HIV PreventionOPTIMIZENCT05755204
A Pharmacist-run PrEP Program for Women
An observational study of HIV Prevention, run by Orlando Immunology Center at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate uptake and retention of long acting cabotegravir (LA-CAB) also known as Apretude versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) also known as Truvada for PrEP among high-risk women in metro-Orlando through week 48 (to also include reasons for… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- LA-CAB and TDF/FTC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 15 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cisgender women at high-risk of HIV acquisition residing in metro-Orlando
Who may be able to join
- Aged 18-65 years at the time of signing the informed consent
- Cisgender women with a negative/non-reactive HIV test (for those who choose LA-CAB, a negative or non-reactive HIV Ag/Ab assay and negative qualitative HIV-1 RNA test will be used to confirm negative HIV status, for those who choose TDF/FTC, a negative HIV Ag/Ab assay alone will be used to confirm negative HIV status)
- If insured, must have a stable form of insurance that is expected to continue without significant changes for at least 48 weeks
- If un-or-underinsured, must be enrolled in the study sponsor's assistance program which will provide study medications and study-required laboratory tests at no cost
- Must be at "high-risk" of sexually acquired HIV-1 infection which will be defined as any condomless vaginal or anal sex in the past 6 months plus ≥1 of the following:
- Partner living with HIV with unknown viral load
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- ≥1 sex partner of unknown HIV status
- Bacterial STI in the past 6 months (GC/Chlamydia or syphilis)
- Cisgender women
- An individual of child-bearing potential (IOCBP) is eligible to participate if they are not pregnant [as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and a negative urine hCG test at Day 1 (a local serum hCG test at Day 1 is allowed if it can be done, and results obtained, within 24 hours prior to Day 1)], not lactating, and at least one of the following conditions applies:
- Non-reproductive potential defined as:
- Pre-menopausal IOCBP with one of the following:
- Documented tubal ligation Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion Hysterectomy Documented Bilateral Oophorectomy Post-menopausal IOCBP defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. IOCBP on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
- Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in IOCBP (see Appendix 7) from at least 14 days prior to the first dose of study medication. Participants will be counseled on the recommendation to continue use of a highly effective method of contraception for at least 14 days after discontinuation of oral CAB and at least 52 weeks after discontinuation of LA-CAB due to the unknown risk to the fetus. This discussion will be recorded in the participant's source notes.
- The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. All subjects participating in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of STI transmission to an uninfected partner.
Who cannot join
- IOCBP who are breastfeeding or plan to become pregnant or breastfeed during the study
- Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HbsAg), Hepatitis B core antibody (antiHBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:
- Subjects positive for HbsAg are excluded. Subjects negative for anti-HBs but positive for anti-HBc (negative HbsAg status) and positive for HBV DNA are excluded.
- Note: Subjects positive for anti-HBc (negative HbsAg status) and positive for antiHBs (past and/or current evidence) are immune to HBV and are not excluded. AntiHBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and NOT anti-HBc IgM.
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- -Evidence of Hepatitis C virus (HCV) infection based on the results of testing at Screening for Hepatitis C antibody (HCV Ab) and HCV RNA as follows:
- Subjects positive for HCV Ab and HCV RNA are excluded Subjects positive for HCV Ab with a negative HCV RNA test are permitted to enroll
- History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
- Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate.
- Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternative medication Participants with a current or anticipated need for chronic systemic anticoagulation or a history of known or suspected bleeding disorder, including a history of prolonged bleeding
- Please note this protocol does not exclude participants who have previously received PrEP medications including IM LA-CAB or oral TDF/FTC
- ALT ≥5x ULN, OR ALT ≥3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin)
- CreCl<50 ml/min for those who elect to start TDF/FTC
- Any other screening grade 3 or 4 lab abnormalities that are unexplained or deemed by the investigator to be a contraindication for study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacist-run, Community-based PrEP Program for High-risk Women-the OPTIMIZE Study
The primary objective of this study is to evaluate uptake and retention of long acting cabotegravir (LA-CAB) also known as Apretude versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) also known as Truvada for PrEP among high-risk women in metro-Orlando through week 48 (to also include reasons for lack of retention in PrEP care)
Read the detailed description
This is a 48-week, open-label, single center pharmacist-run study to assess PrEP uptake and persistence among women at high-risk of HIV-1 acquisition in metro-Orlando at a community-based organization called Let's Beehive. All participants in the study will chose whether they want to start IM LA-CAB (with or without the oral lead-in) vs. daily oral TDF/FTC for PrEP. The study will include a Screening Phase (up to 56 days), and an open-label phase (Day 1 up to Week 48). Approximately 50 women defined as "high-risk" for HIV-1 infection who have a confirmed negative HIV test will be enrolled. All insured participants will be responsible for using their insurance plan to obtain coverage for their chosen PrEP medication, in addition to any labs required by the study. This expectation is clearly outlined in the informed consent. The study team will work with participants to minimize their co-pays for study medications and labs through the use of manufacturer and other external assistance programs. For participants who are under-or-uninsured, the study sponsor will provide financial coverage for approximately 20 participants (10 on LA-CAB and 10 on TDF/FTC) to receive PrEP medication and undergo study-required laboratory testing at no cost.
- Conditions
- HIV Prevention
- Being tested
- LA-CAB, TDF/FTC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LA-CABDrug
Also called Apretude
Intramuscular LA-CAB for PrEP
TDF/FTCDrug
Also called Truvada
Oral TDF/FTC for PrEP
| Study group | Role | What they receive |
|---|---|---|
| Apretude group | High-risk women who choose to initiate intramuscular q8week LA-CAB (Apretude) with or without oral lead in for HIV PrEP Receives: Drug: LA-CAB | |
| Truvada group | High-risk women who choose to initiate daily oral TDF/FTC (Truvada) for HIV PrEP Receives: Drug: TDF/FTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of LA-CAB vs. TDF/FTC for PrEP
proportion of women who initiate LA-CAB vs. TDF/FTC for PrEP
Measured: 48 weeks
Persistence on LA-CAB vs. TDF/FTC for PrEP
proportion of women who remain on LA-CAB vs. TDF/FTC for PrEP
Measured: 48 weeks
Secondary outcomes (16)
Persistence on LA-CAB vs. TDF/FTC for PrEP
proportion of women who remain on LA-CAB vs. TDF/FTC for PrEP
Measured: 24 weeks
Uptake of LA-CAB vs. TDF/FTC for PrEP
proportion of women who initiate LA-CAB vs. TDF/FTC for PrEP
Measured: 24 weeks
HIV incidence
proportion of women with new HIV infections (will be stratified by intervention group)
Measured: 24 weeks
HIV incidence
proportion of women with new HIV infections (will be stratified by intervention group)
Measured: 48 weeks
Awareness of and willingness to initiate PrEP
Proportion of participants who are aware of LA-CAB and daily oral TDF/FTC (based on responses to PrEP awareness and willingness survey)
Measured: Baseline
Preference for chosen PrEP modality
Proportion of participants who elect to initiate LA-CAB vs. daily oral TDF/FTC for PrEP and reasons why (based on responses to PrEP preference survey)
Measured: Baseline and time of PrEP modality switch
Safety and tolerability of LA-CAB vs. TDF/FTC for PrEP
Incidence and severity of AEs and laboratory abnormalities, Investigator assessment of causality of AEs and laboratory abnormalities (drug-relatedness), Proportion of subjects who discontinue PrEP medications due to Aes
Measured: 24 weeks
Safety and tolerability of LA-CAB vs. TDF/FTC for PrEP
Incidence and severity of AEs and laboratory abnormalities, Investigator assessment of causality of AEs and laboratory abnormalities (drug-relatedness), Proportion of subjects who discontinue PrEP medications due to Aes
Measured: 48 weeks
PrEP satisfaction
Proportion of participants who are satisfied with their chosen PrEP modality (based on responses to PrEP satisfaction survey)
Measured: 24 weeks
PrEP satisfaction
Proportion of participants who are satisfied with their chosen PrEP modality (based on responses to PrEP satisfaction survey)
Measured: 48 weeks
PrEP Adherence
Proportion of participants with 100% adherence (target adherence defined as "within window, on-time LA-CAB injection") to LA-CAB vs. at least 6/7 weekly doses of TDF/FTC
Measured: 24 weeks
PrEP Adherence
Proportion of participants with 100% adherence (target adherence defined as "within window, on-time LA-CAB injection") to LA-CAB vs. at least 6/7 weekly doses of TDF/FTC
Measured: 48 weeks
Bacterial STI incidence
Proportion of participants with new STIs (based on proportion with positive results for chlamydia, gonorrhea, trichomonas, and syphilis)
Measured: 24 weeks
Bacterial STI incidence
Proportion of participants with new STIs (based on proportion with positive results for chlamydia, gonorrhea, trichomonas, and syphilis)
Measured: 48 weeks
Treatment-emergent resistance among those who acquire HIV infection
Proportion of participants with treatment-emergent resistance associated mutations (RAMs) on LA-CAB vs. daily oral TDF/FTC
Measured: 24 weeks
Treatment-emergent resistance among those who acquire HIV infection
Proportion of participants with treatment-emergent resistance associated mutations (RAMs) on LA-CAB vs. daily oral TDF/FTC
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start21 Jun 2023
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Why it stopped: This protocol was early terminated on 10/15/2024 due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Immunology Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755204
- Sponsor's protocol ID
- OIC_011
- Acronym
- OPTIMIZE
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacist-run, Community-based PrEP Program for High-risk Women-the OPTIMIZE Study
- ClinicalTrials.gov ID
- NCT05755204
- Acronym / sponsor ID
- OPTIMIZE / OIC_011
- Conditions
- HIV Prevention
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This protocol was early terminated on 10/15/2024 due to low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Orlando Immunology CenterUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 6 Mar 2023 (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 primary objective of this study is to evaluate uptake and retention of long acting cabotegravir (LA-CAB) also known as Apretude versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) also known as Truvada for PrEP among high-risk women in metro-Orlando through week 48 (to also include reasons for lack of retention in PrEP care)
Detailed description
This is a 48-week, open-label, single center pharmacist-run study to assess PrEP uptake and persistence among women at high-risk of HIV-1 acquisition in metro-Orlando at a community-based organization called Let's Beehive. All participants in the study will chose whether they want to start IM LA-CAB (with or without the oral lead-in) vs. daily oral TDF/FTC for PrEP. The study will include a Screening Phase (up to 56 days), and an open-label phase (Day 1 up to Week 48). Approximately 50 women defined as "high-risk" for HIV-1 infection who have a confirmed negative HIV test will be enrolled. All insured participants will be responsible for using their insurance plan to obtain coverage for their chosen PrEP medication, in addition to any labs required by the study. This expectation is clearly outlined in the informed consent. The study team will work with participants to minimize their co-pays for study medications and labs through the use of manufacturer and other external assistance programs. For participants who are under-or-uninsured, the study sponsor will provide financial coverage for approximately 20 participants (10 on LA-CAB and 10 on TDF/FTC) to receive PrEP medication and undergo study-required laboratory testing at no cost.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apretude group | – | Drug: LA-CABHigh-risk women who choose to initiate intramuscular q8week LA-CAB (Apretude) with or without oral lead in for HIV PrEP |
| Truvada group | – | Drug: TDF/FTCHigh-risk women who choose to initiate daily oral TDF/FTC (Truvada) for HIV PrEP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cisgender women at high-risk of HIV acquisition residing in metro-Orlando
Key inclusion criteria (15 listed)
- Aged 18-65 years at the time of signing the informed consent
- Cisgender women with a negative/non-reactive HIV test (for those who choose LA-CAB, a negative or non-reactive HIV Ag/Ab assay and negative qualitative HIV-1 RNA test will be used to confirm negative HIV status, for those who choose TDF/FTC, a negative HIV Ag/Ab assay alone will be used to confirm negative HIV status)
- If insured, must have a stable form of insurance that is expected to continue without significant changes for at least 48 weeks
- If un-or-underinsured, must be enrolled in the study sponsor's assistance program which will provide study medications and study-required laboratory tests at no cost
- Must be at "high-risk" of sexually acquired HIV-1 infection which will be defined as any condomless vaginal or anal sex in the past 6 months plus ≥1 of the following:
Key exclusion criteria (15 listed)
- IOCBP who are breastfeeding or plan to become pregnant or breastfeed during the study
- Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HbsAg), Hepatitis B core antibody (antiHBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:
- Subjects positive for HbsAg are excluded. Subjects negative for anti-HBs but positive for anti-HBc (negative HbsAg status) and positive for HBV DNA are excluded.
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 |
|---|---|---|
| LA-CABAlso: ApretudeIntramuscular LA-CAB for PrEP | Drug | Apretude group |
| TDF/FTCAlso: TruvadaOral TDF/FTC for PrEP | Drug | Truvada group |
Primary outcome
Uptake of LA-CAB vs. TDF/FTC for PrEP
Time frame: 48 weeks
proportion of women who initiate LA-CAB vs. TDF/FTC for PrEP
Persistence on LA-CAB vs. TDF/FTC for PrEP
Time frame: 48 weeks
proportion of women who remain on LA-CAB vs. TDF/FTC for PrEP
16 secondary outcomes
Persistence on LA-CAB vs. TDF/FTC for PrEP
Time frame: 24 weeks
Uptake of LA-CAB vs. TDF/FTC for PrEP
Time frame: 24 weeks
HIV incidence
Time frame: 24 weeks
HIV incidence
Time frame: 48 weeks
Awareness of and willingness to initiate PrEP
Time frame: Baseline
Preference for chosen PrEP modality
Time frame: Baseline and time of PrEP modality switch
Safety and tolerability of LA-CAB vs. TDF/FTC for PrEP
Time frame: 24 weeks
Safety and tolerability of LA-CAB vs. TDF/FTC for PrEP
Time frame: 48 weeks
PrEP satisfaction
Time frame: 24 weeks
PrEP satisfaction
Time frame: 48 weeks
PrEP Adherence
Time frame: 24 weeks
PrEP Adherence
Time frame: 48 weeks
Bacterial STI incidence
Time frame: 24 weeks
Bacterial STI incidence
Time frame: 48 weeks
Treatment-emergent resistance among those who acquire HIV infection
Time frame: 24 weeks
Treatment-emergent resistance among those who acquire HIV infection
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: This protocol was early terminated on 10/15/2024 due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- 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. 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?
An observational study of HIV Prevention, run by Orlando Immunology Center 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 15 inclusion and 15 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: stopped early, as of the sponsor's last update on 14 Feb 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 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?
The study was stopped early (reason given: This protocol was early terminated on 10/15/2024 due to low enrollment). Results are not available in the source record.
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?
Uptake of LA-CAB vs. TDF/FTC for PrEP (time frame: 48 weeks). 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 14 Feb 2025.