEP
- Hypersensitivities to LEN or CAB
- Pregnant or planning to become pregnant
- PI discretion
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Norton Healthcare
Louisville, Kentucky, 40202
NIDI Research Clinic
University of Louisville, School of Public Health and Information Sciences
Louisville, Kentucky, 40202
Elana Nance, 502-852-0418, e.nance@louisville.edu
Jelani Kerr, MSPH, PhD
University of Louisville, Kent School of Social Work
Louisville, Kentucky, 40292
Elana Nance, 502-852-0418, e.nance@louisville.edu
Lesley Harris, MSW, PhD
About this study
Official title: Improving HIV Prevention Outcomes: Insights on Long-Acting Injectable (LAI) HIV Pre-Exposure Prophylaxis (PrEP) Patient-Reported Medication Preferences, Adherence, and Clinical Outcomes (IMPACT) in a Southern US State
The goal of this observational study is to learn about the real world effectiveness, patient satisfaction and clinical outcomes of LAI PrEP with lenacapavir (LEN) versus cabotegravir (CAB) through surveys and interviews.
Participants receiving or initiating LAI PrEP part of their regular medical care will complete surveys and interviews at three study visits over the course of 12 months.
- Conditions
- HIV Pre-exposure Prophylaxis
- Being tested
- Interview and survey to evaluate patient reported outcomes between the two medications.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview and survey to evaluate patient reported outcomes between the two medications.Other
No intervention, the two cohorts will receive the same surveys and interviews.
| Study group | Role | What they receive |
|---|---|---|
| LEN LAI PrEP | Those receiving or initiating LEN LAI PrEP Receives: Other: Interview and survey to evaluate patient reported outcomes between the two medications. | |
| CAP LAI PrEP | Those receiving or initiating CAB LAI PrEP Receives: Other: Interview and survey to evaluate patient reported outcomes between the two medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LAI-SQ-6 Survey, Long-Acting Injectable Satisfaction Questionnaire
The primary endpoint of this study is to compare treatment satisfaction of CAB and LEN LAI PrEP, as measured by the Long-Acting Injectable Satisfaction Questionnaire (LAI-SQ-6), adapted for LAI therapy from the Treatment Satisfaction Questionnaire for Medication- 9 (TSQM-9) [12]. The minimum score possible on this questionnaire is 0 and the maximum score possible on this questionnaire is 36. Higher scores indicate a higher satisfaction, while lower scores suggest areas for improvement in patient experience with injectable medication.
Measured: Time of Enrollment, 6 months, 12 months
Secondary outcomes (8)
Persistence with Injectable PrEP
Calculated by the proportion of days covered (PDC) and identification of gaps in treatment using medication administration data.
Measured: 6 months and 12 months
Injection Adherence
Measured by the Injection Adherence Rating Scale (IARS). The IARS is a Yes/No questionnaire intended to capture valuable insight from patients using long-acting injectable medications, allowing providers to improve adherence by addressing concerns related to adherence to injection schedule, perception of the injection, and the impact of side effects. .
A patient is considered adherent if they answer "No" to questions 1-5 and "Yes" to questions 7-8 (indicating consistent attendance to injections, confidence in the protective effect of the medication, and positive engagement with the regimen).
A patient is considered non-adherent if they answer "Yes" to questions 1-5 (indicating missed or delayed injections due to forgetfulness or lack of consistency) or "Yes" to questions 9-10 (indicating negative feelings about the injection process, which may signal discomfort or side effects affecting adherence).
Measured: Enrollment, 6 months, 12 months
Injection Site Reactions
Injection Site Reaction Questionnaire (ISRQ) for patient-reported symptoms - DAIDS criteria for grading of infusion and injection site reactions. The ISRQ is a Yes/No questionnaire and is a tool intended to capture valuable insight from patients using long-acting injectable medications, allowing providers to assess patient perceived severity of reactions to injectable drugs.
Scoring and Interpretation:
Mild Injection Site Reaction (ISR): A patient is considered to have mild ISR if they respond "Yes" to 1-2 symptoms.
Moderate ISR: A patient is considered to have moderate ISR if they respond "Yes" to 3 symptoms.
Severe ISR: A patient is considered to have severe ISR if they respond "Yes" to ≥ 4 symptoms.
Measured: Enrollment, 6 months, 12 months
HIV Prevention Effectiveness
Reviewing HIV test results to confirm new HIV diagnoses during the study period.
Measured: Baseline, 6 months, and 12 months
Incidence of Co-occurring STIs
Reviewing routine STI testing outcomes to determine the incidence of Co-occurring STIs.
Measured: Enrollment, 6 months, and 12 months
Patient perceptions and preferences
Explored in a subset of 20 patients through the injectable PrEP Experience Interview (IPEI).
Measured: Enrollment, 6 months, and 12 months
Retention in Care
Evaluated through the proportion of appointments attended (PAA) and the proportion of patients with a scheduled end-of-study visit (PESV).
Measured: 6 months and 12 months
Visit Burden Index
Evaluated through the number of PrEP-related visits per patient (i.e. provider visits, injection visits, laboratory visits, and urgent/ emergency department visits for adverse reactions to PrEP and/or additional STI screening).
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HIV Pre-exposure ProphylaxisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anupama Raghuram MD
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, University of Louisville
- Responsible party
- Sponsor-investigator, Anupama Raghuram MD, Norton Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379658
- Sponsor's protocol ID
- 25-N0026
- Acronym
- IMPACT
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse, Corrected version 2.1. [July 2017]. Available from https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf
Lee, E., et al(2010). PMS36 Injection Site Reaction Questionnaire: An Adequate Tool For Measuring Injection Site Reactions? Value in Health, 13(3), A129.
Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophr Res. 2000 May 5;42(3):241-7. doi: 10.1016/s0920-9964(99)00130-9.
PubMed 10785582Bharmal M, Payne K, Atkinson MJ, Desrosiers MP, Morisky DE, Gemmen E. Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health Qual Life Outcomes. 2009 Apr 27;7:36. doi: 10.1186/1477-7525-7-36.
PubMed 19397800Woodcock A, Bradley C. Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health. 2006 Sep-Oct;9(5):320-33. doi: 10.1111/j.1524-4733.2006.00121.x.
PubMed 16961550Murray MI, Markowitz M, Frank I, Grant RM, Mayer KH, Hudson KJ, Stancil BS, Ford SL, Patel P, Rinehart AR, Spreen WR, Margolis DA. Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial. HIV Clin Trials. 2018 Aug;19(4):129-138. doi: 10.1080/15284336.2018.1511346. Epub 2018 Nov 16.
PubMed 30445896Bekker LG, Das M, Abdool Karim Q, Ahmed K, Batting J, Brumskine W, Gill K, Harkoo I, Jaggernath M, Kigozi G, Kiwanuka N, Kotze P, Lebina L, Louw CE, Malahleha M, Manentsa M, Mansoor LE, Moodley D, Naicker V, Naidoo L, Naidoo M, Nair G, Ndlovu N, Palanee-Phillips T, Panchia R, Pillay S, Potloane D, Selepe P, Singh N, Singh Y, Spooner E, Ward AM, Zwane Z, Ebrahimi R, Zhao Y, Kintu A, Deaton C, Carter CC, Baeten JM, Matovu Kiweewa F; PURPOSE 1 Study Team. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women. N Engl J Med. 2024 Oct 3;391(13):1179-1192. doi: 10.1056/NEJMoa2407001. Epub 2024 Jul 24.
PubMed 39046157Hojilla JC, Hurley LB, Marcus JL, Silverberg MJ, Skarbinski J, Satre DD, Volk JE. Characterization of HIV Preexposure Prophylaxis Use Behaviors and HIV Incidence Among US Adults in an Integrated Health Care System. JAMA Netw Open. 2021 Aug 2;4(8):e2122692. doi: 10.1001/jamanetworkopen.2021.22692.
PubMed 34436609Nunn AS, Brinkley-Rubinstein L, Oldenburg CE, Mayer KH, Mimiaga M, Patel R, Chan PA. Defining the HIV pre-exposure prophylaxis care continuum. AIDS. 2017 Mar 13;31(5):731-734. doi: 10.1097/QAD.0000000000001385.
PubMed 28060019CDC. Core indicators for monitoring the Ending the HIV Epidemic initiative: National HIV Surveillance System data reported through September 2023; and PrEP data reported through June 2023. https://www.cdc.gov/hiv/library/reports/surveillance-data-tables. Published December 2023. Accessed March 28, 2025.
Singh, S., et al. Estimating Lifetime Risk of a Diagnosis of HIV Infection Among MSM: United States, 2017-2021. Conference on Retroviruses and Opportunistic Infections, Denver, Colorado, March 3-6 2024 https://www.natap.org/2024/CROI/croi_243.htm
HIV/AIDS Reporting and Statistics - Cabinet for Health and Family Services. HIV/AIDS Annual Surveillance Report 2024. Ky.gov. https://www.chfs.ky.gov/agencies/dph/dehp/hab/Pages/reportsstats.aspx, accessed March 14, 2025
Centers for Disease Control and Prevention. (2024, April 22). Fast Facts: HIV in the United States. CDC.gov. https://www.cdc.gov/hiv/data-research/facts-stats/index.html, accessed March 14, 2025
CDC. (2024). Expanding PrEP Coverage in the United States to Achieve EHE Goals. National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention. https://www.cdc.gov/nchhstp/director-letters/expanding-prep-coverage.html, accessed March 14, 2025
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving HIV Prevention Outcomes: Insights on Long-Acting Injectable (LAI) HIV Pre-Exposure Prophylaxis (PrEP) Patient-Reported Medication Preferences, Adherence, and Clinical Outcomes (IMPACT) in a Southern US State
- ClinicalTrials.gov ID
- NCT07379658
- Acronym / sponsor ID
- IMPACT / 25-N0026
- Conditions
- HIV Pre-exposure Prophylaxis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Anupama Raghuram MDUniversity, hospital or other
- Collaborators
- Gilead Sciences, University of Louisville
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 30 Jan 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.
The goal of this observational study is to learn about the real world effectiveness, patient satisfaction and clinical outcomes of LAI PrEP with lenacapavir (LEN) versus cabotegravir (CAB) through surveys and interviews.
Participants receiving or initiating LAI PrEP part of their regular medical care will complete surveys and interviews at three study visits over the course of 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEN LAI PrEP | – | Other: Interview and survey to evaluate patient reported outcomes between the two medications.Those receiving or initiating LEN LAI PrEP |
| CAP LAI PrEP | – | Other: Interview and survey to evaluate patient reported outcomes between the two medications.Those receiving or initiating CAB LAI PrEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants receiving injectable PrEP in Louisville, KY.
Key inclusion criteria (7 listed)
- Adults aged 18 and older
- Deemed eligible for HIV PrEP per healthcare provider
- Receiving or initiating LAI PrEP, defined as:
- Receiving PrEP services in Louisville, KY
- Able to provide informed consent and complete study assessments
Key exclusion criteria (5 listed)
- HIV diagnosis prior to enrollment
- Currently on oral PrEP with no plans to switch to LAI PrEP
- Hypersensitivities to LEN or CAB
- Pregnant or planning to become pregnant
- PI discretion
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 |
|---|---|---|
| Interview and survey to evaluate patient reported outcomes between the two medications.No intervention, the two cohorts will receive the same surveys and interviews. | Other | CAP LAI PrEP, LEN LAI PrEP |
Primary outcome
LAI-SQ-6 Survey, Long-Acting Injectable Satisfaction Questionnaire
Time frame: Time of Enrollment, 6 months, 12 months
The primary endpoint of this study is to compare treatment satisfaction of CAB and LEN LAI PrEP, as measured by the Long-Acting Injectable Satisfaction Questionnaire (LAI-SQ-6), adapted for LAI therapy from the Treatment Satisfaction Questionnaire for Medication- 9 (TSQM-9) [12]. The minimum score possible on this questionnaire is 0 and the maximum score possible on this questionnaire is 36. Higher scores indicate a higher satisfaction, while lower scores suggest areas for improvement in patient experience with injectable medication.
8 secondary outcomes
Persistence with Injectable PrEP
Time frame: 6 months and 12 months
Injection Adherence
Time frame: Enrollment, 6 months, 12 months
Injection Site Reactions
Time frame: Enrollment, 6 months, 12 months
HIV Prevention Effectiveness
Time frame: Baseline, 6 months, and 12 months
Incidence of Co-occurring STIs
Time frame: Enrollment, 6 months, and 12 months
Patient perceptions and preferences
Time frame: Enrollment, 6 months, and 12 months
Retention in Care
Time frame: 6 months and 12 months
Visit Burden Index
Time frame: 6 months and 12 months
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 30 Jan 2026.
- BackgroundU.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse, Corrected version 2.1. [July 2017]. Available from https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf
- BackgroundLee, E., et al(2010). PMS36 Injection Site Reaction Questionnaire: An Adequate Tool For Measuring Injection Site Reactions? Value in Health, 13(3), A129.
- Background: PubMed 10785582Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophr Res. 2000 May 5;42(3):241-7. doi: 10.1016/s0920-9964(99)00130-9.
- Background: PubMed 19397800Bharmal M, Payne K, Atkinson MJ, Desrosiers MP, Morisky DE, Gemmen E. Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health Qual Life Outcomes. 2009 Apr 27;7:36. doi: 10.1186/1477-7525-7-36.
- Background: PubMed 16961550Woodcock A, Bradley C. Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health. 2006 Sep-Oct;9(5):320-33. doi: 10.1111/j.1524-4733.2006.00121.x.
- Background: PubMed 30445896Murray MI, Markowitz M, Frank I, Grant RM, Mayer KH, Hudson KJ, Stancil BS, Ford SL, Patel P, Rinehart AR, Spreen WR, Margolis DA. Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial. HIV Clin Trials. 2018 Aug;19(4):129-138. doi: 10.1080/15284336.2018.1511346. Epub 2018 Nov 16.
- Background: PubMed 39046157Bekker LG, Das M, Abdool Karim Q, Ahmed K, Batting J, Brumskine W, Gill K, Harkoo I, Jaggernath M, Kigozi G, Kiwanuka N, Kotze P, Lebina L, Louw CE, Malahleha M, Manentsa M, Mansoor LE, Moodley D, Naicker V, Naidoo L, Naidoo M, Nair G, Ndlovu N, Palanee-Phillips T, Panchia R, Pillay S, Potloane D, Selepe P, Singh N, Singh Y, Spooner E, Ward AM, Zwane Z, Ebrahimi R, Zhao Y, Kintu A, Deaton C, Carter CC, Baeten JM, Matovu Kiweewa F; PURPOSE 1 Study Team. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women. N Engl J Med. 2024 Oct 3;391(13):1179-1192. doi: 10.1056/NEJMoa2407001. Epub 2024 Jul 24.
- Background: PubMed 34436609Hojilla JC, Hurley LB, Marcus JL, Silverberg MJ, Skarbinski J, Satre DD, Volk JE. Characterization of HIV Preexposure Prophylaxis Use Behaviors and HIV Incidence Among US Adults in an Integrated Health Care System. JAMA Netw Open. 2021 Aug 2;4(8):e2122692. doi: 10.1001/jamanetworkopen.2021.22692.
- Background: PubMed 28060019Nunn AS, Brinkley-Rubinstein L, Oldenburg CE, Mayer KH, Mimiaga M, Patel R, Chan PA. Defining the HIV pre-exposure prophylaxis care continuum. AIDS. 2017 Mar 13;31(5):731-734. doi: 10.1097/QAD.0000000000001385.
- BackgroundCDC. Core indicators for monitoring the Ending the HIV Epidemic initiative: National HIV Surveillance System data reported through September 2023; and PrEP data reported through June 2023. https://www.cdc.gov/hiv/library/reports/surveillance-data-tables. Published December 2023. Accessed March 28, 2025.
- BackgroundSingh, S., et al. Estimating Lifetime Risk of a Diagnosis of HIV Infection Among MSM: United States, 2017-2021. Conference on Retroviruses and Opportunistic Infections, Denver, Colorado, March 3-6 2024 https://www.natap.org/2024/CROI/croi_243.htm
- BackgroundHIV/AIDS Reporting and Statistics - Cabinet for Health and Family Services. HIV/AIDS Annual Surveillance Report 2024. Ky.gov. https://www.chfs.ky.gov/agencies/dph/dehp/hab/Pages/reportsstats.aspx, accessed March 14, 2025
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Pre-exposure Prophylaxis, run by Anupama Raghuram MD at 3 sites 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 7 inclusion and 5 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 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 NIDI Research Clinic (502-861-4646, SystemNIDI@nortonhealthcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LAI-SQ-6 Survey, Long-Acting Injectable Satisfaction Questionnaire (time frame: Time of Enrollment, 6 months, 12 months). 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 NCT07379658, which also lists 14 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 30 Jan 2026.